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CovClear COVID-19 Rapid Antigen Test

PRODUCT INFORMATION


    CovClear COVID-19 Rapid Antigen Test. This kit include items for 25 tests. Kit has a QR code on it that can be scanned for telehealth, instructions, and result certification. Make sure to scan the QR code before you open the kit.

    CovClear COVID-19 Rapid Antigen Self Test

    The CovClear Rapid Antigen test is a lateral flow assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasal swab specimens directly collected.

    Features:

    • Simple to use with rapid results in minutes
    • High sensitivity, specificity and accuracy
    • Safety advantage with sealed vial protecting against live virus
    • No reader or cassette required, reducing cost and waste
    • Researched, developed & manufactured in the USA

    Specification:

    • Sample Type: Nasal swab
    • Detection Time: 20  minutes
    • Sensitivity/PPA: 95.5 %
    • Specificity/NPA: 100 %
    • Manufactured in the United States
    • Interim order #330172
    • Materials required but not provided: a pair of gloves and timer

    Each Box Contains:

    2-pack25-pack50-pack
    2 Lateral flow assay strips25 Lateral flow assay strips50 Lateral flow assay strips
    2 Chase buffer ampules25 Chase buffer ampules50 Chase buffer ampules
    2 Vials25 Vials50 Vials
    2 Locking caps25 Locking caps50 Locking caps
    2 Individually wrapped swabs25 Individually wrapped swabs50 Individually wrapped swabs
    2 Instructions for use25 Instructions for use50 Instructions for use
    2 Quick reference guides25 Quick reference guides50 Quick reference guides

    Interpretation of Results

    Sample Collection

    Using the Nasal swab for a COVID antigen rapid test

    1) Remove a swab from the pouch.

    Taking a nasal sample for a CovClear rapid antigen at home test

    2) Place the dry swab into one nostril until it reaches resistance.

    Head diagram of nasal swab sample for COVID19 rapid antigen test

    3) Slowly rotate the swab 7 times over the surface inside the nostril.

    Diagram of taking a nasal swab for COVID19 rapid antigen test

    4) Slowly remove the swab from the nostril while still rotating it. Repeat steps 2-4 on other nostril.

    Test Instructions

    Using the reagents for the CovClear Rapid antigen test for COVID-19

    1) Remove a swab from the pouch.

    How to take a CovClear COVID-19 rapid antigen test

    2) Place the dry swab into one nostril until it reaches resistance.

    Cov Clear COVID rapid antigen test instructions logo

    3) Slowly rotate the swab 7 times over the surface inside the nostril.

    NOTE: DO NOT place the cap on the vial. DO NOT remove the swab.

    Cov Clear COVID rapid antigen test instructions logo

    4) Slowly remove the swab from the nostril while still rotating it. Repeat steps 2-4 on other nostril.

    NOTE: DO NOT remove the swab.

    CoVClear COVID-19 rapid Antigen test instructions logo

    5) Place new test strip, arrow pointing down, into vial with the swab.

    NOTE: Touch test strip on the colored end only.

    CovClear Rapid antigen test instructions tube test logo

    6) Place cap securely onto the vial with the test strip and swab inside.

    NOTE: Cap will permanently lock in place. DO NOT tip vial over as this will invalidate the test.

    READ RESULTS AFTER 20 MINUTES.

    Interpretation of Results

    How to read COVID-19 rapid antigen test results. CovClear test. The control line should be red for a valid test. If the Control line is blue the test was not valid. If the test line is green then the result is positive. If the test line is not green the result is negative for COVID-19

    Limitations

    • Failure to follow the instructions for use may adversely affect test performance and/or invalidate the test result.
    • Results from antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2
      infection or to determine infection status.
    • The detection of SARS-CoV-2 nucleocapsid antigen is dependent upon proper specimen collection, handling, storage, and preparation. Failure to observe proper procedures in any one of these steps can lead to incorrect results.
    • Results from the device should be correlated with the clinical history, epidemiological data and other data available.
    • False-negative results may occur if the concentration of the target antigen in the clinical specimen is below the detection limits of the device.
    • There is a higher chance of false negative results with home use tests than with laboratory-based molecular tests. This means that there is a higher chance this test will give you a negative result when you have COVID-19.
    • The performance of this device has not been assessed in a population vaccinated against COVID-19.

    Get more information on Aurora’s Coronavirus (COVID-19) Rapid Test Kits:

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