Labs could run out of Covid-19 testing kit after supply chain failure

NHS laboratories could run out of crucial materials for Covid-19 tests within days after supply chain failure at Roche

  • Pharmaceutical company has experienced ‘significant drop’ in its processing capacity due to a problem with its only UK-based distribution centre in Sussex
  • The problem means a shortage in materials used for Covid tests such as swabs 
  • Company also provides testing materials for other conditions including cancer 
  • Roche warned hospitals it supplies that it may not be resolved for up to 3 weeks 

Concerns have been raised over the supply of vital testing materials for a range of conditions, including Covid-19, following a supply chain problem with pharmaceutical giant Roche.

On Tuesday, Roche said it had experienced a ‘very significant drop’ in its processing capacity due to a problem with its Sussex distribution centre in Newhaven, the only one in the UK.

It has been reported that the shortage includes vital reagents, screening kits and swabs.

In addition to providing these chemicals and parts used in Covid-19 tests, Roche also provides materials for a wide range of procedures including blood and urine tests, as well as diabetic care.

It comes days after the Government confirmed a technical glitch meant 16,000 positive test results had been missed, leaving contract tracers chasing thousands of contacts who needed to self-isolate.

The Government is facing mounting pressure to increase coronavirus testing capacity as cases continue to rise, with 14,542 new cases recorded yesterday – meaning the number of people testing positive for Covid-19 every day has tripled in a fortnight.

Roche has warned hospital labs  issues with its supply chain, which may result in a shortage of vital testing materials for conditions, including Covid-19, may not be solved for three weeks. Pictured: A lab tech holds a container of live Covid-19 samples at a new Lighthouse Lab facility dedicated to the testing for Covid-19, at Queen Elizabeth University Hospital in Glasgow

Roche warned the issues with the supply chain may not be resolved for two to three weeks, but is prioritising the dispatch of Covid-19 and antibody tests.

In a letter, the company told customers to activate their local contingency plans ‘and recommend that you look to prioritise essential services only’.

The letter adds: ‘In September we moved from our old warehouse to a new automated warehouse capable of much higher volumes.

‘However, during the transition we encountered some unforeseen issues and a very significant drop in our processing capacity. Since then we have worked around the clock to prioritise and manage orders as well as increase this capacity’.

It is understood the issue has not had an impact on Covid-19 tests at this point.

However, concerns have been raised about the future supply of tests for the virus and the impact on making diagnoses and monitoring in other aspects of medicine.

The news has already sparked fears among NHS workers that supplies will impact patient care.  

Allan Wilson, president of the Institute of Biomedical Science, told the Financial Times Roche had been ‘unable to fulfil a broad range of orders across the testing range’.

He said: ‘The slightly scary thing is we don’t have an end date to it yet,’ he added. ‘If this isn’t fixed within days there would be an impact on our ability to do not just Covid testing but a broad range of lab testing.’

Tom Lewis, lead clinician for pathology at North Devon District Hospital, told the Financial Times Roche provided the swabs used by his lab for Covid-19 testing.

He added: ‘We have enough supply for another week or so but will run out if expected delivery doesn’t happen,’ he said.

A large number of NHS labs rely on Roche testing platforms to undertake conventional Covid-19 tests, known as PCR tests.

An NHS spokesperson said: ‘Roche has alerted hospitals to an issue with their supply chain, and they will be working urgently to resolve this issue.’

A Roche spokesperson said: ‘We deeply regret that there has been a delay in the dispatch of some products and apologise to any of our customers who have been impacted.

The lead clinician for pathology from North Devon District Hospital, which Roche supplies, says it has enough supplies for another week but could run out if the problem isn’t solved soon

‘As well as extending working hours, we have recruited extra staff and, where they can, our dedicated teams on the ground are working with customers to distribute products and minimise service disruption.

‘We will continue to provide regular updates to our customers and we are doing everything possible to return to routine operations.

‘We are prioritising the dispatch of Covid-19 PCR and antibody tests and doing everything we can to ensure there is no impact on the supply of these to the NHS.’

Munira Wilson, MP for Twickenham and health spokesperson for the Liberal Democrats, expressed her concern about the impact of the issue while the healthcare system was under ‘incredible strain’.

She said: ‘These reports will leave many people incredibly anxious, and rightly so.

‘This does not only have serious consequences for our ability to test for Covid-19, but others with potentially incredibly serious illnesses will also be unable to get the blood tests or screening they need.’

She added: ‘Our NHS must be able to treat everyone, whatever their illness, and Ministers must do everything in their power to resolve this issue with the supply chain as quickly as possible.

‘We cannot allow this virus to get further out of control, as well as further risking the health of thousands of individuals whose diagnosis of serious illness could either be delayed or go undetected.’

The latest disruption follows a technical glitch which meant 15,841 cases between September 25 and October 2 were left out of the reported daily coronavirus cases and were not referred to NHS Test and Trace, meaning potentially tens of thousands of infected Britons were allowed to roam the streets.

And in a slow recovery from Friday’s Excel blunder almost 6,000 covid carriers are yet to be traced, some of whom were given their positive covid-19 diagnosis two weeks ago.

Each of those 6,000 carriers are expected to have made contact with three to four unwitting people before they begun isolating, that’s an estimated 18,000 to 24,000 individuals who have not been informed that they should be isolating due to close contact with covid-19.

Roche was at the centre of controversy in July when the Government was accused of ‘panic-buying’ antibody tests before official reports into their effectiveness had been published

In July this year, the Government was accused of ‘panic-buying’ antibody tests from Roche because the £13.4 million purchase was made before official reports into their effectiveness had been published.

Officials spent £13.46million on the blood tests — now being used to tell which NHS staff have already had Covid-19 — on May 15, government contracts show.

But Public Health England had not officially evaluated any other companies’ tests before officials agreed to buy Roche’s, so didn’t know how good they were in comparison.

The Roche purchase was 10 days after scientists at PHE’s Porton Down laboratory first started looking at the tests but three days before their report was released.

Results of PHE’s tests were leaked to the press on May 13 and reports claimed it had achieved 100 per cent accuracy in the evaluations.

But this later turned out to be on only one of two measures and health chiefs actually deemed the test to be 84 per cent sensitive, meaning it could correctly detect past infection in around eight in 10 people.

In later evaluations other tests performed better than Roche’s but contracts were not announced for those.

Ones made by Abbott Laboratories, which were 94 per cent accurate, were bought in the same week in May for an undisclosed price.

Another made by the German firm Siemens last month achieved 86 per cent sensitivity in PHE’s evaluation. These were bought by officials but to no fanfare.

There was a prior understanding between Roche and the Government that its tests – which were the first to be evaluated – would be bought if PHE approved of them, MailOnline reported.

Yesterday, the Department of Health and Social Care announced the Government had purchased 1 million antibody tests from the UK Rapid Test Consortium (UK-RTC).

Rapid-use antibody tests have been shunned by the Government until now, with private firms struggling to get contracts from officials. The Rapid Test Consortium product is the first of its kind to be approved (stock image)

The home antibody tests will be rolled out as part of the government’s COVID-19 surveillance studies to help build a picture of how the virus has spread across the country and further develop our understanding of how antibodies work.

The test uses a finger-prick device and provides a result within 20 minutes, without the need to be sent to a lab for analysis and therefore has no impact on testing lab capacity. 

Jon Deeks, professor of biostatistics at Birmingham university and lead author of a continuing review into antibody testing by Cochrane, the independent global health organisation, criticised the lack of publicly available evidence on the new antibody test purchased by the government.

He said on Twitter: ‘1,000,000 Rapid Test Consortium AbC antibody tests have been purchased by the DHSC despite the complete lack of reliable public evidence.

‘Mentions PHE report – but still no results. “Follow the science” RIP.’

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