Abstract
BackgroundReliable testing for SARS-CoV-2 is key for the management of the COVID-19 pandemic.AimWe estimate diagnostic accuracy for nucleic acid and antibody tests 5 months into the COVID-19 pandemic, and compare with manufacturer-reported accuracy.MethodsWe reviewed the clinical performance of SARS-CoV-2 nucleic acid and antibody tests based on 93,757 test results from 151 published studies and 20,205 new test results from 12 countries in the European Union and European Economic Area (EU/EEA).ResultsPooling the results and considering only results with 95% confidence interval width ≤ 5%, we found four nucleic acid tests, including one point-of-care test and three antibody tests, with a clinical sensitivity ≥ 95% for at least one target population (hospitalised, mild or asymptomatic, or unknown). Nine nucleic acid tests and 25 antibody tests, 12 of them point-of-care tests, had a clinical specificity of ≥ 98%. Three antibody tests achieved both thresholds. Evidence for nucleic acid point-of-care tests remains scarce at present, and sensitivity varied substantially. Study heterogeneity was low for eight of 14 sensitivity and 68 of 84 specificity results with confidence interval width ≤ 5%, and lower for nucleic acid tests than antibody tests. Manufacturer-reported clinical performance was significantly higher than independently assessed in 11 of 32 and four of 34 cases, respectively, for sensitivity and specificity, indicating a need for improvement in this area.ConclusionContinuous monitoring of clinical performance within more clearly defined target populations is needed.
Highlights
Testing is one of the central pillars of public health actions in epidemic and pandemic situations to allow timely identification, contact tracing and isolation of infectious cases to reduce the spread of infectious diseases
This requires appropriate and sufficiently accurate diagnostic tests to identify individuals who are currently infected with SARS-CoV-2 as well as those who have been infected in the past
By 1 June 2020, minimum performance criteria for tests were publicly available from Belgium, France, the Netherlands and the United Kingdom (UK) (Supplementary Table S1)
Summary
Testing is one of the central pillars of public health actions in epidemic and pandemic situations to allow timely identification, contact tracing and isolation of infectious cases to reduce the spread of infectious diseases. Reliable testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and timely reporting of the data to public health authorities is key for the management of the coronavirus disease (COVID-19) pandemic. This requires appropriate and sufficiently accurate diagnostic tests to identify individuals who are currently infected with SARS-CoV-2 as well as those who have been infected in the past. The United States (US) Food and Drug Administration has granted emergency use authorisations for many commercial tests in the US, and the World Health Organization (WHO) maintains an emergency use listing of commercial tests [1,2] It is, important to note that CE certification is based on a self-declaration of the test manufacturer, including the claims on performance of the test. Conclusion: Continuous monitoring of clinical performance within more clearly defined target populations is needed
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