Antibody Test Control Set AdviseDx SARS-CoV-2 IgG II Level 1 Positive, Level 2 Positive, Negative Level 3 X 4 mL

Features

• The AdviseDx SARS-CoV-2 IgG II assay is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests
• Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
• The AdviseDx SARS-CoV-2 IgG II Control Kit is for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum (including collected using a serum separator tube) and plasma (acid citrate dextrose, sodium citrate, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin in a separator tube, and sodium heparin)
• At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
• The AdviseDx SARS-CoV-2 IgG II assay should not be used to diagnose or exclude acute SARS-CoV-2 infection
• Negative results do not preclude acute SARS-CoV-2 infection; if acute infection is suspected, direct testing for SARS-CoV-2 is necessary
• False positive results for the AdviseDx SARS-CoV-2 IgG II assay 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 a second, different IgG assay
• Negative control contains human plasma
• Positive control 1 and 2 contain SARS-CoV-2 IgG positive human plasma

More Information

• AdviseDx SARS-CoV-2 IgG II FDA EUA Letter
• AdviseDx SARS-CoV-2 IgG II for ARCHITECT i System Control Kit IFU
• AdviseDx SARS-CoV-2 IgG II Recipients Fact Sheet
• AdviseDx SARS-CoV-2 IgG II Healthcare Providers Fact Sheet