41FK10 DEUTSCH ESPAÑOL FRANÇAIS ITALIANO PORTUGUÊS РУССКИЙ

Über den Test n Acerca de la prueba P p nd pu b A propos du Test P p n du A proposito del test 2 Rm m Sobre o Teste P p d T О тесте Процедурапроведениятеста см рисунок
Übersicht S S 30 M Introducción P m m m m P fi D m m m Введение О р цым и и
m R m m m 5 30 C 30 m Introduction m m 5 30 C Introduzione Introdução m 5 30 C 30
Die Coronavirus Krankheit (Covid-19) ist eine Infektionskrankheit. Sie La enfermedad por coronavirus (COVID-19) es una enfermedad La maladie à coronavirus (COVID-19) est une maladie infectieuse La patologia provocata da Coronavirus (COVID-19) è una A doença do Coronavírus (COVID-19) é uma doença infecciosa Болезнь, вызванная коронавирусом (COVID-19), является инфекционным Прим и М ж ю
wird verursacht durch das neuartige Coronavirus, das schwere akute 2 E S V P infecciosa causada por un coronavirus recién descubierto, el 30 m 3 fl B ff m заболеванием, вызываемым недавно обнаруженным коронавирусом ю щ ы
S fl O fl 2 E m causée par un coronavirus nouvellement découvert, le coronavirus 2 R m m malattia infettiva causata da un coronavirus appena scoperto, la m fi causada por um coronavírus recém-descoberto, coronavírus da 2 R m m
respiratorische Syndrom Coronavirus 2 (SARS-CoV-2)1. SARS-CoV-2 síndrome respiratorio agudo severo coronavirus 2 (SARS-CoV-2) du syndrome respiratoire aigu sévère 2 (SARS-CoV-2)1. Le SARS- sindrome respiratoria acuta grave coronavirus 2 (SARS-CoV-2)1. síndrome respiratória aguda grave 2 (SARS-CoV-2)1. O SARS- 2 группы (SARS-CoV-2)1, связанным с тяжелым синдромом острой
3 H S P ff fl S C fi m m m C m П д
gehört der Gattung β an, bei dem es sich um ein umhülltes, nicht 1
. El SARS-CoV-2 es un β-coronavirus, que es un virus de ARN CoV-2 est un β-coronavirus, qui est un virus à ARN sens positif non Il SARS-CoV-2 è un β-coronavirus, che è un virus a RNA a CoV-2 é um β-coronavírus, que é um vírus de RNA com envelope дыхательной недостаточности. SARS-CoV-2 — это β-коронавирус,
E m P ff fl F m 300 μ m П м ы ж м ы
segmentiertes RNA-Virus mit positiver Polarität handelt2. Es wird über de sentido positivo no segmentado con envoltura2. Se transmite segmenté enveloppé2. Il se propage par transmission interhumaine filamento positivo, incapsulato e non segmentato2. Si diffonde de sentido positivo não segmentado2. É transmitido por transmissão который представляет собой оболочечный вирус с несегментированной
E 300 3 S m m 3 fl m m m 3 S m m м м
Tröpfchen oder direkten Kontakt von Mensch zu Mensch übertragen. de persona a persona a través de gotitas o contacto directo, y se via des gouttelettes ou par contact direct, et l'infection a été estimée per trasmissione da uomo a uomo tramite goccioline o contatto A n n S m de humano para humano através de gotículas ou contato direto, e положительно-полярной нитью РНК2. Он распространяется путем И
Panbio Für die Infektion wurde eine Inkubationszeit von 6.4 Tagen ermittelt Ah n B P ff m ha estimado que la infección tiene un período de incubación medio m fl fl m ffi fi m fl m fl передачи от человека человеку воздушно-капельным путем или при
™ 300 μ P S avoir une période d'incubation moyenne de 6,4 jours et un nombre m 300 μ diretto, ed è stato stimato che l'infezione ha un periodo medio estima-se que a infecção tenha um período médio de incubação m 300 μ м Пм ю ю
und die geschätzte Reproduktionszahl liegt bei 2.24-3.58. Bei Patienten m de 6,4 días y un número de reproducción básico de 2,24 a 3,58. de reproduction de base de 2,24 à 3,58. Parmi les patients atteints de di incubazione di 6,4 giorni e un numero di riproduzione di base de 6,4 dias e um número básico de reprodução de 2,24–3,58. прямом контакте; по оценкам, инкубационный период инфекции
m fi ю

COVID-19 Ag Rapid Test Device

mit einer durch SARS-CoV-2 verursachten Lungenentzündung war 4 S S E R Entre los pacientes con neumonía causada por SARS-CoV-2, la pneumonie causée par le SARS-CoV-2, la fièvre était le symptôme A n n S m di 2,24-3,58. Tra i pazienti con polmonite causata dalla SARS- 4 P Entre os pacientes com pneumonia causada por SARS-CoV-2, a Cu d d S m составляет в среднем 6,4 дня, а базовое репродуктивное число — 2,24-3,58. Д ж ф ф м ю
Fieber das häufigste Symptom, gefolgt von Husten3. Der am häufigsten fiebre fue el síntoma más común, seguido de la tos3. Los principales le plus courant, suivie de la toux 3. Les principaux dosages IVD utilisés ffi CoV-2, la febbre era il sintomo più comune, seguita dalla tosse3. febre foi o sintoma mais comum, seguido pela tosse3. Os principais fi m m Среди пациентов с пневмонией, вызванной SARS-CoV-2, лихорадка была
P n mm n n E n 4 C R d mp n dE n ф ым м
für COVID-19 verwendete IVD-Assay ist die Reverse Transkriptase- ensayos de DIV utilizados para COVID-19 emplean la reacción en pour le COVID-19 utilisent une réaction en chaîne transcriptase- 4 P I principali test IVD utilizzati per COVID-19 utilizzano la real- ensaios IVD utilizados para COVID-19 empregam a reação em 4 C наиболее распространенным симптомом, после которого следует кашель3.
N S K P m 45 0 m м
Polymerase-Kettenreaktion (RT-PCR) in Echtzeit, die nur wenige cadena de la polimerasa con transcriptasa inversa en tiempo real R n nd mu polymérase inverse en temps réel (RT-PCR) qui prend quelques time reverse transcriptase-polymerase chain reaction (RT-PCR) cadeia da polimerase-transcriptase reversa em tempo real (RT- В основных анализах, используемых для in vitro диагностики инфекции
m D N P m n nd h n n 45 0 C E d Am Пр д р жд и м ф м
Stunden dauert4. Die Verfügbarkeit eines kostengünstigen, schnellen (RT-PCR) que tarda unas pocas horas4. La disponibilidad de una m COVID-19, используется полимеразная цепная реакция с обратной
(NASOPHARYNGEAL)
heures4. La disponibilité d'un test efficient de diagnostic rapide en m che richiede alcune ore4. La disponibilità di un test diagnostico PCR) que leva algumas horas4. A disponibilidade de um teste de m мж ы ым
diagnostischen Point-of-Care-Diagnosetests ist von entscheidender prueba de diagnóstico rápida y costo efectiva en el lugar de atención 45 0 biologie délocalisée est primordial aux professionnels de santé. Pour point-of-care rapido ed economico è fondamentale per supportare diagnóstico rápido e econômico é fundamental para permitir que транскриптазой (ОТ-ПЦР; RT-PCR) в реальном времени, которая занимает
2 F S m m fl S 45 0 2 m fl 45 0 m ю ш
Bedeutung für die Unterstützung des medizinischen Fachpersonals es fundamental para que los profesionales de la salud puedan ayudar leurs permettre d'aider au diagnostic des patients et d'empêcher gli operatori sanitari nella diagnosi dei pazienti e prevenire profissionais de saúde ajudem no diagnóstico de pacientes e previna несколько часов4. Наличие экономичного и быстрого диагностического
N mG m 2 fl m 2 w m m fl
bei der Diagnose von Patienten und somit für die Verhinderung einer en el diagnóstico de los pacientes y prevenir una mayor propagación 2 fl la propagation du virus 5. Les tests d'antigènes joueront un rôle un'ulteriore diffusione del virus5. I test antigenici avranno un ruolo a disseminação do vírus5. Os testes de antígenos desempenharão теста в месте оказания медицинской помощи имеет решающее значение С р р ц и р ци
m
n o d gno p d e o qu e de e on o SARS CoV 2 n gen Ag weiteren Verbreitung des Virus5. Antigentests werden im Kampf gegen Ah n V w S P m del virus5. Las pruebas de antígeno jugarán un papel fundamental en A n n U m для того, чтобы медицинские работники могли помочь в диагностике м
essentiel dans la lutte contre le COVID-19 6. A n n fondamentale nella lotta contro il COVID-196. m um papel crítico na luta contra a COVID-196. Cu d d U w
n o d gno he S hne e um qu en N hwe on SARS CoV 2 An gen Ag COVID-19 eine entscheidende Rolle spielen6. la lucha contra COVID-196.
P u n U fi пациентов и предотвратить дальнейшее распространение вируса5. Тесты на ы ы м
3 D A m A Principe du Test m Principio del test 3 m Princípio do Teste m
P ueb p d de d gnó o n op de e ón u de n geno Ag de SARS CoV 2 Testprinzip Principio de la prueba m антигены будут играть важнейшую роль в борьбе с COVID-196. м м ж м ю
N ß Öff O Panbio™ COVID-19 Ag Rapid Test Device contient une bande de 3 Il dispositivo Panbio™ COVID-19 Ag Rapid Test Device contiene O Panbio™ COVID-19 Ag Rapid Test Device contém uma tira de 3 O w m
Te p de de d gno n o pou dé e on qu e de n gène SARS CoV 2 Ag Panbio™ COVID-19 Ag Rapid Test Device beinhaltet einen Panbio™ COVID-19 Ag Rapid Test Device contiene una tira de 3 E membrane pré-enduite d'anticorps anti-SARS-CoV-2 immobilisés una striscia di membrana che è pre-rivestita con anticorpo anti- membrana, que é pré-revestida com anticorpo antiSARS-CoV-2 Принцип теста
Membranstreifen, der auf der Testlinie mit immobilisiertem Anti-SARS- membrana, que está pre-revestido con anticuerpo anti-SARS- A n n S
Te d gno o p do n o pe e qu de n gene SARS CoV 2 Ag sur la ligne de test et un anticorps IgY monoclonal de souris anti- SARS-CoV-2 immobilizzato sulla linea di test e un anticorpo imobilizado na linha de teste e IgY monoclonal de camundongo Экспресс-тест Panbio™ COVID-19 Ag (Panbio™ COVID-19 Ag Rapid Test Пр д р жд и И ы
CoV-2-Antikörpern und auf der Kontrolllinie mit monoklonalem Anti- Ah n W mE W CoV-2 inmovilizado en la línea de prueba e IgY anti-pollo monoclonal A n n m m m Cu d d S Device) содержит мембранную полоску, предварительно покрытую
Te e p do de d gnó o n o p de e o qu do n geno SARS CoV 2 Ag P u n S poulet sur la ligne de contrôle. Deux types de conjugués (IgG monoclonale di topo anti-IgY di pollo sulla linea di controllo. Due antigalinha na linha de controle. Dois tipos de conjugados (IgG ф ы м
Huhn-IgY der Maus vorbeschichtet ist. Zwei Arten von Konjugaten S S de ratón en la línea de control. Dos tipos de conjugados (IgG m w m иммобилизованным анти-SARS-CoV-2 антителом на тестовой линии, и
Экспресс тест n v o для качественно о определения анти ена SARS CoV 2 Ag humaine spécifique au SARS-CoV-2 Ag conjugué d'Or et IgY tipi di coniugati (IgG umane specifiche per SARS-CoV-2 Ag humana específica para conjugado de ouro SARS-CoV-2 Ag м ю ю
(humanes IgG, spezifisch für SARS-CoV-2 Ag Goldkonjugat und N humana específica para el conjugado de oro de SARS-CoV-2 Ag 4 S fi m m 3 4 4 E m w 3 4 D мышиным моноклональным анти-куриным IgY на контрольной линии. Два
anti-poulet un conjugué d'Or)se déplacent vers le haut sur la coniugate con oro e IgY di pollo coniugate con oro) si migrano e conjugado de ouro IgY de galinha) movem-se para cima na ж
Hühner-IgY-Goldkonjugat) bewegen sich chromatographisch auf der 4 R S 34M y el conjugado de oro de IgY de pollo) se desplazan hacia arriba en 4 F m 3 4 m w типа конъюгатов (человеческий IgG, специфичный для конъюгата антигена
S S O S mS 4 F m 3 4 D membrane par chromatographie et réagissent respectivement avec cromatograficamente verso l'alto sulla membrana e reagiscono membrana cromatograficamente e reagem com o anticorpo Пр д р жд и м м
ENGLISH Membran nach oben und reagieren mit dem Anti-SARS-CoV-2-
Antikörper bzw. dem vorbeschichteten monoklonalen Anti-Hühner- m
la membrana cromatográficamente y reaccionan con el anticuerpo
anti-SARS-CoV-2 y el anticuerpo monoclonal de ratón anti-IgY
l'anticorps anti-SARS-CoV-2 et l'IgY monoclonal de souris anti-
poulet pré-enduit. Pour un résultat positif, l'IgG humaine spécifique
rispettivamente con l'anticorpo anti-SARS-CoV-2 e con
l'anticorpo monoclonale di topo anti-IgY di pollo pre-rivestito. Per
5 E m m antiSARS-CoV-2 e IgY monoclonal de camundongo antigalinha
pré-revestido respectivamente. Para um resultado positivo, a IgG
5 R m m w
SARS-CoV-2 на золотой подложке, и конъюгат куриного IgY на золотой
подложке) движутся вверх по мембране хроматографически и реагируют ж ю ю
ы
IgY der Maus. Bei einem positiven Ergebnis bildet humanes IgG, das 5 E S mm Bw de pollo pre-revestido respectivamente. Para obtener un resultado 5 R m с анти-SARS-CoV-2 антителом и с предварительно покрытым мышиным
S E 5 R m m au conjugué SARS-CoV-2 Ag et l'anticorps anti-SARS-CoV-2 un risultato positivo, le IgG umane specifiche per SARS-CoV-2 6 R m humana específica para o conjugado de ouro SARS-CoV-2 Ag 6 G w fl m А м м
About the Test 2. Remove the test device from the foil pouch prior to use. Place spezifisch für das Goldkonjugat SARS-CoV-2 Ag ist mit dem Anti-
6 S w S P ff fl
positivo, la IgG humana específica para el conjugado de oro SARS- formeront une ligne de test dans la fenêtre de résultat. Ni la ligne de 6 F fl Ag coniugate con oro e l'anticorpo anti-SARS-CoV-2 formeranno m e o anticorpo antiSARS-CoV-2 formarão uma linha de teste na m
моноклональным анти-куриным IgY, соответственно. Для получения О м м ы
Introduction on a flat, horizontal and clean surface. SARS-CoV-2-Antikörper eine Testlinie im Testergebnislesefenster. CoV-2 Ag y el anticuerpo anti-SARS-CoV-2 formarán una línea de положительного результата человеческий IgG, специфичный к конъюгату
m E D S 6 G m test ni la ligne de contrôle ne sont visibles dans la fenêtre de résultat m una linea di test nella finestra dei risultati. Né la linea del test né m m janela de resultados. Nem a linha de teste nem a linha de controle m m w ы
The Coronavirus disease (COVID-19) is an infectious disease caused 3. Hold the buffer bottle vertically and fill the extraction tube with Weder die Testlinie noch die Kontrolllinie sind vor dem Auftragen der prueba en la ventana de resultados. Ni la línea de prueba, ni la línea антигена SARS-CoV-2 на золотой подложке и анти-SARS-CoV-2 антитела,
m m W E m avant l'application de l'échantillon du patient. Une ligne de contrôle m la linea di controllo sono visibili nella finestra dei risultati prima m são visíveis na janela de resultados antes de aplicar a amostra do m М м щ
by a newly discovered coronavirus, severe acute respiratory syndrome buffer fluid until it flows up to the Fill-line of the extraction tube Patientenprobe im Testergebnislesefenster sichtbar. Eine sichtbare de control son visibles en la ventana de resultados antes de aplicar la образуют в окне результата тестовую линию. Ни тестовая, ни контрольная
S ß mS m m m visible est requise pour indiquer qu'un résultat de test est valide. dell'applicazione del campione del paziente. Una linea di controllo S m paciente. Uma linha de controle visível é necessária para indicar Q w m ю
coronavirus 2 (SARS-CoV-2)1. The SARS-CoV-2 is a β-coronavirus, (300 μl). Kontrolllinie weist nach, dass das Testergebnis valide ist. muestra del paciente. Se requiere una línea de control visible para линии в окне результата до нанесения образца, полученного у пациента,
F E mm Utilisation prévue visibile è necessaria per indicare che il risultato del test è valido. que um resultado de teste é válido. Н м ю ф м
which is an enveloped non-segmented positive-sense RNA virus2. It is Caution: If the amount of buffer is excessive or insufficient, In-vitro diagnostischer Gebrauch indicar que el resultado de una prueba es válido. Q не видны. Видимая контрольная линия необходима, чтобы показать, что
B S B ß Panbio™ COVID-19 Ag Rapid Test Device est un test de diagnostic C m Uso previsto R n nd p d Uso Pretendido R mD p d T результат анализа действителен.
spread by human-to-human transmission via droplets or direct contact, an improper test result may occur. Der Panbio™ COVID-19 Ag Rapid Test Device ist ein in-vitro Uso Indicado м м м
S K E rapide in vitro pour la détection qualitative de l'antigène SARS- Panbio™ COVID-19 Ag Rapid Test Device è un test rapido A O Panbio™ COVID-19 Ag Rapid Test Device é um teste rápido de A m m
and infection has been estimated to have a mean incubation period of 4. Place the extraction tube in the tube rack. diagnostischer Schnelltest zum qualitativen Nachweis von SARS-CoV-2 Panbio™ COVID-19 Ag Rapid Test Device es una prueba rápida Назначение ыж м ю ю м
6.4 days and a basic reproduction number of 2.24-3.58. Among patients R nm K R n nd p d pu b CoV-2 (Ag) dans des échantillons sur écouvillons nasopharyngés R n d p d diagnostico in vitro per la ricerca qualitativa dell'antigene SARS- diagnóstico in vitro para a detecção qualitativa do antígeno SARS-
Specimen Collection & Extraction Antigen (Ag) in menschlichen nasopharyngealen Abstrichproben von de diagnóstico in vitro para la detección cualitativa del antígeno A humains provenant de personnes répondant aux critères cliniques et CoV-2 (Ag) in campioni umani da tampone nasofaringeo CoV-2 (Ag) em amostras de esfregaço nasofaríngeo humano de Экспресс-тест Panbio™ COVID-19 Ag (Panbio™ COVID-19 Ag Rapid Test Device) м мы ю м
with pneumonia caused by SARS-CoV-2, fever was the most common Personen, die die klinischen und / oder epidemiologischen Kriterien von Öff S K D ff m B (Ag) del SARS-CoV-2 en muestras de hisopado nasofaríngeos O 2 D 5 m m 2 D 5 m m - это экспресс-тест in vitro для качественного определения антигена SARS- ы ю
1. Tilt the patient's head back slightly about 45°-70° to straighten / ou épidémiologiques du COVID-19. Panbio™ COVID-19 Ag Rapid provenienti da individui che soddisfano criteri clinici e/o indivíduos que atendem aos critérios clínicos e/ou epidemiológicos
symptom, followed by cough3. The main IVD assays used for COVID-19 COVID-19 erfüllen. Der Panbio™ COVID-19 Ag Rapid Test Device ist E humanos de individuos que cumplen con los criterios clínicos y / o m S N m m S N m CoV-2 (Ag) в образцах мазков из носоглотки, полученных у пациентов,
the passage from the front of the nose. 2 D 5 m m Test Device est destiné à un usage professionnel uniquement et est epidemiologici COVID-19. Il dispositivo Panbio™ COVID-19 Ag da COVID-19. O Panbio™ COVID-19 Ag Rapid Test Device ци й
employ real-time reverse transcriptase-polymerase chain reaction (RT- nur für den professionellen Gebrauch bestimmt und dient als Hilfsmittel 2 G S 5 P epidemiológicos de COVID-19. Panbio™ COVID-19 Ag Rapid Test 2 D m 5 fi m m соответствующих клиническим и / или эпидемиологическим критериям
2. Insert the swab with a flexible shaft through the nostril parallel m S N m destiné à être utilisé comme une aide au diagnostic de l'infection par Rapid Test Device è solo per uso professionale ed è destinato ad destina-se apenas a uso profissional e deve ser usado como auxiliar О ыш ы ж
PCR) that takes a few hours4. The availability of a cost-effective, rapid zur Diagnose einer SARS-CoV-2 Infektion. Das Produkt kann in jeder P S Bw S Device es solo para uso profesional y está destinado a ser utilizado S N m COVID-19. Экспресс-тест Panbio™ COVID-19 Ag (Panbio™ COVID-19 Ag Rapid
to the palate. m le SARS-CoV-2. Le produit peut être utilisé dans tout environnement essere utilizzato come ausilio nella diagnosi dell'infezione da SARS- no diagnóstico da infecção por SARS-CoV-2. O produto pode ser
point-of-care diagnostic test is critical to enable healthcare professionals Laborumgebung sowie Umgebungen außerhalb des Labors eingesetzt mA como ayuda en el diagnóstico de la infección por SARS-CoV-2. A n n m Cu d d A m Test Device) предназначен только для профессионального применения в
to aid in the diagnosis of patients and prevent further spread of the virus5. Caution: Use dedicated nasopharyngeal swab for specimen m de laboratoire et hors laboratoire qui répond aux exigences spécifiées m CoV-2. Il prodotto può essere utilizzato in qualsiasi ambiente, di usado em qualquer ambiente laboratorial e não laboratorial que
werden, die den Anforderungen aus der Gebrauchsanweisung und den vor El producto se puede utilizar en cualquier entorno de laboratorio dans le mode d'emploi et dans la réglementation locale. laboratorio e non, che soddisfi i requisiti specificati nelle Istruzioni m S atenda aos requisitos especificados nas Instruções de Uso e na m m S качестве помощи при диагностике инфекции, вызванной вирусом SARS-
Antigen tests will play a critical role in the fight against COVID-196. collection. P u n m Н
Ort geltenden, regulatorischen Anforderungen entsprechen. Der Test Ah n B mE y no laboratorio que cumpla con los requisitos especificados en las A n n per l'uso e nella normativa locale. m ffi regulamentação local. fi CoV-2. Медицинское изделие может использоваться в любой лабораторной
3. Swab should reach depth equal to distance from nostrils to outer Le test fournit des résultats de test préliminaires. Les résultats мщ ш
Test Principle liefert vorläufige Testergebnisse. Negative Testergebnisse schließen eine E W Instrucciones de uso y la normativa local. Il test fornisce risultati preliminari. I risultati negativi non m O teste fornece resultados preliminares. Resultados negativos m A и не лабораторной среде, которая соответствует требованиям, указанным в
opening of the ear. S fi négatifs n'empêchent pas l'infection par le SARS-CoV-2 et ils ne ы ю
Panbio™ COVID-19 Ag Rapid Test Device contains a membrane strip, SARS CoV-2 Infektion nicht aus und dürfen nicht als alleinige Grundlage m La prueba proporciona resultados preliminares de la prueba. Los S ffi mm precludono l'infezione da SARS-CoV-2 e non possono essere A m não excluem a infecção por SARS-CoV-2 e não podem ser m инструкции по применению и местным нормам.
Caution: If resistance is encountered during insertion of für eine weitere Behandlung oder andere Managemententscheidungen V D ff S S resultados negativos no excluyen la infección por SARS-CoV-2 y A peuvent pas être utilisés comme seule base de traitement ou d'autres m m fi m m Тестирование представляет предварительные результаты тестирования. Пр д р жд и П ы ющ
which is pre-coated with immobilized anti-SARS-CoV-2 antibody on utilizzati come unica base per il trattamento o per altre decisioni usados como única base para o tratamento ou outras decisões.
the swab, remove it and attempt insertion in the opposite nostril. herangezogen werden. R m V S no pueden usarse como la única base para el tratamiento u otras m décisions de prise en charge. Les résultats négatifs doivent être S m 3 F Отрицательные результаты не исключают инфицирование SARS-CoV-2, и м ым
the test line and mouse monoclonal anti-chicken IgY on the control di gestione. I risultati negativi devono essere combinati con le Os resultados negativos devem ser combinados com observações
4. Gently rub and roll the swab, 3-4 times. Leave the swab in place Negative Ergebnisse müssen mit klinischen Beobachtungen, decisiones de manejo. Los resultados negativos deben combinarse m associés aux observations cliniques, aux antécédents du patient et m 3 C m w m m их нельзя использовать в качестве единственного основания для лечения м м
line. Two types of conjugates (human IgG specific to SARS-CoV-2 osservazioni cliniche, l'anamnesi del paziente e le informazioni clínicas, histórico do paciente e informações epidemiológicas. O
for several seconds to absorb secretions. Patientenanamnesen und epidemiologischen Informationen abgeglichen 3 S ß S D ff S con observaciones clínicas, historial del paciente e información 3 C aux informations épidémiologiques. Le test n'est pas destiné à être 3 F m m m или принятия другого решения в рамках ведения пациента. Отрицательные м ж ы ы м
Ag gold conjugate and chicken IgY gold conjugate) move upward epidemiologiche. Il test non è destinato ad essere utilizzato come teste não se destina a ser usado como teste de triagem de doadores
on the membrane chromatographically and react with anti-SARS- 5. Slowly remove swab while rotating it and insert into the werden. Der Test ist nicht für das SARS-CoV-2 Screening von E m m mß epidemiológica. La prueba no está destinada a utilizarse como prueba utilisé comme test de dépistage des donneurs pour le SARS-CoV-2. m m m m m fi 4 m m 5 результаты должны соответствовать клиническим наблюдениям, данным ы О ж ы
m test di screening per SARS-CoV-2 sui donatori. para SARS-CoV-2.
CoV-2 antibody and pre-coated mouse monoclonal anti-chicken IgY extraction tube. Blutspendern vorgesehen. V mE de detección de donantes para el SARS-CoV-2. m 4 A m 5 m N m N 20 m анамнеза заболевания и эпидемиологической информации. Тест не ю ю ы
6. Swirl the swab tip in the buffer fluid inside the extraction tube, ю
respectively. For a positive result, human IgG specific to SARS-CoV-2
pushing into the wall of the extraction tube at least five times
A
4 D m 5m Matériel fourni 4 D m m 5m N
Materiali forniti
20 m
Materiais Fornecidos
5 D m предназначен для использования в качестве скринингового теста доноров
жщю ы м
4 S S U S E 5M 20 m 5 Sm m m
Ag gold conjugate and anti-SARS-CoV-2 antibody will form a test line
and then squeeze out the swab by squeezing the extraction tube Bereitgestellte Materialien S E m 20 M
Materiales Suministrados N 20 m • 25 appareils de test avec dessiccateur dans une pochette
5 Ém m m m • 25 Dispositivi di test confezionati singolarmente in buste di m m fi • 25 dispositivos de teste com dessecante em bolsa individual
на SARS-CoV-2.
м ым м м
in the result window. Neither the test line nor the control line are visible • 25 Testkassetten verpackt in Folienbeutel mit Trockenmittel • 25 dispositivos de prueba con desecante en bolsa de individuelle en aluminium
with your fingers. 5 E S mß 5 D m alluminio con essiccante • Tampão (1 x 9 mL/frasco) ы
in the result window prior to applying the patient specimen. A visible
control line is required to indicate a test result is valid. 7. Break the swab at the breakpoint and close the cap of extraction • Puffer (1x 9 mL/Fläschchen)
V m E
aluminio individual m • Solution tampon (1 x 9 ml / flacon)
• Buffer (1 x 9 ml/flacone)
T mp n d n p n
• 25 tubos de extração
Sw b d C n P N Предоставляемые материалы м мж ы м Н
• 25 Extraktionsröhrchen • Solución tampón (1 x 9 mL / frasco) • 25 tubes d'extraction E u n d n P N fl ff m m S m m • 25 тест-кассет в индивидуальной вакуумной упаковке с
tube. A • 25 Provette di estrazione • 25 tampas de tubo de extração ы ы ш м ш
Intended Use • 25 Deckel für Extraktionsröhrchen • 25 tubos de extracción • 25 bouchons pour les tubes d'extraction fl m m m m m m fl m fl осушителем
H p d n p n • 25 Tappi per provette di estrazione • 1 swab controle positivo И ю ю
Panbio™ COVID-19 Ag Rapid Test Device is an in vitro diagnostic rapid Reaction with Test Device • 1 Positivkontrolltupfer P N Kn • 25 tapas de tubos de extracción • 1 écouvillon de contrôle positif m 300 µ m 300 μ • Буфер (1 x 9 мл / флакон)
S m m • 1 Tampone di controllo positivo • 1 swab controle negativo м ым м м
test for the qualitative detection of SARS-CoV-2 antigen (Ag) in human 1. Open the dropping nozzle cap at the bottom of the extraction • 1 Negativkontrolltupfer H S P ff fl S • 1 hisopo control positivo • 1 écouvillon de contrôle négatif m 300 μ • 25 пробирок экстракционные
m fl • 1 Tampone di controllo negativo A n n S ff • 25 swabs nasofaríngeos esterilizados para coleta de Cu d d S m ы
nasopharyngeal swab specimens from individuals who meet COVID-19 tube. • 25 Sterilisierte nasopharyngeale Tupfer zur Probenahme E m P ff fl F • 1 hisopo control negativo • 25 écouvillons nasopharyngés stérilisés pour le prélèvement • 25 колпачков для пробирок экстракционных
300 μ A n n S m • 25 Tamponi sterili nasofaringei per la raccolta del campione ffi fi amostra fi m m
clinical and / or epidemiological criteria. Panbio™ COVID-19 Ag Rapid 2. Dispense 5 drops of extracted specimens vertically into the • 1 Ständer für Röhrchen E 300 • 25 hisopos nasofaríngeos esterilizados para la recolección d'échantillons • 1 Положительный контрольный образец П жи ый О риц ый р ы р цы
ffi • 1 Rack portaprovette • 1 suporte para tubos 2 C
Test Device is for professional use only and is intended to be used as specimen well (S) on the device. Do not handle or move the test • 1 Kurzanleitung (Nasopharyngeal) de muestras P u n S m • 1 porte tubes • 1 Отрицательный контрольный образец Д ж ф ф м ю
Ah n B P ff m 2 P • 1 Guida rapida di riferimento (Nasofaringeo) 2 P • 1 guia de referência rápida (nasofaríngea) 3 w fl
an aid in the diagnosis of SARS-CoV-2 infection. The product may be device until the test is complete and ready for reading. • 1 Gebrauchsanweisung • 1 gradilla para tubos fi • 1 guide de référence rapide (nasopharyngé) • 25 Стерильных назофарингеальных тампонов (тупферов) для ф ым м
m 3 • 1 Istruzioni per l'uso 3 m • 1 Instrução de uso m m w
used in any laboratory and non-laboratory environment that meets the Caution: Bubbles that occur in the extraction tube can lead • 1 guía de referencia rápida (nasofaríngea) • 1 Notice d'utilisation сбора образцов м
2 S S E R m mm m G w fl
requirements specified in the Instructions for Use and local regulation. to inaccurate results. If you are unable to create sufficient drops, • 1 Instrucciones de uso 2 C Пр д р жд и
Zusätzlich benötigte Materialien 3 F S P N m m F
Materiali richiesti ma non forniti
m m R m
Material Necessário, Mas Não Fornecido
m m • 1 Штатив м ф м
The test provides preliminary test results. Negative results don't preclude this may be caused by clogging in the dispensing nozzle. Shake
the tube gently to release the blockage until you observe free • Persönliche Schutzausrüstung, Uhr, Biohazard-Abfallbehälter P ff fl E w 3 Matériel requis mais non fourni m
• Dispositivi di protezione individuale, Timer, Contenitore • Equipamento de proteção pessoal, cronômetro, recipiente
m m • 1 Краткое руководство (назофарингеальный тампон) мж ы ым
SARS-CoV-2 infection and they cannot be used as the sole basis for m m
treatment or other management decisions. Negative results must be drop formation.
S M S w S S Materiales Requeridos pero NO m G
• Equipements de protection individuelle, minuterie,
per rifiuti a rischio biologico
m
para risco biológico
w m • 1 Инструкция по применению
Пм ж
ю
ы
ш
ы ы
K P ff fl m conteneur à déchets m m m 4 D w m
combined with clinical observations, patient history, and epidemiological 3. Close the nozzle and dispose of the extraction tube containing Aktive Bestandteile der Hauptkomponenten E D S m suministrados m m
Необходимые, но не предоставляемые ф ы
the used swab according to your local regulations and biohazard m
information. The test is not intended to be used as a donor screening test • Testkassette m W E • Equipo de protección personal, temporizador, contenedor
Ingrédients actifs des principaux 4 Ém m m Principi attivi dei componenti principali 4 Sm m m Ingredientes Ativos dos Componentes 5 F m м м Н
for SARS-CoV-2. waste disposal protocol. Goldkonjugat: Human-IgG spezifisch für SARS-CoV-2 S ß mS m F de riesgo biológico m m • 1 Dispositivo di test m m fi 6 S m m R m материалы ю ф м
4. Start timer. Read result at 15 minutes. Do not read results after Ag Goldkolloid und Hühner-IgY - Goldkolloid, Testlinie: E mm composants Coniugato d'oro: IgG umane specifiche verso SARS- 5 C Principais D • Средства индивидуальной защиты, таймер, контейнер для
20 minutes. Maus-monoklonales anti-SARS-CoV-2, Kontrolllinie: Maus- 4 D • 1 Dispositivo de teste
Materials Provided 5. Dispose of the used device according to your local regulations monoklonales Anti-Huhn IgY
4 E S K mß m Ingredientes Activos de los componentes m
• 1 test 5 F m CoV-2 Ag oro colloidale e IgY di pollo – oro colloidale. 6 S R
Conjugado de ouro: IgG humana específica para coloide
биологических опасных отходов м
ю
м
м
ыж м ю
E A Conjugué or : IgG humaines spécifiques au colloïde d'or 6 S R
• 25 Test devices with desiccant in individual foil pouch and biohazard waste disposal protocol. • Puffer principales 5 C
Linea di test: monoclonale di topo anti-SARS-CoV-2
de ouro SARS-CoV-2 Ag e IgY de galinha - coloide nterpretação do Teste (consu te a figura) И ы ы ю
• Buffer (1 x 9 ml/bottle)
Tricin, Natriumchlorid, Tween 20, Natriumazid (<0,1%), Proclin
5 S ß S D E
• 1 Dispositivo de prueba 6 S m R
SARS-CoV-2 Ag et IgY de poulet - colloïde d'or, Ligne de Linea di controllo: monoclonale di topo anti- IgY di pollo
de ouro, linha de teste: antiSARS-CoV-2 monoclonal R A Активные ингредиенты основных м ым м м
Positive / Negative Control Swab 6 B S ß test : anti-SARS-CoV-2 monoclonale de souris, Ligne de
• 25 Extraction tubes
1. Hold the buffer bottle vertically and fill the extraction tube with 300 R m Conjugado de oro: IgG humana específica para el coloide contrôle : IgY monoclonale de souris anti-poulet
• Buffer nterpretaz one de test (Fare r fer mento de camundongo Linha de controle: IgY monoclonal de C m компонентов ы
• 25 Extraction tube caps
buffer fluid until it flows up to the Fill-line of the extraction tube de oro SARS-CoV-2 Ag y coloide de oro IgY de pollo, línea • Tampon
nterprétat on du test (vo r a figure) Tricina , Cloruro di sodio, Tween 20 , Azoturo di sodio
a a figura) camundongo antigalinha m • Тест-кассета
• 1 Positive control swab R m (<0,1%), Proclin 300 2 R A
• Tampão
• 1 Negative control swab (300 μl). Lagerung und Stabilität Test nte p etat on s ehe Abb dung
de prueba: anti-SARS-CoV-2 monoclonal de ratón, línea
control: IgY anti-pollo monoclonal de ratón
nterpretac ón de a prueba (consu te a Tricine, chlorure de sodium, Tween 20 , azide de sodium
C
R
Tricina, Cloreto de Sódio, Tween 20 , Azida de Sódio C
Конъюгат на золотой подложке: человеческий IgG, специфичный ш
Caution: If the amount of buffer is excessive or insufficient, (<0,1%), Proclin 300 C fi к коллоиду антигена SARS-CoV-2 на золотой подложке и
• 25 Sterilized nasopharyngeal swabs for sample collection
an improper test result may occur.
1. Das Test-Kit ist bei einer Temperatur von 2-30 °C zu lagern. Die N E E K C • Tampón figura) Conservazione e Stabilità (<0,1%), Proclin 300 m m коллоиду куриного IgY на золотой подложке; Тестовая линия:
Интерпретациятеста см рисунок
• 1 Tube rack Testkassette und die Komponenten des Test-Kits dürfen nicht R 2 R 1. Il kit deve essere conservato a una temperatura compresa m
Tricina, Cloruro de sodio, Tween 20, Azida de sodio (<0,1%), 2 R Моноклональные мышиные анти-SARS-CoV-2 антитела ;
• 1 Quick reference guide (Nasopharyngeal) 2.
3.
Place the extraction tube in the tube rack.
Insert the positive or negative control swab in the buffer fluid
eingefroren werden. E Proclin 300 C Stockage et stabilité C tra 2 e 30 °C. Non congelare il kit o i suoi componenti. C fi Armazenamento e Estabilidade Cu d d A Контрольная линия: Мышиные моноклональные анти-куриные IgY
О ы Н
• 1 Instructions for use Hinweis: Bei Lagerung im Kühlschrank müssen alle 2 P E E K C 1. Le kit de test doit être conservé à une température comprise m Nota: Se conservato in frigorifero, tutti i componenti del ш ы
inside of the extraction tube and soak the swab for 1 minute. m m 1. O kit de teste deve ser armazenado a uma temperatura m m • Буфер
Komponenten mindestens 30 Minuten vor der entre 2 et 30 ° C. Ne congelez pas le kit ou ses composants. kit devono essere portati a temperatura ambiente (15-30 ы ы
2 R
Materials Required but not Provided
Swirl the control swab tip in the buffer fluid inside of the
Testdurchführung auf Raumtemperatur (15-30 °C) gebracht w E Almacenamiento y estabilidad C Remarque : Lorsqu'ils sont conservés au réfrigérateur, tous A n n °C) per almeno 30 minuti prima di eseguire il test. Non
entre 2 e 30°C. Não congele o kit ou seus componentes. 3 R S C Трицин, хлорид натрия , Твин 20 , Азид натрия (<0,1%), Проклин 300
П ж ы Н
extraction tube, pushing into the wall of the extraction tube at 1. El kit de prueba debe almacenarse a una temperatura A n n Observação: Quando armazenados em um refrigerador, м
• Personal Protective Equipment, Timer, Biohazard container werden. Öffnen Sie die Verpackung nicht, während die Ah n w w m m les composants du kit doivent être portés à température aprire il sacchetto mentre i componenti vengono portati a
least five times and then squeeze out the swab by squeezing the
Komponenten auf Raumtemperatur gebracht werden. w
entre 2 y 30 ° C. No congele el kit ni sus componentes. ambiante (15-30° C) pendant au moins 30 minutes avant 3 R C temperatura ambiente. m todos os componentes do kit devem estar em temperatura Хранение и стабильность ы ж ы
extraction tube with your fingers. Nota: Cuando se almacena en un refrigerador, todos los 3 R C ambiente (15-30°C) por no mínimo 30 minutos antes de 1. Набор следует хранить при температуре от 2 до 30 °C. Не
2. Die Pufferflasche kann für jeden Test geöffnet und wieder 3 U E K C d'effectuer le test. N'ouvrez pas la pochette tant que les ff 2. Il flacone del Buffer può essere aperto e richiuso ad ogni Пр д р жд и Н ы
Active Ingredients of Main Components 4. Dispose of the used control swab in accordance with your
verschlossen werden. Die Kappe der Pufferflasche ist nach componentes del kit deben llevarse a temperatura ambiente P u n
composants ne sont pas à température ambiante. mm test. Il tappo del Buffer deve essere chiuso saldamente fi realizar o teste. Não abra a bolsa enquanto os componentes L m tações de Teste замораживайте набор или его компоненты. Примечание: При ы ж м
• 1 Test device biohazard waste disposal protocol. (15-30 °C) durante un mínimo de 30 minutos antes de m atingem a temperatura ambiente. O хранении в холодильнике все компоненты набора должны быть
jedem Gebrauch fest zu verschließen. Der Puffer ist bis zum E 2. Le flacon de tampon peut être ouvert et refermé pour dopo ogni utilizzo. Il Buffer è stabile fino alla data di Н ы
Gold conjugate: Human IgG specific to SARS-CoV-2 5. Close the cap of the extraction tube. realizar la prueba. No abra la bolsa mientras los componentes 3 R C 2. O frasco de tampão pode ser aberto e selado novamente fi SARSC V 2 m приведены к комнатной температуре (15-30 °C) минимум за 30
Verfallsdatum anwendbar und stabil bei einer Aufbewahrung chaque test. Le bouchon du tampon doit être fermement scadenza se conservato a 2-30 °C. ы
Ag gold colloid and Chicken IgY - gold colloid, Test line: 6. Follow the above test procedure [Reaction with Test Device].
bei 2-30 °C. alcancen la temperatura ambiente. scellé entre chaque utilisation. Le tampon est stable jusqu'à L m tat ons du test 3. Eseguire l'analisi immediatamente dopo aver rimosso il L m taz on de test
para cada ensaio. A tampa do frasco tampão deve ser O m m минут до проведения теста. Не открывайте тест-кассету, пока ым
Mouse monoclonal anti-SARS-CoV-2, Control line: Mouse 3. Führen Sie den Test umgehend nach Entnahme der Testkassette E nsch änkungen 2. La botella de tampón se puede abrir y volver a sellar para la date d'expiration s'il est conservé entre 2 et 30 ° C. dispositivo di test dalla busta di alluminio.
firmemente selada entre cada uso. O tampão é estável até m компоненты не дойдут до комнатной температуры.
a data de validade se mantido entre 2 e 30°C.
monoclonal anti-Chicken IgY Test Interpretation (Refer to Figure) aus der Verpackung durch. D K cada prueba. La tapa del tampón debe sellarse firmemente 3. Effectuez le test immédiatement après avoir retiré le SARS C V 2 4. Non utilizzare il kit oltre la data di scadenza. SARS
2 O m m m 2. Флакон с буфером флакон можно открывать и запечатывать
Ограничениятеста
• Buffer 1. Negative result: The presence of only the control line (C) and no 4. Verwenden Sie den Test nicht nach Ablauf des Verfallsdatums. N w SARSC V 2 A N entre cada uso. El tampón es estable hasta la fecha de L m tac ones de a prueba dispositif de test de la pochette en aluminium. D 5. La durata di conservazione del kit è quella indicata sulla CV2 m A m
3. Realize o teste imediatamente após remover o dispositivo заново для каждого анализа. Крышка флакона с буфером должна
Tricine, Sodium Chloride, Tween 20, Sodium Azide (<0.1%), R A w A P caducidad si se mantiene a 2-30 °C. E 4. N'utilisez pas le kit de test au-delà de sa date d'expiration. de teste da embalagem. m m быть плотно закрыта между использованиями. Буфер стабилен до жм ж
test line (T) within the result window indicates a negative result. 5. Das Verfallsdatum des Kits ist sichtbar gedruckt auf der äußeren confezione esterna.
Proclin 300 E 3. Realice la prueba inmediatamente después de extraer el SARSC V 2 5. La durée de conservation du kit est celle indiquée sur 4. Não use o kit de teste após o prazo de validade. истечения срока годности, если хранится при температуре 2-30 °C. ф
2. Positive result: The presence of the test line (T) and the control Verpackung. 6. Non utilizzare il kit se la confezione è danneggiata o il sigillo
w w dispositivo de prueba de la bolsa de aluminio. O m l'emballage extérieur. 2 5. O prazo de validade do kit está indicado na embalagem 3 Um m 3. Выполните тест сразу же после извлечения тест-кассеты из A м Д ы
line (C) within the result window, regardless of which line 6. Verwenden Sie den Test nicht, wenn die Verpackung oder è rotto. 2 m
2 D N A w m 4. No use el kit de prueba después de su fecha de vencimiento. ff externa. m м ым м жы
Storage and Stability appears first, indicates a positive result. Verpackungssiegel beschädigt sind.
5. La vida útil del kit es la indicada en el empaque exterior.
6. N'utilisez pas le kit de test si la pochette est endommagée
m
7. I campioni con tampone diretto devono essere testati fl 6. Não use se o kit de teste se a bolsa estiver danificada ou se Um m 4.
индивидуальной упаковки.
Не используйте набор после истечения срока годности.
Caution: The presence of any test line (T), no matter how 7. Direkte Abstrichproben sollten unmittelbar nach der Entnahme 2 N m ou si le sceau est brisé. immediatamente dopo il prelievo. Se non è possibile m
1. The test kit should be stored at a temperature between 2-30 E 6. No utilice el kit de prueba si la bolsa está dañada o el sello está 7. Les échantillons directs sur écouvillon doivent être testés a vedação estiver violada. SARS C V 2 fi m 5. Срок годности набора указан на наружной упаковке. Н ю ю
faint, indicates a positive result. getestet werden. Wenn ein sofortiger Test nicht möglich effettuare il test immediatamente, il tampone di raccolta
°C. Do not freeze the kit or its components. Note: When stored 3 E w P roto. m m immédiatement après le prélèvement. Si un test immédiat 3 U 7. As amostras diretas de esfregaço devem ser testadas m m E SA 6. Не используйте набор, если индивидуальная упаковка повреждена мж
3. Invalid result: If the control line (C) is not visible within the result ist, kann die Abstrichprobe in einem mit Extraktionspuffer può essere conservato in una provetta di estrazione 3 U fi m
in a refrigerator, all kit components must be brought to room mß mm w 7. Las muestras de hisopo directo deben analizarse n'est pas possible, l'échantillon sur écouvillon peut être m imediatamente após a coleta. Se o teste imediato não for 4 O m или ее герметичность нарушена. ым м
window after performing the test, the result is considered invalid. (300 μl) gefüllten Extraktionsröhrchen bei Raumtemperatur riempita con Buffer (300 μl) a temperatura ambiente (15- m m
temperature (15-30 °C) for a minimum of 30 minutes prior to E ß M SARS inmediatamente después de la recolección. Si la prueba 3 P conservé dans un tube d'extraction rempli de tampon U m possível, a amostra do esfregaço pode ser mantida em um m 7. Тампоны (тупферы) с образцами должны быть протестированы О ы ы мж ы
(15-30 °C) bis zu zwei Stunden vor dem Test aufbewahrt werden. 30 °C) per un massimo di due ore prima del test. U
performing the test. Do not open the pouch while components CV2 V inmediata no es posible, la muestra de hisopo se puede m m d'extraction (300 μl) à température ambiante (15-30° C) SARS C V 2 fi m tubo de extração cheio de tampão de extração (300 μL) 5 P m m m сразу же после взятия. Если немедленное тестирование ы
come to room temperature. Test Limitations m A E SA w mantener en un tubo de extracción lleno de tampón de U m jusqu'à deux heures avant le test. m E SA
SARS C V 2 m em temperatura ambiente (15-30°C) por até duas horas m m невозможно, тампон (тупфер) с образцом можно хранить в О ы ы ю мж
2. The Buffer bottle may be opened and resealed for each assay. 1. The contents of this kit are to be used for the professional Warnhinweise 4 E ß C m extracción (300 μL) a temperatura ambiente (15-30 °C) SARS C V 2 fi m m 4 D Avvertenze m E SA antes do teste. m m экстракционной пробирке, заполненной экстракционным ф A ж ы ж м
The Buffer cap should be firmly sealed between each use. The and qualitative detection of SARS-CoV-2 antigen from 1. Nur für den Einsatz in der In-vitro Diagnostik. Die Testkassette 1. Solo per uso diagnostico in vitro. Non riutilizzare il 4 м ым м ИФА
E hasta dos horas antes de la prueba. m E SA 6 O m m буфером (300 мкл), при комнатной температуре (15-30 °С) в течение
Buffer is stable until expiration date if kept at 2-30 °C. nasopharyngeal swab. Other specimen types may lead to und die Komponenten des Kits dürfen nicht wiederverwendet 5 F w m m mm w 4
Précautions d'usage 5 P m mm dispositivo di test e i componenti del kit.
Advertências m m двух часов до начала анализа. П ж ы ы ю ю ф
3. Perform the test immediately after removing the test device incorrect results and must not be used. werden. 1. Pour usage de diagnostic in vitro uniquement. Ne réutilisez 2. Queste istruzioni devono essere rigorosamente seguite da 5 P m mm м м
from the foil pouch. 2. Failure to follow the instructions for test procedure and 2. Diese Gebrauchsanweisung ist von einer ausgebildeten, 6
N
D m
m
V
m
m
m
Advertencias pas le dispositif de test et les composants du kit.
m
mm
m
un professionista sanitario qualificato per ottenere risultati m w 1. Somente para uso para diagnóstico in vitro. Não reutilize o
20 m
5m
Д ф м мм м
4. Do not use the test kit beyond its expiration date. interpretation of test results may adversely affect test medizinischen Fachkraft strikt zu befolgen, um genaue D w w mA V
1. Solo para uso diagnóstico in vitro. No reutilice el dispositivo 5 P m m m
2. Ces instructions doivent être strictement suivies par un 6 m accurati. Tutti gli utenti devono leggere le istruzioni prima m dispositivo de teste e os componentes do kit.
8 OP ™ COV D 9 A R D
Меры предосторожности м ы
de prueba ni los componentes del kit. m m 6 m 2. Essas instruções devem ser estritamente seguidas 1. Предназначен только для диагностики in vitro. Не используйте
5. The shelf life of the kit is as indicated on the outer package. performance and/or produce invalid results. Ergebnisse zu erzielen. Alle Anwender müssen die Anleitung vor D A 5M professionnel de santé qualifié pour obtenir des résultats m di eseguire un test. м м ым м м
2. Estas instrucciones deben seguirse estrictamente por m m por profissionais de saúde treinados, para obtenção повторно тест-кассету и компоненты набора.
6. Do not use the test kit if the pouch is damaged or the seal is 3. A negative test result may occur if the specimen was collected, der Test Durchführung sorgfältig lesen. 20 M E précis. Tous les utilisateurs doivent lire les instructions avant 5m 20 3. Non mangiare o fumare mentre si maneggiano i campioni. m m ы жы м
profesionales de la salud entrenados para lograr resultados 6 m 5m 20 de resultados precisos. Todos os usuários devem ler as 2. Эти инструкции должны строго соблюдаться обученным
broken. extracted or transported improperly. A negative test result 3. Essen und Trinken Sie nicht beim Umgang mit Proben. 8 P ™ COV D 9 A R D m d'effectuer un test. m 4. Indossare guanti protettivi durante la manipolazione dei m PCR м ым ым
precisos. Todos los usuarios deben leer las instrucciones m m instruções antes de realizar um teste. медицинским работником для достижения точных результатов.
7. Direct swab specimens should be tested immediately after does not eliminate the possibility of SARS-CoV-2 infection 4. Tragen Sie bei der Handhabung der Proben Schutzhandschuhe N w V 3. Ne pas manger ni fumer pendant la manipulation des échantillons. 8 P ™ COV D 9 A R campioni e lavarsi accuratamente le mani dopo averli ы ш м м
antes de realizar una prueba. 5m 8 P ™ COV D 9 A R D 3. Não coma ou fume durante o manuseio de amostras. Все пользователи должны перед выполнением анализа прочитать
collection. If immediate testing is not possible, the swab and should be confirmed by viral culture or a molecular assay und waschen Sie anschließend die Hände gründlich. S V mm PCR 4. Portez des gants de protection lors de la manipulation des maneggiati. ж м м м ж ю
specimen can be kept in an extraction tube filled with extraction or ELISA. 5. Vermeiden Sie Spritzer oder Aerosolbildung von Proben und M w w
3. No coma ni fume mientras manipula las muestras. 20 m
échantillons et lavez-vous soigneusement les mains par la suite. 5. Evitare spruzzi o la formazione di aerosol di campione e di
4. Use luvas de proteção ao manusear as amostras e lave bem Contro e de Qua dade инструкцию. ы
4. Utilice guantes protectores al manipular las muestras y 8 P ™ COV D 9 A R D m as mãos em seguida. C n d Qu d d n n 3. Не принимайте пищу и не курите при обращении с образцами.
buffer (300 μl) at room temperature (15-30 °C) for up to two 4. Positive test results do not rule out co-infections with other Puffer. 5. Évitez les éclaboussures ou la formation d'aérosols sur m PCR Buffer. ™ O D A ™ O D
lávese bien las manos después. l'échantillon et le tampon. m PCR 5. Evite respingos ou formação de aerossol na amostra e no O m m m 4. При работе с образцами наденьте защитные перчатки, а после -
hours prior to testing. pathogens. 6. Reinigen Sie verschüttete Flüssigkeiten gründlich mit 6. Pulire accuratamente le fuoriuscite utilizzando un A D ж
5. For further information on immune status, additional follow-up geeigneten Desinfektionsmitteln. Qua tätskont o e 5. Evite las salpicaduras o la formación de aerosoles en la m
6. Nettoyez soigneusement les déversements en utilisant un disinfettante appropriato.
tampão. C N m тщательно вымойте руки. ф ф
testing using other laboratory methods is recommended. 7. Dekontaminieren und entsorgen Sie alle Proben, Reaktionskits n n Q n muestra y el tampón. m m PCR
désinfectant approprié. Contrô e de qua té 7. Decontaminare e smaltire tutti i campioni, i kit di reazione Contro o qua tà
6. Limpe bem os derramamentos usando um desinfetante m 5. Избегайте разбрызгивания или образования аэрозолей образцов ы м ж ы ж
Warnings 6. Test results must be evaluated in conjunction with other clinical und potenziell kontaminierten Materialien (d. h. Tupfer, D K C 6. Limpie los derrames a fondo con un desinfectante adecuado. 7. Décontaminer et éliminer tous les échantillons, kits de C n d qu n n e i materiali potenzialmente contaminati (ad es. tampone
apropriado. m m A и буфера. м щ юм ы ПЦ
C n d qu n n
1. For in vitro diagnostic use only. Do not reuse the test device and
data available to the physician. Extraktionsröhrchen, Testkassette) in einem Behälter für O fl D K 7. Descontamine y deseche todas las muestras, kits de reacción Contro de ca dad réaction et matériaux potentiellement contaminés (c'est- di prelievo, provetta di estrazione, dispositivo di test) in
7. Descontamine e descarte todas as amostras, kits de reação m m 6. Тщательно удалите пролитую жидкость с помощью
kit components. m A fb P m y materiales potencialmente contaminados (es decir, hisopo, à-dire écouvillon, tube d'extraction, dispositif de test) dans C N e materiais potencialmente contaminados (ou seja, swab, m m соответствующего дезинфицирующего средства.
biologische Gefahrenstoffe, als ob sie infektiöser Abfall un contenitore a rischio biologico come se fossero rifiuti
2. These instructions must be strictly followed by a trained
7. Reading the test results earlier than 15 minutes or later than 20
wären, und entsorgen Sie sie gemäß den geltenden örtlichen D K V mm tubo de extracción, dispositivo de prueba) en un contenedor C n d d d n n
un récipient contenant des risques biologiques comme s'il infettivi e smaltirli secondo le normative locali vigenti.
C fi N tubo de extração, dispositivo de teste) em um recipiente m 7. Необходимо обеззараживать и утилизировать все образцы, Контролькачества
minutes may give incorrect results. fi m В р ий р
healthcare professional to achieve accurate results. All users w mß w de riesgo biológico como si fueran desechos infecciosos y s'agissait de déchets infectieux et éliminer conformément de risco biológico como se fossem resíduos infecciosos e 2 C n d Qu d d E n наборы и потенциально загрязненные материалы (тампон,
8. Panbio™ COVID-19 Ag Rapid Test Device is not intended Vorschriften. C fi N 8. Non mescolare o scambiare campioni diversi. m
have to read the instruction prior to performing a test. K elimínelos de acuerdo con las regulaciones locales aplicables. aux réglementations locales applicables. descarte de acordo com os regulamentos locais aplicáveis. O fi m m экстракционная пробирка, тест-кассета) в контейнере для Н ы мю
to detect from defective (non-infectious) virus during the 8. Proben dürfen nicht gemischt werden. Stellen Sie sicher, dass 9. Non mescolare reagenti di lotti diversi o di altri prodotti. m
3. Do not eat or smoke while handling specimens. 8. No mezcle ni intercambie muestras diferentes. 8. Ne pas mélanger ni échanger différents échantillons. ff m 8. Não misture ou troque amostras diferentes. m P ™ COV D 9 A R биологически опасных отходов, по правилам для инфицированных Н ы
later stages of viral shedding that might be detected by PCR Proben nicht vertauscht werden. 2 E n Q n m 10. Non conservare il kit alla luce diretta del sole. m
4. Wear protective gloves while handling specimens and wash 9. No mezcle reactivos de diferentes lotes o de otros productos. 9. Ne mélangez pas les réactifs de lots différents ou ceux 9. Não misture reagentes de lotes diferentes ou de outros D fi отходов, в соответствии с местным законодательством.
molecular tests.8 9. Reagenzien von verschiedenen Chargen dürfen nicht gemischt D K m m m m 11. Per evitare la contaminazione, quando si apre la busta non
hands thoroughly afterwards. 10. No almacene el kit de prueba a la luz solar directa. d'autres produits. 2 C n d qu n produtos. m 8. Различные образцы не должны смешиваться или ы ж ы
werden. Mischen Sie diese auch nicht mit anderen Produkten. P ™ COV D 9 A R w m m toccare la testa del tampone di raccolta in dotazione. 2 C n n d qu
5. Avoid splashing or aerosol formation of specimen and buffer. 11. Para evitar la contaminación, no toque la cabeza del hisopo 10. Ne stockez pas le kit de test à la lumière directe du soleil. fi m m 10. Não guarde o kit com exposição à luz solar direta. OC P m взаимозаменяться. ж ым м ы ю
10. Test-Kits dürfen nicht unter direkter Sonneneinstrahlung F A w 12. I tamponi sterili forniti nella confezione devono essere usati
6. Clean up spills thoroughly using an appropriate disinfectant. Quality Control gelagert werden. E D
suministrado al abrir la bolsa del hisopo. 11. Pour éviter toute contamination, ne touchez pas la tête de m P ™ COV D 9 A R solo per la raccolta di campioni nasofaringei.
m
P
m
™ COV D 9 A R
fi 11. Para evitar contaminação, não toque na ponta do swab m OC 9. Не смешивайте реагенты различных серий или реагенты для В ш ий р
7. Decontaminate and dispose of all specimens, reaction kits and 12. Los hisopos esterilizados suministrados en el paquete deben 2 C n d d d n l'écouvillon fourni lors de l'ouverture de la poche de l'écouvillon. D fi fornecido ao abrir a bolsa do swab. N m других медицинских изделий. ы ы ы
1. Internal Quality Control: 11. Um Kontaminationen zu vermeiden, berühren Sie nicht beim P w 13. Per evitare la contaminazione incrociata, non riutilizzare i D fi
potentially contaminated materials (i.e. swab, extraction tube, usarse solo para la recolección de muestras nasofaríngeas. fi m m 12. Les écouvillons stérilisés fournis dans l'emballage ne ff m 12. Os swabs esterilizados fornecidos na embalagem devem ser A m 10. Не храните набор под прямыми солнечными лучами. ы ™ O D A ™
The test device has a test line (T) and a control line (C) on the surface Öffnen des Tupferbeutels die Spitze des Tupfers. m D N tamponi sterili per la raccolta dei campioni. m C
test device) in a biohazard container as if they were infectious 13. Para evitar la contaminación cruzada, no reutilice los hisopos m P ™ COV D 9 A R doivent être utilisés que pour le prélèvement d'échantillons utilizados apenas para coleta de amostras nasofaríngeas. 11. Во избежание загрязнения не прикасайтесь к головке O D A D ю
of the test device. Neither the test line nor the control line are visible in 12. Die im Lieferumfang enthaltenen, sterilen Tupfer sind nur für 14. Non diluire il tampone raccolto con nessuna soluzione P
waste and dispose according to applicable local regulations. esterilizados para la recolección de muestras. D fi nasopharyngés. 13. Para evitar contaminação cruzada, não reutilize os swabs O прилагаемого тампона (тупфера) при открывании упаковки
the result window before appl m die Entnahme von nasopharyngealen Abstrichen zu verwenden. G m fi V w P eccetto il Buffer di estrazione fornito.
8. Do not mix or interchange different specimens. 14. No diluya el hisopo recogido con ninguna solución excepto el m E 13. Pour éviter toute contamination croisée, ne réutilisez pas esterilizados para a coleta de amostras. O m тампона (тупфера). ы П ж ы ж ы
w 13. Um eine Kreuzkontamination zu vermeiden, dürfen die sterilen N m 15. Il tampone contiene <0,1% di azoturo di sodio come
9. Do not mix reagent of different lots or those for other products. tampón de extracción proporcionado. les écouvillons stérilisés pour le prélèvement d'échantillons. 14. Não dilua o swab coletado com qualquer solução, exceto o E 12. Прилагаемые стерильные тампоны (тупферы) в упаковке следует ы м
m w Tupfer nicht zur wiederholten Probenentnahme verwendet conservante che può essere tossico se ingerito. Se smaltito U
10. Do not store the test kit in direct sunlight. 15. El tampón contiene azida sódica <0,1% como conservante E 14. Ne diluez pas l'écouvillon collecté avec une solution à tampão de extração fornecido. C m m использовать только для получения мазков из носоглотки. О ы м
2 E n Q Cn werden. w attraverso un lavandino, sciacquare con abbondante
11. To avoid contamination, do not touch the head of provided swab que puede ser tóxico si se ingiere. Cuando se deseche a l'exception du tampon d'extraction fourni. 15. O tampão contém azida de sódio a <0,1% como conservante m 13. Во избежание перекрестного загрязнения не следует повторно м Н жщ
fi m m 14. Verdünnen Sie den Tupfer nicht mit einer anderen Lösung als F S K B acqua.7
when opening the swab pouch. través de un fregadero, enjuague con una gran cantidad de 15. Le tampon contient < 0,1% d'azide de sodium comme agent Q m ff e pode ser tóxico se ingerido. Quando descartado em uma A m m использовать стерильные тампоны для получения мазков. ж
m P ™ COV D 9 A R D dem mitgelieferten Extraktionspuffer. m
12. The provided sterilized swabs in the package should be used only agua.7 de conservation qui peut être toxique en cas d'ingestion. E pia, lave com bastante água.7 Em m 14. Не смешивайте тампон с образцом с какими-либо растворами, ы м
15. Der Puffer enthält <0,1% Natriumazid als Konservierungsmittel,
for nasopharyngeal specimen collection. m
das bei Verschlucken giftig sein kann. Bei einer Entsorgung über
B
P
m A w D m
Lorsqu'il est éliminé dans un évier, rincez avec un grand A ff Procedura del test (Fare riferimento alla E
m кроме поставляемого экстракционного буфера. ы ю
13. To avoid cross-contamination, do not reuse the sterilized swabs P C w C m А ы
for specimen collection. m N das Waschbecken, ist das Mittel mit einer großen Wassermenge B E K Procedimiento de prueba (consulte la m volume d'eau7. Figura) m Procedimento de Teste (consulte a figura) C Q 15. Буфер содержит <0,1% азида натрия в качестве консерванта,
П ш ющ
weg zu spülen.7 E Campioni da Tampone Nasofaringeo Amostras de Esfregaço Nasofaríngeo который может быть токсичным при проглатывании. При
A
14. Do not dilute the collected swab with any solution except for the C w figura) C À mm
Q
утилизации в водопровод промойте его большим количеством ж ым ым м м
provided extraction buffer. G fi A
Muestras de hisopado nasofaríngeo m Procédure de test (reportez-vous au schéma) Nota: Il personale sanitario deve rispettare le linee guida di sicurezza
personali, tra cui l'uso di dispositivi di protezione personale.
A m Nota: o profissional de saúde deve cumprir as diretrizes de
segurança pessoal, incluindo o uso de equipamento de proteção воды.7
15. The buffer contains <0.1% sodium azide as a preservative which Testablauf (siehe Abbildung) Q A w
Note: El profesional de la salud debe cumplir con las pautas de A Échantillons sur écouvillon nasopharyngé
individual.
П
may be toxic if ingested. When disposed of through a sink, flush w Nasopharyngeale Proben seguridad personal, incluido el uso de equipo de protección personal. A Remarque : le professionnel de santé doit se conformer aux directives Preparazione del test П м ым ым
with a large volume of water.7 m Hinweis: Persönliche Sicherheitsrichtlinien einschließlich der m de sécurité personnelle, y compris l'utilisation d'équipements de 1. Lasciare che tutti i componenti del kit raggiungano una ым м м
R w m Verwendung persönlicher Schutzausrüstung sind durch das Fachpersonal protection individuelle. temperatura tra i 15 e i 30 °C per 30 minuti prima del test. м мым м
W w m einzuhalten.
Test Procedure (Refer to Figure) m
Nasopharyngeal Swab Specimens W w m
Note: Healthcare professionals should comply with personal safety A
guidelines including the use of personal protective equipment. m Q C
Test Preparation Le stungsmerkma e Caracter st cas de desempeño Caractér st ques de performance Caratter st che de e performance Caracter st cas de Desempenho Эксплуатационные характеристики
1. Allow all kit components to reach a temperature between 15-30 E u n
n d P nb ™ COV D 9 A R p d T D É u n n
u P n ™ COV D 9 A R T D V u nn d P nb ™ COV D 9 A R p d T D A E n d P nb ™ COV D 9 A R p d T D 1 Внешняя оценка Эк пре е а Panb o™ COV D 19 Ag Panb o™ COV D 19 Ag Rap d Te Dev e
°C prior to testing for 30 minutes. E n Bw un d P nb ™ COV D 9 A R p d T D E m P ™ COV D 9 A R D m 60 m 8 m P ™ COV D 9 A R D m 60 8 P ™ COV D 9 A R D m m 860 A m P ™ COV D 9 A R D m m 60 m 8 m К инич фф и но Э пр P nb o™ COV D 19 Ag P nb o™ COV D 19 Ag R p d D
D P ™ COV D 9 A R D w 60 SARS C V 2 A A A SARS C V 2 93 3% C 95% 83 3 98 2% fi 99 4% C SARS C V 2 A 93 3% C 95% 83 8 98 2% fi 99 4% C 95% 9 0 00% SARS C V 2 A S 93 3% 95% C 83 8 98 2% fi 99 4% 95% C 9 0 A SARS C V 2 93 3% 95% C 83 3 98 2% fi 99 4% 95% C бы опр д н п м иро ни 60 по ожи ны и 181 о риц ны обр цо н н и н AR CoV 2 Ag
8 P m S 93 3 % 95 % C 83 8 98 2% S fi 99 4 % 95 % C 9 0 00 0% 95% 9 0 00% S m m m FDA EUA R PCR m FDA EUA R PCR 00% m m m m m FDA EUA R PCR 9 0 00% A m m m m m R PCR FDA EUA ч и но ю 93 3% 95% ДИ 83 8 98 2% и п цифично ю 99 4% 95% C 97 0 100% К инич и обр цы бы и опр д ны
mm P N P w m FDA EUA R PCR R m m m m по ожи ны и и о риц ны и по о ни м онно о м од О ПЦР р р ш ннный DA н и по о ни
R u d d P nb ™ COV D 9 A R p d T D P nb ™ COV D 9 A R p d T D R u R u d P nb ™ COV D 9 A R p d T D
E bn ü P nb ™ COV D 9 A R p d T D R u d d P nb ™ COV D 9 A R p d T D чр ыч йны и ци
Performance Character st cs R u d d p u b PCR R u T PCR R u d PCR Ре уль а ы для Эк пре е Panb o™ COV D 19 Ag Panb o™ COV D 19 Ag Rap d Te Dev e
E n u n P nb ™ COV D 9 A R p d T D PCR T bn R u d d d PCR
P N T P N T P P T
C m P ™ COV D 9 A R D w m 60 8 m SARS P N G m Ре уль а ы е а ПЦР
P 56 5 P 56 5 P 56 5 P N T
CV2 A 93 3% 95% C 83 8 98 2% fi 99 4% 95% C 9 0 00% C m w R u d d P nb ™ P nb ™ COV D 9 R u d P nb ™ Положи ельный О рица ельный
E bn ü P nb ™ P 56 5 P 56 5 И оо
m FDA EUA R PCR m COV D 9 A R p d T N 4 80 84 A R pdT D N 4 80 84 COV D 9 A R p d T N 4 80 84 R u d d P nb ™ ре уль а ре уль а
COV D 9 A R p d T N 4 80 84 D R u D COV D 9 A R p d T N 4 80 84
T 60 8 24 T 60 8 24 T 60 8 24 Ре уль а ы для Эк пре Положи ельный ре уль а 56 1 57
P nb ™ COV D 9 A R p d T D R u D G m 60 8 24 D
P S S fi P G P T 60 8 24 е Panb o™ COV D 19
S E fi S S fi О рица ельный ре уль а 4 180 184
PCR T R u K m m P Ag Panb o™ COV D 19 Ag
S S fi 93 3% 83 8% 98 2% 99 4% 9 0% 00 0% 9 9% 95 2% 99 3% S E fi И оо 60 181 241
P N T Ü mm Rap d Te Dev e
93 3% 83 8% 98 2% 99 4% 9 0% 00 0% 9 9% 95 2% 99 3% m COV D 9 93 3% 83 8% 98 2% 99 4% 9 0% 00 0% 9 9% 95 2% 99 3%
P 56 5 93 3% 83 8% 98 2% 99 4% 9 0% 00 0% 9 9% 95 2% 99 3% 93 3% 83 8% 98 2% 99 4% 9 0% 00 0% 9 9% 95 2% 99 3% Общ проц н н
P nb ™ COV D 9 A m COV D 9 m m m m COV D 9 Ч и но ю Сп цифично ю
N 4 80 84 D w S m P V E m COV D 9 о о нно
R pdT D R u m m fi m m 03 m m O m m m COV D 9 m
T 60 8 24 S m m fi m m 03 00 0% = 2 4 89 % = 39 fi m m 03 00 0% m m 93 3% 99 4% 97 9%
D S fi P mA S m m m E w 03 00 0% =2 4 89 % = 39 P ™ COV D 9 A R D C 33 =2 4 89 % =39 E fi m m m 03 m m 83 8% 98 2% 97 0% 100 0% 95 2% 99 3%
S S fi O P A m
S 00 0% = 2 w 4 S 89 % =39 P
™ COV D 9 A R D C 33m 98 2% C mm 8 9 C 33 P ™ COV D 9 A R D m C 33 00 0% =2 4 m m 89 % =39 Д нны о прои оди но и бы и р чи ны н о но и до ни иц подо р мы он COV D 19 и и
93 3% 83 8% 98 2% 99 4% 9 0% 00 0% 9 9% 95 2% 99 3% D Ü mm P ™ COV D 9 A R D m S 98 2% P m C 98 2% C m 8 9 C 33 2 Lm n 98 2% C m m 8 9 C 33 A P ™ COV D 9 A R D m m C 33 m m 98 2% о оры ч ни по дни 7 дн й про и имп омы
P m w m COV D 9 w w m m W 33 R 8 9 P m C W 33 m 2 Lm d d n fi m P ™ COV D 9 A R D 25 0 CD m SARS C V 2 2 Lm d m n C m 8 9 m C 33 m С р ифи ци по ожи ны обр цо по по ни имп омо и и подо р ни н он м жд 0 3 дн ми им
2 N hw n P ™ COV D 9 A R D fi m 2 5X 0 C D m SARS C V 2 fi m COV D 9 C P ™ COV D 9 A R D 2 5X 0 CD m SARS C V 2 2 Lm d D ч и но 100 0% n = 21 4 7 дн й ч и но 89 7% n = 39
S fi m m m w 03 00 0% E w P ™ COV D 9 A R D 2 5X 0 C D m SARS C V 2 w fi m COV D 9 C 3 Eff h m COV D 9 C OP ™ COV D 9 A R D fi m 2 5X 0 C D m SARS C V 2 m По ожи ный о и P nb o™ COV D 19 Ag R p d D ыш д обр цо п ≤33 д ч и но ю 98 2%
=2 4 89 % =39 m COV D 9 P K w 3 E n h ff 0 0 CD m SARS C V 2 fi m COV D 9 C 3 Eff n fi m m COV D 9 C К но р ом нд ци 8 и 9 п ци н ы о н ч ни м п >33 д бо ш н ю ир н ными
P m P ™ COV D 9 A R
D w m C 33 w 98 2% 3 H Eff H Eff N 0 0 CD m SARS C V 2 fi m COV D 9 C 4 R N ff 0 0 CD m SARS C V 2 m COV D 9 C 3 E Gn h 2 Предел обнаружения
A R 8 9 33 w C E H Eff 0 0 C D m SARS C V 2 m COV D 9 P K w 4 R d d u d P ™ COV D 9 A R D 20 2 m m 4 R N m 0 0 CD m SARS C V 2 m fi m m COV D 9 C Под ржд но ч о Э пр P nb o™ COV D 19 Ag P nb o™ COV D 19 Ag R p d D об п чи обн р ж ни
2 D nLm 4 K u n n P ™ COV D 9 A R D 20 2m m fi m m m P ™ COV D 9 A R D 20 2m m 4 R d d Cu d 2 5X10 ЦД м AR CoV 2 ыд нно о п ци н под ржд нной инф ци й COV D 19 Кор
P ™ COV D 9 A R D w fi m 2 5X 0 C D m SARS C V 2 w w m D K P ™ COV D 9 A R D w w m 20 V 2 M m fi m m m m m ff P ™ COV D 9 A R D fi m m m m m A P ™ COV D 9 A R D 20 2 m m A 3 Эффек вы окой до ы Hook Effe
COV D 9 fi m K w D V M m m m P ™ COV D 9 A R D ff P ™ COV D 9 A R D fi m m m O m m При до 1 0 10 ЦД м AR CoV 2 ыд нно о п ци н под ржд нной инф ци й COV D 19 Кор фф
3 H Eff m D V M m E fl P ™ COV D 9 N S C fi R
m P ™ COV D 9 A R D ы о ой до ы о
ff 0 0 C D m SARS C V 2 w w m COV D 9 fi m K A R D N m S C fi R A 3 0X 0 C D m P N m E m C fi R
N E m S R C C F R 4 Перекре ная реак ивно ь
4 C R A 3 0X 0 CD m S A 0X 0 CD m P A 3 0X 0 C D m N
N A P K F П р р н ю р и но Э пр P nb o™ COV D 19 Ag P nb o™ COV D 19 Ag R p d D оц ни и
C P ™ COV D 9 A R D w 20 2 m m A 0X 0 CD m S 3 E 0X 0 C D m P A 0X 0 CD m N A 3 0X 0 C D m Sm
A 3 0X 0 C D m K K п м иро ни 20 ир о и 12 др и ми роор ни мо О онч ны о ы онц н р ции ир о и др и
fi m m m w w 3 E 0X 0 CD m S 4 E 0X 0 CD m P 3 E 0X 0 C D m N A 0X 0 CD m Sm ми роор ни мо при д ны б иц ниж С д ющи ир ы и др и ми роор ни мы н и ю н р ы
m m ff P ™ COV D 9 A R D A 0X 0 CD m K K 3 E 0X 0 C D m Sm
4 E 0X 0 CD m S 5 V H m m VHS 0X 0 CD m P 4 E 0X 0 CD m N н и помощ ю Э пр P nb o™ COV D 19 Ag P nb o™ COV D 19 Ag R p d D
3 E 0X 0 C D m K K 4 E 0X 0 CD m Sm
N S m C R S F C R 5 V m HSV 0X 0 CD m S 6 V H m m VHS 0X 0 CD m P 5 Hm HSV 0X 0 CD m N О онч н о
4 E 0X 0 CD m K K № ипы обр цо Вщ о ы ы ющ п р р н юр цию Р ы
A 3 0X 0 C D m N 6 V m HSV 0X 0 CD m S V M A 0X 0 C D m P 6 Hm HSV 0X 0 CD m N 5 H m HSV 0X 0 CD m Sm онц н р ци
5 M H HSV 0X 0 CD m K K 6 H m HSV 0X 0 CD m Sm А р X ЦД м Н р р р
A 0X 0 CD m N A V P 0X 0 CD m S 8 fl A HN S AV A CC 009 6 X 0 PFU m P M m V A 0X 0 C D m N
3 E 0X 0 C D m N 6 M H HSV 0X 0 CD m K K V m A 0X 0 C D m Sm А р X ЦД м Н р р р
V fl A HN AV 9 fl A HN S A WS 33 50X 0 C D m P 8 fl A HN S AV A CC 009 6 X 0 PFU m N
M m V A 0X 0 C D m K K 8 6 X 0 PFU m S Э р X ЦД м Н р р р
4 E 0X 0 CD m N A CC 009 9 fl A HN S A WS 33 50X 0 C D m N 8 V fl A HN E AV A CC 009 6 X 0 PFU m Sm
8 fl V A H N S mm A V A CC 009 6 X 0 PFU m K K 0 fl A H3N S AH K 8 68 NA P Э р X ЦД м Н р р р
5 Hm HSV 0X 0 CD m N 9 V fl A HN A WS 33 50X 0 CD m S V 0 fl A H3N S AH K 8 68 NA N 9 V A HN E A WS 33 50X 0 C D m Sm
9 fl V A H N S mm A WS 33 50X 0 C D m K K fl BS B 40 0X 0 CD m P V р р HV X ЦД м Н р р р
6 Hm HSV 0X 0 CD m N 0 V V fl A H3N AH K 8 68 NA S fl BS B 40 0X 0 CD m N 0 V fl A H3N E AH K 8 68 NA Sm
0 fl V A H3N S mm A H K 8 68 NA K K P fl NA P V р р HV X ЦД м Н р р р
M m V A 0X 0 C D m N V V fl B B 40 0X 0 CD m S P fl NA N V E B 40 0X 0 CD m Sm
fl V B S mm B 40 0X 0 CD m K K 3 P fl NA P А рм ф р X ЦД м Н р р р
8 fl A HN S AV A CC 009 6 X 0 PFU m N P fl NA S 3 P fl NA N P fl NA Sm
P fl NA K K 4 P fl 3 NA P Ш мм р р А H N A V g A CC X Uм Н р р р
9 fl A HN S A WS 33 50X 0 C D m N 3 P fl NA S 3 P fl NA Sm
5 V R S VRS A 4 X 0 CD m P 4 P fl 3 NA N Ш мм р р А H N AW X ЦД м Н р р р
0 fl A H3N S AH K 8 68 NA N 3 P fl NA K K 4 P fl 3 NA S 4 P fl 3 NA Sm
V 6 V R S RSV B 56 X 0 C D m P 5 R RSV A 4 X 0 CD m N Ш мм р р A H N AH g g НП Н р р р
fl BS B 40 0X 0 CD m N 4 P fl 3 NA K K 5 V RSV A 4 X 0 CD m S 5 V RSV A 4 X 0 CD m Sm р
HC V HKU 0 m P 6 R RSV B 56 X 0 C D m N Ш мм р р X ЦД м Н р р р
P fl NA N 5 R S RSV A 4 X 0 CD m K K 6 V RSV B 56 X 0 CD m S 6 V RSV B 56 X 0 C D m Sm
8 HC V N 63 X 0 CD m P HC V HKU 0 m N р р р НП Н р р р
3 P fl NA N 6 R S RSV B 56 X 0 C D m K K HC V HKU 0 m S HC V HKU 0 m Sm
9 HC V OC43 89X 0 C D m P 8 HC V N 63 X 0 CD m N р р р НП Н р р р
4 P fl 3 NA N HC V HKU 0 m K K 8 HC V N 63 X 0 CD m S
0 HC V 9E 5 X 0 CD m P 9 HC V OC43 89X 0 C D m N 8 HC V N 63 X 0 CD m Sm р р р НП Н р р р
5 R RSV A 4 X 0 CD m N 8 HC V N 63 X 0 CD m K K 9 HC V OC43 89X 0 CD m S р р ы р V A X ЦД м Н р р р
0 HC V 9E 5 X 0 CD m N 9 HC V OC43 89X 0 C D m Sm
6 R RSV B 56 X 0 C D m N 9 HC V OC43 89X 0 C D m K K 0 HC V 9E 5 X 0 CD m S р р ы р V X ЦД м Н р р р
0 HC V 9E 5 X 0 CD m Sm
HC V HKU 0 m N 0 HC V 9E 5 X 0 CD m K K HC VH U м м Н р р р
8 HC V N 63 X 0 CD m N HC VN X ЦД м Н р р р
9 HC V OC43 89X 0 C D m N HC V OC X ЦД м Н р р р
0 HC V 9E 5 X 0 CD m N HC V X ЦД м Н р р р
 No. Types of Specimen Cross Reaction Substance Final Test Concentration Test Result Nr. Art der Probe Kreuzreaktionssubstanz Finale Testkonzentration Testergebnis No, Tipo de muestra Sustancia de reacción cruzada Concentración de prueba final Resultado de la prueba No, Types d' échantillons Substance de réaction croisée Concentration finale du test Résultat du Test No, Tipi di campione Elemento di cross-reazione Concentrazione finale di test Risultato del test Nº Tipos de Espécime Substância de Reação Cruzada Concentração de Teste Final Resultado do Teste Окончательная тестовая
№ Типы образцов Вещество, вызывающее перекрестную реакцию Результаты теста
1 Staphylococcus aureus 1.0 X 106.0 CFU/ml No cross reaction 1 Staphylococcus aureus 1,0 X 106,0 CFU/ml Keine Kreuzreaktion 1 Staphylococcus aureus 1,0 X 106,0 CFU/mL Sin reacción cruzada 1 Staphylococcus aureus 1,0 X 106,0 CFU/ml Pas de réaction croisée 1 Staphylococcus aureus 1,0 X 106,0 CFU/ml Nessuna cross reazione 1 Staphylococcus aureus 1,0 X 106,0 CFU/ml Sem reação cruzada концентрация
2 Staphylococcus saprophyticus 1.0 X 106.0 CFU/ml No cross reaction 2 Staphylococcus saprophyticus 1,0 X 106,0 CFU/ml Keine Kreuzreaktion 2 Staphylococcus saprophyticus 1,0 X 106,0 CFU/mL Sin reacción cruzada 2 Staphylococcus saprophyticus 1,0 X 106,0 CFU/ml Pas de réaction croisée 2 Staphylococcus saprophyticus 1,0 X 106,0 CFU/ml Nessuna cross reazione 2 Staphylococcus saprophyticus 1,0 X 106,0 CFU/ml Sem reação cruzada 1 Staphylococcus aureus 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
3 Neisseria sp.(Neisseria lactamica) 1.0 X 106.0 CFU/ml No cross reaction 3 Neisseria sp,(Neisseria lactamica) 1,0 X 106,0 CFU/ml Keine Kreuzreaktion 3 Neisseria sp,(Neisseria lactamica) 1,0 X 106,0 CFU/mL Sin reacción cruzada 3 Neisseria sp.(Neisseria lactamica) 1,0 X 106,0 CFU/ml Pas de réaction croisée 3 Neisseria sp,(Neisseria lactamica) 1,0 X 106,0 CFU/ml Nessuna cross reazione 3 Neisseria sp,(Neisseria lactamica) 1,0 X 106,0 CFU/ml Sem reação cruzada 2 Staphylococcus saprophyticus 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
4 Escherichia coli 1.0 X 106.0 CFU/ml No cross reaction 4 Escherichia coli 1,0 X 106,0 CFU/ml Keine Kreuzreaktion 4 Escherichia coli 1,0 X 106,0 CFU/mL Sin reacción cruzada 4 Escherichia coli 1,0 X 106,0 CFU/ml Pas de réaction croisée 4 Escherichia coli 1,0 X 106,0 CFU/ml Nessuna cross reazione 4 Escherichia coli 1,0 X 106,0 CFU/ml Sem reação cruzada 3 Neisseria sp.(Neisseria lactamica) 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
5 Staphylococcus haemolyticus 1.0 X 106.0 CFU/ml No cross reaction 5 Staphylococcus haemolyticus 1,0 X 106,0 CFU/ml Keine Kreuzreaktion 5 Staphylococcus haemolyticus 1,0 X 106,0 CFU/mL Sin reacción cruzada 5 Staphylococcus haemolyticus 1,0 X 106,0 CFU/ml Pas de réaction croisée 5 Staphylococcus haemolyticus 1,0 X 106,0 CFU/ml Nessuna cross reazione 5 Staphylococcus haemolyticus 1,0 X 106,0 CFU/ml Sem reação cruzada 4 Escherichia coli 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
6 Streptococcus pyogenes 1.0 X 106.0 CFU/ml No cross reaction 6 Andere Streptococcus pyogenes 1,0 X 106,0 CFU/ml Keine Kreuzreaktion 6 Otros Streptococcus pyogenes 1,0 X 106,0 CFU/mL Sin reacción cruzada 6 Autre Streptococcus pyogenes 1,0 X 106,0 CFU/ml Pas de réaction croisée 6 Streptococcus pyogenes 1,0 X 106,0 CFU/ml Nessuna cross reazione 6 Streptococcus pyogenes 1,0 X 106,0 CFU/ml Sem reação cruzada 5 Staphylococcus haemolyticus 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
Other Microorganism Altro Microorganismo Outro Microrganismo 6 Streptococcus pyogenes 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
7 Streptococcus salivarius 1.0 X 106.0 CFU/ml No cross reaction 7 Mikroorganismen Streptococcus salivarius 1,0 X 106,0 CFU/ml Keine Kreuzreaktion 7 Microorganismos Streptococcus salivarius 1,0 X 106,0 CFU/mL Sin reacción cruzada 7 Microorganisme Streptococcus salivarius 1,0 X 106,0 CFU/ml Pas de réaction croisée 7 Streptococcus salivarius 1,0 X 106,0 CFU/ml Nessuna cross reazione 7 Streptococcus salivarius 1,0 X 106,0 CFU/ml Sem reação cruzada Другой
8 Hemophilus parahaemolyticus 1.0 X 106.0 CFU/ml No cross reaction 8 Hemophilus parahaemolyticus 1,0 X 106,0 CFU/ml Keine Kreuzreaktion 8 Hemophilus parahaemolyticus 1,0 X 106,0 CFU/mL Sin reacción cruzada 8 Hemophilus parahaemolyticus 1,0 X 106,0 CFU/ml Pas de réaction croisée 8 Hemophilus parahaemolyticus 1,0 X 106,0 CFU/ml Nessuna cross reazione 8 Hemophilus parahaemolyticus 1,0 X 106,0 CFU/ml Sem reação cruzada 7 микроорганизм Streptococcus salivarius 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
9 Proteus vulgaris 1.0 X 106.0 CFU/ml No cross reaction 9 Proteus vulgaris 1,0 X 106,0 CFU/ml Keine Kreuzreaktion 9 Proteus vulgaris 1,0 X 106,0 CFU/mL Sin reacción cruzada 9 Proteus vulgaris 1,0 X 106,0 CFU/ml Pas de réaction croisée 9 Proteus vulgaris 1,0 X 106,0 CFU/ml Nessuna cross reazione 9 Proteus vulgaris 1,0 X 106,0 CFU/ml Sem reação cruzada 8 Hemophilus parahaemolyticus 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
10 Moraxella catarrhalis 1.0 X 106.0 CFU/ml No cross reaction 10 Moraxella catarrhalis 1,0 X 106,0 CFU/ml Keine Kreuzreaktion 10 Moraxella catarrhalis 1,0 X 106,0 CFU/mL Sin reacción cruzada 10 Moraxella catarrhalis 1,0 X 106,0 CFU/ml Pas de réaction croisée 10 Moraxella catarrhalis 1,0 X 106,0 CFU/ml Nessuna cross reazione 10 Moraxella catarrhalis 1,0 X 106,0 CFU/ml Sem reação cruzada 9 Proteus vulgaris 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
11 Klebsiella pneumoniae 1.0 X 106.0 CFU/ml No cross reaction 11 Klebsiella pneumoniae 1,0 X 106,0 CFU/ml Keine Kreuzreaktion 11 Klebsiella pneumoniae 1,0 X 106,0 CFU/mL Sin reacción cruzada 11 Klebsiella pneumoniae 1,0 X 106,0 CFU/ml Pas de réaction croisée 11 Klebsiella pneumoniae 1,0 X 106,0 CFU/ml Nessuna cross reazione 11 Klebsiella pneumoniae 1,0 X 106,0 CFU/ml Sem reação cruzada 10 Moraxella catarrhalis 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
12 Fusobacterium necrophorum 1.0 X 106.0 CFU/ml No cross reaction 12 Fusobacterium necrophorum 1,0 X 106,0 CFU/ml Keine Kreuzreaktion 12 Fusobacterium necrophorum 1,0 X 106,0 CFU/mL Sin reacción cruzada 12 Fusobacterium necrophorum 1,0 X 106,0 CFU/ml Pas de réaction croisée 12 Fusobacterium necrophorum 1,0 X 106,0 CFU/ml Nessuna cross reazione 12 Fusobacterium necrophorum 1,0 X 106,0 CFU/ml Sem reação cruzada 11 Klebsiella pneumoniae 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
* No concentration provided by supplier. Undiluted stock solution was tested. * Keine Konzentrationsangabe durch den Lieferanten. Unverdünnte Stammlösung wurde getestet. * Sin concentración proporcionada por el proveedor. Se evaluó la solución madre sin diluir. * Aucune concentration fournie par le fournisseur. La solution mère non diluée a été testée. * Nessuna concentrazione fornita dal fornitore. È stata testata una soluzione di stock non diluito. *Nenhuma concentração fornecida pelo fornecedor. A solução estoque não diluída foi testada. 12 Fusobacterium necrophorum 1,0 X 106.0 КОЕ/мл Нет перекрестной реакции
5. Interfering Substances 5. Interferierende Substanzen 5. Sustancias interferentes 5. Substances interférentes 5. Sostanze interferenti 5. Substâncias Interferentes *Поставщик не предоставил концентрации. Был протестирован неразбавленный исходный раствор.
The following 28 potentially interfering substances have no impact on Panbio™ COVID-19 Ag Rapid Test Device. The final test Die folgenden 28 potenziell interferierenden Substanzen haben keinen Einfluss auf Panbio™ COVID-19 Ag Rapid Test Device. Die Las siguientes 28 sustancias potencialmente interferentes no tienen ningún impacto en Panbio™ COVID-19 Ag Rapid Test Device. Les 28 substances potentiellement interférentes suivantes n'ont aucun impact sur le Panbio™ COVID-19 Ag Rapid Test Device. Les Le seguenti 28 sostanze potenzialmente interferenti non hanno alcun impatto su Panbio™ COVID-19 Ag Rapid Test Device. La As seguintes 28 substâncias potencialmente interferentes não têm impacto no Panbio™ COVID-19 Ag Rapid Test Device. As 5. Интерферирующие вещества
concentrations of the interfering substances are documented in the Table below. endgültigen Testkonzentrationen der Störsubstanzen sind in der folgenden Tabelle dokumentiert. Las concentraciones de prueba finales de las sustancias interferentes se documentan en la siguiente tabla. concentrations d'essai finales des substances interférentes sont documentées dans le tableau ci-dessous. concentrazione finale di test delle sostanze interferenti è documentata nella tabella sotto. concentrações de teste finais das substâncias interferentes estão documentadas na Tabela abaixo. Следующие 28 потенциально интерферирующих веществ не оказывают никакого влияния на Экспресс-тест Panbio™
COVID-19 Ag (Panbio™ COVID-19 Ag Rapid Test Device). Окончательные тестовые концентрации интерферирующих веществ
No. Types of Specimen Interfering Substances Final Test Concentration Test Result Nr. Art der Probe Interferierende Substanzen Finale Testkonzentration Testergebnis No, Tipo de muestra Sustancias Interferentes Concentración de prueba final Resultado de la prueba No, Types d' échantillons Substances interférentes Concentration finale du test Résultat du Test No, Tipi di campione Sostanze interferenti Concentrazione finale di test Risultato del test Nº Tipos de Espécime Substâncias Interferentes Concentração de Teste Final Resultado do Teste
задокументированы в нижеприведенной таблице.
1 Mucin 0.5% No Interference 1 Mucin 0,5% Keine Interferenz 1 Mucina 0,5% Sin interferencia 1 Mucine 0,5% Pas d'interférence 1 Mucin 0,5% Nessuna interferenza 1 Mucina 0,5% Sem Interferências
2 Hämoglobin 100 mg/L Keine Interferenz 2 Hemoglobina 100 mg/L Sin interferencia 2 Hémoglobine 100 mg/L Pas d'interférence 2 Hemoglobin 100 mg/L Nessuna interferenza 2 Hemoglobina 100 mg/L Sem Interferências № Типы образцов Интерферирующие вещества Окончательная тестовая концентрация Результаты теста
2 Hemoglobin 100 mg/L No Interference
3 Triglyceride 1,5 mg/L Keine Interferenz 3 Triglicéridos 1,5 mg/L Sin interferencia 3 Triglycérides 1,5 mg/L Pas d'interférence 3 Triglycerides 1,5 mg/L Nessuna interferenza 3 Triglicerídeos 1,5 mg/L Sem Interferências 1 Муцин 0,5% Нет влияния
3 Triglycerides 1.5 mg/L No Interference
4 Sustancia Endógena Icterico (Bilirrubina) 40 mg/dL Sin interferencia 4 Substance Endogène Ictère (Bilirubine) 40 mg/dL Pas d'interférence 4 Sostanza endogena Icteric (Bilirubin) 40 mg/dL Nessuna interferenza 4 Substância Endógena Icterícia (bilirrubina) 40 mg/dL Sem Interferências 2 Гемоглобин 100 мг/л Нет влияния
4 Endogenous Substance Icteric (Bilirubin) 40 mg/dL No Interference 4 Endogene Substanz Icteric (Bilirubin) 40 mg/dL Keine Interferenz
5 Factor reumatoide 200 IU/mL Sin interferencia 5 Facteur Rhumatoïde 200 IU/ml Pas d'interférence 5 Rheumatoid factor 200 IU/ml Nessuna interferenza 5 Fatores reumatoides 200 IU/ml Sem Interferências 3 Триглицериды 1,5 мг/л Нет влияния
5 Rheumatoid factor 200 IU/ml No Interference 5 Rheuma-Faktor 200 IU/ml Keine Interferenz
6 Anticuerpo antinuclear >1:40 Sin interferencia 6 Anticorps anti-nucléaire >1:40 Pas d'interférence 6 Anti-nuclear antibody >1:40 Nessuna interferenza 6 Anticorpo antinuclear >1:40 Sem Interferências 4 Эндогенная субстанция Билирубин 40 мг/дл Нет влияния
6 Anti-nuclear antibody >1:40 No Interference 6 Anti-nuklearer Antikörper >1:40 Keine Interferenz
7 Embarazo Dilución de 10 veces Sin interferencia 7 Enceinte Dilution au dixième Pas d'interférence 7 Pregnant Diluizione 1:10 Nessuna interferenza 7 Grávida Diluição de 10 vezes Sem Interferências 5 Ревматоидный фактор 200 МЕ/мл Нет влияния
7 Pregnant 10-fold dilution No Interference 7 Schwanger 10-fach verdünnt Keine Interferenz
8 Éter de glicerilo guayacol 1 μg/mL Sin interferencia 8 Éther glycérylique de guaiacol 1 μg/ml Pas d'interférence 8 Guaiacol glyceryl ether 1 μg/ml Nessuna interferenza 8 Guaiacol gliceril éter 1 μg/ml Sem Interferências 6 Антиядерное антитело >1:40 Нет влияния
8 Guaiacol glyceryl ether 1 μg/ml No Interference 8 Guajakol-Glyceryl-Ether 1 μg/ml Keine Interferenz
9 Albuterol 0,005 mg/dL Sin interferencia 9 Albuterol 0,005 mg/dL Pas d'interférence 9 Albuterol 0,005 mg/dL Nessuna interferenza 9 Albuterol 0,005 mg/dL Sem Interferências 7 Беременность 10-кратное разведение Нет влияния
9 Albuterol 0.005 mg/dL No Interference 9 Albuterol 0,005 mg/dL Keine Interferenz
10 Efedrina 0,1 mg/mL Sin interferencia 10 Ephedrine 0,1 mg/ml Pas d'interférence 10 Ephedrine 0,1 mg/ml Nessuna interferenza 10 Efedrina 0,1 mg/ml Sem Interferências 8 Глицериловый эфир гваяколя 1 мкг/мл Нет влияния
10 Ephedrine 0.1 mg/ml No Interference 10 Ephedrin 0,1 mg/ml Keine Interferenz
11 Clorfeniramina 0,08 mg/dL Sin interferencia 11 Chlorpheniramine 0,08 mg/dL Pas d'interférence 11 Chlorpheniramine 0,08 mg/dL Nessuna interferenza 11 Clorfeniramina 0,08 mg/dL Sem Interferências 9 Альбутерол 0,005 мг/дл Нет влияния
11 Chlorpheniramin 0,08 mg/dL Keine Interferenz
11 Chlorpheniramine 0.08 mg/dL No Interference 12 Difenhidramina 0,08 mg/dL Sin interferencia 12 Diphenhydramine 0,08 mg/dL Pas d'interférence 12 Diphenhydramine 0,08 mg/dL Nessuna interferenza 12 Difenidramina 0,08 mg/dL Sem Interferências 10 Эфедрин 0,1 мг/мл Нет влияния
12 Diphenhydramin 0,08 mg/dL Keine Interferenz 11 Хлорфенирамин 0,08 мг/дл Нет влияния
12 Diphenhydramine 0.08 mg/dL No Interference 13 Ribavirina 26,7 μg /mL Sin interferencia 13 Ribavirin 26,7 μg /ml Pas d'interférence 13 Ribavirin 26,7 μg /ml Nessuna interferenza 13 Ribavirina 26,7 μg /ml Sem Interferências
13 Ribavirin 26,7 μg /ml Keine Interferenz 12 Дифенгидрамин 0,08 мг/дл Нет влияния
13 Ribavirin 26.7 μg /ml No Interference 14 Oseltamivir 0,04 mg/dL Sin interferencia 14 Oseltamivir 0,04 mg/dL Pas d'interférence 14 Oseltamivir 0,04 mg/dL Nessuna interferenza 14 Oseltamivir 0,04 mg/dL Sem Interferências
14 Oseltamivir 0,04 mg/dL Keine Interferenz 13 Рибавирин 26,7 мкг/мл Нет влияния
14 Oseltamivir 0.04 mg/dL No Interference 15 Zanamivir 17,3 μg /mL Sin interferencia 15 Zanamivir 17,3 μg /ml Pas d'interférence 15 Zanamivir 17,3 μg /ml Nessuna interferenza 15 Zanamivir 17,3 μg /ml Sem Interferências
15 Zanamivir 17,3 μg /ml Keine Interferenz 14 Осельтамивир 0,04 мг/дл Нет влияния
15 Zanamivir 17.3 μg /ml No Interference 16 Clorhidrato de fenilefrina 15% v/v Sin interferencia 16 Chlorhydrate de phényléphrine 15% v/v Pas d'interférence 16 Phenylephrine hydrochloride 15% v/v Nessuna interferenza 16 Cloridrato de fenilefrina 15% v/v Sem Interferências
16 Phenylephrin-Hydrochlorid 15% v/v Keine Interferenz 15 Занамивир 17,3 мкг/мл Нет влияния
16 Phenylephrine hydrochloride 15% v/v No Interference 17 Clorhidrato de oximetazolina 15% v/v Sin interferencia 17 Chlorhydrate d'oxymétazoline 15% v/v Pas d'interférence 17 Oxymetazolin hydrochloride 15% v/v Nessuna interferenza 17 Cloridrato de oximetazolina 15% v/v Sem Interferências
17 Oxymetazolin-Hydrochlorid 15% v/v Keine Interferenz Sustancia Exógena Substance Exogène Sostanza esogena Substância Exógena 16 Фенилэфрина гидрохлорид 15% об./об. Нет влияния
17 Oxymetazolin hydrochloride 15% v/v No Interference 18 Amoxicilina 5,4 mg/dL Sin interferencia 18 Amoxicilline 5,4 mg/dL Pas d'interférence 18 Amoxicillin 5,4 mg/dL Nessuna interferenza 18 Amoxicilina 5,4 mg/dL Sem Interferências
18 Exogene Substanz Amoxicillin 5,4 mg/dL Keine Interferenz 19 Ácido acetilsalicílico 3 mg/dL Sin interferencia 19 Acide acétylsalicylique 3 mg/dL Pas d'interférence 19 Acetylsalicylic acid 3 mg/dL Nessuna interferenza 19 Ácido acetilsalicílico 3 mg/dL Sem Interferências 17 Оксиметазолина гидрохлорид 15% об./об. Нет влияния
18 Exogenous Substance Amoxicillin 5.4 mg/dL No Interference
19 Acetylsalicylsäure 3 mg/dL Keine Interferenz 20 Ibuprofeno 21,9 mg/dL Sin interferencia 20 Ibuprofène 21,9 mg/dL Pas d'interférence 20 Ibuprofen 21,9 mg/dL Nessuna interferenza 20 Ibuprofeno 21,9 mg/dL Sem Interferências 18 Экзогенная субстанция Амоксициллин 5,4 мг/дл Нет влияния
19 Acetylsalicylic acid 3 mg/dL No Interference 20 Ibuprofen 21,9 mg/dL Keine Interferenz 19 Ацетилсалициловая кислота 3 мг/дл Нет влияния
21 Clorotiazida 2,7 mg/dL Sin interferencia 21 Chlorothiazide 2,7 mg/dL Pas d'interférence 21 Chlorothiazide 2,7 mg/dL Nessuna interferenza 21 Clorotiazida 2,7 mg/dL Sem Interferências
20 Ibuprofen 21.9 mg/dL No Interference 21 Chlorothiazid 2,7 mg/dL Keine Interferenz 20 Ибупрофен 21,9 мг/дл Нет влияния
22 Indapamida 140 ng/mL Sin interferencia 22 Indapamide 140 ng/ml Pas d'interférence 22 Indapamide 140 ng/ml Nessuna interferenza 22 Indapamida 140 ng/ml Sem Interferências
21 Chlorothiazide 2.7 mg/dL No Interference 22 Indapamid 140 ng/ml Keine Interferenz 21 Хлортиазид 2,7 мг/дл Нет влияния
23 Glimepirida (sulfonilureas) 0,164 mg/dL Sin interferencia 23 Glimépiride (sulfonylurées) 0,164 mg/dL Pas d'interférence 23 Glimepiride (Sulfonylureas) 0,164 mg/dL Nessuna interferenza 23 Glimepirida (Sulfonilureias) 0,164 mg/dL Sem Interferências
22 Indapamide 140 ng/ml No Interference 23 Glimepirid (Sulfonylharnstoffe) 0,164 mg/dL Keine Interferenz 22 Индапамид 140 нг/мл Нет влияния
24 Acarbose 0,03 mg/dL Sin interferencia 24 Acarbose 0,03 mg/dL Pas d'interférence 24 Acarbose 0,03 mg/dL Nessuna interferenza 24 Acarbose 0,03 mg/dL Sem Interferências
23 Glimepiride (Sulfonylureas) 0.164 mg/dL No Interference 24 Acarbose 0,03 mg/dL Keine Interferenz 25 Ivermectina 4,4 mg/L Sin interferencia 25 Ivermectine 4,4 mg/L Pas d'interférence 25 Ivermectin 4,4 mg/L Nessuna interferenza 25 Ivermectina 4,4 mg/L Sem Interferências 23 Глимепирид (Сульфонилмочевина) 0,164 мг/дл Нет влияния
24 Acarbose 0.03 mg/dL No Interference 25 Ivermectin 4,4 mg/L Keine Interferenz 26 Lopinavir 16,4 μg/L Sin interferencia 26 Lopinavir 16,4 μg/L Pas d'interférence 26 Lopinavir 16,4 μg/L Nessuna interferenza 26 Lopinavir 16,4 μg/L Sem Interferências 24 Акарбоза 0,03 мг/дл Нет влияния
25 Ivermectin 4.4 mg/L No Interference 26 Lopinavir 16,4 μg/L Keine Interferenz 27 Ritonavir 16,4 μg/L Sin interferencia 27 Ritonavir 16,4 μg/L Pas d'interférence 27 Ritonavir 16,4 μg/L Nessuna interferenza 27 Ritonavir 16,4 μg/L Sem Interferências 25 Ивермектин 4,4 мг/л Нет влияния
26 Lopinavir 16.4 μg/L No Interference 27 Ritonavir 16,4 μg/L Keine Interferenz 28 Fosfato de cloroquina 0,99 mg/L Sin interferencia 28 Phosphate de chloroquine 0,99 mg/L Pas d'interférence 28 Chloroquine phosphate 0,99 mg/L Nessuna interferenza 28 Fosfato de cloroquina 0,99 mg/L Sem Interferências 26 Лопинавир 16,4 мкг/л Нет влияния
27 Ritonavir 16.4 μg/L No Interference 28 Chloroquinphosphat 0,99 mg/L Keine Interferenz 27 Ритонавир 16,4 мкг/л Нет влияния
6. Repetibilidad y reproducibilidad 6. Répétabilité et reproductibilité 6. Ripetibilità e riproducibilità 6. Repetibilidade e Reprodutibilidade
28 Chloroquine phosphate 0.99 mg/L No Interference La repetibilidad y reproducibilidad de Panbio™ COVID-19 Ag Rapid Test Device se estableció utilizando paneles de referencia La répétabilité et la reproductibilité du Panbio™ COVID-19 Ag Rapid Test Device ont été établies à l'aide de panels de référence internes La ripetibilità e la riproducibilità di Panbio™ COVID-19 Ag Rapid Test Device sono state stabilite utilizzando pannelli di riferimento Repetibilidade e reprodutibilidade do Panbio™ COVID-19 Ag Rapid Test Device foram estabelecidas usando painéis de referência 28 Хлорохина фосфат 0,99 мг/л Нет влияния
6. Wiederholbarkeit & Reproduzierbarkeit
6. Repeatability & Reproducibility Die Wiederholbarkeit und Reproduzierbarkeit von Panbio™ COVID-19 Ag Rapid Test Device wurde unter Verwendung eines internen internos que contienen muestras negativas y una variedad de muestras positivas. No se observaron diferencias dentro de las contenant des échantillons négatifs et une gamme d'échantillons positifs.. Aucune différence n'a été observée à l'intérieur des séries, entre les interni contenenti campioni positivi alti, positivi medi, positivi deboli e negativi. Non sono state osservate differenze all'interno della internos contendo amostras negativas e uma gama de amostras positivas. Não houve diferenças observadas dentro da execução, entre 6. Повторяемость и воспроизводимость
Repeatability & Reproducibility of Panbio™ COVID-19 Ag Rapid Test Device was established using in-house reference panels containing Referenzpanels mit negativen Proben und einer Reihe positiver Proben festgestellt. Es wurden keine Unterschiede innerhalb der Testreihe, evaluaciones, entre evaluaciones, entre lotes, entre sitios y entre días. séries, entre les lots, entre les sites et entre les jours. serie, tra le serie, tra i lotti, tra i siti e tra i giorni. execuções, entre lotes, entre locais e entre dias. Повторяемость и воспроизводимость Экспресс-тест Panbio™ COVID-19 Ag (Panbio™ COVID-19 Ag Rapid Test Device) была
negative specimens and a range of positive specimens. There were no differences observed within-run, between-run, between-lots, zwischen den Testreihen, zwischen den Chargen, zwischen den Standorten und zwischen den Tagen festgestellt. определена с использованием собственных эталонных панелей, содержащих отрицательные образцы и ряд положительных
between-sites, and between-days. образцов. Различий в внутри одной серии, между сериями, между центрами и между днями не наблюдали.

PREPARATION / VORBEREITUNG / PREPARACIÓN / PREPARATION / PREPARAZIONE TEST INTERPRETATION / TEST INTERPRETATION / INTERPRETACIÓN DE LA PRUEBA / INTERPRETATION DU TEST /
TEST PROCEDURE / TESTVERFAHREN / PROCEDIMIENTO DE LA PRUEBA / PROCEDURE / PROCEDURA DEL TEST / PROCEDIMENTO DE TESTE / ПРОЦЕДУРА ТЕСТИРОВАНИЯ
/ PREPARAÇÃO / ПОДГОТОВКА INTERPRETAZIONE DEL TEST / INTERPRETAÇÃO DE TESTE / ИНТЕРПРЕТАЦИЯ ТЕСТА

1 1 2 3 4 5
Allow all kit components to reach a temperature Lassen Sie alle Komponenten des Test-Kits 30 Permita que todos los componentes del kit Hold the buffer bottle vertically and DE Halten Sie das Pufferfläschchen EN Place the DE Stellen Sie das Tilt the patient's head back. Neigen Sie den Kopf des EN Insert the swab specimen in the Führen Sie die Abstrichprobe in das Break the swab at Brechen Sie den Tupfer
EN
between 15-30°C prior to testing for 30
DE
Minuten vor Beginn des Testens eine Temperatur
ES
alcancen una temperatura entre 15 y 30 °C
EN
fill the extraction tube with buffer vertikal und füllen Sie das extraction tube Extraktionsröhrchen
EN
Insert the swab through the
DE
Patienten nach hinten. Führen extraction tube. Swirl the swab tip in the
DE
Extraktionsröhrchen ein. Schwenken Sie
EN
the breakpoint and
DE
an der Bruchstelle NEGATIVE / NEGATIV / NEGATIVA / NEGATIF / NEGATIVO / NEGATIVO / ОТРИЦАТЕЛЬНЫЙ
minutes. von 15-30°C erreichen. durante 30 minutos antes de realizar la prueba. fluid until it flows up to the Fill-line Extraktionsröhrchen mit in the tube in den nostril. Gently rub and roll Sie den Tupfer durch das buffer fluid inside the extraction tube, die Tupferspitze in der Pufferflüssigkeit close the cap of ab und schließen
EN The presence of only the control line (C) and no DE Erscheinen eine Kontrolllinie (C) ES La presencia de solo la línea de control (C) y
Note: Healthcare professionals should comply Hinweis: Das medizinische Personal sollte die Note: Los profesional de la salud deben cumplir of the extraction tube (300μl). Pufferflüssigkeit, bis die Fülllinie des rack. Röhrchenständer. the swab, 3-4 times. Leave Nasenloch ein. Reiben und pushing into the wall of the extraction des Extraktionsröhrchens. Drücken Sie extraction tube. Sie den Deckel des
test line (T) within the result window indicates a und keine Testlinie (T) innerhalb des ninguna línea de prueba (T) dentro de la ventana
with personal safety guidelines including the use persönlichen Sicherheitsrichtlinien einschließlich con las pautas de seguridad personal, incluido el Extraktionsröhrchens erreicht ist Coloque el tubo the swab in place for several rollen Sie den Tupfer vorsichtig tube at least five times and then squeeze dabei den Tupfer mindestens fünfmal an Extraktionssröhrchens.
of personal protective equipment. der Verwendung persönlicher Schutzausrüstung uso de equipo de protección personal. Caution: If the amount of (300 μl). ES FR Placez le tube seconds. Slowly remove swab. 3-4 Mal. Lassen Sie den Tupfer out the swab by squeezing the extraction die Wand des Extraktionsröhrchens und
negative result. Testergebnislesefensters, ist das Ergebnis negativ. de resultados indica un resultado negativo.
de extracción d'extraction Quiebre el hisopo en FR Cassez l'écouvillon au
einhalten. buffer is excessive or insufficient, an für einige Sekunden an Ort tube with your fingers. drücken Sie anschließend denn Tupfer ES La présence seule de la ligne de contrôle (C) La presenza della sola linea di controllo (C) e A presença apenas da linha de controle (C) e
Achtung: Bei einer zu hohen oder en la gradilla dans le support el punto de ruptura point de rupture et FR IT PT
improper test result may occur. und Stelle. Entfernen Sie den aus, indem Sie mit den Fingern das et aucune ligne de test (T) dans la fenêtre de nessuna linea di test (T) all'interno della finestra nenhuma linha de teste (T) dentro da janela de
Laissez tous les composants du kit atteindre une Consentire a tutti i componenti del kit di Deixe todos os componentes do kit atingirem para tubos. de tubes. y cierre la tapa del fermez le capuchon
FR IT PT geringen Puffermenge sind falsche Tupfer langsam. Extraktionsröhrchen zusammendrücken. résultat indique un résultat négatif. dei risultati indica un risultato negativo. resultado indica um resultado negativo.
température comprise entre 15 et 30 ° C avant de raggiungere una temperatura tra 15-30°C per uma temperatura entre 15-30°C antes do teste Testergebnisse möglich. IT Posizionare PT Coloque o tubo
tubo de extracción. du tube d'extraction.
procéder au test pendant 30 minutes. 30 minuti prima dell'esecuzione del test. por 30 minutos. la provetta de extração ES Incline la cabeza del paciente FR Inclinez la tête du patient en Inserte la muestra de hisopado en el tubo FR Insérez l'échantillon sur écouvillon dans le Наличие только контрольной линии
ES RU
Remarque: le professionnel de santé doit se Nota: Gli operatori sanitari devono rispettare le Nota: Profissionais de saúde devem cumprir as ES Sostenga el frasco de tampón FR Tenez le flacon de tampon di estrazione no suporte de hacia atrás. Inserte el hisopo a arrière. Insérez l'écouvillon de extracción. Gire la punta del hisopo tube d'extraction. Faites tourbillonner la (С) и отсутствие тестовой линии (Т) в
conformer aux directives de sécurité personnelle, linee guida per la sicurezza personale, incluso l'uso diretrizes de segurança pessoal, incluindo o uso verticalmente y llene el tubo de verticalement et remplissez le tube nel rack tubos. traves de la fosa nasal. Frote y dans la narine. Frottez et en la solución tampón dentro del tubo de pointe de l'écouvillon dans le fluide tampon IT Spezzare il tampone PT Quebre o swab no
окошке для считывания указывает на
y compris l'utilisation d'équipements de protection di dispositivi di protezione personale. de equipamento de proteção individual. extracción con solución tampón d'extraction avec du liquide tampon portaprovette. gire suavemente el hisopo, 3 a roulez doucement l'écouvillon, extracción, empujando hacia la pared del à l'intérieur du tube d'extraction, en nel punto di rottura ponto de quebra e
отрицательный результат теста.
individuelle. hasta que fluya hasta la línea de jusqu'à ce qu'il s'écoule jusqu'à la ligne 4 veces. Deje el hisopo en su 3 à 4 fois. Laissez l'écouvillon tubo de extracción al menos cinco veces poussant dans la paroi du tube d'extraction e chiudere il tappo feche a tampa do
llenado del tubo de extracción de remplissage du tube d'extraction RU Установите lugar durante varios segundos. en place pendant plusieurs y luego exprima el hisopo apretando el au moins cinq fois, puis faites sortir della provetta di tubo de extração.
RU Перед тестированием выдержите все компоненты (300μL). (300 μl). экстракционную Retire lentamente el hisopo. secondes. Retirez lentement tubo de extracción con los dedos. l'écouvillon en pressant le tube d'extraction estrazione.
набора в течение 30 минут при температуре 15-30 °C пробирку в l'écouvillon. avec vos doigts.
Примечание: Медицинский работник должен Precaución: Si la cantidad de Attention: Si la quantité de штатив. RU Тампон
соблюдать правила техники безопасности, включая Inclinare la testa del paziente Incline a cabeça do paciente Inserire il tampone di campionamento Insira a amostra de esfregaço no tubo de разламывают в
tampón es excesiva o insuficiente, tampon est excessive ou insuffisante, IT PT IT PT
all'indietro. Inserire il tampone para trás. Insira o swab pela nella provetta di estrazione. Ruotare la extração. Gire a ponta do swab no fluido точке разлома,
использование средств индивидуальной защиты. puede producirse un resultado de
prueba incorrecto.
un résultat de test incorrect peut se
produire.
attraverso la narice. Strofinare narina. Esfregue e role punta del tampone nel liquido all'interno tampão dentro do tubo de extração, и колпачок POSITIVE / POSITIV / POSITIVA / POSITIF / POSITIVO / POSITIVO / ПОЛОЖИТЕЛЬНЫЙ
e ruotare delicatamente il suavemente o swab, 3-4 vezes. della provetta di estrazione, spingendo empurrando na parede do tubo de extração для пробирки
Tenere il flacone del buffer The presence of the test line (T) and the control Erscheinen eine Kontrolllinie (C) und eine Testlinie La presencia de la línea de prueba (T) y la
PT Segure o frasco de tampão

2
IT tampone 3-4 volte. Lasciare il Deixe o swab no lugar por sulla parete della provetta di estrazione pelo menos cinco vezes e, em seguida, экстракционной EN DE ES
line (C) within the result window, regardless (T) innerhalb des Testergebnislesefensters, línea de control (C) dentro de la ventana de
EN Open the package and look for the following: DE Öffnen Sie die Verpackung und Entnehmen ES Abra el paquete y revise los siguientes verticalmente e riempire la provetta verticalmente e encha o tubo de tampone in posizione per alcuni alguns segundos. Remova o almeno cinque volte e poi premere aperte o swab apertando o tubo de закрывают.
1. Test device with desiccant in individual Sie Folgendes: componentes: di estrazione fino alla linea di extração com fluido de tampão secondi. Rimuovere lentamente swab lentamente. of which line appears first, indicates a positive unabhängig davon, welche Linie zuerst erscheint, resultados, independientemente de la línea que
il tampone strizzando la provetta di extração com os dedos.
foil pouch 1. Testkassetten verpackt in Folienbeutel 1. Dispositivo de prueba con desecante en riempimento della provetta di até que ele flua até a linha de il tampone. result. ist das Ergebnis positiv. aparezca primero, indica un resultado positivo.
estrazione con le dita.
2. Buffer mit Trockenmittel bolsa de aluminio individual estrazione (300 µl). enchimento do tubo de extração Caution: The presence of any test line (T), Achtung: Jede Testlinie (T), unabhängig Precaución: La presencia de cualquier
3. Extraction tube 2. Puffer 2. Solución tampón (300μL). RU Наклоняют голову пациента
Attenzione: Se la quantità di RU Вставьте тампон с образцом no matter how faint, indicates a positive result. davon, wie schwach diese Linie ist, ist als positives línea de prueba (T), no importa cuán débil sea,
4. Extraction tube cap 3. Extraktionsröhrchen 3. Tubo de extracción назад. Вставляют тампон
Cuidado: Se a quantidade de
в экстракционную пробирку. Testergebnis zu bewerten. indica un resultado positivo.
5. Positive control swab 4. Deckel für Extraktionsröhrchen 4. Tapa de tubos de extracción buffer è eccessiva o insufficiente, через. Аккуратно потрите Наконечник тампона
6. Negative control swab 5. Positivkontrolltupfer 5. Hisopo control positivo potrebbe verificarsi un risultato di tampão for excessiva ou insuficiente, поверхность тампоном и проворачивают в буферном La présence de la ligne de test (T) et de la ligne La presenza della linea di test (T) e della A presença da linha de teste (T) e da linha de
FR IT PT
7. Sterilized nasopharyngeal swabs for 6. Negativkontrolltupfer 6. Hisopo control negativo test errato. um resultado de teste impróprio поверните его 3-4 раза. растворе внутри экстракционной de contrôle (C) dans la fenêtre de résultat, linea di controllo (C) all'interno della finestra controle (C) dentro da janela de resultados,
sample collection 7. Sterilisierte nasopharyngeale Tupfer zur 7. Hisopos nasofaríngeos esterilizados para pode ocorrer. Оставляют тампон на пробирки, вдавливая его в стенку quelle que soit la ligne qui apparaît en premier, dei risultati, indipendentemente dalla linea independentemente de qual linha apareça
8. Tube rack Probenahme la recolección de muestras несколько секунд. Медленно экстракционной пробирки не менее indique un résultat positif. visualizzata per prima, indica un risultato primeiro, indica um resultado positivo.
RU Держа флакон с буфером извлекают тампон.
9. Quick reference guide (Nasopharyngeal) 8. Ständer für Röhrchen 8. Gradilla para tubos пяти раз, а затем тампон выжимают, positivo.
вертикально наполните Attention: la présence d'une ligne de test Cuidado: A presença de qualquer linha de
10. Instructions for use 9. Kurzanleitung (Nasopharyngeal) 9. Guía de referencia rápida (nasofaríngea) сдавливая экстракционную
экстракционную пробирку (T), aussi faible soit-elle, indique un résultat Attenzione: La presenza di qualsiasi linea di teste (T), não importa o quão tênue, indica um
10. Gebrauchsanweisung 10. Instrucciones de uso

x5
буферным раствором, пока она пробирку пальцами.
positif. test (T), non importa quanto debole, indica un resultado positivo.
FR Ouvrez la boite et recherchez les éléments IT Aprire la confezione e cercare quanto segue: PT Abra o pacote e observe o seguinte: не дойдет до линии заполнения risultato positivo.
suivants 1. Dispositivo di test confezionato 1. Dispositivo de teste com dessecante em экстракционной пробирки (300
1. Testeur avec déshydratant dans un sachet singolarmente in busta di alluminio con bolsa individual мкл). RU Положительный результат: Наличие
individuel en aluminium essiccante 2. Tampão Предупреждение: Если тестовой (T) и контрольной (C) линии в

3-4x
2. Solution tampon 2. Buffer 3. Tubo de extração окне результата, независимо от того, какая
объем буфера чрезмерен или
3. Tube d'extraction 3. Provetta di estrazione 4. Tampa de tubos de extração линия появляется первой, указывает на
недостаточен, результат теста
4. Bouchon pour les tubes d'extraction 4. Tappo della provetta di estrazione 5. Swab controle positivo положительный результат.
может быть неправильным.
5. Écouvillon de contrôle positif 5. Tampone di controllo positivo 6. Swab controle negativo Предупреждение: Наличие тестовой
6. Écouvillon de contrôle négatif 6. Tampone di controllo negativo 7. Swabs nasofaríngeos esterilizados para линии (Т), какой бы слабой она ни была,
7. Écouvillons nasopharyngés stérilisés pour 7. Tamponi sterili nasofaringei per la coleta de amostra свидетельствует о положительном
le prélèvement d'échantillons raccolta del campione 8. Suporte para tubos результате.
8. Porte tubes 8. Rack portaprovette 9. Guia de referência rápida (nasofaríngea)
9. Guide de référence rapide 9. Guida rapida di riferimento 10. Instruções de uso
(nasopharyngé) (Nasofaringeo)
10. Notice d'utilisation 10. Istruzioni per l'uso

RU Откройте упаковку и проверьте комплектность:

1. Тест-кассета в индивидуальной вакуумной упаковке с
осушителем INVALID / UNGÜLTIG / NO VÁLIDA / INVALIDE / INVALIDO / INVÁLIDO / НЕВЕРНЫЙ РЕЗУЛЬТАТ
2. Буфер
3. Пробирка экстракционная EN If the control line (C) is not visible within the DE Ist die Kontrolllinie (C) nach der Testdurchführung ES Si la línea de control (C) no está visible dentro
4. Колпачок для пробирки экстракционной result window after performing the test, the innerhalb des Testergebnislesefensters nicht de la ventana de resultados después de realizar
5. Положительный контрольный образец result is considered invalid. Instructions may not sichtbar, ist das Ergebnis ungültig. la prueba, el resultado se considera inválido. Es
6. Отрицательный контрольный образец have been followed correctly. It is recommended Die Anweisungen wurden möglicherweise nicht posible que las instrucciones no se hayan seguido

6 7 8 9 10
7. Стерильные назофарингеальные тампоны (тупферов) для to read the IFU again before re-testing the korrekt befolgt. Es wird empfohlen, die IFU correctamente. Se recomienda volver a leer las
EN Open the DE Öffnen Sie die Kappe EN Dispense 5 drops of extracted specimens vertically into the DE Geben Sie 5 Tropfen der extrahierten Proben senkrecht EN Close the nozzle DE Schließen Sie die EN Start timer. Read DE Starten Sie die Uhr EN Dispose of the used DE Entsorgen Sie
сбора образцов specimen with a new test device. erneut zu lesen, bevor die Probe mit einer neuen instrucciones de uso antes de volver a analizar la
dropping nozzle der Dosieröffnung specimen well (S) on the device. Do not handle or move the in die Probenvertiefung (S) der Testkassette. Bewegen Sie and dispose of the Dosieröffnung und entsorgen result at 15 minutes. und lesen Sie das device according to die gebrauchte
8. Штатив Testkassette erneut getestet wird. muestra con un nuevo dispositivo de prueba.
cap at the bottom am Boden des test device until the test is complete and ready for reading. die Testkassette nicht, bis der Test abgeschlossen und zum extraction tube Sie das Extraktionsröhrchen Do not read results Ergebnis nach 15 your local regulations Testkassette gemäß
9. Краткое руководство (назофарингеальный тампон)
of the extraction Extraktionsröhrchens. Ablesen bereit ist. containing the used mit dem gebrauchten after 20 minutes. Minuten ab. Lesen and biohazard waste den örtlichen Si la ligne de contrôle (C) n'est pas visible dans Se la linea di controllo (C) non è visibile Se a linha de controle (C) não estiver visível
10. Инструкция по применению Caution: Bubbles that occur in the extraction tube FR IT PT
tube. swab according to your Tupfer gemäß den örtlichen Sie das Ergebnis disposal protocol. Vorschriften und dem la fenêtre de résultat après l'exécution du test, all'interno della finestra dei risultati dopo na janela de resultados após a realização do
can lead to inaccurate results. If you are unable to create Achtung: Blasen, die im Extraktionsröhrchen auftreten, local regulations and Vorschriften und dem nicht mehr nach 20 Entsorgungsprotokoll
Abra la tapa de Ouvrez le sufficient drops, this may be caused by clogging in the le résultat est considéré comme invalide. Les l'esecuzione del test, il risultato viene teste, o resultado é considerado inválido.
ES FR können zu ungenauen Ergebnissen führen. Wenn Sie nicht biohazard waste disposal Entsorgungsprotokoll für Minuten ab. für biologisch

3
la boquilla de capuchon de la dispensing nozzle. Shake the tube gently to release the instructions peuvent ne pas avoir été suivies considerato non valido. Le istruzioni potrebbero As instruções podem não ter sido seguidas
Carefully read these instructions prior to using Lesen Sie diese Anleitung vor Verwendung des Lea cuidadosamente estas instrucciones de uso in der Lage sind, genügend Tropfen zu erzeugen, kann dies protocol. biologisch gefährliche Abfälle. gefährlichen Abfall. correctement. Il est recommandé de relire la non essere state seguite correttamente. Si corretamente. É recomendável ler o a instrução
EN DE ES goteo en la parte buse à goutte blockage until you observe free drop formation.
Panbio™ COVID-19 Ag Rapid Test Device kit. Panbio™ COVID-19 Ag Rapid Test Device antes de usar Panbio™ COVID-19 Ag Rapid an einer Verstopfung der Dosieröffnung liegen. Schütteln ES De inicio al FR Démarrer le notice d'utilisation avant de tester à nouveau consiglia di leggere nuovamente il foglietto de uso novamente antes de testar novamente a
inferior del tubo au bas du tube Cierre la boquilla y Fermez la buse et jetez
sorgfältig durch. Test Device kit. Sie das Röhrchen leicht, um die Verstopfung zu lösen, bis Sie ES FR temporizador. Leer minuteur, lire le ES Deseche el dispositivo FR L'Elimination des l'échantillon avec un nouveau dispositif de test. illustrativo prima di testare nuovamente il amostra com um novo dispositivo de teste.
de extracción. d'extraction. deseche el tubo de le tube d'extraction resultado a los 15 résultat à 15 minutes. usado de acuerdo appareils usagés se fait
eine freie Tropfenbildung beobachten können. campione con un nuovo dispositivo di test.
Lisez attentivement ces instructions avant Leggere attentamente queste istruzioni prima Leia atentamente estas instruções antes de usar extracción que contiene el avec l'écouvillon usagé minutos. No lea los Ne pas lire le résultat con las regulaciones conformément à la
FR IT PT Aprire il tappo Abra a tampa
d'utiliser le kit de Panbio™ COVID-19 Ag Rapid di utilizzare il kit Panbio™ COVID-19 Ag Rapid o kit Panbio™ COVID-19 Ag Rapid Test Device. IT PT Dispense 5 gotas de las muestras extraídas verticalmente en Distribuer verticalement 5 gouttes d'échantillons extraits hisopo usado de acuerdo conformément à resultados después après 20 minutes. locales y el protocolo réglementation locale RU Если контрольная линия (С) не
dell'ugello do bico de ES FR видна в окне результатов после
Test Device. Test Device. el pocillo de la muestra (S) en el dispositivo. No manipule dans le puits d'échantillon (S) de l'appareil. Ne pas manipuler con las regulaciones vos réglementations de 20 minutos. de eliminación de en vigueur et selon le
posizionato nella gotejamento na выполнения теста, результат считается
ni mueva el dispositivo de prueba hasta que la prueba esté ni déplacer le dispositif de test tant que le test n'est pas locales y el protocolo de locales et au protocole desechos de riesgo protocole d'élimination
Перед использованием Экспресс-теста parte inferiore parte inferior do неверным. Инструкции могли быть
RU completa y lista para leer. terminé et prêt pour la lecture. eliminación de desechos d'élimination des déchets biológico. des déchets dangereux.
Panbio™ COVID-19 Ag (Panbio™ COVID-19 della provetta di tubo de extração. Avviare il timer. Inicie o cronômetro. выполнены неправильно. В этом
de riesgo biológico. biologiques. IT PT
Ag Rapid Test Device) внимательно estrazione. Precaución: Las burbujas que se forman en el tubo Attention: les bulles qui se produisent dans le tube Leggere il risultato Leia o resultado Smaltire il dispositivo PT Descarte o dispositivo случае рекомендуется снова прочитать
IT
прочитайте данные инструкции. Chiudere l'ugello e usato in base alle usado de acordo com
Откройте крышку de extracción pueden dar lugar a resultados incorrectos. d'extraction peuvent conduire à des résultats inexacts. Si IT PT Feche o bico e descarte a 15 minuti. Non do teste em 15 инструкцию по применению перед
RU Si no puede crear suficientes gotas, esto puede deberse a vous ne parvenez pas à créer suffisamment de gouttes, smaltire la provetta di o tubo de extração leggere i risultati minutos. Não leia os normative locali os regulamentos повторным тестированием образца с
колпачка - estrazione contenente contendo o swab usado e al protocollo di locais e o protocolo de
una obstrucción en la boquilla dispensadora. Agite el tubo cela peut être dû à un colmatage de la buse de distribution. dopo 20 minuti. resultados após 20 использованием новой тест-кассетой.

4
капельницы в il tampone usato in de acordo com os smaltimento dei rifiuti descarte de resíduos de
Look at the expiration date of the kit box. If the Beachten Sie das Verfallsdatum der Kit- Revise la fecha de vencimiento de la caja del kit. нижней части suavemente para liberar el bloqueo hasta que observe la Secouez doucement le tube pour libérer le blocage jusqu'à ce minutos.
EN DE ES base alle normative regulamentos locais e o biologici. risco biológico.
expiration date has passed, use another kit. Box. Wenn das Verfallsdatum abgelaufen ist, Si la fecha de vencimiento ha pasado, use otro экстракционной formación de gotas libres. que vous observiez la formation de gouttes libres. RU Запустите таймер.
locali e al protocollo di protocolo de descarte Результат можно
verwenden Sie einen anderen Kit kit. пробирки.
Dispensare 5 gocce di campione estratto verticalmente Dispense 5 gotas das amostras extraídas verticalmente na smaltimento dei rifiuti de resíduos de risco считывать через 15 RU Использованную тест-
IT PT кассету утилизируют
FR Regardez la date d'expiration de la boîte du kit. IT Guarda la data di scadenza della scatola del kit. PT Observe a data de validade da caixa do kit. Se a nel pozzetto del test (S) sul dispositivo. Non maneggiare o cavidade da amostra (S) do dispositivo. Não manuseie ou biologici. biológico. минут. Не считывайте
Si la date d'expiration est dépassée, utilisez un Se la data di scadenza è trascorsa, usa un altro data de validade já passou, use outro kit. spostare il dispositivo fino a quando il test non è completo e mova o dispositivo de teste até que o teste esteja concluído e результаты, если прошло в соответствии с
autre kit. kit. pronto per la lettura. pronto para leitura. Закройте колпачок- 20 минут и больше. местными правилами и
RU
капельницу, и утилизируйте протоколом утилизации
RU Проверьте срок годности набора. Если Attenzione: La comparsa di bolle nella provetta di Cuidado: As bolhas que ocorrem no tubo de экстракционную биологически опасных
срок годности прошел, используйте estrazione può portare a risultati imprecisi. Se non si riuscisse extração podem levar a resultados imprecisos. Se você não пробирку, содержащую отходов.
другой набор. ad ottenere un numero di gocce sufficienti, ciò potrebbe conseguir criar gotas suficientes, isso pode ser causado por использованный тампон в
essere causato dall'intasamento dell'ugello di erogazione. entupimento no bico dispensador. Agite o tubo suavemente соответствии с местными
Agitare delicatamente la provetta per rimuovere l'ostruzione para liberar o bloqueio até observar a formação livre de gotas. правилами и протоколом

5
fino a osservare la formazione di goccia libera. утилизации биологически
EN Open the foil pouch and look for the following: DE Öffnen Sie den Folienbeutel und schauen Sie nach ES Abra la bolsa de aluminio y revise lo siguiente:
опасных отходов. GLOSSARY OF SYMBOLS / SYMBOLVERZEICHNIS / GLOSARIO DE SÍMBOLOS / GLOSSAIRE DES SYMBOLES / GLOSSARIO DEI SIMBOLI
1. Result window Folgendem: 1. Ventana de resultados
2. Specimen well 1. Testergebnislesefenster 2. Pocillo de muestra RU Внесите 5 капель раствора из экстракционной / GLOSSÁRIO DE SÍMBOLOS / ГЛОССАРИЙ ОБОЗНАЧЕНИЙ
пробирки вертикально в ячейку для образца (S) на
Then, label the device with the patient identifier. 2. Probenvertiefung Luego, rotule el dispositivo con el identificador del
тест-кассете. Не трогайте и не перемещайте тест-
Beschriften Sie die Testkassette mit der Patient-ID. paciente.
кассету, пока тест не будет завершен и готов к Contains sufficient for X tests
Temperature limitation Lot Number Manufacturer
FR Ouvrez la pochette en aluminium et recherchez IT Aprire la busta di alluminio e cercare quanto PT Abra a bolsa de alumínio e observe o seguinte: считыванию. Temperaturbegrenzung Chargencode Hersteller Ausreichend für X Prüfungen
les éléments suivants: segue: 1. Janela de resultados Limitación de temperatura Número de lote Fabricante Contiene suficiente para X pruebas
1. Fenêtre de résultats 1. Finestra dei risultati 2. Cavidade de amostra Предупреждение: Пузырьки, возникающие Contient suffisamment pour les tests X
Limitation de température Numéro de lot Fabricant
2. Échantillon bien 2. Pozzetto del campione Em seguida, rotule o dispositivo com o в экстракционной пробирке, могут привести к Limitazione di temperatura Numero di lotto Produttore Contenuto sufficiente per X test
Ensuite, étiquetez l'appareil avec l'identifiant du Quindi, etichettare il dispositivo con l'identificatore identificador do paciente. неточным результатам. Если отмерить достаточное Limitação de temperatura Número de Lote Fabricante Contém suficiente para X testes
количество капель не удается, это может быть Температурный диапазон Номер серии Производитель Содержит материалы, достаточные для
patient. del paziente. выполнения Х тестов
вызвано засорением колпачка-капельницы.
RU Откройте индивидуальную упаковку тест-
1 2 Осторожно встряхните пробирку, чтобы устранить
15-20
5x
кассеты и проверьте комплектность: For in vitro diagnostic use only Catalog Number Date of manufacture Biological Risks
обструкцию, пока не образуются свободные капли. Medizinprodukt für in-vitro Diagnostik Artikelnummer Herstellungsdatum Biologisches Risiko
1. Окно результата
2. Ячейка для образца
MIN Sólo para uso diagnóstico in vitro Número de catalogo Fecha de manufactura Riesgos biológicos
Pour un usage de diagnostic in vitro uniquement Numéro de catalogue Date de fabrication Risques biologiques
Затем наклейте на тест-кассету Ad uso esclusivo diagnostico in vitro Numero di catalogo Data di produzione Rischi biologici
идентификатор пациента. Somente para uso para diagnóstico in vitro Número no Catálogo Data de fabricação Riscos Biológicos
Медицинское изделие для диагностики In Vitro Каталожный номер Дата производства Биологическая опасность

Do not reuse Consult instructions for use Keep away from sunlight Do not use if package is damaged
Nicht wiederverwenden Gebrauchsanleitung beachten Von Sonnenlicht fernhalten Bei beschädigter Verpackung nicht verwenden
No reutilizar Consultar instrucciones de uso Mantener alejado de la luz solar No lo use si el paquete está dañado
Ne pas réutiliser Consulter les instructions d'utilisation Tenir à l'écart de la lumière du soleil Ne pas utiliser si le colis est endommagé
Non riutilizzare Consultare le istruzioni per l'uso Tenere lontano dalla luce solare Non utilizzare se la confezione è danneggiata
Não reutilizar Consulte as instruções de uso Manter longe da luz solar Não use se o pacote estiver danificado
: 5 drops of the extracted specimen / 5 Tropfen der extrahierten Probe / 5 gotas de la muestra extraída Не использовать повторно См. Инструкцию по применению Беречь от попадания солнечных лучей Не используйте, если упаковка
повреждена
/ 5 gouttes de l'échantillon extrait / 5 gocce del campione estratto / 5 gotas da amostra extraída
/ 5 капель раствора из экстракционной пробирки Use By Keep dry Caution CE mark
Verwendbar bis Trocken aufbewahren Achtung CE Zeichen
Usar por Mantener seco Precaución Marca CE
Utiliser par Garder au sec Attention Marquage CE
Utilizzare per Mantenere asciutto Attenzione Marcatura CE
Usar até Manter seco Cuidado Marca CE
Date Issued : 2020.08 Использовать до Хранить в сухом месте Предупреждение Знак соответствия продукции техническим
References / Referenzen / Referencias / Références /Riferimenti / Referências / 4. In Vitro Diagnostic Assays for COVID-19: Recent Advances and Emerging Trends (Sandeep Kumar Vashist, 2020 April TECHNICAL SUPPORT / TECHNISCHER SUPPORT / SOPORTE TÉCNICO / SUPPORT TECHNIQUE / SUPPORTO TECNICO / SUPORTE TÉCNICO
05: diagnostics) / ОТДЕЛ ТЕХНИЧЕСКОЙ ПОДДЕРЖКИ 41FK10-07-A0 регламентам ЕС
Использованная литература 5. Nano Research for COVID-19 (http://dx.doi.org/10.1021/acsnano.0c02540) Do not re-sterilize Sterilized using irradiation Sterilized using ethylene oxide
1. Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J 6. Coronavirus (COVID-19) Update: FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Europe & Middle East / Europa & Mittlerer Osten / Europa y Medio Oriente / Europe & Moyen Orient +44 161 483 9032 | EMEproductsupport@abbott.com Nicht sterilisieren Sterilisiert durch Bestrahlung Sterilisiert mit Ethylenoxid
Autoimmun. 2020; Feb 26:102433. doi: 10.1016/j.jaut.2020.102433. Causes COVID-19 in Patients (Stephen M, Hahn M.D. 2020 May 09: Commisioner of Food and Drugs / Europe & Middle East / Europa e Oriente Médio / Европа, Ближний Восток No volver a esterilizar Esterilizado mediante irradiación. Esterilizado con óxido de etileno.
2. Guo YR, Cao QD, Hong ZS, et al. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) Ne pas re-stériliser Stérilisé par irradiation Stérilisé à l'oxyde d'éthylène
7. Current Intelligence Bulletin 13: Explosive Azide Hazard DHHS (NIOSH) Publication Number 78-127 August 16, 1976 Africa, Russia & CIS / Afrika, Russland & CIS / África, Rusia y CEI / Afrique, Russie & CIS +27 10 500 9700 | ARCISproductsupport@abbott.com Non risterilizzare Sterilizzato con irradiazione Sterilizzato con ossido di etilene
outbreak-an update on the status. Mil Med Res. 2020; Mar 13; 7(1):11.doi:10.1186/s40779-020-00240-0. 8. CDC. Discontinuation of Transmission-Based Precautions and Disposition of Patients with COVID-19 in Healthcare
Abbott Rapid Diagnostics Jena GmbH
/ Africa, Russia & CIS / África, Rússia e CEI / Африка, Россия и СНГ Orlaweg 1, D-07743 Jena, Germany Não reesterilize Esterilizado por irradiação Esterilizado com óxido de etileno
3. Lai CC, Shih TP, Ko WC, et al. Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) and coronavirus Settings (Interim Guidance). (2020).
disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020; Mar 55(3): 105924.doi: Asia Pacific / Asien Pazifik / Asia Pacífico / Asie Pacifique / Asia Pacific / Ásia-Pacífico / Азия, Океания +61 7 3363 7711 | APproductsupport@abbott.com abbott.com/poct Не стерилизуйте повторно Стерилизовано с использованием Стерилизовано окисидом этилена
9. CDC. Duration of Isolation and Precautions for Adults with COVID-19. (2020). облучения
10.1016/j.ijantimicag.2020.105924. Latin America / Lateinamerika / America Latina / Amérique Latine / Latin America / América Latina +57 2 661 8797 | LAproductsupport@abbott.com
/ Латинская Америка © 2020 Abbott. All rights reserved.
All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners.
 4. Dispose of the used control swab in accordance with your biohazard waste disposal protocol. 5. Interfering Substances
41FK10

5. Close the cap of the extraction tube. The following 42 potentially interfering substances have no impact on Panbio™ COVID-19 Ag Rapid Test

6. Follow the above test procedure [Reaction with Test Device]. Device. The final test concentrations of the interfering substances are documented in the Table below.

Types of
No. Interfering Substances Final Test Concentration Test Result
Test Interpretation (Refer to Figure) Specimen
1. Negative result: The presence of only the control line (C) and no test line (T) within the result window indicates 1 Mucin 0.5% No Interference

a negative result. 2 Hemoglobin 100 mg/L No Interference
2. Positive result: The presence of the test line (T) and the control line (C) within the result window, regardless of
3 Triglycerides 1.5 mg/L No Interference

which line appears first, indicates a positive result.
Endogenous
Caution: The presence of any test line (T), no matter how faint, indicates a positive result. 4 Icteric (Bilirubin) 40 mg/dL No Interference
Substance
3. Invalid result: If the control line (C) is not visible within the result window after performing the test, the result 5 Rheumatoid factor 200 IU/ml No Interference

is considered invalid.
6 Anti-nuclear antibody >1:40 No Interference
7 Pregnant 10-fold dilution No Interference
Test Limitations
Panbio ™ 1. The contents of this kit are to be used for the professional and qualitative detection of SARS-CoV-2 antigen 8 Guaiacol glyceryl ether 1 μg/ml No Interference

from nasopharyngeal swab. Other specimen types may lead to incorrect results and must not be used. 9 Albuterol 0.005 mg/dL No Interference

COVID-19 Ag
2. Failure to follow the instructions for test procedure and interpretation of test results may adversely affect test 10 Ephedrine 0.1 mg/ml No Interference

performance and/or produce invalid results.
3. A negative test result may occur if the specimen was collected, extracted or transported improperly. A negative 11 Chlorpheniramine 0.08 mg/dL No Interference
12 Diphenhydramine 0.08 mg/dL No Interference

test result does not eliminate the possibility of SARS-CoV-2 infection and should be confirmed by viral culture

Rapid Test Device

or a molecular assay or ELISA. 13 Ribavirin 26.7 μg /ml No Interference
4. Positive test results do not rule out co-infections with other pathogens.
14 Oseltamivir 0.04 mg/dL No Interference

5. For further information on immune status, additional follow-up testing using other laboratory methods is
15 Zanamivir 17.3 μg /ml No Interference

recommended.
6. Test results must be evaluated in conjunction with other clinical data available to the physician. 16 Phenylephrine hydrochloride 15% v/v No Interference

7. Reading the test results earlier than 15 minutes or later than 20 minutes may give incorrect results.
(NASOPHARYNGEAL)
17 Oxymetazolin hydrochloride 15% v/v No Interference

8. Panbio™ COVID-19 Ag Rapid Test Device is not intended to detect from defective (non-infectious) virus 18 Amoxicillin 5.4 mg/dL No Interference
19 Acetylsalicylic acid 3 mg/dL No Interference

during the later stages of viral shedding that might be detected by PCR molecular tests.8
9. Positive results may occur in cases of infection with >2.5 ng/mL SARS-CoV. 20 Ibuprofen 21.9 mg/dL No Interference
In vitro diagnostic rapid test for qualitative detection of SARS-CoV-2

21 Chlorothiazide 2.7 mg/dL No Interference
antigen (Ag) Quality Control 22 Indapamide 140 ng/ml No Interference
1. Internal Quality Control: 23 Glimepiride (Sulfonylureas) 0.164 mg/dL No Interference

The test device has a test line (T) and a control line (C) on the surface of the test device. Neither the test line nor the
24 Acarbose 0.03 mg/dL No Interference
control line are visible in the result window before applying a specimen. The control line is used for procedural control and
About the Test should always appear if the test procedure is performed properly and the test reagents of the control line are working. 25 Exogenous Ivermectin 4.4 mg/L No Interference
Introduction 26 Substance Lopinavir 16.4 μg/L No Interference
The Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus, severe acute 2. External Quality Control:

respiratory syndrome coronavirus 2 (SARS-CoV-2)1. The SARS-CoV-2 is a β-coronavirus, which is an enveloped non- The controls are specifically formulated and manufactured to ensure performance of the Panbio™ COVID-19 Ag Rapid 27 Ritonavir 16.4 μg/L No Interference
segmented positive-sense RNA virus2. It is spread by human-to-human transmission via droplets or direct contact, Test Device and are used to verify the user’s ability to properly perform the test and interpret the results. The Positive 28 Chloroquine phosphate 0.99 mg/L No Interference
and infection has been estimated to have a mean incubation period of 6.4 days and a basic reproduction number of Control will produce a positive test result and has been manufactured to produce a visible test line (T). The Negative
Sodium chloride with
2.24-3.58. Among patients with pneumonia caused by SARS-CoV-2, fever was the most common symptom, followed Control will produce a negative test result. 29 4.44 mg/ml No Interference
preservatives
by cough3. The main IVD assays used for COVID-19 employ real-time reverse transcriptase-polymerase chain reaction Good laboratory practice suggests the use of positive and negative controls to ensure that:
• Test reagents are working, and 30 Beclomethasone 4.79 ng/ml No Interference
(RT-PCR) that takes a few hours4. The availability of a cost-effective, rapid point-of-care diagnostic test is critical to

enable healthcare professionals to aid in the diagnosis of patients and prevent further spread of the virus5. Antigen tests • The test is correctly performed. 31 Dexamethasone 0.6 µg/ml No Interference

will play a critical role in the fight against COVID-196. Run the external controls under the following circumstances: 32 Flunisolide 0.61 µg/ml No Interference
• With each new operator prior to performing testing on patient specimens,
Test Principle 33 Triamcinolone 1.18 ng/ml No Interference

• When receiving a new test shipment,
Panbio™ COVID-19 Ag Rapid Test Device contains a membrane strip, which is pre-coated with immobilized anti-

• At periodic intervals as dictated by local, state and country requirements, and/or by the user’s Quality Control 34 Budesonide 2.76 ng/ml No Interference
SARS-CoV-2 antibody on the test line and mouse monoclonal anti-chicken IgY on the control line. Two types of

procedures. 35 Mometasone 1.28 ng/ml No Interference
conjugates (human IgG specific to SARS-CoV-2 Ag gold conjugate and chicken IgY gold conjugate) move upward
on the membrane chromatographically and react with anti-SARS-CoV-2 antibody and pre-coated mouse monoclonal 36 Fluticasone 2.31 ng/ml No Interference
anti-chicken IgY respectively. For a positive result, human IgG specific to SARS-CoV-2 Ag gold conjugate and anti- Performance Characteristics 37 Sulfur 9.23 µg/ml No Interference
SARS-CoV-2 antibody will form a test line in the result window. Neither the test line nor the control line are visible in 1. External evaluation of Panbio™ COVID-19 Ag Rapid Test Device
38 Benzocaine 0.13 mg/ml No Interference

the result window prior to applying the patient specimen. A visible control line is required to indicate a test result is valid. Clinical performance of Panbio™ COVID-19 Ag Rapid Test Device was determined by testing 140 positive and
445 negative specimens for SARS-CoV-2 antigen (Ag) to have a sensitivity of 91.4% (95% CI: 85.5-95.5%) and 39 Menthol 0.15 mg/ml No Interference
Intended Use
specificity of 99.8% (95% CI: 98.8-100%). Clinical specimens were determined to be positive or negative using an 40 Mupirocin 10 µg/ml No Interference
Panbio™ COVID-19 Ag Rapid Test Device is an in vitro diagnostic rapid test for the qualitative detection of SARS-
CoV-2 antigen (Ag) in human nasopharyngeal swab specimens from individuals who meet COVID-19 clinical and / or FDA EUA RT-PCR reference method. 41 Tobramycin 24.03 µg/ml No Interference
epidemiological criteria. Panbio™ COVID-19 Ag Rapid Test Device is for professional use only and is intended to be Panbio™ COVID-19 Ag Rapid Test Device Results 42 Biotin 1.2 ug/ml No Interference
used as an aid in the diagnosis of SARS-CoV-2 infection. The product may be used in any laboratory and non-laboratory
PCR Test Result 6. Repeatability & Reproducibility
environment that meets the requirements specified in the Instructions for Use and local regulation.

Repeatability & Reproducibility of Panbio™ COVID-19 Ag Rapid Test Device was established using in-
The test provides preliminary test results. Negative results don’t preclude SARS-CoV-2 infection and they cannot be Positive Negative Total house reference panels containing negative specimens and a range of positive specimens. There were no
used as the sole basis for treatment or other management decisions. Negative results must be combined with clinical
Positive 128 1 129 differences observed within-run, between-run, between-lots, between-sites, and between-days.
observations, patient history, and epidemiological information. The test is not intended to be used as a donor screening
Panbio™ COVID-19 Ag
test for SARS-CoV-2. Negative 12 444 456
Rapid Test Device Results
Total 140 445 585 References
Materials Provided Overall Percent
1. Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19)

• 25 Test devices with desiccant in individual foil pouch Sensitivity Specificity outbreak. J Autoimmun. 2020; Feb 26:102433. doi: 10.1016/j.jaut.2020.102433.
Agreement 2. Guo YR, Cao QD, Hong ZS, et al. The origin, transmission and clinical therapies on coronavirus disease

• Buffer (1 x 9 ml/bottle)

91.4% 99.8% 97.8% 2019 (COVID-19) outbreak-an update on the status. Mil Med Res. 2020; Mar 13; 7(1):11.doi:10.1186/

• 25 Extraction tubes
[85.5%;95.5%] [98.8%;100%] [96.2%;98.8%] s40779-020-00240-0.

• 25 Extraction tube caps
3. Lai CC, Shih TP, Ko WC, et al. Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) and

• 1 Positive control swab • Performance data was calculated from a study of individuals suspected of exposure to COVID-19 or who

coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents.

• 1 Negative control swab

have presented with symptoms in the last 7 days. 2020; Mar 55(3): 105924.doi: 10.1016/j.ijantimicag.2020.105924.

• 25 Sterilized nasopharyngeal swabs for sample collection
• Stratification of the positive specimens post onset of symptoms or suspected exposure between 0-3 days 4. In Vitro Diagnostic Assays for COVID-19: Recent Advances and Emerging Trends (Sandeep Kumar

• 1 Tube rack


has a sensitivity of 94.9% (n=39) and 4-7 days has a sensitivity of 90.1% (n=101). Vashist, 2020 April 05: diagnostics)

• 1 Quick reference guide (Nasopharyngeal)
• Positive agreement of the Panbio™ COVID-19 Ag Rapid Test Device is higher with samples of Ct values 5. Nano Research for COVID-19 (http://dx.doi.org/10.1021/acsnano.0c02540)

• 1 Instructions for use

6. Coronavirus (COVID-19) Update: FDA Authorizes First Antigen Test to Help in the Rapid Detection

≤33 with a sensitivity of 94.1%. As suggested in References 8 and 9, patients with Ct value >33 are no


of the Virus that Causes COVID-19 in Patients (Stephen M, Hahn M.D. 2020 May 09: Commisioner

DRAFT
longer contagious.8, 9
Materials Required but not Provided 2. Detection Limit of Food and Drugs
• Personal Protective Equipment, Timer, Biohazard container 7. Current Intelligence Bulletin 13: Explosive Azide Hazard DHHS (NIOSH) Publication Number 78-

Panbio™ COVID-19 Ag Rapid Test Device was confirmed to detect 2.5X101.8 TCID50/ml of SARS-CoV-2


which was isolated from a COVID-19 confirmed patient in Korea. 127 August 16, 1976
Active Ingredients of Main Components 3. Hook Effect 8. CDC. Discontinuation of Transmission-Based Precautions and Disposition of Patients with

COVID-19 in Healthcare Settings (Interim Guidance). (2020).

• 1 Test device There is no hook effect at 1.0x105.8 TCID50/ml of SARS- CoV-2 which was isolated from a COVID-19
9. CDC. Duration of Isolation and Precautions for Adults with COVID-19. (2020).

Gold conjugate: Human IgG specific to SARS-CoV-2 Ag gold colloid and Chicken IgY - gold colloid, Test line: confirmed patient in Korea.

Mouse monoclonal anti-SARS-CoV-2, Control line: Mouse monoclonal anti-Chicken IgY 4. Cross Reactivity

• Buffer Cross-reactivity of Panbio™ COVID-19 Ag Rapid Test Device was evaluated by testing 25 viruses and 14
Date Issued : 2020.08

Tricine, Sodium Chloride, Tween 20, Sodium Azide (<0.1%), Proclin 300 other microorganisms. The final test concentrations of viruses and other microorganisms are documented
in the Table below. The following viruses and other microorganisms except the Human SARS-coronavirus 41FK10-01-EN-A2
Nucleoprotein have no effect on the test results of Panbio™ COVID-19 Ag Rapid Test Device.
Storage and Stability Panbio™ COVID-19 Ag Rapid Test Device has cross-reactivity with Human -SARS-coronavirus
1. The test kit should be stored at a temperature between 2-30 °C. Do not freeze the kit or its components. Nucleoprotein at a concentration of 25 ng/ml or more because SARS-COV has high homologous (79.6%)

Note: When stored in a refrigerator, all kit components must be brought to room temperature (15-30 °C) to the SARS-COV-2.
for a minimum of 30 minutes prior to performing the test. Do not open the pouch while components come Types of Final Test Concen-
to room temperature. No. Cross Reaction Substance Test Result
Specimen tration
2. The Buffer bottle may be opened and resealed for each assay. The Buffer cap should be firmly sealed between
1 Adenovirus Type3 2.0 X 106.5 TCID50/ml No cross reaction

each use. The Buffer is stable until expiration date if kept at 2-30 °C.
3. Perform the test immediately after removing the test device from the foil pouch. 2 Adenovirus Type7 2.0 X 104.75 TCID50/ml No cross reaction

4. Do not use the test kit beyond its expiration date. 3 Echovirus2 1.0 X 106.5 TCID50/ml No cross reaction

5. The shelf life of the kit is as indicated on the outer package. 4 Echovirus11 2.0 X105.25 TCID50/ml No cross reaction

6. Do not use the test kit if the pouch is damaged or the seal is broken.
5 Human herpesvirus (HSV) 1 2.0 X 106.25 TCID50/ml No cross reaction

7. Direct swab specimens should be tested immediately after collection. If immediate testing is not possible, the

swab specimen can be kept in an extraction tube filled with extraction buffer (300 μl) at room temperature 6 Human herpesvirus (HSV) 2 2.0 X 104.75 TCID50/ml No cross reaction
(15-30 °C) for up to two hours prior to testing. 7 Mumps Virus Ag 2.0 X 103.5 TCID50/ml No cross reaction
Influenza virus A (H1N1) Strain (A/Virginia/
8 2.6 X 105.0 PFU/ml No cross reaction
Warnings ATCC1/2009)
1. For in vitro diagnostic use only. Do not reuse the test device and kit components. 9 Influenza virus A (H1N1) Strain (A/WS/33) 5.0 X 107.25 TCID50/ml No cross reaction

2. These instructions must be strictly followed by a trained healthcare professional to achieve accurate results. All Influenza virus A(H3N2) Strain (A/Hong
10 N/A* No cross reaction

users have to read the instruction prior to performing a test. Kong/8/68)
3. Do not eat or smoke while handling specimens. 11 Influenza virus B Strain (B/Lee/40) 2.0 X 105.25 TCID50/ml No cross reaction

4. Wear protective gloves while handling specimens and wash hands thoroughly afterwards.
12 Parainfluenza Type 1 N/A* No cross reaction

5. Avoid splashing or aerosol formation of specimen and buffer.
Virus

6. Clean up spills thoroughly using an appropriate disinfectant. 13 Parainfluenza Type 2 N/A* No cross reaction

7. Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials (i.e. swab, 14 Parainfluenza Type 3 N/A* No cross reaction

extraction tube, test device) in a biohazard container as if they were infectious waste and dispose according to
15 Parainfluenza Type 4A 1.97 X 107.0 PFU/mL No cross reaction
applicable local regulations.
8. Do not mix or interchange different specimens. 16 Respiratory syncytial virus (RSV) type A 4.22 X 105.0 TCID50/ml No cross reaction

9. Do not mix reagent of different lots or those for other products. 17 Respiratory syncytial virus (RSV) type B 5.62 X 105.0 TCID50/ml No cross reaction

10. Do not store the test kit in direct sunlight. 18 HCoV-HKU1 10 ug/ml No cross reaction

11. To avoid contamination, do not touch the head of provided swab when opening the swab pouch.
19 Rhinovirus A16 8.8 X 105.0 PFU/mL No cross reaction

12. The provided sterilized swabs in the package should be used only for nasopharyngeal specimen collection.
20 HCoV-NL63 1.7 X 105.0 TCID50/ml No cross reaction

13. To avoid cross-contamination, do not reuse the sterilized swabs for specimen collection.

14. Do not dilute the collected swab with any solution except for the provided extraction buffer. 21 HCoV-OC43 8.9 X 105.0 TCID50/ml No cross reaction

15. The buffer contains <0.1% sodium azide as a preservative which may be toxic if ingested. When disposed of 22 HCoV-229E 1.51 X 106.0 TCID50/ml No cross reaction

through a sink, flush with a large volume of water.7
23 Human SARS-coronavirus Nucleoprotein 25 ng/ml Cross reaction
24 MERS-CoV Nucleoprotein 0.25 mg/ml No cross reaction
Test Procedure (Refer to Figure) Human Metapneumovirus (hMPV) 16
Nasopharyngeal Swab Specimens 25 1.06 X 106.0 PFU/mL No cross reaction
Note: Healthcare professionals should comply with personal safety guidelines including the use of personal protective Type A1
equipment. 1 Staphylococcus aureus 1.0 X 106.0 CFU/ml No cross reaction
Test Preparation 2 Staphylococcus saprophyticus 1.0 X 106.0 CFU/ml No cross reaction
1. Allow all kit components to reach a temperature between 15-30 °C prior to testing for 30 minutes. 3 Neisseria sp.(Neisseria lactamica) 1.0 X 106.0 CFU/ml No cross reaction

2. Remove the test device from the foil pouch prior to use. Place on a flat, horizontal and clean surface.
4 Escherichia coli 1.0 X 106.0 CFU/ml No cross reaction

3. Hold the buffer bottle vertically and fill the extraction tube with buffer fluid until it flows up to the Fill-line of
5 Staphylococcus haemolyticus 1.0 X 106.0 CFU/ml No cross reaction

the extraction tube (300 μl).
Caution: If the amount of buffer is excessive or insufficient, an improper test result may occur. 6 Streptococcus pyogenes 1.0 X 106.0 CFU/ml No cross reaction
4. Place the extraction tube in the tube rack. 7 Other Streptococcus salivarius 1.0 X 106.0 CFU/ml No cross reaction

Specimen Collection & Extraction 8 Microorganism Hemophilus parahaemolyticus 1.0 X 106.0 CFU/ml No cross reaction
1. Tilt the patient’s head back slightly about 45°-70° to straighten the passage from the front of the nose. 9 Proteus vulgaris 1.0 X 106.0 CFU/ml No cross reaction

2. Insert the swab with a flexible shaft through the nostril parallel to the palate. 10 Moraxella catarrhalis 1.0 X 106.0 CFU/ml No cross reaction

Caution: Use dedicated nasopharyngeal swab for specimen collection. 11 Klebsiella pneumoniae 1.0 X 106.0 CFU/ml No cross reaction
3. Swab should reach depth equal to distance from nostrils to outer opening of the ear.
12 Fusobacterium necrophorum 1.0 X 106.0 CFU/ml No cross reaction

Caution: If resistance is encountered during insertion of the swab, remove it and attempt insertion in the
13 Mycobacterum tuberculosis 10 mg/ml No cross reaction
opposite nostril.
4. Gently rub and roll the swab, 3-4 times. Leave the swab in place for several seconds to absorb secretions. 14 Pooled human nasal wash N/A No cross reaction

5. Slowly remove swab while rotating it and insert into the extraction tube. * No concentration provided by supplier. Undiluted stock solution was tested.

6. Swirl the swab tip in the buffer fluid inside the extraction tube, pushing into the wall of the extraction tube at

least five times and then squeeze out the swab by squeezing the extraction tube with your fingers.
7. Break the swab at the breakpoint and close the cap of extraction tube.

Reaction with Test Device
1. Open the dropping nozzle cap at the bottom of the extraction tube.

2. Dispense 5 drops of extracted specimens vertically into the specimen well (S) on the device. Do not handle or

move the test device until the test is complete and ready for reading.
Caution: Bubbles that occur in the extraction tube can lead to inaccurate results. If you are unable to create TECHNICAL SUPPORT
sufficient drops, this may be caused by clogging in the dispensing nozzle. Shake the tube gently to release the
blockage until you observe free drop formation. Europe & Middle East +44 161 483 9032 | EMEproductsupport@abbott.com
3. Close the nozzle and dispose of the extraction tube containing the used swab according to your local regulations
Africa, Russia & CIS +27 10 500 9700 | ARCISproductsupport@abbott.com

and biohazard waste disposal protocol.
4. Start timer. Read result at 15 minutes. Do not read results after 20 minutes. Asia Pacific +61 7 3363 7711 | APproductsupport@abbott.com

5. Dispose of the used device according to your local regulations and biohazard waste disposal protocol.

Positive / Negative Control Swab Latin America +57 2 661 8797 | LAproductsupport@abbott.com
1. Hold the buffer bottle vertically and fill the extraction tube with buffer fluid until it flows up to the Fill-line of

the extraction tube (300 μl).
Caution: If the amount of buffer is excessive or insufficient, an improper test result may occur. Abbott Rapid Diagnostics Jena GmbH
2. Place the extraction tube in the tube rack. Orlaweg 1, D-07743 Jena, Germany

3. Insert the positive or negative control swab in the buffer fluid inside of the extraction tube and soak the swab abbott.com/poct

for 1 minute. Swirl the control swab tip in the buffer fluid inside of the extraction tube, pushing into the wall of
the extraction tube at least five times and then squeeze out the swab by squeezing the extraction tube with © 2020 Abbott. All rights reserved. All trademarks referenced are trademarks of either
your fingers. the Abbott group of companies or their respective owners.
 41FK10
TEST PROCEDURE TEST INTERPRETATION

1 2
Hold the buffer bottle
vertically and fill the
extraction tube with buffer
fluid until it flows up to the
Fill-line of the extraction tube
(300μl).
Caution: If the amount
Panbio ™
of buffer is excessive or
3 4
Place the Tilt the patient’s head
extraction tube back. Insert the swab
in the tube through the nostril.
rack. Gently rub and roll the
swab, 3-4 times. Leave
the swab in place for
several seconds. Slowly
remove swab.
5 NEGATIVE
Insert the swab specimen in the Break the swab at
extraction tube. Swirl the swab the breakpoint and
tip in the buffer fluid inside close the cap of
the extraction tube, pushing extraction tube. The presence of only the control line (C) and no test
into the wall of the extraction line (T) within the result window indicates a negative
tube at least five times and result.
then squeeze out the swab by
squeezing the extraction tube
with your fingers.

COVID-19 Ag
insufficient, an improper test
result may occur.

Rapid Test Device x5

POSITIVE
(NASOPHARYNGEAL) The presence of the test line (T) and the control line
(C) within the result window, regardless of which line
3-4x appears first, indicates a positive result.
In vitro diagnostic rapid test for qualitative detection of SARS-CoV-2 Caution: The presence of any test line (T), no
antigen (Ag) matter how faint, indicates a positive result.

PREPARATION

1 Allow all kit components to reach a temperature between 15-30°C

prior to testing for 30 minutes.
Note: Healthcare professionals should comply with personal safety
guidelines including the use of personal protective equipment.
INVALID

6 7 8 9 10
DRAFT
Open the Dispense 5 drops of extracted specimens Close the nozzle and Start timer. Dispose of the
dropping vertically into the specimen well (S) on dispose of the extraction Read result at used device If the control line (C) is not visible within the result
nozzle cap at the device. Do not handle or move the test tube containing the 15 minutes. according to your window after performing the test, the result is

2 Open the package and look for the following: the bottom of device until the test is complete and ready for used swab according to Do not read local regulations
considered invalid. Instructions may not have been
1. Test device with desiccant in individual foil pouch the extraction reading. your local regulations results after 20 and biohazard
tube. and biohazard waste minutes. waste disposal
followed correctly. It is recommended to read the

2. Buffer Caution: Bubbles that occur in the IFU again before re-testing the specimen with a new
disposal protocol. protocol.

3. Extraction tube extraction tube can lead to inaccurate test device.

4. Extraction tube cap results. If you are unable to create sufficient

5. Positive control swab drops, this may be caused by clogging in the
dispensing nozzle. Shake the tube gently to

6. Negative control swab
release the blockage until you observe free

7. Sterilized nasopharyngeal swabs for sample collection
drop formation.

8. Tube rack

9. Quick reference guide (Nasopharyngeal)

10. Instructions for use

15-20
MIN

3 Carefully read these instructions prior to using Panbio™ COVID-19 Ag

Rapid Test Device kit.
5x
GLOSSARY OF SYMBOLS

Temperature Lot
limitation
Manufacturer
Number

4 Look at the expiration date of the kit box. If the expiration date has
passed, use another kit. For in vitro diagnostic
use only
Catalog
Number
Date of
manufacture

Consult Keep away from

Do not reuse

5
instructions sunlight
Open the foil pouch and look for the following: for use
1. Result window

2. Specimen well Use By Keep dry Caution

Then, label the device with the patient identifier.
Contains sufficient for Biological
1 2 X tests Risks
Do not use
if package is
damaged

Sterilized using
CE mark
ethylene oxide

Do not re- Sterilized using

sterilize irradiation
: 5 drops of the extracted specimen
 Panbio™ QUICK REFERENCE GUIDE
COVID-19 Ag RAPID TEST DEVICE 41FK10
(NASOPHARYNGEAL)

1 2 3 4
DE
Kurzanleitung
(NASOPHARYNGEAL)
Technischer Support:
Abbott.com/POCT
Panbio™
COVID-19 Ag 3-4x
ES

C
15 min

Guía de referencia rápida

T
COVID-19 Ag RAPID
(NASOFARÍNGEA) TEST DEVICE
Asistencia técnica:
Abbott.com/POCT
41FK10

FR
Guide de référence rapide
(Prélèvement Nasopharyngé)
Support Technique ;
Abbott.com/POCT
5 x5 6 7 Panbio™
8 Panbio™
COVID-19 Ag

COVID-19 Ag
IT

C
15 min

T
Guida Rapida di Riferimento
(NASOFARINGEO)
Supporto Tecnico 15-20

C
15 min
5x
Abbott.com/POCT
MIN

+–

T
PT
Guia de referência rápida C T

COVID-19 Ag
(NASOFARÍNGEA)
Panbio™
Suporte técnico: 15 min

Abbott.com/POCT

RU
Краткое руководство
(назофарингеальный тампон)
Техническая поддержка: TECHNICAL SUPPORT: ABBOTT.COM/POCT
Abbott.com/POCT © 2020 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. 41FK10-07-QRG-A0