For in vitro diagnostic use only.
The COVID-19 Antigen Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swab and oropharyngeal swab from individuals who are suspected of COVID-19 by their healthcare provider.
Results are for the identification of SARS-CoV-2 nucleocapsid antigen. Antigen is generally detectable in nasopharyngeal swab and oropharyngeal swab 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 bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
Negative results do not rule out SARS-CoV-2 infection 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, and confirmed with a molecular assay, if necessary for patient management.
The COVID-19 Antigen Rapid Test Cassette is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures.
The novel coronaviruses (SARS-CoV-2) belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
COVID-19 Antigen Rapid Test Cassette is an immunoassay based on the principle of the double antibody-sandwich technique. The COVID-19 Antigen Rapid Test Cassette is designed to detect nucleocapsid antigen from the SARS-CoV-2 in nasopharyngeal swab and oropharyngeal swab, from patients who are suspected of COVID-19 by their healthcare provider.
During testing, a specimen migrates upward by capillary action. The SARS-CoV-2 antigens if present in the specimen will bind to the antibody conjugates. The immune complex is then captured on the membrane by the pre-coated SARS-Co-2 nuclenocapsid protein monoclonal antibody, and a visible colored line will show up in the test line region indicating a positive result. In the absence of SARS-CoV-2 antigens, a colored line will not form in the test line region indicating a negative result.
To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.