1. Head-to-Head Evaluation of Five Automated SARS-CoV-2 Serology Immunoassays in Various Prevalence Settings
- Author
-
Nicolas Vuilleumier, Hervé Spechbach, Jean-Luc Reny, Idris Guessous, Jérôme Stirnemann, Claire-Anne Siegrist, Isabelle Arm-Vernez, Thomas Agoritsas, Sabine Yerly, Pascale Roux-Lombard, Giuseppe Togni, Benjamin Meyer, Isabella Eckerle, Laurent Kaiser, Diego O. Andrey, and Silvia Stringhini
- Subjects
medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,Head to head ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Population ,Large population ,lcsh:Medicine ,serology ,ddc:616.07 ,Gastroenterology ,anti-N ,Article ,Serology ,anti-S ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,electrochemiluminescent immunoassay (ECLIA) ,Diasorin ,Medicine ,030212 general & internal medicine ,enzyme-linked immunosorbent assay (ELISA) ,education ,030304 developmental biology ,Roche ,ddc:613 ,ddc:616 ,0303 health sciences ,education.field_of_study ,ddc:618 ,Receiver operating characteristic ,business.industry ,SARS-CoV-2 ,lcsh:R ,COVID-19 ,General Medicine ,Euroimmun ,Lower prevalence ,Epitope ,business - Abstract
Purpose: To assess the diagnostic performances of five automated anti-SARS-CoV-2 immunoassays, Epitope (N), Diasorin (S1/S2), Euroimmun (S1), Roche N (N), and Roche S (S-RBD), and to provide a testing strategy based on pre-test probability. Methods: We assessed the receiver operating characteristic (ROC) areas under the curve (AUC) values, along with the sensitivity, specificity, positive predictive values (PPVs), and negative predictive values (NPVs), of each assay using a validation sample set of 172 COVID-19 sera and 185 negative controls against a validated S1-immunofluorescence as a reference method. The three assays displaying the highest AUCs were selected for further serodetection of 2033 sera of a large population-based cohort. Results: In the validation analysis (pre-test probability: 48.1%), Roche N, Roche S and Euroimmun showed the highest discriminant accuracy (AUCs: 0.99, 0.98, and 0.98) with PPVs and NPVs above 96% and 94%, respectively. In the population-based cohort (pre-test probability: 6.2%) these three assays displayed AUCs above 0.97 and PPVs and NPVs above 90.5% and 99.4%, respectively. A sequential strategy using an anti-S assay as screening test and an anti-N as confirmatory assays resulted in a 96.7% PPV and 99.5% NPV, respectively. Conclusions: Euroimmun and both Roche assays performed equally well in high pre-test probability settings. At a lower prevalence, sequentially combining anti-S and anti-N assays resulted in the optimal trade-off between diagnostic performances and operational considerations.
- Published
- 2021