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10.1128/JCM.01694-20

http://scihub22266oqcxt.onion/10.1128/JCM.01694-20
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suck abstract from ncbi


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pmid32747400      J+Clin+Microbiol 2020 ; 58 (10): ä
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  • Development and Validation of the Elecsys Anti-SARS-CoV-2 Immunoassay as a Highly Specific Tool for Determining Past Exposure to SARS-CoV-2 #MMPMID32747400
  • Muench P; Jochum S; Wenderoth V; Ofenloch-Haehnle B; Hombach M; Strobl M; Sadlowski H; Sachse C; Torriani G; Eckerle I; Riedel A
  • J Clin Microbiol 2020[Sep]; 58 (10): ä PMID32747400show ga
  • The Elecsys Anti-SARS-CoV-2 immunoassay (Roche Diagnostics) was developed to provide accurate, reliable detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We evaluated sensitivity, specificity, cross-reactivity, and agreement with a vesicular stomatitis virus-based pseudoneutralization assay for the Elecsys Anti-SARS-CoV-2 immunoassay. Sensitivity and agreement between Elecsys Anti-SARS-CoV-2 immunoassay and pseudoneutralization assay measurements were evaluated using samples from patients with PCR-confirmed SARS-CoV-2 infection, a majority of whom were hospitalized. Specificity was evaluated using samples from routine diagnostic testing/blood donors collected before December 2019 and thus deemed negative for SARS-CoV-2-specific antibodies. Cross-reactivity was evaluated using samples containing a wide range of potentially cross-reacting analytes, purchased from commercial vendors. For sensitivity and specificity, point estimates and 95% confidence intervals (CIs) were calculated. Agreement between the Elecsys Anti-SARS-CoV-2 immunoassay and the pseudoneutralization assay was calculated. The sensitivity of the Elecsys Anti-SARS-CoV-2 immunoassay in patients with prior PCR-confirmed SARS-CoV-2 infection was 99.5% (95% CI, 97.0 to 100.0%) at >/=14 days post-PCR confirmation. Overall specificity (n = 10,453) was 99.80% (95% CI, 99.69 to 99.88%). Only 4/792 samples containing potential cross-reacting analytes were reactive with the Elecsys Anti-SARS-CoV-2 immunoassay, resulting in an overall specificity in this cohort of 99.5% (95% CI, 98.6 to 99.9%). Positive, negative, and overall agreement (n = 46) between the Elecsys Anti-SARS-CoV-2 immunoassay and the pseudoneutralization assay were 86.4% (95% CI, 73.3 to 93.6%), 100% (95% CI, 34.2 to 100%), and 87.0% (95% CI, 74.3 to 93.9%), respectively. The Elecsys Anti-SARS-CoV-2 immunoassay demonstrated high sensitivity (99.5% at >/=14 days post-PCR confirmation) and specificity (99.80%), supporting its use as a tool for identification of past SARS-CoV-2 infection, including use in populations with low disease prevalence.
  • |*Immunoassay[MESH]
  • |Antibodies, Viral/blood[MESH]
  • |Betacoronavirus/immunology/*isolation & purification[MESH]
  • |COVID-19 Testing[MESH]
  • |Clinical Laboratory Techniques[MESH]
  • |Coronavirus Infections/blood/diagnosis/epidemiology[MESH]
  • |Cross Reactions[MESH]
  • |Humans[MESH]
  • |Reproducibility of Results[MESH]
  • |SARS-CoV-2[MESH]


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