PropertyValue
?:abstract
  • BACKGROUND: In the context of the COVID-19 pandemic, numerous new serological test systems for the detection of anti-SARS-CoV-2 antibodies rapidly have become available. However, the clinical performance of many of these is still insufficiently described. Therefore, we compared three commercial, CE-marked, SARS-CoV-2 antibody assays side by side. METHODS: We included a total of 1,154 specimens from pre-COVID-19 times and 65 samples from COVID-19 patients (≥14 days after symptom onset) to evaluate the test performance of SARS-CoV-2 serological assays by Abbott, Roche, and DiaSorin. RESULTS: All three assays presented with high specificities: 99.2% (98.6-99.7) for Abbott, 99.7% (99.2-100.0) for Roche, and 98.3% (97.3-98.9) for DiaSorin. In contrast to the manufacturers’ specifications, sensitivities only ranged from 83.1% to 89.2%. Although the three methods were in good agreement (Cohen’s Kappa 0.71-0.87), McNemar tests revealed significant differences between results obtained from Roche and DiaSorin. However, at low seroprevalences, the minor differences in specificity resulted in profound discrepancies of positive predictive values at 1% seroprevalence: 52.3% (36.2-67.9), 77.6% (52.8-91.5), and 32.6% (23.6-43.1) for Abbott, Roche, and DiaSorin, respectively. CONCLUSION: We found diagnostically relevant differences in specificities for the anti-SARS-CoV-2 antibody assays by Abbott, Roche, and DiaSorin that have a significant impact on the positive predictive values of these tests.
?:creator
?:doi
  • 10.1093/clinchem/hvaa198
?:doi
?:journal
  • Clin_Chem
?:license
  • no-cc
?:pdf_json_files
  • document_parses/pdf_json/a02bd129f84f5d227ba1ab7ffb63d946086054d1.json
?:pmcid
?:pmid
?:pmid
  • 32777031.0
?:publication_isRelatedTo_Disease
?:sha_id
?:source
  • Medline; PMC
?:title
  • Side by side comparison of three fully automated SARS-CoV-2 antibody assays with a focus on specificity
?:type
?:year
  • 2020-08-10

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