TY - JOUR
T1 - Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid and antibody tests up to 22 August 2020
AU - Van Walle, Ivo
AU - Leitmeyer, Katrin
AU - Broberg, Eeva K.
AU - Van Esbroeck, Marjan
AU - Vermeersch, Pieter
AU - Beuselinck, Kurt
AU - Karagiannis, Christos
AU - Melin, Merit
AU - Ekström, Nina
AU - Erlund, Iris
AU - Vihervaara, Terhi
AU - Escuret, Vanessa
AU - Frobert, Emilie
AU - Gaymard, Alexandre
AU - Mentis, Andreas
AU - Lampropoulou, Stavroula
AU - Kurolt, Ivan Christian
AU - Abdelrahman, Tamir
AU - Nguyen, Trung
AU - Fournier, Guillaume
AU - Reusken, Chantal B.E.M.
AU - Van Den Beld, Maaike J.C.
AU - Rahamat-Langendoen, Janette
AU - Wegdam-Blans, Marjolijn C.A.
AU - Tjhie, Jeroen H.T.
AU - Croughs, Peter
AU - GeurtsvanKessel, Corine H.
AU - Reimerink, Johan
AU - Ong, David S.Y.
AU - Koeleman, Hans G.M.
AU - Berkhout, Hannke
AU - Van Der Donk, Christel F.M.
AU - De Jong, Menno D.
AU - Zonneveld, Rens
AU - Jurriaans, Suzanne
AU - Van Burgel, Nathalie
AU - Wintermans, Bas B.
AU - Rijkers, Ger T.
AU - Murk, Jean Luc
AU - Thai, Khoa T.D.
AU - De Graaf, Melanie J.
AU - Van, t Veen
AU - Timmerman, Cornelis P.
AU - Van Corteveen-Splinter, Annette
AU - Geeraedts, Felix
AU - Klak, Adrian
AU - Konstantinovski, Maria M.
AU - Batstra, Manou R.
AU - Van Loo, Inge H.M.
AU - Savelkoul, Paul H.M.
AU - European COVID-19 microbiological laboratories group
N1 - Publisher Copyright:
© 2021 European Centre for Disease Prevention and Control (ECDC). All rights reserved.
PY - 2021/11/11
Y1 - 2021/11/11
N2 - Background: Reliable testing for SARS-CoV-2 is key for the management of the COVID-19 pandemic. Aim: We estimate diagnostic accuracy for nucleic acid and antibody tests 5 months into the COVID-19 pandemic, and compare with manufacturer-reported accuracy. Methods: We 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). Results: Pooling the results and considering only results with 95% confidence interval width = 5%, we found four nucleic acid tests, including one pointof- 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. Conclusion: Continuous monitoring of clinical performance within more clearly defined target populations is needed.
AB - Background: Reliable testing for SARS-CoV-2 is key for the management of the COVID-19 pandemic. Aim: We estimate diagnostic accuracy for nucleic acid and antibody tests 5 months into the COVID-19 pandemic, and compare with manufacturer-reported accuracy. Methods: We 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). Results: Pooling the results and considering only results with 95% confidence interval width = 5%, we found four nucleic acid tests, including one pointof- 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. Conclusion: Continuous monitoring of clinical performance within more clearly defined target populations is needed.
U2 - 10.2807/1560-7917.ES.2021.26.45.2001675
DO - 10.2807/1560-7917.ES.2021.26.45.2001675
M3 - Article
SN - 1560-7917
VL - 26
JO - Eurosurveillance
JF - Eurosurveillance
IS - 45
M1 - 2001675
ER -