The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.
NOTE: The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection and should not be used to diagnose acute SARS-CoV-2 infection.
STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated (2-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date
Application: For suspicious patients with symptoms, mild symptoms, or even without symptoms, also for testing people with close contact of infected patients and people under quarantine control.