Development and Validation of the Elecsys Anti-SARS-CoV-2 Immunoassay as a Highly Specific Tool for Determining Past Exposure to SARS-CoV-2
This article has been Reviewed by the following groups
Listed in
- Evaluated articles (ScreenIT)
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 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.
Article activity feed
-
-
SciScore for 10.1101/2020.06.16.20132803: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: For studies with anonymised leftover specimens, no ethics committee vote is required. Randomization not detected. Blinding not detected. Power Analysis 27 The following sample sizes for a seronegative cohort would be required to obtain alpha = 5% and power = 80%: p0 = 0.99, n = 368; p0 = 0.995, n = 736; p0 = 0.996, n = 921; p0 = 0.997, n = 1228; p0 = 0.998, n = 1843; p0 = 0.999, n = 3688; p0 = 0.9995, n = 7376. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources For the present study, the Elecsys Anti-SARS-CoV-2 immunoassay was performed according to manufacturer instructions and assay results were interpreted as follows: … SciScore for 10.1101/2020.06.16.20132803: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: For studies with anonymised leftover specimens, no ethics committee vote is required. Randomization not detected. Blinding not detected. Power Analysis 27 The following sample sizes for a seronegative cohort would be required to obtain alpha = 5% and power = 80%: p0 = 0.99, n = 368; p0 = 0.995, n = 736; p0 = 0.996, n = 921; p0 = 0.997, n = 1228; p0 = 0.998, n = 1843; p0 = 0.999, n = 3688; p0 = 0.9995, n = 7376. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources For the present study, the Elecsys Anti-SARS-CoV-2 immunoassay was performed according to manufacturer instructions and assay results were interpreted as follows: cut-off index <1.0, non-reactive/negative for anti-SARS-CoV-2 antibodies; cut-off index ≥1.0, reactive/positive for anti-SARS-CoV-2 antibodies. anti-SARS-CoV-2suggested: NoneAll samples were collected before December 2019 (i.e. before the first description of an infection with SARS-CoV-2) and were thus deemed negative for SARS-CoV-2-specific antibodies. SARS-CoV-2-specificsuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:A limitation is that this was a single-centre study and our results should be confirmed by additional assessments at other study sites. Further clinical data on the samples were not available due to data regulations, and thus it was not possible to analyse specific sub-cohorts according to age, disease severity, onset of symptoms, etc. We are confident that our results regarding the sensitivity of the Elecsys Anti-SARS-CoV-2 immunoassay and the time course of antibody response are of general value. However, the findings should be interpreted with some caution. Although the samples used in this study were not selected on the basis of patient criteria, the majority of samples were drawn from hospitalised patients and therefore probably represent more severe cases of COVID-19. Furthermore, the availability of samples depended on the need of consequent routine clinical chemistry diagnosis after PCR-confirmation of SARS-CoV-2 infection. Again, it can be assumed that extensive subsequent diagnosis was predominantly performed in cases with more severe disease. The validity of our findings in ambulatory settings or in patients with asymptomatic/mildly symptomatic SARS-CoV-2 infection is yet to be shown and requires further study.
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
-
