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    Frequently Asked Questions About COVIX-19

  • Frequently Asked Questions

    Are COVIX-19 Tests specific to COVID-19?

    Yes. COVIX-19 Tests are designed to detect COVID-19 specific antibodies in blood samples, or antigen in nasopharyngeal samples..

    Is there clinical data available on COVIX-19?

    Yes. Clinical studies were performed in March, 2020, and continue to be updated. We continue to test COVIX-19 regularly with clinical trials. The reports are available upon request.

    What are storage conditions for COVIX-19 Tests?

    COVIX-19 must be stored between 2°C-30°C (35.6°F - 86°F) and must be performed at room temperature.

    What is the shelf-life of COVIX-19?

    Based on stability testing for both the test strips and the buffer, COVIX-19 is stable for 18 months from the date of manufacture.

    Do COVIX-19 Tests have CLIA-Waived Status?

    At this time, COVIX-19 has requested CLIA-Waived status from the FDA. Because of the nature of COVIX-19, results are reliable within 10 minutes from the time of performing the test.

    Is COVIX-19 FDA Notified?

    Yes. COVIX-19 Antibody Tests are fully FDA notified, compliant and acknowledged, with full FDA Emergency Use Authorization submitted. Contact us for our EUA number.

    Does COVIX-19 need hardware / lab processing?

    No. COVIX-19 is completely self contained, and the kit includes all components required to run the test, without the need for specialized equipment or specific labs.

    Does COVIX-19 detect COVID-19 viral DNA?

    No. COVIX-19 Antibody Tests detect IgG and IgM antibodies, specific to COVID-19 with over 95% accuracy. COVIX-19 Antigen Tests detect COVID-19 specific antigens with over 95% accuracy.

    Does COVIX-19 detect early infection?

    Yes. COVIX-19 Antibody tests, in most cases, will show IgG / IgM positivity within the first few days of symptomatic infection of COVID-19. COVIX-19 Antigen tests will do the same.

    Can I perform COVIX-19 at home?

    No. According to FDA policy these tests must be performed by a healthcare practitioner, and we do not sell them for home use at this time.

    Is COVIX-19 available for sale in the USA?

    Yes. In the USA, our tests are available for purchase through our distribution network. Please email us for more information.

    Is COVIX-19 available for purchase worldwide?

    Yes. HELIX-19 is available to healthcare professionals and governments worldwide. Please email us for more information.

    Are COVIX-19 Antibody Tests a PCR Test?

    No. COVIX-19 Antibody Tests detect COVID-19 specific IgG / IgM antibodies, and do not look for any RT-PCR viral reactions.

    Are COVIX-19 Antigen Tests a PCR Test?

    No. COVIX-19 Antigen Tests detect COVID-19 specific antigens, and do not look for any RT-PCR viral reactions.