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AccessBio

CareStart OTC COVID-19 Rapid Antigen Home 2-Pack Tests

$24.00 per package (2 tests per package)

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    Description

    Features

    • Fast and easy to self-test at anywhere
    • Easy to interpret the results using mobile application
    • Qualitatively detect the SARS-CoV-2 nucleocapsid protein
    • Use for nasal swab specimen
    • Fast results only in 10 minutes
    • Identify an individual’s current infection status to COVID-19

     

    Product Details

    The CareStart™ COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2. Under FDA’s EUA, CareStart™ COVID-19 Antigen Home Test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

     

    Kit Components

    • Test Devices
    • Extraction Vials and Caps
    • Nasal Swab
    • User Instructions with Fact Sheet for Individuals

     

    Important Documents

     

    Notices from AccessBio:

    • The emergency use of this product 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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
    • This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
    • This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA.

     

    Feel free to contact us any time with questions at support@meenta.io, and we’d be happy to help you out!

    Want to learn more about picking the perfect COVID-19 test for your situation? Check out our blog on this topic here.

    Sample Details

    Authorized Labeling

    Important Numbers

    • Turnaround Time: 30 minutes
    • Specificity: 87%
    • Sensitivity: 98%
    • Limit of Detection: 2.8×103 TCID50/ml

    Important Notes:

    • Swabbing the nostrils is critical for obtaining an accurate result. If you do not swab your nose, the device will produce a false negative result.

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    Payment Methods
    • Credit Card
    • HSA Card
    • ACH
    • PayPal
    • PO Number

    Note: These products and services are not returnable. Check your kit expiration date upon receipt. Using expired test kits is not recommended because they may provide inaccurate results.

    Questions?

    Call (888) 204-5303 or email support@meenta.io

    More information about COVID-19 can be found on the CDC website and the Meenta blog.