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BackgroundThe Elecsys(R) Anti-SARS-CoV-2 S immunoassay (Roche Diagnostics International Ltd, Rotkreuz, Switzerland) has been developed for the in vitro quantitative detection of antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein. We evaluated the performance of this assay using samples from seven sites in Germany, Austria, and Switzerland. MethodsAnonymized frozen, residual serum, or plasma samples from blood donation centers or routine diagnostic testing were used for this study. For specificity and sensitivity analyses, presumed negative samples collected before October 2019 and SARS-CoV-2 PCR-confirmed single or sequential samples were tested, respectively. The performance of the Elecsys Anti-SARS-CoV-2 S immunoassay was also compared with other commercial immunoassays. ResultsThe overall specificity (n=7880 pre-pandemic samples) and sensitivity (n=240 PCR-positive samples [[≥]14 days post-PCR]) for the Elecsys Anti-SARS-CoV-2 S immunoassay were 99.95% (95% confidence interval [CI]: 99.87-99.99) and 97.92% (95% CI: 95.21- 99.32), respectively. Compared with seven other immunoassays, the Elecsys Anti-SARS-CoV-2 S assay had comparable or greater specificity and sensitivity. The Elecsys Anti-SARS-CoV-2 S immunoassay had significantly higher specificity compared with the LIAISON(R) SARS-CoV-2 S1/S2 IgG, ADVIA Centaur(R) SARS-CoV-2 Total, ARCHITECT SARS-CoV-2 IgG, iFlash-SARS-CoV-2 IgM, and EUROIMMUN Anti-SARS-CoV-2 IgG and IgA assays, and significantly higher sensitivity ([≥]14 days post-PCR) compared with the ARCHITECT SARS-CoV-2 IgG, iFlash-SARS-CoV-2 IgG and IgM, and EUROIMMUN Anti-SARS-CoV-2 IgG assays. ConclusionThe Elecsys Anti-SARS-CoV-2 S assay demonstrated a robust and favorable performance across samples from multiple European sites, with a very high specificity and sensitivity for the detection of anti-S antibodies.
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BackgroundThe Elecsys(R) Anti-SARS-CoV-2 electrochemiluminescence immunoassay (Roche Diagnostics International Ltd) was developed for the in vitro qualitative detection of antibodies to SARS-CoV-2. We evaluated the sensitivity of the Elecsys Anti-SARS-CoV-2 immunoassay in samples from a diverse cross-section of patients across multiple sites and compared results against commercially available comparators. MethodsSensitivity of the Elecsys Anti-SARS-CoV-2 immunoassay was evaluated using anonymised, frozen, residual single and sequential serum and plasma samples from patients with polymerase chain reaction (PCR)-confirmed SARS-CoV-2 infection. Point estimates and 95% confidence intervals (CIs) were calculated and method comparisons performed versus the following comparator assays: Euroimmun Anti-SARS-CoV-2 IgG, Abbott ARCHITECT SARS-CoV-2 IgG, Siemens ADVIA Centaur SARS-CoV-2 Total, and YHLO iFlash SARS-CoV-2 IgG and IgM. ResultsOverall sensitivity for the Elecsys Anti-SARS-CoV-2 immunoassay in 219 samples drawn [≥]14 days post-PCR confirmation was 93.6% (95% CI 89.5-96.5). Across the three study sites, sensitivity in samples drawn [≥]14 days post-PCR confirmation ranged from 85.7-98.9%. Sensitivity was significantly higher for the Elecsys Anti-SARS-CoV-2 immunoassay compared with the YHLO iFlash SARS-CoV-2 IgM assay for samples drawn [≥]14 days post-PCR confirmation (86.3% [95% CI 76.7-92.9] versus 33.8% [95% CI 23.6-45.2]). Both Siemens ADVIA Centaur SARS-CoV-2 Total and YHLO iFlash SARS-CoV-2 IgG assays had a significantly higher sensitivity compared with the Elecsys Anti-SARS-CoV-2 immunoassay for samples drawn [≥]14 days post-PCR confirmation (95.1% [95% CI 87.8-98.6] versus 85.2% [95% CI 75.6-92.1]; 93.8% [95% CI 86.0-97.9] versus 86.3% [95% CI 76.7-92.9]). Differences in sensitivity between the Elecsys Anti-SARS-CoV-2 immunoassay and the Euroimmun Anti-SARS-CoV-2 IgG (90.3% [95% CI 83.7-94.9] versus 95.2% [95% CI 89.8-98.2]) and Abbott ARCHITECT SARS-CoV-2 IgG (84.8% [95% CI 75.0-91.9] versus 87.3% [95% CI 78.0-93.8]) assays for samples drawn [≥]14 days post-PCR confirmation were not significant. ConclusionsThe Elecsys Anti-SARS-CoV-2 immunoassay demonstrated high sensitivity in samples collected [≥]14 days post-PCR confirmation of SARS-CoV-2 infection, and comparable sensitivity to several commercially available comparator assays across multiple sites, supporting the use of this assay as a tool to aid in determination of previous exposure to SARS-CoV-2. Required information for submission systemO_ST_ABSEthical guidelinesC_ST_ABSThe study was conducted in accordance with the study protocol provided by Roche Diagnostics and in accordance with the principles of the Declaration of Helsinki. All human samples utilised at the three study sites in Germany (Augsburg, Heidelberg, Berlin) were anonymised, frozen, residual samples, therefore no ethical approval or waiver was required in accordance with local legislation from ZEKO (Central Ethics Commission at the German Medical Association). A statement was obtained from the Ethics Committee of the Landesarztekammer Bayern confirming that there are no objections to the coherent use of anonymised residual samples. Research reporting guidelinesPlease see separate STARD checklist. Data availability statementQualified researchers may request access to individual patient level data through the clinical study data request platform (https://vivli.org/). Further details on Roches criteria for eligible studies are available here: https://vivli.org/members/ourmembers/. For further details on Roches Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm
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The true prevalence and population seropositivity of SARS-CoV-2 infection remains unknown, due to the number of asymptomatic infections and limited access to high-performance antibody tests. To control the COVID-19 pandemic it is crucial to understand the true seroprevalence, but not every region has access to extensive centralized PCR and serology testing. Currently available rapid antibody tests lack the accuracy needed for recommendation by health authorities. To fill this gap, we analyzed and validated the clinical performance of a new point-of-care SARS-CoV-2 Rapid Antibody Assay, a chromatographic immunoassay for qualitative detection of IgM/IgG antibodies for use in near-patient settings. Analysis was performed using 42 Anti-SARS-Cov-2 positive (CoV+) and 92 Anti-SARS-Covid-2 negative (CoV-) leftover samples from before December 2019, using the Elecsys(R) Anti-SARS-CoV-2 as the reference assay. Analytical specificity was tested using leftover samples from individuals with symptoms of common cold collected before December 2019. The SARS-CoV-2 Rapid Antibody Test was 100.0% (95% CI 91.59-100.00) sensitive and 96.74% (95% CI 90.77-99.32) specific with an assay failure rate of 0.00%. No cross-reactivity was observed against the common cold panel. Method comparison was additionally conducted by two external laboratories, using 100 CoV+/275 CoV-samples, also comparing whole blood versus plasma matrix. The comparison demonstrated for plasma 96.00% positive/96.36% negative percent agreement with the Elecsys Anti-SARS-CoV-2 and overall 99.20% percent agreement between whole blood and EDTA plasma. The SARS-CoV-2 Rapid Antibody Test demonstrated similar clinical performance to the manufacturer's data and to a centralized automated immunoassay, with no cross-reactivity to common cold panels.
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BackgroundThe Elecsys(R) Anti-SARS-CoV-2 immunoassay (Roche Diagnostics) was developed to provide an accurate and reliable method for the detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We evaluated the specificity of the Elecsys Anti-SARS-CoV-2 immunoassay in prepandemic sample cohorts across five sites in Germany, Austria and Switzerland. MethodsSpecificity of the immunoassay was evaluated using anonymised, frozen, residual serum and/or plasma samples from blood donors or routine diagnostic testing. All samples were collected before September 2019 and therefore presumed negative for SARS-CoV-2-specific antibodies. Cohorts included samples from blood donors, pregnant women and paediatric patients. Point estimates and 95% confidence intervals (CIs) were calculated. ResultsOverall specificities for the Elecsys Anti-SARS-CoV-2 immunoassay in 9575 samples from blood donors (n = 6714) and diagnostic specimens (n = 2861) were 99.82% (95% CI 99.69-99.91) and 99.93% (95% CI 99.75-99.99), respectively. Among 2256 samples from pregnant women, specificity was 99.91% (95% CI 99.68-99.99). Among 205 paediatric samples, specificity was 100% (95% CI 98.22-100). ConclusionThe Elecsys Anti-SARS-CoV-2 immunoassay demonstrated a very high specificity across blood donor samples and diagnostic specimens from Germany, Austria and Switzerland. Our findings support the use of the Elecsys Anti-SARS-CoV-2 immunoassay as a potential tool for determination of an immune response following previous exposure to SARS-CoV-2 in the general population, including in blood donors, pregnant women and paediatric populations.
