Multicenter Evaluation of the Clinical Performance and the Neutralizing Antibody Activity Prediction Properties of 10 High-Throughput Serological Assays Used in Clinical Laboratories

As the coronavirus disease 2019 (COVID-19) pandemic second wave is emerging, it is of the upmost importance to screen the population immunity in order to keep track of infected individuals. Consequently, immunoassays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with high specific...

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Published in:	Journal of clinical microbiology Vol. 59; no. 3
Main Authors:	Therrien, C, Serhir, B, Bélanger-Collard, M, Skrzypczak, J, Shank, D K, Renaud, C, Girouard, J, Loungnarath, V, Carrier, M, Brochu, G, Tourangeau, F, Gilfix, B, Piche, A, Bazin, R, Guérin, R, Lavoie, M, Martel-Laferrière, V, Fortin, C, Benoit, A, Marcoux, D, Gauthier, N, Laumaea, A M, Gasser, R, Finzi, A, Roger, M
Format:	Journal Article
Language:	English
Published:	United States American Society for Microbiology 18-02-2021
Subjects:	Antibodies, Neutralizing - analysis Antibodies, Viral - analysis COVID-19 - diagnosis COVID-19 - immunology High-Throughput Screening Assays - standards Humans Immunoassays Laboratories Reproducibility of Results SARS-CoV-2 Sensitivity and Specificity Seroepidemiologic Studies COVID-19 immunoassays neutralizing antibodies SARS-CoV-2 antigen serology
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Summary:	As the coronavirus disease 2019 (COVID-19) pandemic second wave is emerging, it is of the upmost importance to screen the population immunity in order to keep track of infected individuals. Consequently, immunoassays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with high specificity and positive predictive values are needed to obtain an accurate epidemiological picture. As more data accumulate about the immune responses and the kinetics of neutralizing-antibody (nAb) production in SARS-CoV-2-infected individuals, new applications are forecast for serological assays such as nAb activity prediction in convalescent-phase plasma from recovered patients. This multicenter study, involving six hospital centers, determined the baseline clinical performances, reproducibility, and nAb level correlations of 10 commercially available immunoassays. In addition, three lateral-flow chromatography assays were evaluated, as these devices can be used in logistically challenged areas. All assays were evaluated using the same patient panels in duplicate, thus enabling accurate comparison of the tests. Seven immunoassays examined in this study were shown to have excellent specificity (98 to 100%) and good to excellent positive predictive values (82 to 100%) when used in a low (5%)-seroprevalence setting. We observed sensitivities as low as 74% and as high as 95% at ≥15 days after symptom onset. The determination of optimized cutoff values through receiver operating characteristic (ROC) curve analyses had a significant impact on the diagnostic resolution of several enzyme immunoassays by increasing the sensitivity significantly without a large trade-off in specificity. We found that spike-based immunoassays seem to be better correlates of nAb activity. Finally, the results reported here will add to the general knowledge of the interlaboratory reproducibility of clinical performance parameters of immunoassays and provide new evidence about nAb activity prediction.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-3 content type line 23 ObjectType-Undefined-2 Citation Therrien C, Serhir B, Bélanger-Collard M, Skrzypczak J, Shank DK, Renaud C, Girouard J, Loungnarath V, Carrier M, Brochu G, Tourangeau F, Gilfix B, Piche A, Bazin R, Guérin R, Lavoie M, Martel-Laferrière V, Fortin C, Benoit A, Marcoux D, Gauthier N, Laumaea AM, Gasser R, Finzi A, Roger M. 2021. Multicenter evaluation of the clinical performance and the neutralizing antibody activity prediction properties of 10 high-throughput serological assays used in clinical laboratories. J Clin Microbiol 59:e02511-20. https://doi.org/10.1128/JCM.02511-20.
ISSN:	0095-1137 1098-660X
DOI:	10.1128/JCM.02511-20