Abbott Calibrator Kit AdviseDx SARS-CoV-2 IgG II 6 X 2 mL For the Calibration of the ARCHITECT i ...
| Item Id | 1187913 |
| MF Id# | 06S6001 |
| Brand | AdviseDx |
| Manufacturer | Abbott |
| Country of Origin | Ireland |
| Application | Calibrator Kit |
| Container Type | Vial |
| For Use With | For the Calibration of the ARCHITECT 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 A, B, C, D, E, F |
| Lot_Tracking_Flag | N |
| On_Allocation | N |
| Product Dating | McKesson Acceptable Dating: we will ship >= 30 days |
| Storage Requirements | Keep Frozen |
| Supplier_ID | 4446496 |
| Test Name | SARS-CoV-2 IgG II |
| Test Type | Antibody Test |
| UNSPSC Code | 41116145 |
| Volume | 6 X 2 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 Calibrator Kit is for the calibration 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
- Calibrator A contains phosphate buffer and protein (bovine) stabilizer
- Calibrators B through F contain anti-SARS-CoV-2 IgG (human, monoclonal) in phosphate buffer with protein (bovine) stabilizer