The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) 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 from anticoagulated blood (Li+ heparin, K2EDTA and sodium citrate), or serum. For Emergency Authorization Use (EUA) only.
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.
Controls Sold Separately
Human plasma based negative control, Volume: 0.1 mL
Positive control containing SARS-CoV-2 Spike protein specific recombinant human IgG and SARS-CoV-2 Spike protein specific recombinant human IgM diluted with human plasma, Volume: 0.1 mL
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 )