INTENDED USE

The SARS-CoV-2 Antigen Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of Novel coronavirus in human swab (oropharyngeal swab, nasopharyngeal swabs and Anterior nasal swab). It is suitable for the auxiliary diagnosis of SARS-COV-2 virus infection.

INTRODUCTION

COVID-19 caused by SARS-CoV-2 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. The SARS-CoV-2 Antigen Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of SARS-CoV-2 Antigen in human swab (oropharyngeal swab, nasopharyngeal swab and Anterior nasal swab) specimen.

PRINCIPLE

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 NP antibody for the detection of SARS-CoV-2 NP 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 NP antibody conjugates. The immunocomplex is then captured on the membrane by the pre-coated mouse anti- SARS-CoV-2 NP antibody, forming a burgundy colored T band, indicating a Covid-19 NP 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. Otherwise, the test result is invalid, and the specimen must be retested with another device.