This included a complete of 7903 samples comprising both confirmed positive samples from sensitivity testing and presumed positive samples with at least one positive antibody end result (n?=?1011), aswell as presumed bad examples from specificity assessment cohort examples (n?=?6892: n?=?4068 blood vessels donors; n?=?2824 regimen diagnostic)
This included a complete of 7903 samples comprising both confirmed positive samples from sensitivity testing and presumed positive samples with at least one positive antibody end result (n?=?1011), aswell as presumed bad examples from specificity assessment cohort examples (n?=?6892: n?=?4068 blood vessels donors; n?=?2824 regimen diagnostic). 272 different sufferers had been tested, respectively. Zearalenone The entire specificity and awareness (2 weeks post-PCR) for the Elecsys Anti-SARS-CoV-2 S immunoassay had been 99.95% (95% confidence interval [CI]: 99.87C99.99; 7876/7880) and 97.92% (95% CI: 95.21C99.32; 235/240), respectively. The Elecsys Anti-SARS-CoV-2 S immunoassay had higher specificity weighed against the LIAISON significantly? SARS-CoV-2 S1/S2 IgG (99.95% [2032/2033] vs 98.82% [2009/2033]), ADVIA Centaur? SARS-CoV-2 Total (100% [928/928] vs 86.96% [807/928]), ARCHITECT SARS-CoV-2 IgG (99.97% [2931/2932] vs 99.69% [2923/2932]), iFlash-SARS-CoV-2 IgM (100.00% [928/928] vs 99.57% [924/928]), and EUROIMMUN Anti-SARS-CoV-2 IgG (100.00% [903/903] vs 97.45% [880/903]) and IgA (100.00% [895/895] vs 95.75% [857/895]) assays. The Elecsys Anti-SARS-CoV-2 S immunoassay acquired significantly higher awareness (2 weeks post-PCR) weighed against the ARCHITECT SARS-CoV-2 IgG (98.70% [76/77] vs 87.01% [67/77]), iFlash-SARS-CoV-2 IgG (100.00% [76/76] vs 93.42% [71/76]) and IgM (100.00% [76/76] vs 35.53% [27/76]), and EUROIMMUN Anti-SARS-CoV-2 IgG (98.26% [113/115] vs 93.91% [108/115]) assays. As a result, the Elecsys Anti-SARS-CoV-2 S assay showed a reliable functionality across various sample populations for the detection of anti-S antibodies. quantitative detection of antibodies, including IgG, against the SARS-CoV-2 S protein RBD in human serum and plasma (Roche Diagnostics GmbH, 2021a). The objective of this multicenter European study was to qualitatively evaluate the specificity and sensitivity of the Elecsys Anti-SARS-CoV-2 S immunoassay using pre-pandemic samples (from routine diagnostics or blood donation) and polymerase chain reaction (PCR)-positive samples, respectively, as well as compare the performance of this quantitative test with other commercially available immunoassays in terms of specificity and sensitivity. 2.?Materials and methods 2.1. Study design The study was executed from August 17, 2020 to September 1, 2020 with samples tested at four European sites: Labor Augsburg MVZ GmbH, Augsburg, Germany; MVZ Labor Dr. Limbach & Kollegen GbR, Heidelberg, Germany; Interregionale Blutspende SRK AG (SRK Bern), Bern, Switzerland; and Krankenhaus Barmherzige Brder, Regensburg, Germany. Samples were collected from those four sites, as well as from three additional sites: Labor Berlin C Charit Vivantes GmbH, Berlin, Germany; Tirol Kliniken, Innsbruck, Austria; and Deutsches Rotes Kreuz Blutspendedienst West, Hagen, Germany. Samples from Augsburg and Heidelberg included those referred to the respective study site by physicians. Heidelberg also tested samples from employees and hospitalized patients, including a subset from patients receiving dialysis. All samples provided by the study site in Berlin were collected from hospitalized patients, including a subset from patients monitored in the intensive care unit. Samples tested in Regensburg were taken from employees and pediatric patients referred to the site by physicians. These samples were collected and tested in accordance with applicable regulations, including relevant European Union directives and regulations, and the principles of the Declaration of Helsinki. All samples from Augsburg, Heidelberg, Berlin and Hagen were anonymized. A statement was obtained from the Ethics Committee (EC) of the Landes?rztekammer Bayern confirming that there are no objections to the use of anonymized leftover samples. From the EC at the study site in Bern (Switzerland) a waiver was received and from the Rabbit polyclonal to ZAK internal EC at the study site in Innsbruck (Austria) an approval was received. For Regensburg (Germany), EC approvals were already in place, amendments were submitted to notify the EC about Elecsys Anti-SARS-CoV-2 S testing. At Augsburg, Heidelberg, and Bern the assays were performed around the cobas e 801 analyzer (Roche Diagnostics International Ltd, Rotkreuz, Switzerland), whereas at Regensburg the assays were performed around the cobas e 601 analyzer (Roche Diagnostics International Ltd, Rotkreuz, Switzerland). To assess the proper function of cobas Zearalenone Zearalenone e devices, applications and reagents, a familiarization experiment was performed with quality control material and successfully exceeded at all measuring sites. Sites were requested to run quality controls after every calibration, for each reagent kit, and at least once every 24?h, and to proceed only if the recovery was within the acceptance criteria. 2.2. Serum and plasma samples Anonymized frozen, residual serum or plasma samples (300?l volume) from blood donation centers or routine laboratory diagnostics, as well as banked samples, were used for this study. For specificity analysis of the Elecsys Anti-SARS-CoV-2 S assay, 7880 samples (5056 blood donor and 2824 diagnostic routine samples) that were collected before the COVID-19 pandemic in October 2019, and therefore presumed to be unfavorable for SARS-CoV-2, were tested. The diagnostic routine cohort included samples from women attending pregnancy screening and from pediatrics. For the sensitivity analysis of the Elecsys Anti-SARS-CoV-2 S assay, 827 PCR-confirmed single or sequential samples from 272 different patients, with known time difference between blood draw and.