The COVID-19 IgG/IgM Rapid Test Cassette Controls for use with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) 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.
COVID-19 IgG/IgM Rapid Test Cassette Controls ONLY
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 )
The testing and analysis was conducted by the National Cancer Institute.
This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has not been FDA cleared or approved.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
This product is intended for professional use and not for home use. Not for the screening of donated blood.
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Documentation and Videos
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) product insert, authorized Fact Sheet for Healthcare Providers, authorized Fact Sheet for Recipients and additional studies are provided below: