Fecha:

Fecha: 07 de diciembre de 2020, 12:53

Laboratorio: LabGenetics
Laboratorio: LabGenetics
Empresa: Democratest-Barcelona
Empresa: Democratest-Barcelona
Pág. 11de
Pág. de11

Informe del estudio genético para la detección del

RNA del coronavirus SARS-CoV-2
[VOHH000010] VICENTE PERA ZACARIAS, NIF/NIE 24433039

Muestra recibida: Hisopado naso y orofaríngeo

01_ Objetivo del estudio genético

El objetivo de este procedimiento es detectar por RT-qPCR tres genes específicos de la cepa viral patogénica
SARS-CoV-2, mediante la utilización del kit TaqPath COVID-19 CE-IVD RT-PCR Kit (Thermofisher, USA), que
detecta simultáneamente tres regiones altamente conservadas (genes que codifican para ORF1ab, N Protein y S
Protein) del virus RNA SARS-CoV-2, junto con un control positivo interno (MS2-IPC) en una única reacción de
PCR.

02_ Análisis realizado - Metodología

Obtención del RNA viral utilizando alguno de los siguientes reactivos y kits comerciales:
> Chemagic Viral DNA/RNA 300 Kit H96 (Perkin Elmer)
> Quick-DNA/RNA Viral MagBead (Zymo Research)
> Total RNA Purification 96-Well Kit (Norgen Biotek Corporation)

Purificación del RNA viral utilizado algunas de las siguientes plataformas automáticas:
> Chemagic 360 Instrument (Perkin Elmer)
> Fluent Automation Workstation (Tecan)

RT-qPCR utilizando el kit TaqPath COVID-19 CE-IVD RT-PCR Kit (Thermofisher) y detección de las regiones
ORF1ab, N Protein y S Protein del virus SARS-CoV-2 en alguna de las siguientes plataformas:
> 7500 Real-Time PCR instrument (Thermofisher)
> 7500 FAST Real-Time PCR instrument (Thermofisher)
> QuantStudio 5 Real-Time PCR instrument (Thermofisher)
> QuantStudio 6 Real-Time PCR instrument (Thermofisher)
> ViiA 7 Real-Time PCR System (Thermofisher)

03_ Resultado obtenido

Resultado de la detección del RNA de SARS-CoV-2 NEGATIVO

El procedimiento llevado a cabo y los resultados obtenidos han sido validados por: Firma:

Nombre y apellidos: Dr. Jorge Puente Prieto

Laboratorio: LabGenetics

alianzacovid19.es
ARQUIMEA Medical S.L.U.
Este documento es propiedad de ARQUIMEA Medical S.L.U., compañía del área de salud B-87739587
de ARQUIMEA Group. Queda prohibida su difusión o distribución total o parcial sin Margarita Salas, 10
su correspondiente aprobación escrita. (28919) Leganés, Madrid
Date:
Date: 7th December 2020 12:53
Laboratory: LabGenetics
Laboratory: LabGenetics
Petitioner: Democratest-Barcelona
Petitioner: Democratest-Barcelona
Page 11 of
Page of11

Genetic Testing Report for the Detection of SARS-

CoV-2 RNA
[VOHH000010] VICENTE PERA ZACARIAS, Document 24433039

Sample received: Nasopharyngeal swap

01_ Goal of the genetic study

The aim of this procedure is the multiplex real-time detection of RNA from SARS-CoV-2, based on the reverse transcription
polymerase chain reaction (RT-PCR), using the TaqPath COVID-19 CE-IVD RT-PCR Kit (Thermofisher, USA), that
detects simultaneously three regions highly conserved (genes encoding ORF1ab, N Protein and S Protein), along with
an internal positive control (MS2-IPC) in a single PCR reaction.

02_ Analysis performed - Methodology

Viral RNA extraction using one of the following reagents and commercial kits:
> Chemagic Viral DNA/RNA 300 Kit H96 (Perkin Elmer)
> Quick-DNA/RNA Viral MagBead (Zymo Research)
> Total RNA Purification 96-Well Kit (Norgen Biotek Corporation)

RNA Purification using some of the following automated platforms:

> Chemagic 360 Instrument (Perkin Elmer)
> Fluent Automation Workstation (Tecan)

RT-qPCR using the TaqPath COVID-19 CE-IVD RT-PCR Kit (Thermofisher) for the detection of three specific regions of
SARS-CoV-2 virus (ORF1ab, N Protein and S Protein) in one of the following real-time PCR instruments:
> 7500 Real-Time PCR instrument (Thermofisher)
> 7500 FAST Real-Time PCR instrument (Thermofisher)
> QuantStudio 5 Real-Time PCR instrument (Thermofisher)
> QuantStudio 6 Real-Time PCR instrument (Thermofisher)
> ViiA 7 Real-Time PCR System (Thermofisher)

03_ Result

Result of the detection of SARS-CoV-2 RNA NEGATIVE

Analytical methods, procedures and results validated by: Signature:

Name and surname: Dr. Jorge Puente Prieto

Laboratory: LabGenetics

alianzacovid19.es
ARQUIMEA Medical S.L.U.
B-87739587
This document is property of ARQUIMEA Medical SLU, health Business Unit of Arquimea
Group. It is forbidden its diffusion or distribution total or partially without the proper written Margarita Salas, 10
authorisation (28919) Leganés, Madrid