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Testing COVID-19 tests faces methodological challenges.

ABSTRACT: In battling the COVID-19 pandemic, testing is essential. The detection of viral RNA allows the identification of infected persons, whereas the detection of antibodies may reveal a response to a previous infection. Tests for coronavirus should be rigorously evaluated in terms of their analytical and clinical performance. This poses not only logistic challenges, but also methodological ones. Some of these are generic for the diagnostic accuracy paradigm, whereas others are more specific for tests for viruses. Problematic for evaluations of the clinical performance of tests for viral RNA is the absence of an independent reference standard. Many studies lack rigor in terms of the recruitment of study participants. Study reports are often insufficiently informative, which makes it difficult to assess the applicability of study findings. Attempts to summarize the performance of these tests in terms of a single estimate of the clinical sensitivity fail to do justice to the identifiable sources of the large heterogeneity in mechanisms for generating false negative results.

SUBMITTER: Bossuyt PM

PROVIDER: S-EPMC7332449 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Testing COVID-19 tests faces methodological challenges.

Bossuyt Patrick M PM

Journal of clinical epidemiology 20200703

In battling the COVID-19 pandemic, testing is essential. The detection of viral RNA allows the identification of infected persons, whereas the detection of antibodies may reveal a response to a previous infection. Tests for coronavirus should be rigorously evaluated in terms of their analytical and clinical performance. This poses not only logistic challenges, but also methodological ones. Some of these are generic for the diagnostic accuracy paradigm, whereas others are more specific for tests ...[more]

PMID: 32622902

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Project description:Sweden's use of soft response measures early in the COVID-19 pandemic received a good deal of international attention. Within Sweden, one of the most debated aspects of the pandemic response has been COVID-19 testing and the time it took to increase testing capacity. In this article, the development of and the debate surrounding COVID-19 testing in Sweden during 2020 is described in detail, with a particular focus on the coordination between national and regional actors in the decentralised healthcare system. A qualitative case study was carried out based on qualitative document analysis with a chronological presentation. To understand COVID-19 testing in Sweden, two aspects of its public administration model emerged as particularly important: (i) the large and independent government agencies and (ii) self-governing regions and municipalities. In addition, the responsibility principle in Swedish crisis management was crucial. Overall, the results show that mass testing was a new area for coordination and involved a number of national and regional actors with partly different views on their respective roles, responsibilities and interpretations of the laws and regulations. The description shows the ambiguities in the purpose of testing and the shortcomings in communication and cooperation during the first half of 2020, but after that an increasing consistency among the crucial actors. During the first half of 2020, testing capacity in Sweden was limited and reserved to protect the most vulnerable in society. Because mass testing for viruses is not normally carried out by the 21 self-governing regions responsible for healthcare and communicable disease prevention, and the Public Health Agency of Sweden stated that there was no medical reason to test members of the public falling ill with COVID-like symptoms, the responsibility for mass testing fell through the cracks during the first few months of the pandemic. This article thus illustrates problems associated with multi-level governance in healthcare during a crisis and illustrates the discrepancy between the health service's focus on the individual and the public health-oriented work carried out within communicable disease control.

Project description:The aim of the current study is to perform model calculations on the possible use of SARS-CoV-2-rapid point-of-care tests as mass tests, using the quality criteria extracted from evidence-based research as an example for the Federal Republic of Germany. In addition to illustrating the problem of false positive test results, these calculations are used to examine their possible influence on the 7-day incidence. For a substantial period of time, this parameter formed the decisive basis for decisions on measures to protect the population in the wake of the COVID pandemic, which were taken by the government. Primarily, model calculations were performed for a base model of 1,000,000 SARS-CoV-2-rapid point-of-care tests per week using various sensitivities and specificities reported in the literature, followed by sequential testing of the test positives obtained by a SARS-CoV-2 PCR test. Furthermore, a calculation was performed for an actual maximum model based on self-test contingents by the German Federal Ministry of Health. Assuming a number of 1,000,000 tests per week at a prevalence of 0.5%, a high number of false positive test results, a low positive predictive value, a high negative predictive value, and an increase in the 7-day incidence due to the additional antigen rapid tests of approx. 5/100,000 were obtained. A previous maximum calculation based on contingent numbers for self-tests given by the German Federal Ministry of Health even showed an additional possible influence on the 7-day incidence of 84.6/100,000. The model calculations refer in each case to representative population samples that would have to be drawn if the successive results were comparable which should be given, as far-reaching actions were based on this parameter. The additionally performed SARS-CoV-2-rapid point-of-care tests increase the 7-day incidence in a clear way depending on the number of tests and clearly show their dependence on the respective number of tests. SARS-CoV-2-rapid point-of-care tests as well as the SARS-CoV-2-PCR test method should both be used exclusively in the presence of corresponding respiratory symptoms and not in symptom-free persons.

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Testing COVID-19 tests faces methodological challenges.

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Testing COVID-19 tests faces methodological challenges.

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