Principle of the Test:

Biocan Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of a red colored conjugate pad containing recombinant COVID-19 antigen conjugated with colloid gold (SARS-CoV-2 conjugates), quality control antibody gold conjugates, nitrocellulose membrane strip containing two test lines (T1 and T2) and a control line (C). The T2 line is pre-coated with monoclonal anti-human IgG for the detection of IgG anti-SARS-CoV-2, the T1 line is pre-coated with reagents for the detection of IgM anti-SARS-CoV-2 and the C line 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 red colored T1 line, 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 red colored T2 line, indicating a SARS-CoV-2 IgG positive test result. Absence of any test lines (T1 and T2) suggests a negative result. The test cassette also contains a quality control line C. Regardless of the presence or absence of a detection band, the red quality control band C should appear. 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 cassette.