Reagent Kit Access® Antibody Test SARS-CoV-2 IgG II For use with Access Family of Immunoassay Systems 2 X 100 Tests 20 µL Sample Volume

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