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24th March 2020  Content supplied by: 20/20 Genesystems

CoronaCheck Lateral-Flow Test Manufacturers Confirm Mass-Production Capacity


20/20 BioResponse, a business unit of 20/20 GeneSystems, has announced that it will begin taking orders for its CoronaCheck COVID-19 Rapid Antibody Test Kit. The company's action follows discussions with officials from the U.S. Food & Drug Administration (FDA) this week after the agency's March 16 Guidance issued to "expand the number and variety of diagnostic tests" as the "severity and scope of the current COVID-19 situation around the globe necessitates greater testing capacity than is currently available."

The test kits are rapid chromatographic immunoassays (configured like a home pregnancy test) to detect IgM and IgG antibodies to COVID-19 SARS-CoV-2 in blood, which is the cause of COVID-19. IgM antibody generally begins to rise within one week of initial infection. IgG appears about 14 days after infection. According to the March 16 FDA Guidance, antibody blood tests of this nature are "less complex" than the nucleic acid testing that the CDC and laboratories throughout the U.S. have been running since the start of this emergency.

Advantages of these types of tests, approved by the Chinese FDA and compliant with medical device regulations in Europe, include the following:

  • Rapid results (under 15 minutes)
  • Accurate: High sensitivity (~97%) and specificity (~92%)
  • Well-validated on numerous cohorts in China
  • CE approved and widely used in many European countries
  • Whole blood testing likely remedies some false negatives inherent in respiratory swab samples
  • Low cost
  • Ease of use; no need for laboratory personnel, equipment or sample transport
  • Can be easily mass-produced to over 200,000 per day

CoronaCheck was evaluated in China using 760 clinical samples. In this cohort, 286 samples were confirmed positive. Manufacturers have reported a sensitivity of 97.2% and specificity of 92%.

Furthermore, in a soon to be published manuscript from a group of over 20 medical practitioners who were on the front lines fighting the coronavirus outbreak in China, (including Wuhan), the physicians concluded that IgM / IgG rapid tests "have great potential benefit for the fast screening of COVID-19 infections and it has already generated tremendous interest and increased clinical usage after a short time testing in Chinese hospitals."

20/20 will immediately make this test available to U.S. based public health providers, hospitals, urgent care centers, and occupational health providers, especially those serving first responders. It will also request from FDA an Emergency Use Authorization to make these kits available to consumers through retail and internet purchase.

Please refer to www.CoronaCheckTest.com for product details, updates, and ordering information. (More than one product configuration may be offered; features and performance may vary slightly among configurations.)


    

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Date Published: 24th March 2020

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