Concerns over reliability and cost of coronavirus antibody tests

Leading experts have raised concerns about the reliability, cost and clinical use of the coronavirus antibody testing kits.

Covid-19 antibody tests are designed to tell whether a person has had the illness in the past.

The first phase of the Government's antibody testing programme is set to assess the NHS and care staff.

Clinicians will be able to request tests for patients in both hospital and social care settings.

But a letter from academics and clinicians, published in the BMJ, raises concerns about the performance of the tests, the clinical reasoning and their cost.

Coronavirus antibody tests have been sold in Superdrug for up to £69, but other private clinics are offering tests from as much as £110 or more.

A team of academics wrote: “We are writing to express concerns over aspects of the establishment of SARS-CoV-2 antibody testing in England.

“NHS England and NHS Improvement wrote to NHS trusts and pathology networks on 25 May 2020, asking them to offer antibody testing at short notice and ramp up capacity to thousands of samples a day.

“We have three concerns about the request. Firstly, there is no specific clinical indication for the test on an individual basis.

Clinicians will be able to request tests for patients in both hospital and social care settings. Credit: PA

"Secondly, the performance of these assays has not yet been assessed to the standard typically required of a novel test. And thirdly, the resource implications are not considered."

They added the result of the test, whether positive of negative, would not change the treatment they are receiving and a positive result "does not indicate immunity".

They also dismissed the concept of "immunity passports" and said those who had tested positive on the antibody tests should still be cautious of being reinfected.

They raised concerns about the "unproven performance" of the tests" and the "unprecedented pace and scale" they had been rolled out without "adequate assessment".

There is an effort to have the widespread rollout of antibody testing kits. Credit: PA

The Government website states: “While the results of an antibody test will not allow people to make any changes to their behaviour, such as easing social distancing measures, there’s clear value in knowing whether NHS and care workers and hospital patients and care home residents have had the virus, and in collecting data on the test results.”

A spokesman for Roche Diagnostics UK told The BMJ: “We are rolling out antibody tests to the NHS as part of the crucial next step in understanding the spread of this virus, and providing greater confidence and reassurance as we move into the next phase of our response to this pandemic.”

A Public Health England spokesman said: “Our evaluations have been completed in record time using the samples and tests that were available to us. We are confident that the volume of samples and methodology was of a high standard.”

In a statement to The BMJ, the Department of Health and Social Care said: “We do not currently know how long an antibody response to the virus lasts, nor whether having antibodies means a person cannot transmit it to others.”

But the spokesman reiterated that antibody testing “will play an increasingly important role as we move into the next phase of our response to this pandemic”.

Coronavirus: Everything you need to know