tetano
Editor, Senior Moderator
Clin Microbiol
. 2020 Aug 3;JCM.01694-20.
doi: 10.1128/JCM.01694-20. Online ahead of print.
Development and Validation of the Elecsys Anti-SARS-CoV-2 Immunoassay as a Highly Specific Tool for Determining Past Exposure to SARS-CoV-2
Peter Muench[SUP] 1 [/SUP], Simon Jochum[SUP] 1 [/SUP], Verena Wenderoth[SUP] 1 [/SUP], Beatus Ofenloch-Haehnle[SUP] 1 [/SUP], Michael Hombach[SUP] 2 [/SUP], Matthias Strobl[SUP] 1 [/SUP], Henrik Sadlowski[SUP] 3 [/SUP], Christopher Sachse[SUP] 4 [/SUP], Giulia Torriani[SUP] 5 [/SUP], Isabella Eckerle[SUP] 5 6 7 8 9 [/SUP], Alexander Riedel[SUP] 1 [/SUP]
Affiliations
Abstract
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 pseudo-neutralisation assay for the Elecsys Anti-SARS-CoV-2 immunoassay.Sensitivity and agreement between the Elecsys Anti-SARS-CoV-2 immunoassay and pseudo-neutralisation assay measurements were evaluated using samples from patients with polymerase chain reaction (PCR)-confirmed SARS-CoV-2 infection, a majority of whom were hospitalised. Specificity was evaluated using samples from routine diagnostic testing/blood donors collected pre-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 pseudo-neutralisation assay was calculated.Sensitivity of the Elecsys Anti-SARS-CoV-2 immunoassay in patients with prior PCR-confirmed SARS-CoV-2 infection was 99.5% (95% CI 97.0-100.0) at ≥14 days post-PCR confirmation. Overall specificity (n=10,453) was 99.80% (99.69-99.88). 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% (98.6-99.9). Positive, negative and overall agreement (n=46) between Elecsys Anti-SARS-CoV-2 immunoassay and a pseudo-neutralisation assay were 86.4% (73.3-93.6), 100% (34.2-100) and 87.0% (74.3-93.9), 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 in populations with low disease prevalence.
. 2020 Aug 3;JCM.01694-20.
doi: 10.1128/JCM.01694-20. Online ahead of print.
Development and Validation of the Elecsys Anti-SARS-CoV-2 Immunoassay as a Highly Specific Tool for Determining Past Exposure to SARS-CoV-2
Peter Muench[SUP] 1 [/SUP], Simon Jochum[SUP] 1 [/SUP], Verena Wenderoth[SUP] 1 [/SUP], Beatus Ofenloch-Haehnle[SUP] 1 [/SUP], Michael Hombach[SUP] 2 [/SUP], Matthias Strobl[SUP] 1 [/SUP], Henrik Sadlowski[SUP] 3 [/SUP], Christopher Sachse[SUP] 4 [/SUP], Giulia Torriani[SUP] 5 [/SUP], Isabella Eckerle[SUP] 5 6 7 8 9 [/SUP], Alexander Riedel[SUP] 1 [/SUP]
Affiliations
- PMID: 32747400
- DOI: 10.1128/JCM.01694-20
Abstract
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 pseudo-neutralisation assay for the Elecsys Anti-SARS-CoV-2 immunoassay.Sensitivity and agreement between the Elecsys Anti-SARS-CoV-2 immunoassay and pseudo-neutralisation assay measurements were evaluated using samples from patients with polymerase chain reaction (PCR)-confirmed SARS-CoV-2 infection, a majority of whom were hospitalised. Specificity was evaluated using samples from routine diagnostic testing/blood donors collected pre-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 pseudo-neutralisation assay was calculated.Sensitivity of the Elecsys Anti-SARS-CoV-2 immunoassay in patients with prior PCR-confirmed SARS-CoV-2 infection was 99.5% (95% CI 97.0-100.0) at ≥14 days post-PCR confirmation. Overall specificity (n=10,453) was 99.80% (99.69-99.88). 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% (98.6-99.9). Positive, negative and overall agreement (n=46) between Elecsys Anti-SARS-CoV-2 immunoassay and a pseudo-neutralisation assay were 86.4% (73.3-93.6), 100% (34.2-100) and 87.0% (74.3-93.9), 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 in populations with low disease prevalence.