Home / Clinical Laboratory / Clinical Analyzer Calibrators and Reagents / Reagents / Reagent Kit / Reagent Kit Access® Antibody Test SARS-CoV-2 IgG (1st IS) For use on Access Family of Immunoassay Systems 2 X 100 Tests 20 µL Sample VolumeC74339
Picture of Reagent Kit Access® Antibody Test SARS-CoV-2 IgG (1st IS) For use on Access Family of Immunoassay Systems 2 X 100 Tests 20 µL Sample VolumeC74339

Reagent Kit Access® Antibody Test SARS-CoV-2 IgG (1st IS) For use on Access Family of Immunoassay Systems 2 X 100 Tests 20 µL Sample VolumeC74339

Reagent-Kit-Access®-Antibody-Test-SARS-CoV-2-IgG-(1st-IS)-For-use-on-Access-Family-of-Immunoassay-Systems-2-X-100-Tests-20-µL-Sample-VolumeC74339

SKU #

#1193451

MPN #

C74339

Brand

Beckman Coulter

Stock

In Stock

Quantity

100

Features

REAGENT KIT, ACCESS SARS-COV-2IGG (200TST/KT) D/S

$1,299.25 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1193451
Manufacturer # C74339
Brand Access®
Manufacturer Beckman Coulter
Application Reagent Kit
Container Type Well
For Use With For use on Access Family of Immunoassay Systems
Number of Tests 2 X 100 Tests
Sample Type Human Serum / Plasma Sample
Test Name SARS-CoV-2 IgG (1st IS)
Test Type Antibody Test
Time To Results 30 Minutes Time to First Result
Type Chemiluminescent Immunoassay
Volume 20 µL Sample Volume
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  • This test has not been reviewed by the FDA
  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests
  • The Access SARS-CoV-2 IgG (1st IS) assay is a paramagnetic particle, chemiluminescent immunoassay intended for the quantitative and qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, serum separator tubes and plasma (heparin, EDTA and citrate)
  • The Access SARS-CoV-2 IgG (1st IS) assay 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
  • Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
  • Negative results do not preclude acute SARS-CoV-2 infection; if acute infection is suspected, direct testing for SARS-CoV-2 is necessary
  • 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
  • Access SARS-CoV-2 IgG (1st IS) test is to be used with the fully automated Access Family of Immunoassay Analyzers including the standalone Access 2, UniCel DxI 600, and UniCel 800 analyzers and integrated chemistry/immunoassay platforms; UniCel DxC 600i, UniCel DxC 680i, UniCel DxC 880i, UniCel DxC 660i and UniCel DxC 860
  • 200 determinations, 2 packs, 100 tests/pack
  • Access SARS-CoV-2 IgG (1st IS) is traceable to the 1st WHO International Standard for anti-SARS-CoV-2, 20/136
  • PPA: 100% (95% CI: 95.1 - 100.0%) ≥ 15 days post-symptom onset
  • NPA: 99.8% (95% CI: 99.4 - 99.9%)