Covid-19: Government ramps up “Moonshot” mass testing
BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4460 (Published 17 November 2020) Cite this as: BMJ 2020;371:m4460Read our latest coverage of the coronavirus outbreak
Linked Opinion
Screening the healthy population for covid-19 is of unknown value, but is being introduced nationwide
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Dear Editor
Gareth Iacobucci makes important observations about the limitations of mass testing for Covid-19.
He reports that the lateral flow test has an overall sensitivity of 76.8% when compared with PCR, with sensitivity dropping to 58% when the test is done by members of the public. Manufacturers of rapid tests tend to report their test performance in comparison with the best comparator (PCR), but actually the sensitivity of the PCR test, as assessed with repeat PCR testing of the same patient, is much less than 100%.
Jessica Watson and colleagues estimated that the sensitivity of PCR for Covid-19 is just about 70%.(1) Similarly Lauren Kucirka and colleagues reported that the probability of a false-negative PCR result in an infected person was 67% the day before symptoms onset, 38% on the day of symptom onset and 20% 3 days later.(2) Thus, the real clinical sensitivity of the lateral flow test is likely to be well below 50%, when the limited sensitivity of the comparator test (PCR) is taken into account.
Iacobucci also reports Jon Deeks's assessment of the poor positive predictive value of the lateral flow test, even with the assumed specificity of 99% based on a comparison with PCR. Again, it is not correct to assume that PCR is 100% specific, as the experience based on repeat testing suggests that PCR specificity might only be 97%.(3) Thus, the poor positive predictive value reported by Iacobucci for lateral flow tests could be even worse.
The Editor in Chief of the Journal of Clinical Microbiology has come to the same conclusions as Iacobucci: mass testing is not the way out of the Covid-19 pandemic.(4) Matthew Binnickera has argued that the huge number of false-positive results generated by mass testing would have consequences.(5)
1. Watson J, Whiting PF, Brush JE. Interpreting a covid-19 test result. BMJ 2020; 369 doi: https://doi.org/10.1136/bmj.m1808
2. Kucirka LM, Lauer SA, Laeyendecker O, et al. Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction–Based SARS-CoV-2 Tests by Time Since Exposure. Ann Intern Med 2020; https://doi.org/10.7326/M20-1495
3. Katz AP; Civantos FJ; Sargi Z et al. False-positive reverse transcriptase polymerase chain reaction screening for SARS-CoV-2 in the setting of urgent head and neck surgery and otolaryngologic emergencies during the pandemic: Clinical implications. Head & Neck 2020; https://doi.org/10.1002/hed.26317
4. Pettengill MA, McAdam AJ. Can We Test Our Way Out of the COVID-19 Pandemic? J Clin Microbiol 2020; https://jcm.asm.org/content/58/11/e02225-20
5. Matthew J. Binnickera. Challenges and Controversies to Testing for COVID-19. J Clin Microbiol 2020; https://doi.org/10.1128/JCM.01695-20
Competing interests: No competing interests
Dear Editor
In 2018 the NIH: National Human Genome Research Institute (NHGRI) launched a new round of strategic planning, entitled, ‘Developing a 2020 vision for genomics’. (1)
Its strategic plan for data science stated, “By 2025, the total amount of genomics data alone is expected to equal or exceed totals from the three other major producers of large amounts of data: astronomy, YouTube, and Twitter….Clinical Data and Patient-related data is both quantitative and qualitative and can arise from a wide array of sources, including specialized research projects and trials; epidemiology; genomic analyses; clinical-care processes; imaging assessments; patient-reported outcomes; environmental-exposure records; and a host of social indicators now linked to health such as educational records, employment history, and genealogical records". (2)
The ‘Strategic vision for improving human health at The Forefront of Genomics’ was published in October 2020, stating that researchers have created, “rich catalogues of human genomic variants, to gain an ever-deepening understanding of the functional complexities of the human genome”. It also stated that ethical, legal, and social implications (ELSI) research should, “examine the implications of studying genetic associations with bio-behavioural traits (such as intelligence, sexual behaviour, social status, and educational attainment) and of a future in which machine learning and artificial intelligence are used to adapt risk communication and clinical decisions based on analysing an individual’s genome sequence”.
“Implementation” included, “Test(ing) public health approaches for implementing population-wide genomic screening”.(3)
Since the current public health situation includes, “epidemiology”, “clinical-care processes” and, increasingly, ”social indicators linked to health”, might it be too good an opportunity to miss as regards, “population-wide genomic screening”, in view of the push for widespread testing?
And should we be concerned?
(1) https://www.genome.gov/news/news-release/Developing-a-2020-vision-for-ge...
(2) https://datascience.nih.gov/sites/default/files/NIH_Strategic_Plan_for_D...
(3) https://www.nature.com/articles/s41586-020-2817-4
Competing interests: No competing interests
Coronavirus mass testing - a gross waste of money and resources
Dear Editor
England's health secretary, Matt Hancock, says "Mass testing is a vital tool to help us control this virus and get life more normal".[1]
I disagree. Extraordinary amounts of money and resources are being expended on testing around the world - is this justifiable?
In Australia 9,872,011 tests have been conducted with 0.3% being positive.[2]
According to Gareth Iacobucci's report, "as at 16 November the Liverpool pilot had tested 100,000 asymptomatic people, of whom 700 (0.7%) tested positive for covid-19".[1] [3]
In the Australian and Liverpool examples, there appears to be a huge waste of resources with this mass testing, with more than 99% of the tests being negative.
How much is all this testing costing, not just money and direct resources, but also in causing disruption in people's lives, worry about results, loss of productivity etc?
A WHO report providing guidance for surveillance during an influenza pandemic, published in 2017, recommends "case-based reporting (the counting of individual cases) should cease once there is broad community transmission in a country - at this point, syndromic data from sentinel sites, hospital-based data and systematic laboratory testing should be used instead".[4]
Doesn't this mean that widespread testing of asymptomatic people should be ceased?
Surely scarce money and resources can be better targeted in the coronavirus response? As Professor Allyson Pollock says, mass screening proposals risk causing harm through "significant diversion of healthcare resources".[1]
Ongoing testing and questionable 'case' numbers are being used to implement drastic limitations on people's freedom of movement and association around the world, including lockdowns which interfere with people's right to earn their own living, to freely associate with others, to simply live their lives freely.
There must be an urgent reappraisal of the worth of mass testing.
References:
1. Gareth Iacobucci. Covid-19: Government ramps up "Moonshot" mass testing. BMJ 2020;371:m4460
2. Coronavirus (COVID-19) current situation and case numbers. Australian Government Department of Health: https://www.health.gov.au/news/health-alerts/novel-coronavirus-2019-ncov... As accessed 27 November 2020.
3. Re "tested positive for covid-19". I argue the reference to 'covid-19' is incorrect terminology, and this should be "tested positive for SARS-CoV-2": See: Re: Covid-19 vaccines...or SARS-CoV-2 vaccines? Clarification needed. BMJ 2020;370:m3258
4. WHO guidance for surveillance during an influenza pandemic. 2017 Update: https://www.who.int/influenza/preparedness/pandemic/WHO_Guidance_for_sur...
Competing interests: No competing interests