Documentos de Académico
Documentos de Profesional
Documentos de Cultura
Materiales Controles
Materiales Controles
CALIDAD
Materiales para control interno de la
calidad y materiales de referencia
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Biorad materiales QC
Chemistry Controls
Serum Chemistry Controls
Liquid Assayed Multiqual
Liquid Unassayed Multiqual
Lyphochek Assayed Chemistry Control
Lyphochek Unassayed Chemistry Control (Human)
Liquichek Unassayed Chemistry Control (Human)
Liquichek Lipids Control
Liquichek Pediatric Control
Liquichek Ethanol/Ammonia Control
Urine Chemistry Controls
Lyphochek Quantitative Urine Control
Liquichek Urine Chemistry Control
Liquichek Microalbumin Control
Urinalysis Controls
qUAntify Control
qUAntify Plus Control
Liquichek Urinalysis Control
RANDOX Materiales de QC
INTENDED USE
This product is intended for in vitro diagnostic use in the quality control of diagnostic assays. The Assayed
Human multi-sera is for the control of accuracy.
DEVICE DESCRIPTION
The Assayed Human multi-sera is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for
the analytes listed in the value section at both levels.
SAFETY PRECAUTIONS AND WARNINGS
For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling
laboratory reagents. Human source material from which this product has been derived has been tested at donor
level for the Human Immunodeficiency Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg),
and Hepatitis C Virus (HCV) antibody and found to be NON-REACTIVE. FDA approved methods have been
used to conduct these tests. However, since no method can offer complete assurance as to the absence of
infectious agents, this material and all patient samples should be handled as though capable of transmitting
infectious diseases and disposed of accordingly. Health and Safety Data Sheets are available on request.
ACTIVIDAD
CATALITICA DE UNA
ENZIMA
A
SH
C
CONDICION DE MEDIDA
Material conmutable
35
30
Mtodo A
25
20
15
10
5
0
0
10
15
20
25
30
35
Mtodo B
35
30
25
20
Mtodo A
15
10
5
0
0
10
15
Mtodo B
20
25
30
35
Materiales control:
Cantidad para cubrir por lo menos un ao.
Estabilidad durante todo el periodo
Variabilidad obtenida del material de control debe ser
menor que la variacin esperada para el procedimiento de
medida que se esta monitoreando.
Debe ser diferente que los calibradores.
Las concentraciones deben cubrir el rango analtico de
medicin.
Usar materiales controles en niveles de decisin mdica
Calibracin
Calibrador: es un material o aparato de conocida o asignada
Categoria
Mtodo de
referencia
Material de
referencia
primario
Material de
referencia
secundario
Ejemplos
Si
Si
Posible
Glucosa
Si
No
Posible
Enzimas
Si
No
No
Coagulacin
No
No
Si
Marcadores
tumorales
No
No
No
EBV Serologa
procedimiento de medida
de referencia
fabricante
procedimiento de medida
de rutina
Laboratorio
calibrador (patrn
secundario)
MUESTRA
Material de referencia
certificado (IRMM-NIST)
Procedimientos de medida de
referencia (IFCC)
Procedimiento de medida
de referencia o de rutina
Material de referencia
secundario
Procedimiento de rutina
F
A
B
RI
C
A
N
T
E
Calibrador comercial
Procedimiento de
medida de rutina
LABORATORIO
CLINICO
dbustos@ffyb.uba.ar