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    Manufacturer: MyHealthConnection
    15 minute finger prick at-home blood test for SARS-CoV-2 IgG/IgM RAPID SEROLOGY TEST
    SKU: CLCOV01
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    The Clungene™ SARS CoV-2 Virus (COVID-19) IgM/IgG Rapid Test is an onsite kit with a single panel for IgM/IgG simpler detection of Coronavirus in 10-15 minutes, whether you have been exposed to the virus within the past 4 to 24 days.

    The Clungene™ Coronavirus SARS CoV-2 Virus (COVID-19) IgM/IgG Rapid Test Kit includes:

    • 25 Tests (Cassettes)
    • 25 Droppers
    • 25 Tubes
    • 25 Foil Pouches
    • 25 Alcohol Pad
    • 1 Buffer
    • 1 Package Insert 

    Negative compliance rate
    100% conformance rate (specificity) for 126 negative controls with subjects not infected with SARS-CoV-2.

    Positive compliance rate sensitivity
    Early infection stage (day 4-10): IgM 70.0% Late infection stage (day 11 - 24): IgM 92.3% Late infection stage (day 11 -24): IgG 98.6%

    An Effective Screening Point-of-care Test

    When the body has been exposed to the SARS-CoV-2 virus, it produces IgM and IgG antibodies in an attempt to defend itself against infection. By measuring the concentration of these particular antibodies, the SARS-CoV-2 Rapid Test can determine in 20 minutes whether you have been exposed to the virus fast and with reliaxble results.

    The test is very simple.
    Two drops of blood are taken from a patient’s fingertip and placed in the specimen window of a test cassette, along with two drops of buffer solution.

    This product is not for at-home use and is meant for health professionals following guidance from the FDA for Emergency Use Authorizations of tests submitted for approval on March 16, 2020. Suitable for the qualitative detection of Coronavirus (SARS-CoV-2 / COVID-19) N-Protein IgM / IgG antibodies in human serum, plasma, whole blood, or finger-prick samples. This test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

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