Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, has announced that production of their Covid-19 antibody tests is underway at its state-of-the-art facility in Pencoed, near Bridgend in South Wales.


In early April, Life Sciences Hub Wales made a national industry call out for companies to support Wales’ work to combat the virus and to which Ortho Clinical Diagnostics responded.

A global leader in its field, Ortho has developed a manufacturing base for serological testing in Wales over the past 40 years. Today, the company employs over 500 people at their site in Pencoed and produces millions of tests each week for a wide range of disease states and medical conditions for distribution globally. 

Working in partnership with Public Health Wales, Ortho will provide their Covid-19 assays that are produced in the Pencoed manufacturing facility to support Covid-19 testing across Wales.

The tests detect antibodies that can be used to identify an immune response confirming a previous and recent Covid-19 infection and may be critical in back-to-work strategies. Ortho has secured FDA and CE certification for its antibody tests, which offer 100 per cent specificity to help reduce false positives to ensure that people will not be identified as having an immune response to the virus when they do not.

Paul Hales, Senior Director of Operations at Ortho, said:

“We have built a deep manufacturing expertise here in Wales over many years enabling us to produce these important products.  The team has been working day and night to reach a mass scale of production of our Covid-19 assays. At Ortho, we believe every test is a life and are proud to see these kits being used in Wales.”

The company is one of a number to produce the antibody tests for the UK – it became involved after responding to a call to action to help with the coronavirus response from the First Minister and Life Sciences Hub Wales.   

Health Minister Vaughan Gething today welcomed the availability of the new test, saying Wales will decide how the test is rolled out, prioritised and managed. It is expected it will be available in care homes.

An expert group is currently working on the antibody testing strategy for Wales and will make an announcement shortly.

The Health Minister said:

“The approval and production of the new antibody test is an important step forward in our efforts to stop the spread of the virus, protect the public and ease lockdown restrictions.

“This test will tell us if people have already had coronavirus. But it is important to say although the test can tell if someone has had the virus, it’s not certain as to how much immunity they’ll have to the virus.

“We are also looking to deliver another type of antibody test, which can give a result in minutes. Together with the test announced today this will form an important part of our Test, Trace, Protect strategy to help Wales come out of lockdown. I will shortly be announcing how these antibody tests will fit into the strategy and when our critical workers and general public will be able to get access to them.”

Cari-Anne Quinn, CEO of Life Sciences Hub Wales, said:

“Today’s news exemplifies Wales’ position at the forefront of the international life sciences sector and the critical role Welsh businesses are playing in efforts to combat Covid-19 here in Wales and across the globe. 

“The company’s history and pedigree in infectious disease testing allowed us to quickly identify Ortho as a Wales-based company with proven capabilities that would place it at the international forefront of antibody testing. We are proud to facilitate a partnership that has enabled these vital tests to be qualified by Public Health Wales for the benefit of people in Wales and beyond.”

The test may further help the Welsh Government and epidemiologists research the spread and impact of the virus as well as inform health care providers when treatment is necessary.

David Heyburn, Head of Operations for Microbiology and Health Protection at Public Health Wales, said:

“Antibody testing is an important part of our strategy to counter the spread of Covid-19 and to help us understand who has had the disease. Knowing that the production of the test will be local to us in Wales was of great importance to us as we determined which suppliers to rely on.”

Welsh Government Minister for Economy, Transport and North Wales, Ken Skates said: “The response of businesses throughout Wales to support our effort in beating Coronavirus continues to be truly remarkable.

“Ortho’s work to produce these vital antibody tests at their facility in Pencoed is a clear demonstration of the company’s innovative capability and wealth of expertise.

“I’d like to thank Ortho, its workers and all partners involved for their commitment and effort in delivering these essential products right here in Wales.”

Paul Hackworth, Ortho Managing Director UK, said:

“We are delighted to be working with Public Health Wales and Welsh Government to play our part in the overall testing strategy for Wales. We were one of the first in vitro diagnostics providers to step up to this unique challenge and are proud that our Covid-19 antibody tests will provide a flexible, reliable solution for the Welsh Government to maximise the effectiveness of their approach.”