POINT OF CARE (POC) IGG/IGM Antibody Rapid Diagnostics Test (RDT) for COVID 19 (SARS-COV 2 or SARS 2) Whole Blood Fingertip

The COVID-19 Antibody (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. 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. Results are for the detection of SARS CoV-2 antibodies. IgM and IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have a detectable virus present for several weeks following seroconversion.

Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

The sensitivity of COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If an acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

False-positive results for COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false-positive results, confirmation of positive results should be considered using second, different IgG or IgM assay.

The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is only for use under the Food and Drug Administration’s Emergency Use Authorization.

MATERIALS SUPPLIED

• Individually packed test devices
• Buffer
• Disposable pipettes
• Package insert
• Sterile safety lancet
• Alcohol Prep pad
• Instructions

FEATURES

• Results in 10 Minutes
• For Emergency Authorization Use (EUA) only
• For in vitro diagnostic use only
• For prescription use only