Ortho Clinical Diagnostics Reagent Kit Vitros® Antibody Test Anti-SARS-CoV-2 IgG For use with Vit...
| Item Id | 1166249 |
| MF Id# | 6199919 |
| Brand | Vitros® |
| Manufacturer | Ortho Clinical Diagnostics |
| Country of Origin | United Kingdom |
| Application | Reagent Kit |
| Container Type | Well |
| For Use With | For use with Vitro ECi / ECiQ (Available End of May) / Vitros 3600 / 5600 / XT7600 |
| Form | Liquid |
| Number of Tests | 100 Tests |
| Product Dating | McKesson Acceptable Dating: we will ship >= 90 days |
| Sample Type | Human Serum |
| Storage Requirements | Requires Refrigeration |
| Test Method | Chemiluminescent Immunoassay |
| Test Name | Anti-SARS-CoV-2 IgG |
| Test Type | Antibody Test |
| Time to Results | 48 Minute Results |
| UNSPSC Code | 41116020 |
Features
- VITROS Anti-SARS-CoV-2 IgG test is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. section 263a, to perform moderate and high complexity tests
- Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
- The sensitivity of VITROS Anti-SARS-CoV-2 IgG test in early infection is unknown; 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 VITROS Anti-SARS-CoV-2 IgG test may occur due to cross-reactivity from pre-existing antibodies or other possible causes
- VITROS Anti-SARS-CoV-2 IgG test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection
- At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
- VITROS Anti-SARS-CoV-2 IgG test should not be used to diagnose acute SARS-CoV-2 infection
- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator is a chemiluminescent immunoassay test intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum
- Reagent Pack contains: 100 coated wells (recombinant SARS-CoV-2 antigen derived from human cells, coated at 110 ng/well), 18.0 mL assay reagent (buffer with bovine protein stabilizers and antimicrobial agent), 20.4 mL conjugate reagent [anti-human IgG (murine monoclonal) conjugated to horseradish peroxidase, 5 ng/mL] in buffer with bovine protein stabilizers and antimicrobial agent
- Rx ONLY, For in vitro diagnostic and Laboratory Professional use; For Emergency Authorization Use ONLY