Comparative Performance of Five Commercially Available Serologic Assays To Detect Antibodies to SARS-CoV-2 and Identify Individuals with High Neutralizing Titers

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1. 

   ScreenIT

   Mar 1, 2021

   SciScore for 10.1101/2020.08.31.20184788: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IRB: Ethics statement: This study used stored samples and data from two parent studies that were approved by The Johns Hopkins University School of Medicine Institutional Review Board.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	not detected.
   Cell Line Authentication	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   The Roche assay measures total antibodies to SARS-CoV-2, whereas the others measure only IgG to SARS-CoV-2.	SARS-CoV-2 suggested: None
   Experimental Models: Cell Lines
   Sentences	Resources
   Microneutralization assay: Plasma nAb titers were quantified against 100 fifty percent tissue culture …

   SciScore for 10.1101/2020.08.31.20184788: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IRB: Ethics statement: This study used stored samples and data from two parent studies that were approved by The Johns Hopkins University School of Medicine Institutional Review Board.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	not detected.
   Cell Line Authentication	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   The Roche assay measures total antibodies to SARS-CoV-2, whereas the others measure only IgG to SARS-CoV-2.	SARS-CoV-2 suggested: None
   Experimental Models: Cell Lines
   Sentences	Resources
   Microneutralization assay: Plasma nAb titers were quantified against 100 fifty percent tissue culture infectious doses (TCID50) using a microneutralization (NT) assay in VeroE6-TMPRSS2 cells, which has been previously described.	VeroE6-TMPRSS2 suggested: JCRB Cat# JCRB1819, RRID:CVCL_YQ49)
   Software and Algorithms
   Sentences	Resources
   Statistical analyses were performed in Stata/MP, version 15.2 (StataCorp, CollegeStation, TX) and R statistical software.	StataCorp suggested: (Stata, RRID:SCR_012763)

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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:

   This study has limitations. First, the data were cross-sectional, so we were unable to capture the influence of longitudinal antibody dynamics on diagnostic accuracy. Second, there were several types of specimens that were not included in the evaluation, such as samples from early in SARS-CoV-2 infection (e.g., <14 days post-symptom onset), samples from individuals who were asymptomatic when infected with SARS-CoV-2, and samples from convalescent individuals who were infected >6 months ago—all of which could potentially influence our estimates of assay sensitivity. Third, the samples used to examine assay specificity were not well-characterized due to the identity-unlinked design of the JHHED serosurvey. However, given that we used samples from patients in an inner-city emergency department that delivers primary care to the local underserved community, several included patients who were likely seeking care for viral respiratory illnesses. Finally, the samples evaluated were primarily from the Baltimore-Washington D.C. region, and results may not be generalizable elsewhere. Implementation of the appropriate EIAs to detect SARS-CoV-2 antibodies will require careful consideration of the inferential purpose (e.g., individual-vs. population-level inference), context (e.g., prevalence in target population), operational feasibility (e.g., high-throughput platform vs. manual ELISA) and the underlying test performance characteristics of the assays. Although the output ratio results fo...

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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 10.1128/jcm.02257-20

   Jan 21, 2021
3. 

   Version published to 10.1101/2020.08.31.20184788 on medRxiv

   Sep 2, 2020