Ortho Clinical Diagnostics Completes Evaluation with Public Health England and Achieves CE Marking for Much Needed Antibody Tests for COVID-19
Ortho's Strong UK Manufacturing Presence to Support Efforts
- Ortho completes evaluation with Public Health England of its COVID-19 IgG antibody test
- Ortho's COVID-19 total and IgG antibody tests have received CE Marking
- Both tests offer excellent performance, with 100% specificity
- Ortho's state of the art manufacturing facility located in Pencoed, Wales will be producing millions of tests each month
LONDON, May 26, 2020 /PRNewswire/ -- Ortho Clinical Diagnostics, a global leader of in vitro diagnostics with a rich history of bringing critical tests for infectious diseases to market, today announced its COVID-19 IgG antibody test has completed evaluation with Public Health England. The test also received CE Marking on May 18, 2020. The test offers excellent performance, with 100% specificity and will be available from the end of May.
Ortho's COVID-19 IgG antibody test detects the IgG antibody. The test can be used, among others, as part of back-to-work strategies and in serological surveys to understand rates of infection and immune response in the general population.
Ortho previously announced the CE marking of its total antibody test, which detects all COVID-19 related antibodies (IgA, IgM and IgG), which appear in the early, acute stage of infection, and help determine the onset of a patient's immune response by monitoring all antibodies generated through disease progression.
Ortho is the only company providing both a CE-Marked IgG test and a total antibody test in the fight against COVID-19. Both of Ortho's tests help health care professionals understand if a patient has been exposed to and has developed antibodies to the SARS-CoV-2 virus.
One major challenge of the COVID-19 crisis has been securing the timely importation and delivery of critical products to support front-line staff in their fight against the virus.
Ortho is the only organization with fully automated, high-throughput analyzers that will be producing millions of COVID-19 antibody tests each month from a manufacturing facility within the UK (Pencoed, Wales).
Ortho has a more than 80-year history and rich legacy in developing infectious disease assays. With over 4,000 employees globally, Ortho has developed its manufacturing base for immunoassays in the greater Cardiff area over the past 40 years. Today, Ortho employs over 500 people in the UK and produces many millions of immunoassay tests each week.
"We have built a deep manufacturing expertise here in the UK over many years enabling us to produce these important products," said Paul Hackworth, Ortho's Managing Director in the UK. "Our teams have been working day and night as we prepare to reach a mass scale of production of our COVID-19 tests, and we are looking forward to playing our part as the product reaches the hands of our frontline NHS workers and the wider population in the UK."
The test runs on Ortho's high-throughput, fully automated analyzers including its flagship VITROS® XT 7600 Integrated System, the VITROS® 3600 Immunodiagnostic System and the VITROS® 5600 Integrated System. VITROS® Systems are self-contained and do not require an external water source to run, offering labs placement flexibility.
Ortho is collaborating with the Department of Health and Social Care (DHSC) as to how they might work together to ensure these important tests can be made available across the UK.
About Ortho Clinical Diagnostics
Ortho Clinical Diagnostics is a global leader of in vitro diagnostics dedicated to improving and saving lives through innovative laboratory testing and blood-typing solutions.
Because Every Test is a Life™, we never stop innovating to offer streamlined, sustainable laboratory solutions that deliver fast, accurate, reliable test results that support exceptional patient care.
For more information about Ortho's solutions and services, visit Ortho's website or social media channels: LinkedIn, Twitter, Facebook, Instagram and YouTube.
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