Immunoassay Reagent Access® SARS-CoV-2 IgG II For Access Immunoassay Systems 2 X 100 Tests

Features

• This test has not been reviewed by the FDA
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests
• For U.S.A. only, Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to by or on the order of a physician
• The concentration of SARS-CoV-2 IgG in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods and reagent specificity; values obtained with different assay methods should not be used interchangeably
• The Access SARS-CoV-2 IgG II assay is a paramagnetic particle, chemiluminescent immunoassay intended for the semi-quantitative and qualitative determination of IgG antibodies to SARS-CoV-2 in human serum, serum separator tubes, and plasma (EDTA, citrate and heparin)
• At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity; Access SARS-CoV-2 IgG II assay should not be used to diagnose or exclude acute SARS-CoV-2 infection
• Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
• Negative results do not preclude acute SARS-CoV-2 infection
• 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
• 200 determinations, 2 packs, 100 tests/pack
• The positive percent agreement (PPA) of the Access SARS-CoV-2 IgG II assay is 96.0% at 8-14 days post symptom onset
• The negative percent agreement (NPA) of the Access SARSCoV-2 IgG assay is 99.9% evaluated in a study with 1,448 samples
• Time-to-first result (approx.) 32 Minutes

More Information

• Access SARS-CoV-2 IgG II IFU