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. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests.
25 sealed pouches each containing a test cassette, a dropper and a desiccant
1 Package insert
Features and Benefits
• Rapid results in 10 minutes (Positive results as soon as 2 minutes)
• Emergency Use Authorized for both Moderately Complex and Highly Complex Labs
• Small sample volume: only 5 µL of serum/plasma or 10 µL of whole blood
• Visual test; no analyzer needed.
• High sensitivity and speciﬁcity (summary data below )