Results are for the identification of SARS-CoV-2 antigen which is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out a bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results, from patients with symptom onset beyond ten days, should be treated as presumptive, and confirmation with a molecular assay if necessary, for patient management, may be performed. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19.
Principle of the Test:
Biocan Tell Me Fast COVID19 Antigen Test is a lateral flow chromatographic immunoassay. The test strip consists of 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 and a nitrocellulose membrane strip containing a 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 pad of the test strip, the specimen migrates by capillary action across the strip. 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 pink-colored T band, indicating a Covid-19 antigen-positive test result. The absence of test band (T) suggests a negative result. The test contains an internal control (C band) which should exhibit a pink-colored band of the immunocomplex of goat anti-rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on of the test band. If the control line does not appear, the test result is not valid. The presence of this pink band serves as 1) verification that sufficient volume is added, 2) that proper flow is obtained and 3) as an internal control for the reagents.
Our COVID19 Antigen Test is currently not approved for sale in Canada.