Evaluating tests for diagnosing COVID-19 in the absence of a reliable reference standard: pitfalls and potential solutions

Korevaar, Daniël A.; Toubiana, Julie; McInnes, Matthew D. F.; Cohen, Jérémie F.

doi:10.1016/j.jclinepi.2021.07.021

Cited by 10 publications

(11 citation statements)

References 44 publications

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“…Its use as the 'gold' reference standard is neither the result of nor implies that it has a 0% false negative rate [5] . It relies on the viral RNA (with the PCR targets) being present in the tissue from which it was sampled, the quality of the sampling process, and no major error in further processing [18] , [19] , [20] . Secondly, C t values used as a cut-off to declare an active infection (such as C t < 30) lead to a different probability of an active infection in the proliferation vs. clearance phase [2] , and are not in general equivalent between labs.…”

mentioning

confidence: 99%

SARS-CoV-2 rapid antigen tests provide benefits for epidemic control – observations from Austrian schools

Polechová¹,

Johnson²,

Payne³

et al. 2022

Journal of Clinical Epidemiology

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Objective : This paper motivates and justifies the use of antigen tests for epidemic control as distinct from a diagnostic test. Study Design and Setting : We discuss the relative advantages of antigen and PCR tests, summarising evidence from both the literature as well as Austrian schools, which conducted frequent, mass rapid antigen testing during the spring of 2021. While our report on testing predates Delta, we have updated the review with recent data on viral loads in breakthrough infections and more information about testing efficacy, especially in children. Results : Rapid antigen tests detect proteins at the surface of virus particles, identifying the disease during its infectious phase. In contrast, PCR tests detect viral genomes: they can thus diagnose COVID-19 before the infectious phase but also react to remnants of the virus genome, even weeks after live virus ceases to be detectable in the respiratory tract. Furthermore, the logistics for administering the tests are different. Large-scale rapid antigen testing in Austrian schools showed low false-positive rates along with an approximately 10% lower effective reproduction number in the tested cohort. Conclusion : Using antigen tests at least 2-3 times per week could become a powerful tool to suppress the COVID-19 pandemic.

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confidence: 99%

SARS-CoV-2 rapid antigen tests provide benefits for epidemic control – observations from Austrian schools

Polechová¹,

Johnson²,

Payne³

et al. 2022

Journal of Clinical Epidemiology

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“…We recommend manufacturers and researchers perform studies to validate saliva as an acceptable specimen type for viruses other than SARS-CoV-2. Bringing more saliva-based commercial assays to market will be crucial for laboratories that do not have the capabilities to validate their own in-house test.There is no single laboratory reference standard for COVID-19 diagnosis [86] , so we chose NAAT on NPS or NPS+OPS specimens as the reference comparator. PCR on upper respiratory tract specimens is the first-line test in many settings, but it is an imperfect test.…”

Section: Discussionmentioning

confidence: 99%

Performance of saliva compared with nasopharyngeal swab for diagnosis of COVID-19 by NAAT in cross-sectional studies: Systematic review and meta-analysis

Duncan

Mackett

Ali

et al. 2023

Clinical Biochemistry

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“…In this way, primacy is given to outcomes that are of greater relevance to the public and to policy‐makers (such as infection and hospitalisation rates), rather than technical performance issues (such as sensitivity and specificity). 55 …”

Section: Discussionmentioning

confidence: 99%

Effectiveness of rapid antigen testing for screening of asymptomatic individuals to limit the transmission of SARS‐CoV‐2: A rapid review

Walsh

Broderick

Ahern

et al. 2022

Reviews in Medical Virology

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Rapid antigen detection tests (RADTs) offer advantages over gold‐standard reverse transcription polymerase chain reaction (RT‐PCR) tests in that they are cheaper and provide faster results, thus enabling prompt isolation of positive SARS‐CoV‐2 cases and quarantine of close contacts. The aim of this study was to collate and synthesise empirical evidence on the effectiveness of rapid antigen testing for the screening (including serial testing) and surveillance of asymptomatic individuals to limit the transmission of SARS‐CoV‐2. A rapid review was undertaken in MEDLINE (EBSCO), EMBASE (OVID), Cochrane Library, Europe PMC and Google Scholar up until 19 July 2021, supplemented by a grey literature search. Of the identified 1222 records, 19 reports referring to 16 studies were included. Eight included studies examined the effectiveness of RADTs for population‐level screening, four for pre‐event screening and four for serial testing (schools, a prison, a university sports programme and in care homes). Overall, there is uncertainty regarding the effectiveness of rapid antigen testing for the screening of asymptomatic individuals to limit the transmission of SARS‐CoV‐2. This uncertainty is due to the inconsistent results, the relatively low number of studies identified, the predominantly observational and/or uncontrolled nature of the study designs used, and concerns regarding methodological quality. Given this uncertainty, more real‐world research evidence in relevant settings, which is of good quality and timely, as well as economic evaluation, is required to inform public policy on the widespread use of RADTs in asymptomatic individuals.

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Evaluating tests for diagnosing COVID-19 in the absence of a reliable reference standard: pitfalls and potential solutions

Cited by 10 publications

References 44 publications

SARS-CoV-2 rapid antigen tests provide benefits for epidemic control – observations from Austrian schools

SARS-CoV-2 rapid antigen tests provide benefits for epidemic control – observations from Austrian schools

Performance of saliva compared with nasopharyngeal swab for diagnosis of COVID-19 by NAAT in cross-sectional studies: Systematic review and meta-analysis

Effectiveness of rapid antigen testing for screening of asymptomatic individuals to limit the transmission of SARS‐CoV‐2: A rapid review

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