2(SARS-COV-2)IGM/IGG, ANTIBODY ASSAY KIT

Item Code: MC-IM4102079

Description:

For in vitro diagnostic use in the qualitative determination of IgM and IgG antibodies to SARS-CoV-2 virus in human serum, plasma and whole blood specimens. It is intended for use only in individuals with clinical signs and symptoms consistent with SARS-CoV-2 infection as a supplementary detection indicator in conjunction with nucleic acid detection. It cannot be used as the sole basis for the confirmation or exclusion of novel coronavirus-infected pneumonia. And it is for medical institutions use only.
Specification:

PARAMETER
IgM and IgC Antibodies

PRINCIPLE
Lateral Flow Immunochromatography

SAMPLE
Human Whole blood

SPEED
Results in 10-15min

RANGE
1. Limit of detection (LOD). Detection of 3 SARS-CoV-2-IgG enterprise LOD reference products, L1 is positive, L2 can be positive or negative, and L3 is negative. Detection of 3 SARS-CoV-2-IgM enterprise LOD reference products, L1 is positive, L2 can be positive or negative, and L3 is negative.

2. Positive coincidence rate.Detection of 5 SARS-CoV-2- IgM/IgG enterprise positive reference products, IgG antibodies in P1, P2, and P3 are positive, IgM antibodies in P4 and P5 are positive, and the positive coincidence rate≥5/5.

3. Negative coincidence rate. Detection of 20 SARS-CoV-2- IgM/IgG enterprise negative reference products,the coincidence rate of IgG antibody≥20/20, and the coincidence rate of IgM antibody negative reference products≥18/20. "

MEMORY
N/A

CALIBRATION
Factorycalibrated according to ICSH


 


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