Multicentre Performance Evaluation of the Elecsys Anti-SARS-CoV-2 Immunoassay as an Aid in Determining Previous Exposure to SARS-CoV-2
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SciScore for 10.1101/2021.02.11.21250290: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: A statement was obtained from the Ethics Committee of the Landesärztekammer Bayern confirming that there are no objections to the coherent use of anonymised residual samples. Randomization not detected. Blinding not detected. Power Analysis 15 It was determined that for an assumed sensitivity of 0.999 a sample size of 32–50 samples would be required to obtain a significance level of 0.05 at a power of 0.8. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Assay: The Elecsys Anti-SARS-CoV-2 electrochemiluminescence immunoassay was developed for the in vitro qualitative detection of antibodies to SARS-CoV-2, including IgG, in … SciScore for 10.1101/2021.02.11.21250290: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: A statement was obtained from the Ethics Committee of the Landesärztekammer Bayern confirming that there are no objections to the coherent use of anonymised residual samples. Randomization not detected. Blinding not detected. Power Analysis 15 It was determined that for an assumed sensitivity of 0.999 a sample size of 32–50 samples would be required to obtain a significance level of 0.05 at a power of 0.8. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Assay: The Elecsys Anti-SARS-CoV-2 electrochemiluminescence immunoassay was developed for the in vitro qualitative detection of antibodies to SARS-CoV-2, including IgG, in human serum and plasma. SARS-CoV-2, including IgGsuggested: NoneThe Elecsys Anti-SARS-CoV-2 immunoassay is intended for use on cobas e analysers, and utilises a recombinant protein representing the N antigen in a double-antigen sandwich test format to detect antibodies to SARS-CoV-2.14 The Elecsys Anti-SARS-CoV-2 immunoassay detects antibodies independent of isotype, detecting predominantly mature, high-affinity IgG, but also IgA and IgM antibodies. IgMsuggested: NoneSamples with a COI <1.0 were considered non-reactive and deemed negative for anti-SARS-CoV-2 antibodies, while those with a COI ≥1.0 were considered reactive and deemed positive for anti-SARS-CoV-2 antibodies. anti-SARS-CoV-2suggested: 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:It is possible that the observed difference in sensitivity performance of the Elecsys Anti-SARS-CoV-2 immunoassay among sites was caused in part by the pre-characterisation and selection of cohorts applied at each study site; however, given the unprecedented situation of the ongoing COVID-19 pandemic, the clinical heterogeneity included in this study should be considered a strength rather than a limitation. Moreover, approximately 50% of all samples tested at Heidelberg were from patients undergoing dialysis, in whom infections are one of the main causes of morbidity and mortality.23,24 Patients with end-stage renal disease (ESRD) have poor renal function, which is associated with uraemia-associated immune deficiency.24 In addition, it has been shown that even a single dialysis procedure can have an immunomodulatory effect, contributing to immune deficiency in patients with ESRD.25 Therefore, it is less likely that these patients were able to mount a detectable antibody response to SARS-CoV-2.26,27 This could explain the fact that 10 of 12 non-reactive samples collected ≥14 days post-PCR confirmation at Heidelberg were from patients receiving dialysis, and supports the use of PCR confirmation alongside serological testing for immunocompromised patients in order to ensure an accurate test result. In accordance with previous findings, the sensitivity of the Elecsys Anti-SARS-CoV-2 immunoassay was lowest 0–6 days post-PCR confirmation at 43.1%, before increasing to >90% for samp...
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.
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