Description
Description
This test detects human SARS-CoV-2IgM and IgG that are generated as part of the human adaptive immune response to the COVID-19 virus and is to be performed only using human serum, plasma, or venipuncture whole blood specimens.
The outbreak of the novel corona virus disease (COVID-19) has created an urgent need for an accurate and rapid test methods to quickly identify large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. HealGen provides rapid and simple point-of-care lateral flow immunoassays which can detect IgM and IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 10 minutes.
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is only authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42U.S.C. §263a, to perform moderate or high complexity tests.