Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests
| Autor: | 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, Silvia Stringhini |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
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 |
| Zdroj: | Journal of Clinical Medicine Journal of Clinical Medicine, Vol. 9, No 8 (2020) P. 2369 Volume 9 Issue 8 Journal of Clinical Medicine, Vol 9, Iss 2369, p 2369 (2020) |
| ISSN: | 2077-0383 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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