The basis for the MHRA extending its exceptional use authorisation for Innova lateral flow tests must be published immediately if public trust is to be restored, say Allyson M Pollock and Peter Roderick
Last month, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that it had extended for just over two months its exceptional use authorisation for the NHS rebranded Innova lateral flow tests (LFTs). The authorisation for them to be used by asymptomatic people testing themselves will now run until 28 August. The original six month authorisation expired on 22 June, and so without an extension the government’s covid-19 mass testing programme, Operation Moonshot, could not have continued. The extension came, however, just one week after the US Food and Drug Administration (FDA) said the tests should be put “in the trash.”
Unlike in the UK, no authorisation had been given for their use in the US, and the FDA has expressed its “significant concerns that the performance of the test has not been adequately established, presenting a risk to health,” along with warning that their labelling was “false or misleading.” Innova had earlier recalled the tests in the US in what the FDA described as “the most serious type of recall.”
The MHRA has said that it conducted a review following the FDA’s action, which reached a hardly resounding “satisfactory outcome,” allowing the authorisation to be extended. It is not known, however, what this review consisted of, what evidence the MHRA has as to whether the conditions of the original authorisation have been complied with and which justified the extension, why the extension is only for two months, and what the terms of the extended authorisation are. This is because the MHRA has refused to disclose this information, despite freedom of information requests. The recent publication by the Department of Health and Social Care (DHSC) on the test performance of LFTs is very limited. Why has this completely unacceptable state of affairs arisen?
The MHRA is an agency of the DHSC and has no independent legal status. Bizarrely, the authorisation is given by the secretary of state for health and social care (acting as the MHRA) to themselves (as the DHSC and deemed legal manufacturer) to supply the tests. The DHSC has entered into several contracts with Innova Medical Group for the tests, valued at perhaps as much as £3.2 billion. Innova is owned by Pasaca Capital, a California based, Nevada registered, private equity firm. It is reported to be setting up a manufacturing plant in Wales. Currently, according to their instructions for use, the tests are manufactured for Innova by Xiamen Biotime Biotechnology, based in Fujian, China, and are intended to be used on those “suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.” Yet in the UK millions of them are being used for twice weekly testing of asymptomatic people in schools, communities, nursing homes, workplaces, and for attending hospitals and clinics—in other words, not in accordance with the real manufacturer’s instructions.
In addition, it is clear that the tests are being used not only outside their instructions for use, but also as a “test to enable,” which the original authorisation explicitly states is not supported by the MHRA. This is because there has been no scientific evidence to date that supports their use as “green light tests” to enable activities such as attending school, nursing homes, football matches, workplaces, or public hearings. They are at best “red light tests” to detect infection when used by health professionals.
All tests can do harm, and key issues with LFTs are that performance is markedly impaired when they are not administered by experienced professionals. This results in false negatives, including in symptomatic people who opt for a home LFT as a more accessible alternative to the polymerase chain reaction (PCR) test. False positives will outnumber true positives when prevalence is very low, as occurred in initial testing of schoolchildren. For example, recent evidence suggests that at very low prevalence, testing a population of 50 million twice a week would produce more than 200 000 false positive results each month, with relatively few infected people detected. A recent evaluation of the community testing of asymptomatic adults in Liverpool was published, but there is still no evaluation of the sensitivity of LFTs when used as unsupervised self-tests in asymptomatic people. There are no data for testing in children. The current regulatory framework is deficient in having allowed tests to come to market without adequate evaluation of their clinical and analytic performance in the settings and populations for which and for whom they are intended.
Even an excellent test is valueless unless followed by an effective intervention. In the case of a positive covid test, this is contact tracing, quarantine, and isolation. Giving billions of pounds of public funds to a private equity firm for poor tests is of a piece with the government’s allocation of £37 billion for contact tracing carried out by Serco and other providers. The public accounts committee highlighted the absence of evidence that test and trace had altered the course of the pandemic, yet Serco has recently predicted increased profits, having given bonuses of £5.5million to its chief executive, Rupert Soames, and its chief financial officer, Angus Cockburn.
Incompetence, corruption, and outsourcing to the private sector are the hallmarks of the UK government’s approach to both testing and tracing during the covid-19 pandemic. The extended authorisation for Innova tests and the basis for the extension must be published immediately, along with all of the evidence of performance and evaluation of these LFTs, if a modicum of public trust is to be restored.
Allyson M Pollock, professor in public health, Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, UK.
Competing interests: AP was a member of Independent SAGE.
Peter Roderick is a principal research associate in the Population Health Sciences Institute at Newcastle University, UK
Competing interests: none declared