> Covid-19: Government buried negative data on its favoured antibody testBritish > Medical Journal 2020; 371 doi: https://doi.org/10.1136/bmj.m4353 (Published > 12 November 2020) > > 1. <[email protected]> > > https://www.bmj.com/content/371/bmj.m4353 > > The UK government delayed the findings of a Public Health England (PHE) > study that question the accuracy of a leading covid antibody test just as > it was about to announce that it had spent £75m (€84.3m; $99.4m) on buying > one million of the tests. > > The study,1 <https://www.bmj.com/content/371/bmj.m4353#ref-1> published > online this week at bmj.com, is the first independent assessment of the > test and finds it to be significantly less accurate than a manufacturer > funded study has claimed. If the test is used in the community as intended, > and assuming that 10% of recipients have previously been infected, around > one in five positive AbC-19 tests would be a false positive, the findings > suggest. > > The AbC-19 Rapid Test uses a drop of blood from a finger prick to see > whether someone has previously been infected with SARS-CoV-2. It gives > results in 20 minutes, without the need to go to a laboratory, and is > approved for use by health professionals in the UK and the EU. > > The study findings contrast with those of an earlier study2 > <https://www.bmj.com/content/371/bmj.m4353#ref-2>—published as a preprint > and not yet peer reviewed, which was funded by some of the consortium > developing and producing the test—that suggested that the test gave no > false positive results. > > The authors of the BMJ study, from PHE and the universities of Bristol, > Cambridge, and Warwick, warned, “If the AbC-19 test were to be used for > mass population screening in a relatively low prevalence setting, we would > anticipate a large number of false positive results (eg, 18 900 for every 1 > million tests carried out).” > “Minimal mention” > > Researchers tested blood samples in a laboratory from 2847 key workers in > England in June 2020. Unlike previous studies, researchers estimated the > test’s sensitivity in the real world, not in a laboratory setting. > > In a linked editorial published on bmj.com,3 > <https://www.bmj.com/content/371/bmj.m4353#ref-3> researchers say that > this study “identifies notable limitations of the UK government’s antibody > test of choice and provides good evidence that its specificity in a > ‘real-life’ setting is highly unlikely to be 100%.” > > They add, “Apart from limited surveillance to estimate the proportion of a > population that has been infected, widespread use of this assay in any > other role could risk considerable harm.” > > Emails seen by The BMJ show a discussion between PHE and the Department > of Health and Social Care on how to handle an announcement by the health > minister James Bethell that the government had bought £75m worth of tests > from Abingdon Health. > > The plan, a department email said, was for “minimal mention” of the PHE > study in Bethell’s announcement, “but we do need to mention it as we will > get asked.” > > PHE staff warned of “significant risks” in not publishing the PHE > evaluation showing the low accuracy of the tests and asked whether holding > back the results had been agreed by ministers. The department replied, “Yes > everyone is aligned as far as I know. No 10 now aligned.” > Department reply > > A Department of Health and Social Care spokesperson said that the one > million tests it had bought were not intended for “widespread public use.” > > They explained, “These tests are approved for use in surveillance studies, > which is what they were purchased for. They were never intended for, and > have never been issued for, widespread public use, and it is misleading and > unnecessarily inflammatory to purposefully ignore this fact. > > “This robust evaluation was carried out by PHE at the department’s request > before any purchase was made, and PHE approved the test for use in > surveillance studies.” > > The findings of the BMJ study suggest that the test can deliver a > sufficient degree of accuracy for surveillance studies of the population, > but laboratory confirmation of positive results is likely to be needed if > these tests are to be used to provide evidence of protection from the virus. > > > References > > 1. ↵ <https://www.bmj.com/content/371/bmj.m4353#xref-ref-1-1> > 1. Mulchandani R, > 2. Jones HE, > 3. Taylor-Phillips S, > 4. et al., > 5. EDSAB-HOME and COMPARE Investigators > . Accuracy of UK Rapid Test Consortium (UK-RTC) “AbC-19 Rapid Test” > for detection of previous SARS-CoV-2 infection in key workers: test > accuracy study. BMJ2020;371:m4262. > Abstract/FREE Full Text > > <https://www.bmj.com/lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiQUJTVCI7czoxMToiam91cm5hbENvZGUiO3M6MzoiYm1qIjtzOjU6InJlc2lkIjtzOjE3OiIzNzEvbm92MTFfOC9tNDI2MiI7czo0OiJhdG9tIjtzOjIzOiIvYm1qLzM3MS9ibWoubTQzNTMuYXRvbSI7fXM6ODoiZnJhZ21lbnQiO3M6MDoiIjt9>Google > Scholar > > <https://www.bmj.com/lookup/google-scholar?link_type=googlescholar&gs_type=article&author[0]=R+Mulchandani&author[1]=HE+Jones&author[2]=S+Taylor-Phillips&author[3]=EDSAB-HOME%20and%20COMPARE%20Investigators&title=Accuracy+of+UK+Rapid+Test+Consortium+(UK-RTC)+%E2%80%9CAbC-19+Rapid+Test%E2%80%9D+for+detection+of+previous+SARS-CoV-2+infection+in+key+workers:+test+accuracy+study&publication_year=2020&journal=BMJ&volume=371> > 2. ↵ <https://www.bmj.com/content/371/bmj.m4353#xref-ref-2-1> > SARS-CoV-2 antibody testing in a UK population: detectable IgG for up > to 20 weeks post infection. medRxiv2020.09.29.20201509; doi: > 10.1101/2020.09.29.20201509. > Abstract/FREE Full Text > > <https://www.bmj.com/lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiQUJTVCI7czoxMToiam91cm5hbENvZGUiO3M6NzoibWVkcnhpdiI7czo1OiJyZXNpZCI7czoyMToiMjAyMC4wOS4yOS4yMDIwMTUwOXYxIjtzOjQ6ImF0b20iO3M6MjM6Ii9ibWovMzcxL2Jtai5tNDM1My5hdG9tIjt9czo4OiJmcmFnbWVudCI7czowOiIiO30=>Google > Scholar > > <https://www.bmj.com/lookup/google-scholar?link_type=googlescholar&gs_type=article&q_txt=SARS-CoV-2+antibody+testing+in+a+UK+population%3A+detectable+IgG+for+up+to+20+weeks+post+infection.+medRxiv+2020.09.29.20201509%3B+doi%3A10.1101%2F2020.09.29.20201509.> > 3. ↵ <https://www.bmj.com/content/371/bmj.m4353#xref-ref-3-1> > Gill D, Ponsford MJ. Testing for antibodies to SARS-COV-2. BMJ > 2020;371:m4288 > > ---
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