SARS-CoV-2 IgM/IgG Antibody Test Kit

The Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit is a single-use rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M(IgM) and Immunoglobulin G(IgG) antibodies to SARS-CoV-2 in human serum, plasma (heparin, dipotassium EDTA, and sodium citrate), and venous whole blood (heparin, dipotassium EDTA, and sodium citrate). The Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests.

The Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization.

The kit has received Emergency Use Authorization (EUA) from the FDA for use as an aid in identifying individuals with recent or prior infections with SARS-CoV-2. The qualitative test detects and differentiates both IgM and IgG antibodies against the virus that causes COVID-19 in human serum, plasma, and venipuncture whole blood specimen samples.

OPERATION PROCEDURE

RESULT INTERPRETATION (C : Control M : IgM G : IgG)

A retrospective study was carried out with 186 samples from a local hospital during the COVID- 19 pandemic, including 78 samples of other (non SARS-CoV-2-mediated) respiratory tract infections (negative for SARS-CoV-2 infection by PCR) and 108 samples of healthy individuals (lacking respiratory symptoms by physical examination and negative for SARS-CoV-2 infection by PCR). All samples were tested with Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit and negative percent agreement to PCR was evaluated.

Negative Percent Agreement (NPA) of IgM and IgG

To evaluate the performance of the Biohit SARS- CoV-2- IgM/IgG Antibody Test Kit over time with PCR positive patients, 197 serum samples were collected serially from 40 hospitalized SARS-CoV-2 PCR positive patients at different days following the onset of symptoms between 1-7, 8-14 and at least 15 days.

Positive Percent Agreement (PPA) (According to Days from Onset of Symptoms)

Store at 2 °C – 30 °C.