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Validation of a commercially available SARS-CoV-2 serological immunoassay.
Meyer, B; Torriani, G; Yerly, S; Mazza, L; Calame, A; Arm-Vernez, I; Zimmer, G; Agoritsas, T; Stirnemann, J; Spechbach, H; Guessous, I; Stringhini, S; Pugin, J; Roux-Lombard, P; Fontao, L; Siegrist, C-A; Eckerle, I; Vuilleumier, N; Kaiser, L.
  • Meyer B; Centre for Vaccinology, Department of Pathology and Immunology, University of Geneva, Geneva, Switzerland.
  • Torriani G; Department of Microbiology and Molecular Medicine, University of Geneva, Geneva, Switzerland.
  • Yerly S; Laboratory of Virology, Geneva University Hospitals, Geneva, Switzerland.
  • Mazza L; Laboratory of Virology, Geneva University Hospitals, Geneva, Switzerland.
  • Calame A; Division of Infectious Disease, Geneva University Hospitals, Geneva, Switzerland.
  • Arm-Vernez I; Laboratory of Virology, Geneva University Hospitals, Geneva, Switzerland.
  • Zimmer G; Institute of Virology and Immunology (IVI), Mittelhäusern, Switzerland; Department of Infectious Diseases and Pathobiology (DIP), Vetsuisse Faculty, University of Bern, Bern, Switzerland.
  • Agoritsas T; Division of General Internal Medicine, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland; Department of Health Research Methods, Evidence, and Impact, Hamilton, Ontario, Canada.
  • Stirnemann J; Division of General Internal Medicine, Department of Medicine, Geneva University Hospitals, Geneva, Switzerland.
  • Spechbach H; Division and Department of Primary Care Medicine, Geneva University Hospitals, Geneva, Switzerland.
  • Guessous I; Division and Department of Primary Care Medicine, Geneva University Hospitals, Geneva, Switzerland.
  • Stringhini S; Division and Department of Primary Care Medicine, Geneva University Hospitals, Geneva, Switzerland; Unit of Population Epidemiology, Division of Primary Care, Geneva University Hospitals, Geneva, Switzerland.
  • Pugin J; Division of Intensive Care, Geneva University Hospitals, Geneva, Switzerland.
  • Roux-Lombard P; Division of Laboratory Medicine, Department of Diagnostics, Geneva University Hospitals and Geneva University, Geneva, Switzerland.
  • Fontao L; Division of Dermatology and of Laboratory Medicine, Geneva University Hospitals, Geneva, Switzerland.
  • Siegrist CA; Centre for Vaccinology, Department of Pathology and Immunology, University of Geneva, Geneva, Switzerland.
  • Eckerle I; Department of Microbiology and Molecular Medicine, University of Geneva, Geneva, Switzerland; Division of Infectious Disease, Geneva University Hospitals, Geneva, Switzerland; Geneva Centre for Emerging Viral Diseases, Geneva University Hospitals, Geneva, Switzerland.
  • Vuilleumier N; Division of Laboratory Medicine, Department of Diagnostics, Geneva University Hospitals and Geneva University, Geneva, Switzerland; Division of Laboratory Medicine, Department of Medicine, Faculty of Medicine, Geneva, Switzerland.
  • Kaiser L; Laboratory of Virology, Geneva University Hospitals, Geneva, Switzerland; Division of Infectious Disease, Geneva University Hospitals, Geneva, Switzerland; Geneva Centre for Emerging Viral Diseases, Geneva University Hospitals, Geneva, Switzerland. Electronic address: Laurent.Kaiser@hcuge.ch.
Clin Microbiol Infect ; 26(10): 1386-1394, 2020 Oct.
Article in English | MEDLINE | ID: covidwho-628848
Preprint
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ABSTRACT

OBJECTIVES:

To validate the diagnostic accuracy of a Euroimmun SARS-CoV-2 IgG and IgA immunoassay for COVID-19.

METHODS:

In this unmatched (12) case-control validation study, we used sera of 181 laboratory-confirmed SARS-CoV-2 cases and 326 controls collected before SARS-CoV-2 emergence. Diagnostic accuracy of the immunoassay was assessed against a whole spike protein-based recombinant immunofluorescence assay (rIFA) by receiver operating characteristic (ROC) analyses. Discrepant cases between ELISA and rIFA were further tested by pseudo-neutralization assay.

RESULTS:

COVID-19 patients were more likely to be male and older than controls, and 50.3% were hospitalized. ROC curve analyses indicated that IgG and IgA had high diagnostic accuracies with AUCs of 0.990 (95% Confidence Interval [95%CI] 0.983-0.996) and 0.978 (95%CI 0.967-0.989), respectively. IgG assays outperformed IgA assays (p=0.01). Taking an assessed 15% inter-assay imprecision into account, an optimized IgG ratio cut-off > 2.5 displayed a 100% specificity (95%CI 99-100) and a 100% positive predictive value (95%CI 96-100). A 0.8 cut-off displayed a 94% sensitivity (95%CI 88-97) and a 97% negative predictive value (95%CI 95-99). Substituting the upper threshold for the manufacturer's, improved assay performance, leaving 8.9% of IgG ratios indeterminate between 0.8-2.5.

CONCLUSIONS:

The Euroimmun assay displays a nearly optimal diagnostic accuracy using IgG against SARS-CoV-2 in patient samples, with no obvious gains from IgA serology. The optimized cut-offs are fit for rule-in and rule-out purposes, allowing determination of whether individuals in our study population have been exposed to SARS-CoV-2 or not. IgG serology should however not be considered as a surrogate of protection at this stage.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Immunoglobulin A / Immunoglobulin G / Immunoassay / Coronavirus Infections / Clinical Laboratory Techniques / Betacoronavirus / Antibodies, Viral Type of study: Diagnostic study / Observational study / Prognostic study Limits: Adult / Child / Female / Humans / Male Language: English Journal: Clin Microbiol Infect Journal subject: Communicable Diseases / Microbiology Year: 2020 Document Type: Article Affiliation country: J.cmi.2020.06.024

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Immunoglobulin A / Immunoglobulin G / Immunoassay / Coronavirus Infections / Clinical Laboratory Techniques / Betacoronavirus / Antibodies, Viral Type of study: Diagnostic study / Observational study / Prognostic study Limits: Adult / Child / Female / Humans / Male Language: English Journal: Clin Microbiol Infect Journal subject: Communicable Diseases / Microbiology Year: 2020 Document Type: Article Affiliation country: J.cmi.2020.06.024