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Evaluation of four commercial, fully automated SARS-CoV-2 antibody tests suggests a revision of the Siemens SARS-CoV-2 IgG assay
- Source :
- Clinical chemistry and laboratory medicineReferences. 59(6)
- Publication Year :
- 2020
-
Abstract
- Objectives Serological tests detect antibodies against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in the ongoing coronavirus disease-19 (COVID-19) pandemic. Independent external clinical validation of performance characteristics is of paramount importance. Methods Four fully automated assays, Roche Elecsys Anti-SARS-CoV-2, Abbott SARS-CoV-2 IgG, Siemens SARS-CoV-2 total (COV2T) and SARS-CoV-2 IgG (COV2G) were evaluated using 350 pre-pandemic samples and 700 samples from 245 COVID-19 patients (158 hospitalized, 87 outpatients). Results All tests showed very high diagnostic specificity. Sensitivities in samples collected at least 14 days after disease onset were slightly lower than manufacturers’ claims for Roche (93.0%), Abbott (90.8%), and Siemens COV2T (90.3%), and distinctly lower for Siemens COV2G (78.8%). Concordantly negative results were enriched for immunocompromised patients. ROC curve analyses suggest a lowering of the cut-off index for the Siemens COV2G assay. Finally, the combination of two anti-SARS-CoV-2 antibody assays is feasible when considering borderline reactive results. Conclusions Thorough on-site evaluation of commercially available serologic tests for detection of antibodies against SARS-CoV-2 remains imperative for laboratories. The potentially impaired sensitivity of the Siemens COV2G necessitates a switch to the company’s newly filed SARS-CoV-2 IgG assay for follow-up studies. A combination of tests could be considered in clinical practice.
- Subjects :
- 0301 basic medicine
Adult
Male
medicine.medical_specialty
Disease onset
Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Clinical Biochemistry
Siemens
medicine.disease_cause
Antibodies, Viral
Sensitivity and Specificity
Serology
COVID-19 Serological Testing
03 medical and health sciences
Young Adult
0302 clinical medicine
Internal medicine
Medicine
Humans
030212 general & internal medicine
Pandemics
Coronavirus
Aged
Aged, 80 and over
biology
business.industry
SARS-CoV-2
Biochemistry (medical)
COVID-19
General Medicine
Middle Aged
030104 developmental biology
Fully automated
ROC Curve
Immunoglobulin G
biology.protein
Female
Antibody
business
Subjects
Details
- ISSN :
- 14374331
- Volume :
- 59
- Issue :
- 6
- Database :
- OpenAIRE
- Journal :
- Clinical chemistry and laboratory medicineReferences
- Accession number :
- edsair.doi.dedup.....85ef133354cf7a299d0b49195ac75154