Abbott Antibody Test Control Kit AdviseDx SARS-CoV-2 IgG II Level 1 Positive, Level 2 Positive, N...
| Item Id | 1187914 |
| MF Id# | 06S6010 |
| 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 ARCHITECT i System when used for the Qualitative and Semi-Quantitative Detection of IgG Antibodies to SARS-CoV-2 in Human Serum |
| Levels | Level 1 Positive, Level 2 Positive, Negative Level |
| Product Dating | McKesson Acceptable Dating: we will ship >= 90 days |
| Storage Requirements | Keep Frozen |
| 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 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