Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests

Diego O Andrey; Patrick Cohen; Benjamin Meyer; Giulia Torriani; Sabine Yerly; Lena Mazza; Adrien Calame; Isabelle Arm-Vernez; Idris Guessous; Silvia Stringhini; Pascale Roux-Lombard; Lionel Fontao; Thomas Agoritsas; Jerôme Stirnemann; Jean-Luc Reny; Claire-Anne Siegrist; Isabella Eckerle; Laurent Kaiser; Nicolas Vuilleumier

doi:10.3390/jcm9082369

Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests

J Clin Med. 2020 Jul 24;9(8):2369. doi: 10.3390/jcm9082369.

Authors

Diego O Andrey^{1

2}, Patrick Cohen¹, Benjamin Meyer³, Giulia Torriani⁴, Sabine Yerly^{1

2}, Lena Mazza², Adrien Calame², Isabelle Arm-Vernez¹, Idris Guessous⁵, Silvia Stringhini^{5

6}, Pascale Roux-Lombard^{1

7}, Lionel Fontao^{1

8}, Thomas Agoritsas⁹, Jerôme Stirnemann⁹, Jean-Luc Reny⁹, Claire-Anne Siegrist^{1

3

10}, Isabella Eckerle^{2

4

11}, Laurent Kaiser^{1

2

11}, Nicolas Vuilleumier¹

Affiliations

¹ Division of Laboratory Medicine, Department of Diagnostics, Geneva University Hospitals and Geneva University, 1205 Geneva, Switzerland.
² Division of Infectious Diseases, Department of Medicine, Geneva University Hospitals, 1205 Geneva, Switzerland.
³ Centre for Vaccinology, Department of Pathology and Immunology, University of Geneva, 1211 Geneva, Switzerland.
⁴ Department of Microbiology and Molecular Medicine, University of Geneva, 1211 Geneva, Switzerland.
⁵ Division and Department of Primary Care Medicine, Geneva University Hospitals, 1205 Geneva, Switzerland.
⁶ Unit of Population Epidemiology, Division of Primary Care, Geneva University Hospitals, 1205 Geneva, Switzerland.
⁷ Division of Immunology and Allergy, Department of Medicine, Geneva University Hospitals, 1205 Geneva, Switzerland.
⁸ Division of Dermatology, Geneva University Hospitals, 1205 Geneva, Switzerland.
⁹ Division of General Internal Medicine, Department of Medicine, Geneva University Hospitals, 1205 Geneva, Switzerland.
¹⁰ Department of Childhood and Adolescence, Geneva University Hospitals, 1205 Geneva, Switzerland.
¹¹ Geneva Centre for Emerging Viral Diseases, Geneva University Hospitals and Faculty of Medicine, University of Geneva, 1205 Geneva, Switzerland.

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' median time from RT-PCR to serology was 22 days (interquartile range (IQR) 13-31 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: 78-98) and specificity (SP) 100% (95% CI: 91-100), RDT-B showed 87% SN (95% CI: 72-95) and 98% SP (95% CI: 88-100), and RDT-C 100% SN (95% CI: 88-100) and 98% SP (95% CI: 88-100). 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.

Keywords: COVID-19; ELISA; IgM/IgG serology; SARS-CoV-2; immunofluorescence; rapid test.