1. Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests
- Author
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Laurent Kaiser, Nicolas Vuilleumier, Patrick Cohen, Giulia Torriani, Sabine Yerly, Lionel Fontao, Idris Guessous, Jérôme Stirnemann, Claire-Anne Siegrist, Thomas Agoritsas, Isabella Eckerle, Benjamin Meyer, Isabelle Arm-Vernez, Jean-Luc Reny, Pascale Roux-Lombard, Adrien Calame, Lena Mazza, Diego O. Andrey, and Silvia Stringhini
- Subjects
medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,Head to head ,Concordance ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,lcsh:Medicine ,ddc:616.07 ,Gastroenterology ,Article ,Serology ,03 medical and health sciences ,0302 clinical medicine ,rapid test ,Interquartile range ,Internal medicine ,parasitic diseases ,Medicine ,030212 general & internal medicine ,immunofluorescence ,Igg elisa ,health care economics and organizations ,ddc:613 ,Whole blood ,ddc:616 ,0303 health sciences ,ddc:618 ,IgM/IgG serology ,030306 microbiology ,business.industry ,SARS-CoV-2 ,lcsh:R ,COVID-19 ,General Medicine ,equipment and supplies ,ELISA ,business - Abstract
Background: Comparative data of SARS-CoV-2 IgM/IgG serology rapid diagnostic tests (RDTs) is scarce. We thus performed a head-to-head comparison of three RDTs. Methods: In this unmatched case-control study, blood samples from 41 RT-PCR-confirmed COVID-19 cases and 50 negative controls were studied. The diagnostic accuracy of three commercially available COVID-19 RDTs: NTBIO (RDT-A), Orient-Gene (RDT-B), and MEDsan (RDT-C), against both a recombinant spike-expressing immunofluorescence assay (rIFA) and Euroimmun IgG ELISA, was assessed. RDT results concordant with the reference methods, and between whole blood and plasma, were established by the Kendall coefficient. Results: COVID-19 cases&rsquo, median time from RT-PCR to serology was 22 days (interquartile range (IQR) 13&ndash, 31 days). Whole-blood IgG detection with RDT-A, -B, and -C showed 0.93, 0.83, and 0.98 concordance with rIFA. Against rIFA, RDT-A sensitivity (SN) was 92% (95% CI: 78&ndash, 98) and specificity (SP) 100% (95% CI: 91&ndash, 100), RDT-B showed 87% SN (95% CI: 72&ndash, 95) and 98% SP (95% CI: 88&ndash, 100), and RDT-C 100% SN (95% CI: 88&ndash, 100) and 98% SP (95% CI: 88&ndash, 100). Against ELISA, SN and SP were above 90% for all three RDTs. Conclusions: RDT-A and RDT-C displayed IgG detection SN and SP above 90% in whole blood. These RDTs could be considered in the absence of routine diagnostic serology facilities.
- Published
- 2020