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10.1093/clinchem/hvaa336

http://scihub22266oqcxt.onion/10.1093/clinchem/hvaa336
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33399823!7929008!33399823
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suck abstract from ncbi


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pmid33399823      Clin+Chem 2021 ; 67 (5): 742-752
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  • Evaluation of High-Throughput SARS-CoV-2 Serological Assays in a Longitudinal Cohort of Patients with Mild COVID-19: Clinical Sensitivity, Specificity, and Association with Virus Neutralization Test #MMPMID33399823
  • Bal A; Pozzetto B; Trabaud MA; Escuret V; Rabilloud M; Langlois-Jacques C; Paul A; Guibert N; D'Aubarede-Frieh C; Massardier-Pilonchery A; Fabien N; Goncalves D; Boibieux A; Morfin-Sherpa F; Pitiot V; Gueyffier F; Lina B; Fassier JB; Trouillet-Assant S
  • Clin Chem 2021[Apr]; 67 (5): 742-752 PMID33399823show ga
  • BACKGROUND: The association between SARS-CoV-2 commercial serological assays and virus neutralization test (VNT) has been poorly explored in mild patients with COVID-19. METHODS: 439 serum specimens were longitudinally collected from 76 healthcare workers with RT-PCR-confirmed COVID-19. The clinical sensitivity (determined weekly) of 9 commercial serological assays were evaluated. Clinical specificity was assessed using 69 pre-pandemic sera. Correlation, agreement, and concordance with the VNT were also assessed on a subset of 170 samples. Area under the ROC curve (AUC) was estimated at 2 neutralizing antibody titers. RESULTS: The Wantai Total Ab assay targeting the receptor binding domain (RBD) within the S protein presented the best sensitivity at different times during the course of disease. The clinical specificity was greater than 95% for all tests except for the Euroimmun IgA assay. The overall agreement with the presence of neutralizing antibodies ranged from 62.2% (95%CI; 56.0-68.1) for bioMerieux IgM to 91.2% (87.0-94.2) for Siemens. The lowest negative percent agreement (NPA) was found with the Wantai Total Ab assay (NPA 33% (21.1-48.3)). The NPA for other total Ab or IgG assays targeting the S or the RBD was 80.7% (66.7-89.7), 90.3% (78.1-96.1), and 96.8% (86.8-99.3) for Siemens, bioMerieux IgG, and DiaSorin, respectively. None of the commercial assays have sufficient performance to detect a neutralizing titer of 80 (AUC < 0.76). CONCLUSIONS: Although some assays show a better agreement with VNT than others, the present findings emphasize that commercialized serological tests, including those targeting the RBD, cannot substitute a VNT for the assessment of functional antibody response.
  • |Adult[MESH]
  • |Aged[MESH]
  • |Antibodies, Neutralizing/*blood[MESH]
  • |Antibodies, Viral/*blood[MESH]
  • |COVID-19 Serological Testing/methods[MESH]
  • |COVID-19/blood/*diagnosis[MESH]
  • |Cohort Studies[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Longitudinal Studies[MESH]
  • |Male[MESH]
  • |Neutralization Tests[MESH]
  • |Prospective Studies[MESH]
  • |SARS-CoV-2[MESH]


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