CovClear COVID-19 Rapid Antigen Test

PRODUCT INFORMATION


    covclear-rapid-antigen-test

    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

    Why CovClear?

    CovClear

    Other Cassettes

    Safety Seal cap permanently contains all bio-exposed test components. Can throw used contents in the bin.Unsealed potentially infectious material.
    Tamper-proof design locks in results with 100% identification certainty.Cassette easily opened and results compromised. Must be disposed of using biomedical waste disposal protocols.
    Buffer quantity calibrated for absorbent pad – no excess liquid media.Media over flow creates reservoir for bio waste flooding.

    Interpretation of Results

    Sample Collection

    1) Remove a swab from the pouch.

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

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

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

    Test Instructions

    1) Remove a swab from the pouch.

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

    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.

    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.

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

    NOTE: Touch test strip on the colored end only.

    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

    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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