LEE'S SUMMIT, Mo., May 7, 2020 /PRNewswire/ -- Viracor Eurofins, Inc. (Viracor) a leading infectious disease testing laboratory for more than 35 years, announced the launch of its antibody assays for Coronavirus (COVID-19) SARS-CoV-2. The CAP-accredited and CLIA/NY State-certified laboratory has been at the forefront of SARS-CoV-2 testing, creating a proprietary RT-PCR test used by hundreds of hospitals nationwide. Viracor's SARS-CoV-2 PCR test, received an Emergency Use Authorization from the Food and Drug Administration (FDA) on April 6. Viracor will begin offering IgG and IgM serology assays developed by Gold Standard Diagnostics.
The assays, developed in accordance with the FDA's Emergency Use Notification process, are based on the ELISA (Enzyme-linked Immunosorbent Assay) technique. The tests can detect IgM antibodies (typically present approximately 2-5 days post-infection) and IgG antibodies (typically present approximately 2-4 weeks post-infection). Viracor has the capacity to result more than 2,000 tests per day with a 24 hour turnaround from specimen receipt. Eurofins U.S. Clinical Diagnostics, which includes Viracor and six other laboratories, has the capacity to run up to 10,000 antibody tests per day and is expecting to triple that number by the end of this month.
According to a preliminary study, Viracor's IgG serology assay was 100% accurate in finding antibodies in COVID-19 positive patient samples (12 days post symptom onset). Using a wider sample group from PCR positive patients, the IgG test showed a specificity of 99.1% (9 days post symptom onset).
Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. However, reliable serology testing, when used in conjunction with the PCR assay, can help determine the timing and status of the infection. Antibody tests can also help identify which recovered patients have antibodies to be a potential plasma donor to a critical COVID-19 patient. Finally, as knowledge around immunity strength and duration develops, antibody testing may also provide information on the statistical likelihood of getting re-infected.
ABOUT VIRACOR
With over 30 years of specialized expertise in infectious disease, immunology and allergy testing for immunocompromised and critical patients, Viracor Eurofins is committed to helping medical professionals, transplant teams, reference laboratories and biopharmaceutical companies get results faster, when it matters most. Viracor is passionate about delivering value to its clients by providing timely, actionable information, never losing sight of the connection between the testing it performs and the patients it ultimately serves. Viracor is a 100 percent subsidiary of Eurofins Scientific (EUFI.PA), the global leader in bio-analytical testing, and one of the world leaders in genomic services. For more information, please visit https://www.eurofins.com/ and https://www.viracor-eurofins.com/.
ABOUT EUROFINS – A GLBOAL LEADER IN BIO-ANALYSIS
Eurofins Scientific, through its subsidiaries (hereinafter "Eurofins" or "the Group"), believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. In addition, Eurofins is one of the leading global emerging players in esoteric clinical diagnostic testing. With over 47,000 staff across a network of more than 900 independent companies in over 50 countries generally specialised by end client markets and operating more than 800 laboratories, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services. The Group's objective is to provide customers with high-quality and innovative services, accurate results on time and, when requested, expert advice by its highly qualified staff.
Eurofins is committed to pursuing its dynamic growth strategy by expanding both its technology portfolio and its geographic reach. Through R&D and acquisitions, the Group draws on the latest developments in the field of biotechnology and analytical chemistry to offer its clients unique analytical solutions and a very large range of testing methods.
As one of the most innovative and quality-oriented international companies in its industry, Eurofins is ideally positioned to support its clients' increasingly stringent quality and safety standards and the increasing demands of regulatory authorities and healthcare practitioners around the world.
Shares in Eurofins Scientific are listed on the Euronext Paris Stock Exchange (ISIN FR0000038259, Reuters EUFI.PA, Bloomberg ERF FP).
ABOUT GOLD STANDARD DIAGNOSTICS GROUP
Gold Standard Diagnostics Group is a clinical diagnostics group comprised of Gold Standard Diagnostics Inc., VIROTECH Diagnostics GmbH, and NovaTec Immundiagnostica GmbH. The companies develop, manufacture and distribute a portfolio of instrumentation and diagnostic test kits to clinical laboratories worldwide. The US GSD Inc. is headquartered in Davis, CA. Gold Standard Diagnostics is a member of the Eurofins Technologies group of companies.
SOURCE Viracor Eurofins
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