SARS-CoV-2 Antigen Assay (SCAA)


25 tests per kit.

Used for in vitro qualitative detection of SARS-CoV-2 antigens in human swabs samples (Nasopharyngeal swab and oropharyngeal swab). It can only be used as a supplementary test indicator for suspected cases with negative PCR test of SARS-CoV-2 or used in conjunction with PCR testing in the diagnosis of suspected cases.


Description

For Research Use Only. Not for use in Diagnostic Procedures.

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

When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. SARS-CoV-2 virus if present in the specimen will bind to the monoclonal mouse anti- SARS-CoV-2 antibody conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse anti- SARS-CoV-2 antibody, forming a burgundy colored T band, indicating a Covid-19 antigen positive test result.  Absence of test band (T) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands.