The SARS-CoV-2 IgG/IgM Rapid Test  is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant SARS-CoV-2 antigen conjugated with colloid gold (SARS-CoV-2 conjugates) and quality control antibody gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (IgG and IgM bands) and a control band (C band). The IgG band is pre-coated with monoclonal anti-human IgG for the detection of IgG anti- SARS-CoV-2, IgM band is pre-coated with reagents for the detection of IgM anti- SARS-CoV-2 and the C band is pre-coated with quality control antibody.

When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the cassette. SARS-CoV-2 IgM antibodies if present in the specimen will bind to the SARS-CoV-2 conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a burgundy colored IgM band, indicating SARS-CoV-2 IgM positive test result.

SARS-CoV-2 IgG antibodies if present in the specimen will bind to the SARS-CoV-2 conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a burgundy colored IgG band, indicating a SARS-CoV-2 IgG positive test result.

Absence of any test bands (IgG and IgM) suggests a negative result. The test card also contains a quality control band C. Regardless of the presence or absence of a detection band, the red quality control band C should appear.  The quality control band is a color band of the quality control antibody immune complex. If the quality control band C does not appear, the test result is invalid, and the sample needs to be tested again with another test card.