A coronavirus antibody test said to be 99.8% accurate has been approved for use in the US, amid reports it could be available within weeks in the UK.
Roche Diagnostics’ new serology test detects antibodies in patients who have been exposed to the virus that causes COVID-19, which could help to indicate if a person has gained immunity against the disease.
The Swiss firm says the test – called Elecsys – has a specificity greater than 99.8% and sensitivity of 100%, meaning it gives no false negative results and only one in 500 false positives.
An effective antibody test is thought to be crucial in easing coronavirus lockdowns.
And as the kits were approved for emergency use by the US Food and Drug Aministration (FDA), the company reportedly said it was “in dialogue” with the NHS and the UK government with a view to a “phased roll-out of the test from mid-May”.
“We will be able to provide hundreds of thousands of antibody tests to the UK per week,” a spokesman was quoted by the Daily Mail as saying.
“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.”
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It comes after Deputy Chief Medical Officer for England Dr Jenny Harries said officials did not have enough information yet on the issue of immunity.
“The WHO (World Health Organisation) position is very similar to the one we would have, which basically says we actually don’t have enough information yet to be very clear on the immune status,” she said.
She added that signs of immunity could vary from patient to patient but that doctors would expect people to have some immunity about 10 days after being ill.
Professor John Newton, the UK’s testing effort co-ordinator, said it was “encouraging” to see evidence from South Korea that suggests people are developing immunity, although it remains unclear how long any protection lasts.
Geoff Twist, managing director of Roche Diagnostics UK & Ireland, said: “Reliable antibody testing is the crucial next step in helping us to understand the spread of the virus and to provide much-needed reassurance to our valued key workers, enabling them to continue providing their vital support.
“More than ever, it is critical that industry works in collaboration with the NHS to help alleviate pressures and provide a solution, and we are extremely proud to be able to deliver our high quality antibody test, which will lead to greater confidence as we move into the next phase.
“We will continue to work closely with the NHS, public health bodies and the UK government to enable the roll out of the test across the UK.”
The government previously admitted that 3.5 million antibody tests it ordered from China were “not good enough to be worth rolling out in very large scale”.
Roche said it would provide “high double-digit millions of tests” in May for countries accepting the CE mark and in the US, while continuing to increase capacity.
Public Health England has been contacted for comment.
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