First U.S. clinical trial confirms Clungene® SARS-CoV-2 Virus IgG/IgM 15-minute rapid test accurately identified antibodies in 100% of COVID-positive patients after 13 days
Plymouth Meeting, PA /PRNewswire/ - A U.S. clinical trial of a COVID-19 rapid test approved by an institutional review board found the Specificity of confirmed negative Covid-19 patients by RT-PCR was 100% (95% CI, 88.4%-100.0%); meaning there was 100% agreement between a negative RT-PCR and negative Clungene® serological test result. There was over 90% agreement between the Clungene® SARS-CoV-2 Virus IgG/IgM 15-minute rapid test and a polymerase chain reaction (PCR) test in patients who tested positive for the virus after 13 days. The results suggest these tests could be an effective tool for detecting the presence of antibodies in people who have contracted the virus. The trial was conducted by Sharp Healthcare in San Diego, California, and included patients at both in- and out-patient facilities. The trial was carried out before vaccines were widely available. The peer-reviewed original research results were published in the LymphoSign Journal (https://lymphosign.com/journal/lpsn).
"These results are incredibly encouraging because they show that the CLUNGENE® SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette is highly effective at identifying individuals with an adaptive immune response indicating recent or prior infection as intended under the US FDA's current Emergency Use Authorization policy" said Dr. Fadi Haddad, an infectious disease expert with the Sharp Medical Community Group who helped conduct the study. "This is incredibly important at a time when millions of people remain unvaccinated and the potential for infection is still a very real concern."
"We are extremely proud of the results of the trial," said Proven CEO Scott Wise. "The trial confirms the role of tests like the Clungene® SARS-CoV-2 Virus IgG/IgM 15-minute rapid test to assist health care professionals. Its simplicity and ease of use make it a useful diagnostic tool."
The Clungeneâ SARS-CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Cassette produces results in 15 minutes. The test does not require complicated laboratory equipment to process readouts.
About Proven Pharma
Established in 2012, Proven Pharma is a service provider to the healthcare and life science industries. The company offers a wide range of solutions that include specialty distribution, comparator sourcing for clinical trials, dedicated inside sales teams, marketing support, digital transformation, and technology consulting. Their solutions are informed by more than two decades of extensive experience across many areas of the healthcare landscape.
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
Hangzhou Clongene Biotech is a high-tech, leading manufacturer of biological raw materials and in vitro diagnostic products. The company has a solid reputation for offering diversified services and superior flexibility to professional distributors and partnering affiliates in the global market.
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 (FDA Registration number: 3009414546).
The CLUNGENE® SARS-COV-2 VIRUS (COVID-19) IgG/IgM Rapid Test Cassette is available under the FDA EUA guidance: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-serology-and-other-adaptive-immune-response-tests-sars-cov-2
Any use or claim other than what is stated in the Instructions For Use (IFU) is strictly prohibited. Visit www.proven.com website or call 1-855-678-7768 for more information.