Performance evaluation of the Roche Elecsys Anti-SARS-CoV-2 S immunoassay
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SciScore for 10.1101/2021.03.02.21252203: (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 (EC) of the Landesärztekammer Bayern confirming that there are no objections to the use of anonymized leftover samples. Randomization not detected. Blinding not detected. Power Analysis Assuming specificities between 0.998 and 0.999 and a sensitivity of 0.999, samples sizes of 1698 to 20964 and 32 to 50 respectively, would be required to obtain a significance level of 0.05 and a power of 0.8. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Results are automatically reported as the analyte concentration of each sample in U/mL, with <0.80 U/mL interpreted as negative for … SciScore for 10.1101/2021.03.02.21252203: (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 (EC) of the Landesärztekammer Bayern confirming that there are no objections to the use of anonymized leftover samples. Randomization not detected. Blinding not detected. Power Analysis Assuming specificities between 0.998 and 0.999 and a sensitivity of 0.999, samples sizes of 1698 to 20964 and 32 to 50 respectively, would be required to obtain a significance level of 0.05 and a power of 0.8. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Results are automatically reported as the analyte concentration of each sample in U/mL, with <0.80 U/mL interpreted as negative for anti-SARS-CoV-2 S antibodies and ≥0.80 U/mL interpreted as positive for anti-SARS-CoV-2 S antibodies (Roche Diagnostics GmbH. anti-SARS-CoV-2 Ssuggested: NoneThe Elecsys Anti-SARS-CoV-2 assay is an ECLIA for the in vitro qualitative detection of antibodies, including IgG, against SARS-CoV-2, using a recombinant protein representing the nucleocapsid (N) antigen (27). antigen (27suggested: NoneResults are automatically calculated in the form of a cutoff index (COI), with COI values <1.0 interpreted as non-reactive (negative) for anti-SARS-CoV-2 N antibodies and ≥1.0 as reactive (positive) for anti-SARS-CoV-2 N antibodies (27). anti-SARS-CoV-2 Nsuggested: NoneThe LIAISON SARS-CoV-2 S1/S2 IgG assay is an indirect chemiluminescence immunoassay (CLIA) for the quantitative detection of IgG anti-S1 and IgG anti-S2 antibodies to SARS-CoV-2 (28). anti-S1suggested: Noneanti-S2suggested: NoneThe EUROIMMUN Anti-SARS-CoV-2 IgG and IgA assays are separate enzyme-linked immunosorbent assay (ELISAs) that detect IgG or IgA anti-S1 antibodies to SARS-CoV-2 (29, 30). Anti-SARS-CoV-2 IgGsuggested: NoneResults are reported in index values, with <1.0 interpreted as non-reactive (negative) for anti-SARS-CoV-2 antibodies and ≥1.0 interpreted as reactive (positive) for anti-SARS-CoV-2 antibodies (32). anti-SARS-CoV-2suggested: NoneThe iFlash system automatically calculates the analytic concentration of each sample, with <10 AU/mL interpreted as non-reactive and ≥10 AU/mL interpreted as reactive for anti-SARS-CoV-2 IgM or IgG antibodies. anti-SARS-CoV-2 IgMsuggested: NoneIgGsuggested: NoneSoftware and Algorithms Sentences Resources Data availability: Qualified researchers may request access to individual patient level data through the clinical study data request platform (https://vivli.org/). https://vivli.org/suggested: (Vivli, RRID:SCR_018080)Results 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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.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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