The One Step SARS-CoV2(COVID-19)IgG/IgM Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to COVID-19 virus in Whole Blood /Serum / Plasma to aid in the diagnosis of COVID-19 viral infection.
The One Step SARS-CoV2(COVID-19)IgG/IgM (Whole Blood/Serum/Plasma) is a lateral flow immunochromatographic assay. The test uses anti-human lgM antibody (test line IgM), anti-human lgG(test line lgG and goat anti-rabbit igG (control line C) immobilised on a nitrocellulose strip. The burgundy colored conjugate pad contains colloidal gold conjugated to recombinant COVID-19 antigens conjugated with colloid gold (COVID-19 conjugatesand rabbit lgG-gold conjugates. When a specimen followed by assay buffer is added to the sample well, IgM &/or lgG antibodies if present, will bind to COVID-19 conjugates making antigen antibodies complex. This complex migrates through nitrocellulose membrane by capillary action. When the complex meets the line of the corresponding immobilized antibody (anti-human IgM &/or anit-human lgG) the complex is trapped forming a burgundy colored band which confirm a reactive test result. Absence of colored band in the test region indicates a non-reactive test result.
The test contains an internal control(C band)which should exhibit a burgundy colored band of the immunocomplex goat anti rabbit IgG/rabbit lgG-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.