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 for use under an Emergency Use Authorization Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas#individual-serological 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 assay is a chemiluminescent microparticle immunoassay (CMIA) intended 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) on the Alinity i system 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 A positive result may not indicate previous SARS-CoV-2 infection; consider other information
• including clinical history and local disease prevalence
• in assessing the need for a second but different serology test to confirm an immune response A negative result for an individual subject indicates the absence of detectable anti-SARS CoV-2 antibodies; Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions A negative result can occur if the quantity of the anti-SARS-CoV-2 antibodies in the specimen is below the detection limits of the assay
• or if the antibodies are not present during the stage of disease in which a sample is collected 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 Alinity 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) Negative control contains negative human plasma Positive control 1 and positive control 2 contain SARS-CoV-2 IgG positive human plasma