COVID-19 rapid diagnostic test RCCOVST

for antibodiesSARS-COV-2nasal

The test is a lateral flow immunoassay designed to detect SARS-CoV-2 viral antigens in a swab sample. This test is intended for use in individuals to suspect a COVID-19 infection. The REDCELL COVID-19 Self Test is a rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 antigens from nasal or mid-turbinate nasal swabs that are self-collected by an individual aged 16 years or older or are collected by an adult from an individual 2 years of age and older. PRINCIPLE REDCELL COVID-19 Antigen test is a lateral flow immunochromatographic assay for the detection of SARS-CoV-2 N-protein antigens in nasal or mid-turbinate nasal swabs specimens from individuals. Nasal swabs require a sample preparation step in which the sample is eluted into the extraction buffer solution.Extracted swab sample is added to the sample well of the test device to initiate the test. When the swab sample migrates in the test strip, SARS-CoV-2 viral antigens bind to anti-SARS-CoV-2 antibodies conjugated to indicator and capture particles in the test strip forming an immune complex. The immune complex is then captured by the test line on the nitrocellulose membrane as it migrates through the strip. DIAGNOSTIC RELEVANCE Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The antigen is generally detectable in nasal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but the clinical correlation with medical history and other diagnostic information is necessary to determine infection status.