Characteristics of Three Different Chemiluminescence Assays for Testing for SARS-CoV-2 Antibodies.

Autor: Weber MC; Landesspital Liechtenstein, Heiligkreuz, 9490 Vaduz, Liechtenstein., Risch M; Central Laboratory, Kantonsspital Graubünden, Loësstrasse 170, 7000 Chur, Switzerland., Thiel SL; Landesspital Liechtenstein, Heiligkreuz, 9490 Vaduz, Liechtenstein., Grossmann K; Labormedizinisches zentrum Dr Risch, Wuhrstrasse 14, 9490 Vaduz, Liechtenstein.; Private Universität im Fürstentum Liechtenstein, Dorfstrasse, 9495 Triesen, Liechtenstein., Nigg S; Department of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St. Gallen, Rohrschacherstrasse 95, 9007 St. Gallen, Switzerland., Wohlwend N; Labormedizinisches zentrum Dr Risch, Wuhrstrasse 14, 9490 Vaduz, Liechtenstein., Lung T; Labormedizinisches zentrum Dr Risch, Wuhrstrasse 14, 9490 Vaduz, Liechtenstein., Hillmann D; Labormedizinisches zentrum Dr Risch, Wuhrstrasse 14, 9490 Vaduz, Liechtenstein., Ritzler M; Labormedizinisches zentrum Dr Risch, Wuhrstrasse 14, 9490 Vaduz, Liechtenstein., Ferrara F; Labormedizinisches zentrum Dr Risch, Wuhrstrasse 14, 9490 Vaduz, Liechtenstein., Bigler S; Labormedizinisches zentrum Dr Risch, Waldeggstrasse 37, 3097 Liebefeld, Switzerland., Egli K; Labormedizinisches zentrum Dr Risch, Waldeggstrasse 37, 3097 Liebefeld, Switzerland., Bodmer T; Labormedizinisches zentrum Dr Risch, Waldeggstrasse 37, 3097 Liebefeld, Switzerland., Imperiali M; Centro medicina di laboratorio Dr Risch, Via Arbostra 2, 6963 Pregassona, Switzerland., Salimi Y; Clm Dr Risch arc lémanique SA, Chemin de l'Esparcette 10, 1023 Crissier, Switzerland., Fleisch F; Division of Infectious Diseases, Kantonsspital Graubünden, Loësstrasse 170, 7000 Chur, Switzerland., Cusini A; Division of Infectious Diseases, Kantonsspital Graubünden, Loësstrasse 170, 7000 Chur, Switzerland., Heer S; Blutspendedienst Graubünden, Loësstrasse 170, 7000 Chur, Switzerland., Renz H; Institute of Laboratory Medicine and Pathobiochemistry, Molecular Diagnostics, Philipps University Marburg, University Hospital Giessen and Marburg, Baldingerstraße, 35043 Marburg, Germany., Paprotny M; Landesspital Liechtenstein, Heiligkreuz, 9490 Vaduz, Liechtenstein., Kohler P; Department of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St. Gallen, Rohrschacherstrasse 95, 9007 St. Gallen, Switzerland., Vernazza P; Department of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St. Gallen, Rohrschacherstrasse 95, 9007 St. Gallen, Switzerland., Risch L; Labormedizinisches zentrum Dr Risch, Wuhrstrasse 14, 9490 Vaduz, Liechtenstein.; Private Universität im Fürstentum Liechtenstein, Dorfstrasse, 9495 Triesen, Liechtenstein.; Center of Laboratory Medicine, University Institute of Clinical Chemistry, University of Bern, Bern, Switzerland., Kahlert CR; Department of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St. Gallen, Rohrschacherstrasse 95, 9007 St. Gallen, Switzerland.; Department of Infectious Diseases and Hospital Epidemiology, Children's Hospital of Eastern Switzerland, Claudiusstrasse 6, 9006 St. Gallen, Switzerland.
Jazyk: angličtina
Zdroj: Disease markers [Dis Markers] 2021 Jan 06; Vol. 2021, pp. 8810196. Date of Electronic Publication: 2021 Jan 06 (Print Publication: 2021).
DOI: 10.1155/2021/8810196
Abstrakt: Several tests based on chemiluminescence immunoassay techniques have become available to test for SARS-CoV-2 antibodies. There is currently insufficient data on serology assay performance beyond 35 days after symptoms onset. We aimed to evaluate SARS-CoV-2 antibody tests on three widely used platforms. A chemiluminescent microparticle immunoassay (CMIA; Abbott Diagnostics, USA), a luminescence immunoassay (LIA; Diasorin, Italy), and an electrochemiluminescence immunoassay (ECLIA; Roche Diagnostics, Switzerland) were investigated. In a multigroup study, sensitivity was assessed in a group of participants with confirmed SARS-CoV-2 ( n = 145), whereas specificity was determined in two groups of participants without evidence of COVID-19 (i.e., healthy blood donors, n = 191, and healthcare workers, n = 1002). Receiver operating characteristic (ROC) curves, multilevel likelihood ratios (LR), and positive (PPV) and negative (NPV) predictive values were characterized. Finally, analytical specificity was characterized in samples with evidence of the Epstein-Barr virus (EBV) ( n = 9), cytomegalovirus (CMV) ( n = 7), and endemic common-cold coronavirus infections ( n = 12) taken prior to the current SARS-CoV-2 pandemic. The diagnostic accuracy was comparable in all three assays (AUC 0.98). Using the manufacturers' cut-offs, the sensitivities were 90%, 95% confidence interval [84,94] (LIA), 93% [88,96] (CMIA), and 96% [91,98] (ECLIA). The specificities were 99.5% [98.9,99.8] (CMIA), 99.7% [99.3,99.9] (LIA), and 99.9% [99.5,99.98] (ECLIA). The LR at half of the manufacturers' cut-offs were 60 (CMIA), 82 (LIA), and 575 (ECLIA) for positive and 0.043 (CMIA) and 0.035 (LIA, ECLIA) for negative results. ECLIA had higher PPV at low pretest probabilities than CMIA and LIA. No interference with EBV or CMV infection was observed, whereas endemic coronavirus in some cases provided signals in LIA and/or CMIA. Although the diagnostic accuracy of the three investigated assays is comparable, their performance in low-prevalence settings is different. Introducing gray zones at half of the manufacturers' cut-offs is suggested, especially for orthogonal testing approaches that use a second assay for confirmation.
Competing Interests: The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analysis, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.
(Copyright © 2021 Myriam C. Weber et al.)
Databáze: MEDLINE
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