Correlation of ELISA based with random access serologic immunoassays for identifying adaptive immune response to SARS-CoV-2

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   ScreenIT

   Jul 8, 2020

   SciScore for 10.1101/2020.07.06.20145938: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Institutional Review Board Statement	not detected.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   The wells are washed and treated with the anti-human IgG antibodies conjugate labeled with peroxidase.	anti-human IgG suggested: None
   The antibodies bind to the solid phase through the recombinant S1 and S2 antigens.	S2 suggested: None
   Samples with AU/mL of ≥15 are considered positive for IgG antibodies.	IgG suggested: None
   The Elecsys Anti-SARS-CoV-2 assay is performed on the Roche cobas e601 analyzer for total antibodies specific for IgG, IgM and IgA which target nucleocapsid protein, in human …

   SciScore for 10.1101/2020.07.06.20145938: (What is this?)

   Please note, not all rigor criteria are appropriate for all manuscripts.

   Table 1: Rigor

   Institutional Review Board Statement	not detected.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   The wells are washed and treated with the anti-human IgG antibodies conjugate labeled with peroxidase.	anti-human IgG suggested: None
   The antibodies bind to the solid phase through the recombinant S1 and S2 antigens.	S2 suggested: None
   Samples with AU/mL of ≥15 are considered positive for IgG antibodies.	IgG suggested: None
   The Elecsys Anti-SARS-CoV-2 assay is performed on the Roche cobas e601 analyzer for total antibodies specific for IgG, IgM and IgA which target nucleocapsid protein, in human serum or plasma.	IgA which target nucleocapsid protein suggested: None
   Samples with COI ≥1.0 are considered reactive or positive for anti-SARS-COV-2 antibodies.	anti-SARS-COV-2 suggested: None
   Software and Algorithms
   Sentences	Resources
   The Abbott SARS-CoV-2 IgG assay was run on the Abbott Architect i2000SR analyzer that measures IgG antibodies to the nucleocapsid protein.	Abbott Architect suggested: (Abbott ARCHITECT i1000sr System, RRID:SCR_019328)
   Statistical analysis: All test results were collated using a Microsoft Excel (Microsoft, Redmond, WA) spreadsheet.	Microsoft Excel suggested: (Microsoft Excel, RRID:SCR_016137)
   Concordance was calculated using the macro formula in Excel.	Excel suggested: None

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   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).

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   Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

   Project Limitations: Our quality assurance project has some notable limitations. At this stage of the disease, true clinical sensitivity and specificity for different methodologies is difficult to determine because of our limited understanding of the disease process and kinetics. Secondly, our assumption that ELISA has better limits of detection is based on circumstantial evidence, as certified standards quantifying limits of detection on different platforms are not available. Third, the cutoffs provided by manufacturers were relied on which may not have undergone extensive validation. Establishing laboratory specific cut-off is akin to establishing reference ranges, which is highly dependent on prevalence of disease in local population.

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   Results from TrialIdentifier: No clinical trial numbers were referenced.

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   Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

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   Results from JetFighter: We did not find any issues relating to colormaps.

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   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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2. 

   Version published to 10.1101/2020.07.06.20145938v1 on medRxiv

   Jul 8, 2020