As a preferred provider, Confirm BioSciences will have an ample supply of COVID-19 IgG/IgM Rapid Test kits for medical professional use starting in May
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SAN DIEGO, June 1, 2020 /PRNewswire/ -- Confirm BioSciences, a leading provider of comprehensive screening tools and solutions, today announced that the U.S. Food & Drug Administration (FDA) has authorized emergency use of its COVID-19 IgG/IgM Rapid Test kits. Confirm BioSciences is the largest North American distributor for Healgen Scientific, a subsidiary of Zhejiang Orient Gene Biotech, maker of the COVID-19 test. The FDA authorization and preferred provider status mean Confirm BioSciences will have an ample supply of test kits for medical professional use starting in early May. The Emergency Use Authorization is significant because it increases the availability of COVID-19 tests to the medical community. Confirm BioSciences will have millions of tests available, enough to satisfy existing pre-orders and future orders. Infectious disease experts say testing is a key component of an effective strategy to control the spread of COVID-19. As part of the FDA review, a National Institutes of Health (NIH) study comparing rapid test kits found that the Zhejiang Orient Gene Biotech COVID-19 Rapid Test was among the top performers. Once finalized, these data will be published as the NIH focuses on four key research priorities to combat the spread of the virus. "We have received positive feedback on the test from our customers and independent studies, so the FDA Emergency Use Authorization validates what we already knew from real-world clinical applications," said Albert Berger, Chief Executive Officer, Confirm BioSciences. "This pandemic is an enormous challenge for medical professionals and everyone else, and as a major distributor, we're proud to do our part to increase testing capacity so that healthcare professionals can help contain the spread of the virus." An easy-to-use test kit that provides results in just 10 minutes, COVID-19 IgG/IgM Rapid Test kits are designed for use with whole blood, serum or plasma samples. With a high degree of accuracy, the kits detect IgM that may appear in blood within 3-5 days following incubation and IgG that appears as soon as 1-2 weeks. Since the tests are authorized for medical use only, a licensed phlebotomist or a medical professional should conduct the test. The kits have a shelf life of 24 months from the date of manufacture and can be stored at room temperature or in a refrigerator. If you are a medical professional or supply medical professionals or medical facilities, please click here to learn more about our COVID-19 IgG/IgM Rapid Test kits. For additional information on coronavirus testing and resources, please visit Confirm BioSciences Covid-19 Resources. About Confirm BioSciences Media Contact Info: SOURCE Confirm BioSciences |
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