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Side by side comparison of three fully automated SARS-CoV-2 antibody assays with a focus on specificity
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Academic Article
research paper
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Covid-on-the-Web dataset
title
Side by side comparison of three fully automated SARS-CoV-2 antibody assays with a focus on specificity
Creator
Perkmann, Thomas
Binder, Christoph
Hartl, Sylvia
Strassl, Robert
Aletaha, Daniel
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source
MedRxiv
abstract
Background: In the context of the COVID-19 pandemic, numerous new serological test systems for the detection of anti-SARS-CoV-2 antibodies have become available quickly. However, the clinical performance of many of them 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's test 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 predictability at 1% seroprevalence: 52.3% (36.2-67.9), 77.6% (52.8-91.5), and 32.6% (23.6-43.1) for Roche, Abbott, and DiaSorin, respectively. Conclusion: We find 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 predictability of these tests.
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2020-06-05
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10.1101/2020.06.04.20117911
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medrxiv
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a73a02a9097483e778f6ac110c1477b81aa64dc7
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https://doi.org/10.1101/2020.06.04.20117911
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Side by side comparison of three fully automated SARS-CoV-2 antibody assays with a focus on specificity
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covid:a73a02a9097483e778f6ac110c1477b81aa64dc7#body_text
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named entity 'tested positive'
named entity 'SARS-CoV-2'
named entity 'HKU1'
named entity 'coronaviruses'
named entity 'medRxiv'
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