This site is intended for health professionals only


NHS Covid-19 test kits made by private laboratory ‘paused’ over safety concerns



Covid-19 tests used as part of the NHS testing system have been temporarily stopped because some of the kits may not have met safety standards.

The Government has issued a warning for all settings to ‘pause’ the use of test kits produced by Randox laboratories ‘with immediate effect and until further notice’.

Randox said it had suspended its distribution of home sample kits provided by one supplier of swabs.

The private laboratory and sample kit provider is contracted to work with the NHS Test and Trace programme, which is also running testing from the Government-backed Lighthouse Laboratories.

The Department of Health and Social Care said the safety risk from Randox kits was ‘low’ and that only unused Randox test kits should be paused.

It stressed samples from Randox kits that have already been used can still be collected for processing.

It comes as the latest official figures from the NHS Test and Trace programme reveal little improvement in the number of infected people – and their close contacts – being reached and asked to self isolate.

In the week leading up to 8 July around 22% of the 3,579 people who tested positive were not able to be reached by tracers.

Of those who were spoken with, a further 29% of their close contacts – or 3,996 people – were not made contact with by callers.

Dr Layla McCay, a director at NHS Confederation, representing health service providers, said: ‘It is heartening to see there has been a slight improvement in the percentage of people reached who had their case transferred to the contact tracing system – but there is still more work to do, as the scheme is still not reaching the 80% target for tracing close contacts recommended by SAGE.’

A DHSC statement on the Randox kits said: ‘NHS Test and Trace has been notified that some test kits produced by Randox laboratories may not meet our required safety standards for coronavirus testing.

‘As a precautionary measure and while we investigate further, NHS Test and Trace are requesting that all settings pause the use of Randox test kits with immediate effect and until further notice.’

It added: ‘The risk to safety is low and test results from Randox kits are not affected. We will be supporting all testing settings to receive replacement kits as soon as possible.

‘All other kits from NHS Test and Trace can continue to be used for testing.’

Randox said in a statement: ‘As an immediate precautionary measure we have temporarily suspended distribution of home sample collection kits using one particular batch / supplier of swabs.

‘This is a temporary measure and does not apply to our private business which uses a different supplier of swabs.

‘Test results from Randox kits are not affected.’

Pulse voluntary donation scheme

Since the outbreak of this pandemic, Pulse has strived to support you, whether it be through our resources page, our ‘Clinical Crises’ series, holding policymakers to account with exclusives such as practices being supplied with faulty masks, or GPs being told to stop routine services in the hardest hit areas.

However, good journalism cannot be done on the cheap and, like the whole publishing industry, we have been affected by the economic slowdown. We also strongly believe the content we produce should remain free as we feel it is essential for you. Because of this, we have set up a voluntary donation scheme. There is no compulsion whatsoever to donate. But if you feel we are helping you, and you would like to support us, anything you can spare would be greatly appreciated. Read more here.

Donate here