-
,for, Item ID-
- #1246631
- Ortho Clinical Diagnostics #6174442
Antibody Test Control Set Vitros® Anti-SARS-CoV-2 Total N Antibody Positive Level / Negative Level 3 X 2 mL
CONTROL, VITROS ANTI SARDS COV-2 TOT N (1/PK)
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Features
- The Vitros Anti-SARS-CoV-2 Total N Antibody test 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-serology-and-other-adaptive-immune-response-tests-sars-cov-2
- For use in monitoring the performance of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N test when used on the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
- 3 sets of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Controls 1 and 2 (defibrinated human plasma with anti-microbial agent, 2 mL); control 1 is non-reactive and Control 2 is reactive
- More …
Product Details Email
Product Specifications
McKesson # | 1246631 |
---|---|
Manufacturer # | 6174442 |
Brand | Vitros® |
Manufacturer | Ortho Clinical Diagnostics |
Country of Origin | Unknown |
Application | Control Set |
Container Type | Vial |
For Use With | For Vitros ECi / ECiQ / 3600 Immunodiagnostic Systems and the Vitros 5600 / XT 7600 Integrated Systems |
Form | Lyophilized |
Levels | Positive Level / Negative Level |
Product Dating | McKesson Acceptable Dating: we will ship >= 30 days |
Storage Requirements | Keep Frozen |
Test Category | Respiratory |
Test Name | Anti-SARS-CoV-2 Total N Antibody |
Test Type | Antibody Test |
UNSPSC Code | 41116145 |
Volume | 3 X 2 mL |
Features
- The Vitros Anti-SARS-CoV-2 Total N Antibody test 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-serology-and-other-adaptive-immune-response-tests-sars-cov-2
- For use in monitoring the performance of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N test when used on the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
- 3 sets of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Controls 1 and 2 (defibrinated human plasma with anti-microbial agent, 2 mL); control 1 is non-reactive and Control 2 is reactive
- Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests
- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators is a chemiluminescent immunoassay test intended for the qualitative detection of total antibody (including IgG, IgA and IgM) to SARS-CoV-2 nucleocapsid protein in human serum and plasma (K2 -EDTA)
- Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
- The sensitivity of VITROS Anti-SARS-CoV-2 Total N Antibody 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 Total N Antibody test may occur due to cross-reactivity from pre-existing antibodies or other possible causes
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E
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