Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid and antibody tests up to 22 August 2020

• Published in: Euro surveillance : bulletin européen sur les maladies transmissibles Vol. 26; no. 45; p. 1
• Main Authors: Van Walle, Ivo, Leitmeyer, Katrin, Broberg, Eeva K
• Format: Journal Article
• Language: English
• Published: Sweden Centre Europeen pour la Surveillance Epidemiologique du SIDA (European Centre for the Epidemiological Monitoring of AIDS) 11.11.2021; European Centre for Disease Prevention and Control (ECDC)
• Subjects: Antibodies; Clinical trials; COVID-19; Humans; Medical tests; Meta-analysis; Nucleic Acids; Pandemics; SARS-CoV-2; Sensitivity and Specificity; Severe acute respiratory syndrome coronavirus 2; COVID-19; SARS-CoV-2; meta-analysis; specificity; accuracy; diagnostic; sensitivity
• ISSN: 1560-7917; 1025-496X; 1560-7917
• DOI: 10.2807/1560-7917.ES.2021.26.45.2001675

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.