Antibody Test Control Kit 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