Beckman Coulter Reagent Kit Access® Antibody Test SARS-CoV-2 IgG II For use with the Access Family of Immunoassay Systems 2 X 100 Tests 20 µL Sample Volume - M-1183726-3018 - Kit of 1

$2,575.99
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Beckman Coulter

Reagent Kit

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M-1183726-3018

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$2,575.99
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Delivery - 7-10 Days, Ship Directly from Manufacturer

  • 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
  • For U.S.A. only, 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 concentration of SARS-CoV-2 IgG in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods and reagent specificity; values obtained with different assay methods should not be used interchangeably
  • The Access SARS-CoV-2 IgG II assay is a paramagnetic particle, chemiluminescent immunoassay intended for the semi-quantitative and qualitative determination of IgG antibodies to SARS-CoV-2 in human serum, serum separator tubes, and plasma (EDTA, citrate and heparin)
  • At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity; Access SARS-CoV-2 IgG II assay should not be used to diagnose or exclude acute SARS-CoV-2 infection
  • 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
  • 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
  • 200 determinations, 2 packs, 100 tests/pack
  • The positive percent agreement (PPA) of the Access SARS-CoV-2 IgG II assay is 96.0% at 8-14 days post symptom onset
  • The negative percent agreement (NPA) of the Access SARSCoV-2 IgG assay is 99.9% evaluated in a study with 1,448 samples
  • Time-to-first result (approx.) 32 Minutes

    • Item Id 1183726
    MF ID C69057
    Brand Access®
    Manufacturer Beckman Coulter
    Application Reagent Kit
    Container Type Well
    For Use With For use with the Access Family of Immunoassay Systems
    Number of Tests 2 X 100 Tests
    Sample Type Serum / Plasma Sample
    Test Name SARS-CoV-2 IgG II
    Test Type Antibody Test
    Time To Results 32 Minute Results
    Type Two-step Enzyme Immunoassay
    UNSPSC Code 41116010
    Volume 20 µL Sample Volume

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    FDA Disclaimer: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."