Premier Biotech FaStep Rapid Antibody Fingerprick Test

Premier Biotech

Premier Biotech FaStep Rapid Antibody Fingerprick Test

Premier Biotech
SKU: MD550690
MFG Part #: CV-AZ19W
  • 10-Minute Test
  • Simultaneous detection of IgG and IgM with control line to ensure test validity
  • Room temperature storage or refrigerated (2-30°C / 36-86°F) when not in use
  • Fingerstick whole blood, venous whole blood, serum or plasma
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    Price:
    $361.00 20 / Kit

    Description

    The FaStep COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test is a rapid lateral flow chromatography immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma from anticoagulated blood or serum. The FaStep COVID-19 IgG/IgM Rapid 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.

    Features

    • The Assure COVID-19 IgG/IgM Rapid Test Device is for use under FDA Emergency Use Authorization
    • Use of this test with all authorized specimen types 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; this test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
    • The Assure COVID-19 IgG/IgM Rapid Test Device is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood
    • The Assure COVID-19 IgG/IgM Rapid Test Device 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
    • False positive results for Assure COVID-19 IgG/IgM Rapid Test Device may occur due to cross-reactivity from pre-existing antibodies or other possible causes
    • Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG or IgM assay
    • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner

    Product Specifications and Resources

    Number of Tests 20 Tests
    Reading Type Visual Read
    Sample Type Human Whole Blood / Serum / Plasma Sample
    Test Format Cassette Format
    Test Method Lateral Flow Method
    Test Name COVID-19 IgG / IgM
    Test Type Antibody Test
    Time to Results 15 Minute Results
    UNSPSC Code 41116126
    What's in the Box
  • (20) Test Cassettes
  • Disposable Pipettes
  • Buffer
  • Package Insert
  • Sterile Safety Lancet
  • Alcohol Prep Pad
    Documents & Resources

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