COVID-19 Antibody Rapid Detection Kit
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. This test is intended to screen patients, symptomatic or asymptomatic, for COVID-19. IgM antibodies will appear within blood as soon as 3-5 days for symptomatic patients and 7 days for asymptomatic patients. IgG antibodies appear in blood within 2 weeks after infection. Over time blood concentrations of both IgM and IgG decrease, where IgM will become undetectable, but IgG will remain elevated.Results obtained should not be the sole determinant for clinical decision.Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals and birds that cause respiratory, enteric, hepatic and neurologic diseases. Four viruses - 229E, OC43, NL63 and HKU1 are prevalent and typically cause common cold symptoms in immunocompromised individuals. Three other strains SARS-CoV, MERS-CoV and SARS-CoV-2 (COVID-19) are can be transmitted from between non-human vertebrates to humans.
This test has been validated but independent review by the FDA is not yet complete.