Validation of a commercially available SARS-CoV-2 serological immunoassay

Autor: Giulia Torriani, Hervé Spechbach, Nicolas Vuilleumier, Sabine Yerly, Lena Mazza, Laurent Kaiser, Gert Zimmer, Isabelle Arm-Vernez, Lionel Fontao, Idris Guessous, Jérôme Stirnemann, Claire-Anne Siegrist, Benjamin Meyer, Jérôme Pugin, Isabella Eckerle, Thomas Agoritsas, Adrien Calame, Pascale Roux-Lombard, Silvia Stringhini
Jazyk: angličtina
Rok vydání: 2020
Předmět:
0301 basic medicine
Immunoglobulin A
Male
Serological testingstrategy
ddc:616.07
Antibodies
Viral
Gastroenterology
Severity of Illness Index
Immunoglobulin G
Serology
0302 clinical medicine
COVID-19 Testing
030212 general & internal medicine
Child
610 Medicine & health
ddc:616
Immunoassay
biology
medicine.diagnostic_test
ddc:617
recombinant immunofluorescence assay
General Medicine
Serological Assays
Infectious Diseases
Area Under Curve
Population study
Female
ELISA
Coronavirus Infections
Adult
Microbiology (medical)
medicine.medical_specialty
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
030106 microbiology
Pneumonia
Viral
Pseudovirus neutralisation assay
Immunofluorescence
Serological testing strategy
Sensitivity and Specificity
Article
03 medical and health sciences
Recombinant immunofluorescence assay
Betacoronavirus
Internal medicine
medicine
Humans
In patient
Pandemics
ddc:613
Receiver operating characteristic
business.industry
Clinical Laboratory Techniques
SARS-CoV-2
Immune Sera
COVID-19
Confidence interval
ROC Curve
Case-Control Studies
biology.protein
570 Life sciences
business
Zdroj: Meyer, Benjamin; Torriani, Giulia; Yerly, Sabine; Mazza, Lena; Calame, Adrien; Arm-Vernez, Isabelle; Zimmer, Gert; Agoritsas, Thomas; Stirnemann, Jérôme; Spechbach, Hervé; Guessous, Idris; Stringhini, Silvia; Pugin, Jérôme; Roux-Lombard, Pascale; Fontao, Lionel; Siegrist, Claire-Anne; Eckerle, Isabella; Vuilleumier, Nicolas; Kaiser, Laurent (2020). Validation of a commercially available SARS-CoV-2 serological immunoassay. Clinical microbiology and infection, 26(10), pp. 1386-1394. Elsevier 10.1016/j.cmi.2020.06.024
Clinical Microbiology and Infection
Clinical Microbiology and Infection (2020)
ISSN: 1198-743X
DOI: 10.1016/j.cmi.2020.06.024
Popis: ObjectivesTo validate the diagnostic accuracy of a Euroimmun SARS-CoV-2 IgG and IgA immunoassay for COVID-19.MethodsIn this unmatched (1:1) case-control validation study, we used sera of 181 laboratory-confirmed SARS-CoV-2 cases and 176 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.ResultsCOVID-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 0.992 (95% Confidence Interval [95%CI]: 0.986-0.996) and 0.977 (95%CI: 0.963-0.990), respectively. IgG assays outperformed IgA assays (p=0.008). Taking an assessed 15% inter-assay imprecision into account, an optimized IgG ratio cut-off > 1.5 displayed a 100% specificity (95%CI: 98–100) and a 100% positive predictive value (95%CI: 97-100). A 0.5 cut-off displayed a 97% sensitivity (95%CI: 93–99) and a 97% negative predictive value (95%CI: 93–99). Substituting these thresholds for the manufacturer’s, improved assay performance, leaving 12% of IgG ratios indeterminate between 0.5-1.5.ConclusionsThe 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.
Databáze: OpenAIRE
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