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10.1093/ajcp/aqaa200

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33033840!7665294!33033840
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suck abstract from ncbi


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pmid33033840      Am+J+Clin+Pathol 2021 ; 155 (2): 267-279
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  • Differences in Performance Characteristics Among Four High-Throughput Assays for the Detection of Antibodies Against SARS-CoV-2 Using a Common Set of Patient Samples #MMPMID33033840
  • Manthei DM; Whalen JF; Schroeder LF; Sinay AM; Li SH; Valdez R; Giacherio DA; Gherasim C
  • Am J Clin Pathol 2021[Feb]; 155 (2): 267-279 PMID33033840show ga
  • OBJECTIVES: Serologic testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has experienced a changing landscape of available assays coupled with uncertainty surrounding performance characteristics. Studies are needed to directly compare multiple commercially available assays. METHODS: Residual serum samples were identified based on SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) testing, clinical test results, and collection dates. Serum samples were analyzed using assays from four different manufacturers: DiaSorin anti-SARS-CoV-2 S1/S2 IgG, EUROIMMUN anti-SARS-CoV-2 IgG ELISA, Roche Elecsys anti-SARS-CoV-2, and Siemens SARS-CoV-2 Total antibody assays. RESULTS: Samples from SARS-CoV-2 RT-PCR-positive patients became increasingly positive as time from symptom onset increased. For patients with latest sample 14 or more days after symptom onset, sensitivities reached 93.1% to 96.6%, 98.3%, and 96.6% for EUROIMMUN, Roche, and Siemens assays, respectively, which were superior to the DiaSorin assay at 87.7%. The specificity of Roche and Siemens assays was 100% and superior to DiaSorin and EUROIMMUN assays, which ranged from 96.1% to 97.0% and 86.3% to 96.4%, respectively. CONCLUSIONS: Laboratories should be aware of the advantages and limitations of serology testing options for SARS-CoV-2. The specificity and sensitivity achieved by the Roche and Siemens assays would be acceptable for testing in lower-prevalence regions and have the potential of orthogonal testing advantages if used in combination.
  • |Antibodies, Viral/*blood[MESH]
  • |COVID-19 Serological Testing/*methods[MESH]
  • |COVID-19/*diagnosis[MESH]
  • |Female[MESH]
  • |High-Throughput Screening Assays/*methods[MESH]
  • |Humans[MESH]
  • |Male[MESH]
  • |Predictive Value of Tests[MESH]
  • |SARS-CoV-2/*immunology[MESH]


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