Home / Clinical Laboratory / Controls / Quality Control / Antibody Test Quality Control Access® SARS-CoV-2 IgG Positive Level / Negative Level 3 X 4 mLC58964
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Antibody Test Quality Control Access® SARS-CoV-2 IgG Positive Level / Negative Level 3 X 4 mLC58964

Antibody-Test-Quality-Control-Access®-SARS-CoV-2-IgG-Positive-Level--Negative-Level-3-X-4-mLC58964

SKU #

#1167488

MPN #

C58964

Brand

Beckman Coulter

Stock

In Stock

Quantity

100

Features

CONTROL, ACCESS SARS-COV-2 IGG(1/BX) D/S

$381.43 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1167488
Manufacturer # C58964
Brand Access®
Manufacturer Beckman Coulter
Application Quality Control
Container Type Vial
For Use With For Monitoring Performance of Access SARS-CoV-2 IgG Assay on the Access Family of Immunoassay Systems
Levels Positive Level / Negative Level
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Storage Requirements Requires Refrigeration
Test Name SARS-CoV-2 IgG
Test Type Antibody Test
UNSPSC Code 41116145
Volume 3 X 4 mL
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  • The Access SARS-CoV-2 IgG assay 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. §263a, that meet requirements to perform moderate or high complexity tests
  • The Access SARS-CoV-2 IgG 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 positive 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
  • False positive results for the Access SARS-CoV-2 IgG assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
  • Provided ready to use
  • Refer to the QC value card for mean values and standard deviations (SD)
  • QC1: Negative: TRIS buffer, defibrinated human plasma negative for anti-SARS-CoV-2 surfactant and protein (bovine), < 0.1% sodium azide and 0.5% ProClin 300
  • QC2: Positive: TRIS buffer, defibrinated human plasma containing anti-SARS-CoV-2 IgG, surfactant and protein (bovine), < 0.1% sodium azide and 0.5% ProClin 300