Abbott Antibody Test Control Kit AdviseDx SARS-CoV-2 IgG II Level 1 Positive, Level 2 Positive, N...
| Item Id | 1187910 |
| MF Id# | 06S6110 |
| Brand | AdviseDx |
| Manufacturer | Abbott |
| Country of Origin | Ireland |
| Application | Control Kit |
| Container Type | Vial |
| For Use With | 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 |
| Is_Active_Vendor | Y |
| Is_DSCSA | N |
| Is_Discontinued | N |
| Is_Medical_Device | N |
| Levels | Level 1 Positive, Level 2 Positive, Negative Level |
| Lot_Tracking_Flag | N |
| On_Allocation | N |
| Product Dating | McKesson Acceptable Dating: we will ship >= 90 days |
| Storage Requirements | Keep Frozen |
| Supplier_ID | 4446496 |
| Test Name | SARS-CoV-2 IgG II |
| Test Type | Antibody Test |
| UNSPSC Code | 41116145 |
| Volume | 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