An observational study released today revealed 100 percent agreement between a rapid antibody test administered by trained health professionals and the PCR tests widely used to determine COVID-19 infections.
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PLYMOUTH MEETING, Pa., Aug. 17, 2020 /PRNewswire/ -- An observational study released today revealed 100 percent agreement between a rapid antibody test administered by trained health professionals and the PCR tests widely used to determine COVID-19 infections.
Doctors compared the results of PCR tests with the results from a SARS-CoV-2 rapid antibody test distributed exclusively in the United States by Proven Pharma. The study offers additional evidence that rapid screening tests to identify patients with COVID-19 antibodies who had a positive PCR test, symptomatic without a PCR test or asymptomatic can be an effective tool for healthcare professionals to determine or confirm past infections "This study further establishes the importance of rapid serological testing," said Dr. Gerald Osher, of North Shore Medical Associates who oversaw the study in North Suburban Chicago. "Serological tests are valuable tools in identifying antibodies, which in turn help assess patient immunity and establish guidelines for responsible reopening procedures." In April and May, two physician practices in north suburban Chicago conducted rapid serological tests on 114 study participants. The study found 100% positive agreement between a PCR test and the Clungene® SARS-CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Cassette. The study successfully investigated the use of a point of care antibody test in a physician's office to determine which patients have developed antibodies indicating an immune response to SARS-CoV-2. "We are pleased to see how well the product works and the value it provides to healthcare workers and patients alike and proud to be the exclusive distributor of the Clungene 15 minute rapid antibody test," said Proven CEO Scott Wise. The Clungene® SARS-CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Cassette produces rapid results in 15 minutes from venipuncture whole blood, serum or plasma. The test does not require complicated laboratory equipment, software or specialized training to process readouts. Users do not have to send samples to labs in order to obtain results. Use of this product is for in vitro diagnostic use under emergency use authorization only (Submission Number: EUA201121) and should be limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests. Results should not be used for diagnosis of acute COVID-19. Do not use this product as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status of COVID-19. ABOUT PROVEN PHARMA In an industry full of uncertainty, Proven Pharma provides confidence to its customers. The company delivers on-time, every time – using recognized best practice and process to ensure safety and compliance every step of the way. Proven Pharma is dedicated to constantly improving its customers' experience so those customers can improve the lives of their patients. The company's success results from the honesty, integrity and dependability of its team. About Hangzhou Clongene Biotech Founded in 2004, Hangzhou Clongene Biotech is equipped with state-of-the-art ISO 13485:2016 accredited China GMP compliant R&D and manufacturing facilities covering 19,000 square meters in Hangzhou, China. Their products have obtained CE certificates, FSC certificates, and US FDA 510(k) Clearances.
SOURCE Proven Pharma |
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