The first clinical trial in the United States confirmed that the 15-minute rapid test of Clungene® SARS-CoV-2 virus IgG/IgM accurately identified the antibodies of 100% of COVID-positive patients after 13 days
Plymouth, Pennsylvania Conference, June 15, 2021/PRNewswire/-A U.S. clinical trial for rapid COVID-19 testing approved by the Institutional Review Board found that the specificity of Covid-19-negative patients confirmed by RT-PCR was 100% (95% confidence interval, 88.4%-100.0%); this means 100% agreement between negative RT-PCR and negative Clungene® serological test results. In patients who tested positive for the virus after 13 days, the agreement between the Clungene® SARS-CoV-2 virus IgG/IgM 15-minute rapid test and the polymerase chain reaction (PCR) test was more than 90%. The results indicate that these tests may be an effective tool to detect the presence of antibodies in people infected with the virus. The trial was conducted by Sharp Healthcare of San Diego, California, and included patients in inpatient and outpatient facilities. The trial was conducted before the vaccine was widely available. The original peer-reviewed research results are published in LymphoSign magazine (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 kit is very effective in identifying individuals with adaptive immune responses, indicating that the recent or previous The infection is in line with the expected US Food and Drug Administration’s current emergency use authorization policy,” said Dr. Fadi Haddad, an infectious disease expert from the Sharp Medical Community Group who helped conduct this research. “This is very important at a time when millions of people have not been vaccinated and the possibility of infection is still a very real issue.”
“We are very proud of the results of the trial,” said Proven CEO Scott Wise. “This test confirms the usefulness of tests like the Clungene® SARS-CoV-2 virus IgG/IgM 15-minute rapid test in assisting healthcare professionals. Its simplicity and ease of use make it a useful diagnosis tool.”
The Clungeneâ SARS-CoV-2 virus (COVID-19) IgG/IgM rapid test kit can produce results within 15 minutes. This test does not require complicated laboratory equipment to process the readings.
About PROVEN PHARMA Founded in 2012, Proven Pharma is a service provider in the healthcare and life science industries. The company provides a wide range of solutions, including professional distribution, clinical trial comparator procurement, dedicated internal sales team, marketing support, digital transformation and technical consulting. They have more than two decades of rich experience in many areas of the healthcare field and provide them with solutions.
In an industry full of uncertainty, Proven Pharma provides its customers with confidence. The company delivers on time every time-using recognized best practices and processes to ensure safety and compliance at every step. Proven Pharma is committed to continuously improving the customer experience so that these customers can improve the lives of patients. The company’s success stems from the honesty, integrity and reliability of its team.
About Hangzhou Kelon Biotechnology Hangzhou Kelon Biotechnology Co., Ltd. is a high-tech, leading manufacturer of biological materials and in vitro diagnostic products. The company has a reputation for providing diversified services and superior flexibility to professional distributors and partners in the global market.
Hangzhou Kelon Biotechnology Co., Ltd. was established in 2004. It has the most advanced ISO 13485:2016 certified R&D and manufacturing facilities in Hangzhou, China, in line with China’s GMP, covering an area of 19,000 square meters. Its products have obtained CE certificates, FSC certificates and US FDA 510(k) approval (FDA registration number: 3009414546).
CLUNGENE® SARS-COV-2 virus (COVID-19) IgG/IgM rapid test kit can be obtained according to FDA EUA guidelines: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19- Emergency use authorization-medical device/in vitro diagnostic-euas-serology-and-other-adaptive-immune-response-tests-sars-cov-2
Except for the content specified in the Instructions for Use (IFU), any use or statement is strictly prohibited. Please visit www.proven.com or call 1-855-678-7768 for more information.
Post time: Jun-18-2021