Home / Clinical Laboratory / Clinical Analyzer Calibrators and Reagents / Reagents / Reagent Kit / Reagent Kit Vitros® Antibody Test Anti-SARS-CoV-2 IgG For use with Vitro ECi / ECiQ (Available End of May) / Vitros 3600 / 5600 / XT7600 100 Tests6199919
Picture of Reagent Kit Vitros® Antibody Test Anti-SARS-CoV-2 IgG For use with Vitro ECi / ECiQ (Available End of May) / Vitros 3600 / 5600 / XT7600 100 Tests6199919

Reagent Kit Vitros® Antibody Test Anti-SARS-CoV-2 IgG For use with Vitro ECi / ECiQ (Available End of May) / Vitros 3600 / 5600 / XT7600 100 Tests6199919

Reagent-Kit-Vitros®-Antibody-Test-Anti-SARS-CoV-2-IgG-For-use-with-Vitro-ECi--ECiQ-(Available-End-of-May)--Vitros-3600--5600--XT7600-100-Tests6199919

SKU #

#1166249

MPN #

6199919

Brand

Ortho Clinical Diagnostics

Stock

In Stock

Quantity

100

Features

REAGENT, VITROS ANTI-SARS-COV-2 IGG AB (100TESTS/EA) D/S

$2,145.56 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1166249
Manufacturer # 6199919
Brand Vitros®
Manufacturer Ortho Clinical Diagnostics
Application Reagent Kit
Container Type Wells
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 Name Anti-SARS-CoV-2 IgG
Test Type Antibody Test
Time To Results 48 Minute Results
Type Chemiluminescent Immunoassay
UNSPSC Code 41116020
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  • 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