Home / Clinical Laboratory / Controls / Quality Control / Antibody Test Quality Control Access® SARS-CoV-2 IgG (1st IS) Level 1, 2 6 X 4 mLC74341
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Antibody Test Quality Control Access® SARS-CoV-2 IgG (1st IS) Level 1, 2 6 X 4 mLC74341

Antibody-Test-Quality-Control-Access®-SARS-CoV-2-IgG-(1st-IS)-Level-1,-2-6-X-4-mLC74341

SKU #

#1193453

MPN #

C74341

Brand

Beckman Coulter

Stock

In Stock

Quantity

100

Features

CONTROL, ACCESS QC SARS-COV-2 IGG 3X4ML D/S

$381.43 USD

Attribute Name Attribute Value
McKesson # 1193453
Manufacturer # C74341
Brand Access®
Manufacturer Beckman Coulter
Application Quality Control
Container Type Vial
For Use With For use on Access Family of Immunoassay Systems
Levels Level 1, 2
Test Name SARS-CoV-2 IgG (1st IS)
Test Type Antibody Test
Volume 6 X 4 mL

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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
  • Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to by or on the order of a physician
  • The Access SARS-CoV-2 IgG (1st IS) QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG (1st IS) assay using the Access Immunoassay Systems
  • 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
  • The analyte in the Access SARS-CoV-2 IgG (1st IS) QC is traceable to the First WHO International Standard Anti-SARS-CoV-2 Immunoglobulin (Human), NIBSC code, 20/136
  • QC1-QC2, 4 mL/vial, 3 vials each level
  • QC1: Negative: TRIS buffer, defibrinated human plasma negative for anti-SARS-CoV-2, surfactant, protein (bovine), < 0.1% sodium azide and 0.5% ProClin 300
  • QC2: Positive: TRIS buffer, defibrinated human plasma, human anti-SARS-CoV-2 monoclonal IgG, surfactant, protein (bovine), < 0.1% sodium azide and 0.5% ProClin 300