RE: “We’ve yet to find a UK-based lateral flow test that’s good enough,”4 Nov 2020 07:27
Extracted from FT article
Contracts
The government has so far signed at least 10 contracts with companies based in the UK, US and China, totalling more than £1bn, for rapid testing technology and logistics, according to publicly available contracts on the EU public procurement site, Ted, and information shared with the non-profit legal firm the Good Law Project.
The FT shared its calculations with the Department of Health, which declined to comment on the contracts, citing commercial sensitivity.
Despite a drive to turbocharge the UK diagnostics industry, the contracts show that the Department of Health spent £138m on millions of lateral flow tests produced by US company Innova, whose tests will be used in the Liverpool pilot.
It has spent more than £80m on two tests made by US companies Abbott and LumiraDX, which is also being offered by the pharmaceuticals retailer Boots, according to the documents. One person close to the procurement process said the government had also spent an unspecified sum on lateral flow tests produced by the Chinese company Zhejiang Orient Gene and the Korean medtech company SD Biosensor.
Another contract published last week shows that the government spent more than £1.35m to fly lateral flow tests from China to the UK, although it did not disclose further details.
“We’ve yet to find a UK-based lateral flow test that’s good enough,” according to a person directly involved in the validation process
The Innova tests, expected to play a main role in the Liverpool trial, were found to have 100 per cent specificity, avoiding false positives, and 96 per cent sensitivity, avoiding false negatives, in clinical trials.
However, the company’s instructions state that the tests can pick up infections from people “who are suspected of Covid-19 by their healthcare provider within the first five days of the onset of symptoms” and that they are designed for use by trained healthcare and laboratory staff.
“The Innova test is not approved for community use,” said Jon Deeks, professor of biostatistics at Birmingham university. “This is dangerous and not how science should proceed.”
One person close to the validation process said that some field studies of the tests in community settings, such as universities, had produced poorer results than others, indicating the need for robust training.
The different testing technologies
The government has mostly focused its investment on four testing technologies.
While the gold-standard reverse transcription polymerase chain reaction (PCR) tests are highly accurate, they are time consuming to process and require lab equipment and clinical expertise to analyse. They allow scientists to take a sample containing a very small amount of virus RNA, convert it to DNA, and multiply it so it can be detected.