Swiss pharmaceutical giant Roche said Thursday that one of its antibody tests for COVID-19 has successfully completed an independent evaluation by Public Health England that is reliable and precise.
“Roche Diagnostics is in dialogue with the NHS [National Health Service] and the UK Government about a phased rollout of the test as soon as possible,” Karsten Kleine, a media relations officer from the Roche Group, told Anadolu Agency.
He said that the test “was independently evaluated” by Public Health England at its reference laboratory at Porton Down.
“The detection of these antibodies could help to indicate if a person has gained immunity against the virus,” said Kleine.
“It could also help identify people who have been infected by the virus, but did not display symptoms,” he said.
The public health valuation confirmed the test is highly reliable and precise on May 7, and it complies with EU safety rules and can be made available in markets, including the UK, said Roche.
Kleine cited an earlier announcement by Geoff Twist, managing director of Roche Diagnostics UK and Ireland, about the successful completion of the test.
In that statement, Twist said the company was moving to the next phase “to enable the rollout of our test across the UK as soon as possible.”
Kleine said Roche had also received Emergency Use Authorization from the US Food and Drug Administration on May 2.
“We will be able to provide hundreds of thousands of antibody tests to the UK per week,” said Kleine.
“Hospitals and reference laboratories can run the test on fully-automated equipment already widely installed by Roche Diagnostics at sites across the UK with results provided in 18 minutes.”
Roche said its diagnostics’ section has a new serology test that supports the detection of antibodies in patients who have been exposed to the virus that causes COVID-19.
The test requires a blood sample to be taken by a qualified health care professional and processed in a laboratory.
“The test is one of the most reliable on the market, reporting 100% sensitivity (14-days post PCR [Polymerase chain reaction] confirmation) and over 99.8% specificity,” said Roche.
“The high specificity indicates how precisely this test finds the exact COVID-19 antibodies it is looking for in each test sample.”
Roche said that such a level of accuracy is vitally important because there are several viruses with very similar antibodies to COVID-19, including the common cold, and other SARS strains.
These can produce a positive result in some less accurate antibody tests.
“The test can also help identify both immunoglobulin M (IgM) antibodies – which are produced by the body in the initial fight against the infection – and immunoglobulin G (IgG) antibodies – which remain longer in the body,” said Roche.
Prof. John Newton, national coordinator of the UK coronavirus testing programme described the possibility of use of the test “positive”.
“This is a very positive development because such a highly specific antibody test is a very reliable marker of past infection,” BBC News quoted him as saying.
“This in turn may indicate some immunity to future infection, although the extent to which the presence of antibodies indicates immunity remains unclear.”
More than 33 thousand people died from COVID-19 across the UK so far, according to the official figures.
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