{"id":50634,"date":"2021-07-11T12:04:13","date_gmt":"2021-07-11T11:04:13","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=50634"},"modified":"2021-07-16T11:13:05","modified_gmt":"2021-07-16T10:13:05","slug":"why-all-the-secrecy-around-innova-lateral-flow-tests","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2021\/07\/11\/why-all-the-secrecy-around-innova-lateral-flow-tests\/","title":{"rendered":"Why all the secrecy around Innova lateral flow tests?"},"content":{"rendered":"<p class=\"standfirst\">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<\/p>\n<p><!--more--><span style=\"font-weight: 400\">Last month, the Medicines and Healthcare products Regulatory Agency (<\/span><a href=\"https:\/\/www.gov.uk\/government\/news\/following-a-satisfactory-review-mhra-extends-authorisation-of-nhs-test-and-trace-lateral-flow-devices\"><span style=\"font-weight: 400\">MHRA) announced<\/span><\/a><span style=\"font-weight: 400\"> 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\u2019s covid-19 mass testing programme, <\/span><a href=\"https:\/\/www.bmj.com\/content\/370\/bmj.m3558\"><span style=\"font-weight: 400\">Operation Moonshot<\/span><\/a><span style=\"font-weight: 400\">, 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 <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/safety-communications\/stop-using-innova-medical-group-sars-cov-2-antigen-rapid-qualitative-test-fda-safety-communication?utm_medium=email&amp;utm_source=govdelivery\"><span style=\"font-weight: 400\">\u201cin the trash.\u201d<\/span><\/a><span style=\"font-weight: 400\">\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">Unlike in the UK, no authorisation had been given for their use in the US, and the FDA has expressed its \u201csignificant concerns that the performance of the test has not been adequately established, presenting a risk to health,\u201d along with warning that their labelling was <\/span><a href=\"https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/warning-letters\/innova-medical-group-inc-614819-06102021\"><span style=\"font-weight: 400\">\u201cfalse or misleading.\u201d<\/span><\/a><span style=\"font-weight: 400\"> Innova had earlier <\/span><a href=\"https:\/\/www.fda.gov\/medical-devices\/medical-device-recalls\/innova-medical-group-recalls-unauthorized-sars-cov-2-antigen-rapid-qualitative-test-risk-false-test\"><span style=\"font-weight: 400\">recalled the tests<\/span><\/a><span style=\"font-weight: 400\"> in the US in what the FDA described as \u201cthe most serious type of recall.\u201d\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">The MHRA has said that it conducted a review following the FDA\u2019s action, which reached a hardly resounding \u201csatisfactory outcome,\u201d 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 <\/span><a href=\"https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/999866\/asymptomatic-testing-for-SARS-CoV-2-using-antigen-detecting-lateral-flow-devices-evidence-from-performance-data-Oct-2020-to-May-2021.pdf\"><span style=\"font-weight: 400\">recent publication by the Department of Health and Social Care (DHSC)<\/span><\/a><span style=\"font-weight: 400\"> on the test performance of LFTs is very limited. Why has this completely unacceptable state of affairs arisen?<\/span><\/p>\n<p><span style=\"font-weight: 400\">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 <\/span><a href=\"https:\/\/www.standard.co.uk\/business\/government-covid-private-contracts-30-billion-pwc-deloitte-british-airways-b933081.html\"><span style=\"font-weight: 400\">as much as \u00a33.2 billion<\/span><\/a><span style=\"font-weight: 400\">. Innova is owned by Pasaca Capital, a <\/span><a href=\"https:\/\/businesssearch.sos.ca.gov\/Document\/RetrievePDF?Id=04577091-28052236\"><span style=\"font-weight: 400\">California based, Nevada registered<\/span><\/a><span style=\"font-weight: 400\">, private equity firm. It is <\/span><a href=\"https:\/\/www.business-live.co.uk\/enterprise\/wales-chosen-firm-new-factory-20673435\"><span style=\"font-weight: 400\">reported<\/span><\/a><span style=\"font-weight: 400\"> to be setting up a manufacturing plant in Wales. Currently, according to their <\/span><a href=\"https:\/\/cdn.website-editor.net\/6f54caea7c6f4adfba8399428f3c0b0c\/files\/uploaded\/Innova-SARS-Cov-2-Antigen-test-IFU.pdf\"><span style=\"font-weight: 400\">instructions for use<\/span><\/a><span style=\"font-weight: 400\">, the tests are manufactured for Innova by <\/span><a href=\"https:\/\/www.xiamenbiotime.com\/\"><span style=\"font-weight: 400\">Xiamen Biotime Biotechnology<\/span><\/a>, based in Fujian, China, and are intended to be used on those \u201csuspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.\u201d 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\u2014in other words, not in accordance with the real manufacturer\u2019s instructions.<\/p>\n<p><span style=\"font-weight: 400\">In addition, it is clear that the tests are being used not only outside their instructions for use, but also as a \u201ctest to enable,\u201d 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 \u201cgreen light tests\u201d to enable activities such as attending school, nursing homes, football matches, workplaces, or public hearings. They are at best \u201cred light tests\u201d to detect infection when used by health professionals.<\/span><\/p>\n<p><span style=\"font-weight: 400\">All tests can do harm, and key issues with LFTs are that performance is markedly impaired when they <\/span><a href=\"https:\/\/www.bmj.com\/content\/371\/bmj.m4469\"><span style=\"font-weight: 400\">are not administered by experienced professionals<\/span><\/a><span style=\"font-weight: 400\">. 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, <\/span><a href=\"https:\/\/www.bmj.com\/content\/374\/bmj.n1733\"><span style=\"font-weight: 400\">recent evidence suggests that<\/span><\/a><span style=\"font-weight: 400\"> at very low prevalence, testing a population of 50 million twice a week would produce more than 200\u2009000 false positive results each month, with relatively few infected people detected. <\/span><span style=\"font-weight: 400\">A <a href=\"https:\/\/www.bmj.com\/content\/374\/bmj.n1637\">recent evaluation of the community testing of asymptomatic adults<\/a> in Liverpool was published, but there is still no evaluation of the sensitivity of LFTs when used as unsupervised self-tests in asymptomatic people<\/span><span style=\"font-weight: 400\">. There are no data for testing in children. The current regulatory framework is deficient in having allowed tests to come to market <a href=\"https:\/\/rss.org.uk\/policy-campaigns\/policy-groups\/working-group-on-diagnostic-tests\/\">without adequate evaluation<\/a><\/span><span style=\"font-weight: 400\"> of their clinical and analytic performance in the settings and populations for which and for whom they are intended.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Even an excellent test is valueless unless followed by an effective intervention.<\/span><span style=\"font-weight: 400\">\u00a0In the case of a positive covid test, this is contact tracing, quarantine, and isolation<\/span><span style=\"font-weight: 400\">. <\/span><span style=\"font-weight: 400\">Giving billions of pounds of public funds to a private equity firm for poor tests is of a piece with the government\u2019s allocation of \u00a337 billion <\/span><a href=\"https:\/\/committees.parliament.uk\/committee\/127\/public-accounts-committee\/news\/150988\/unimaginable-cost-of-test-trace-failed-to-deliver-central-promise-of-averting-another-lockdown\/\"><span style=\"font-weight: 400\">for contact tracing<\/span><\/a><span style=\"font-weight: 400\"> carried out by Serco and other providers. The <\/span><a href=\"https:\/\/committees.parliament.uk\/committee\/127\/public-accounts-committee\/news\/150988\/unimaginable-cost-of-test-trace-failed-to-deliver-central-promise-of-averting-another-lockdown\/\"><span style=\"font-weight: 400\">public accounts committee<\/span><\/a><span style=\"font-weight: 400\"> highlighted the absence of evidence that test and trace had altered the course of the pandemic, yet Serco has recently <\/span><a href=\"https:\/\/www.theguardian.com\/business\/2021\/jun\/14\/serco-upgrades-profit-forecast-as-covid-test-and-trace-work-soars\"><span style=\"font-weight: 400\">predicted increased profits<\/span><\/a><span style=\"font-weight: 400\">, having given bonuses of \u00a35.5million to its chief executive, Rupert Soames, and its chief financial officer, Angus Cockburn.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400\">Incompetence, corruption, and outsourcing to the private sector are the hallmarks of the UK government\u2019s 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.<\/span><\/p>\n<p><em><strong>Allyson M Pollock<\/strong>, professor in public health, Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, UK.<\/em><\/p>\n<p><strong>Competing interests<\/strong>: AP was a member of Independent SAGE.<\/p>\n<p><em><strong>Peter Roderick<\/strong> is a principal research associate in the Population Health Sciences Institute at Newcastle University, UK\u00a0<\/em><\/p>\n<p><strong>Competing interests<\/strong>: none declared<\/p>\n","protected":false},"excerpt":{"rendered":"<p>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 [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bmj\/2021\/07\/11\/why-all-the-secrecy-around-innova-lateral-flow-tests\/\">More&#8230;<\/a><\/p>\n","protected":false},"author":419,"featured_media":49371,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[223],"tags":[],"class_list":["post-50634","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-guest-bloggers"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Why all the secrecy around Innova lateral flow tests? 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