التفاصيل البيبلوغرافية
| العنوان: |
Development and Validation of the Elecsys Anti-SARS-CoV-2 Immunoassay as a Highly Specific Tool for Determining Past Exposure to SARS-CoV-2 |
| المؤلفون: |
Muench, Peter, Jochum, Simon, Wenderoth, Verena, Ofenloch-Haehnle, Beatus, Hombach, Michael, Strobl, Matthias, Sadlowski, Henrik, Sachse, Christopher, Torriani, Giulia, Eckerle, Isabella Anne, Riedel, Alexander |
| المصدر: |
ISSN: 0095-1137 ; Journal of Clinical Microbiology, vol. 58, no. 10 (2020) p. e01694-20. |
| سنة النشر: |
2020 |
| المجموعة: |
Université de Genève: Archive ouverte UNIGE |
| مصطلحات موضوعية: |
info:eu-repo/classification/ddc/616, Antibodies, Viral/blood, Betacoronavirus/immunology/isolation & purification, COVID-19 Testing, Clinical Laboratory Techniques, Coronavirus Infections/blood/diagnosis/epidemiology, Cross Reactions, Humans, Immunoassay, Reproducibility of Results, SARS-CoV-2, Sensitivity and Specificity |
| الوصف: |
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 ... |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/32747400; info:eu-repo/semantics/dataset/url/https://vivli.org/; https://archive-ouverte.unige.ch/unige:150569; unige:150569 |
| الاتاحة: |
https://archive-ouverte.unige.ch/unige:150569 |
| Rights: |
info:eu-repo/semantics/openAccess |
| رقم الانضمام: |
edsbas.2B8D7720 |
| قاعدة البيانات: |
BASE |