20/20 BioResponse, a business unit of 20/20 GeneSystems, Inc. announced today that it will begin shipping its CoronaCheck tm COVID-19 Rapid Antibody Test Kit. The company's action follows a study involving over 50 patients being treated or evaluated at five hospitals and medical practices in Washington D.C., Colorado, New Jersey, South Carolina, and Pennsylvania.
This study tested patients previously diagnosed as positive or negative for SARS-CoV-2 by the standard molecular diagnostic tests. Testing was performed at five separate sites throughout the United States and involved 50 patients. "The test results were found to be statistically consistent with the manufacturer's stated performance characteristics and appear to meet the expectation of front-line physicians who participated in the study," said Michael S. Lebowitz, Ph.D. 20/20's Chief Scientific Officer.
One of the evaluators, Dr. Charles H. Miranda, MD, from South Denver Internal Medicine, reported the product to be "highly reliable." "I congratulate 20/20 BioResponse for being one of the first companies in the nation to understand the need and importance of providing clinicians with rapid point of care COVID-19 antibody testing," said Miranda.
The test kits are rapid immunoassays (configured like a home pregnancy test) to detect IgM and IgG antibodies to SARS-CoV-2 in blood. SARS-CoV-2 is the coronavirus which is the cause of COVID-19 disease. Antibodies that bind to SARS-CoV-2 are detectable in most people between 7 and 10 days after the onset of symptoms. 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. These tests give results in less than 15 minutes.
The subject test, made in China and approved by the Chinese FDA, was previously evaluated in using 188 clinical samples. The manufacturers reported a sensitivity of 87% and a specificity of 100%.
The need for these tests is well understood by experts in infectious disease. A recent editorial published by the American Society for Microbiology, including both the President and the CEO of that organization as two of eight authors, suggested that "antibody tests for SARS?CoV-2 may facilitate (i) contact tracing?RNA-based tests can help with this as well; (ii) serologic surveillance at the local, regional, state, and national levels; and (iii) identification of those who have already had the virus and thus may (if there is protective immunity) be immune."
20/20 is now making this test available to U.S. based public health providers, hospitals, urgent care centers, and occupational health providers, especially those serving first responders. It also plans to 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.)
About 20/20 GeneSystems
20/20 GeneSystems, Inc. (www.2020Gene.com) is a Rockville, MD based company focused on innovative diagnostics and detection products. In addition to the company's blood tests that aid in the early cancer detection (www.OneTestforCancer.com), 20/20 has also commercialized its patented BioCheck® detection kit to help fire departments and other emergency response organizations screen suspicious powders. (www.BioCheckInfo.com).
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