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Andrey DO, Cohen P, Meyer B, et al. Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests. J Clin Med. 2020;9(8)doi: 10.3390/jcm9082369.
Andrey, D. O., Cohen, P., Meyer, B., Torriani, G., Yerly, S., Mazza, L., Calame, A., Arm-Vernez, I., Guessous, I., Stringhini, S., Roux-Lombard, P., Fontao, L., Agoritsas, T., Stirnemann, J., Reny, J. L., Siegrist, C. A., Eckerle, I., Kaiser, L., & Vuilleumier, N. (2020). Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests. Journal of clinical medicine, 9(8), . https://doi.org/10.3390/jcm9082369
Andrey, Diego O, et al. "Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests." Journal of clinical medicine vol. 9,8 (2020). doi: https://doi.org/10.3390/jcm9082369
Andrey DO, Cohen P, Meyer B, Torriani G, Yerly S, Mazza L, Calame A, Arm-Vernez I, Guessous I, Stringhini S, Roux-Lombard P, Fontao L, Agoritsas T, Stirnemann J, Reny JL, Siegrist CA, Eckerle I, Kaiser L, Vuilleumier N. Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests. J Clin Med. 2020 Jul 24;9(8). doi: 10.3390/jcm9082369. PMID: 32722191; PMCID: PMC7463984.
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J Clin Med. 2020 Jul 24;9(8). doi: 10.3390/jcm9082369.

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

Journal of clinical medicine

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

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.

PMID: 32722191 PMCID: PMC7463984 DOI: 10.3390/jcm9082369

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

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