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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.

  • Muench P Roche Diagnostics GmbH, Penzberg, Germany.
  • Jochum S Roche Diagnostics GmbH, Penzberg, Germany.
  • Wenderoth V Roche Diagnostics GmbH, Penzberg, Germany.
  • Ofenloch-Haehnle B Roche Diagnostics GmbH, Penzberg, Germany.
  • Hombach M Roche Diagnostics International Ltd, Rotkreuz, Switzerland michael.hombach@roche.com.
  • Strobl M Roche Diagnostics GmbH, Penzberg, Germany.
  • Sadlowski H Labor Berlin-Charité Vivantes Services GmbH, Berlin, Germany.
  • Sachse C KRH Labor GmbH, Hannover, Germany.
  • Torriani G Department of Molecular Medicine and Microbiology, Faculty of Medicine, Université de Genève, Geneva, Switzerland.
  • Eckerle I Department of Molecular Medicine and Microbiology, Faculty of Medicine, Université de Genève, Geneva, Switzerland.
  • Riedel A Roche Diagnostics GmbH, Penzberg, Germany.
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  • 2020-08-05
Published in:
  • Journal of clinical microbiology. - 2020
SARS-CoV-2
cross-reactivity
diagnosis
immunoassay
neutralization testing
sensitivity
specificity
Antibodies, Viral
Betacoronavirus
Clinical Laboratory Techniques
Coronavirus Infections
Cross Reactions
Humans
Immunoassay
Reproducibility of Results
Sensitivity and Specificity
English 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.
Language
  • English
Open access status
hybrid
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Persistent URL
https://sonar.ch/global/documents/216500
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