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10.1093/clinchem/hvaa198

http://scihub22266oqcxt.onion/10.1093/clinchem/hvaa198
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32777031!7454460!32777031
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suck abstract from ncbi


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pmid32777031      Clin+Chem 2020 ; 66 (11): 1405-1413
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  • Side-by-Side Comparison of Three Fully Automated SARS-CoV-2 Antibody Assays with a Focus on Specificity #MMPMID32777031
  • Perkmann T; Perkmann-Nagele N; Breyer MK; Breyer-Kohansal R; Burghuber OC; Hartl S; Aletaha D; Sieghart D; Quehenberger P; Marculescu R; Mucher P; Strassl R; Wagner OF; Binder CJ; Haslacher H
  • Clin Chem 2020[Nov]; 66 (11): 1405-1413 PMID32777031show ga
  • 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 3 commercial CE-marked, SARS-CoV-2 antibody assays side by side. METHODS: We included a total of 1154 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 3 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 3 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.
  • |*Clinical Laboratory Techniques[MESH]
  • |Antibodies, Viral/blood[MESH]
  • |Automation, Laboratory[MESH]
  • |Betacoronavirus/*immunology[MESH]
  • |COVID-19[MESH]
  • |COVID-19 Testing[MESH]
  • |Coronavirus Infections/*diagnosis[MESH]
  • |Cross-Sectional Studies[MESH]
  • |False Positive Reactions[MESH]
  • |Humans[MESH]
  • |Immunoglobulin G/blood[MESH]
  • |Limit of Detection[MESH]
  • |Pandemics[MESH]
  • |Pneumonia, Viral/*diagnosis[MESH]
  • |Prospective Studies[MESH]
  • |ROC Curve[MESH]
  • |SARS-CoV-2[MESH]


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