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Anti-SARS-CoV-2 Rapid Test, COVID-19, 50 tests per kit, by AutoBio Diagnostics

Product is not available for on-line ordering. Please contact your Hardy Sales Representative for further information or to set up an account. If you already have an active account with us, you can place an order by contacting Customer Service (800)-266-2222.

This kit is FDA Emergency Use Authorization (EUA) Approved
This kit is CE MARKED–IVD

PK 50 (50 tests per kit)

The Anti-SARS-CoV-2 Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood (Heparin/ EDTA/ sodium citrate) or serum from individuals with signs and symptoms of infection who are suspected of COVID-19 infection. The Anti-SARS-CoV-2 Rapid Test is also intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests. The Anti-SARS-CoV-2 Rapid Test is intended for use by clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.

Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in recent contact with the virus, due to the lag time between exposure and the patient’s antibody response. 

This test should not be used as the sole basis for patient management decisions. Test results must be combined with clinical observations, patient history, and epidemiological information.

Follow-up testing with a molecular diagnostic test should be considered to confirm the infection status. This test is not intended for the screening of donated blood.

Features and Benefits

  • Results in 15 minutes
  • No special equipment needed
  • Easy-to-interpret results
  • Built-in-controls
  • Room temperature storage

Sensitivity at >/= 15 days after onset of symptoms

  • IgM - 95.7%
  • IgG - 99.0%

    Specificity

  • IgM - 99%
  • IgG - 99%

    *Contact your sales representative for pricing.



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    Cat No. Description Price Curr UOM
    RTA0203 Anti-SARS-CoV-2 Rapid Tes
    AutoBio, 50 tests EUA
    $0.00 USD EA

    Manufacturer Category Organism
    AutoBio Diagnostics Co., Ltd.

    Rapid ID Test Kits

    N/A

    Instructions for Use Video SDS






    N/A



    Brochures and Studies BioSafety Level




















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