Analytical and clinical performances of five immunoassays for the detection of SARS-CoV-2 antibodies in comparison with neutralization activity

Article activity feed

1. 

   ScreenIT

   Mar 1, 2021

   SciScore for 10.1101/2020.08.01.20166546: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IRB: The study protocol (number 23307) was approved by the Ethics Committee of the University-Hospital, Padova.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	, 21 autoimmune patients, 8 pregnant women) were included in the study (Table 1).
   Cell Line Authentication	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   In the same samples, a high-throughput PRNT method was developed for the fast and accurate quantification of neutralizing antibodies in plasma samples collected from patients exposed to SARS-CoV-2.	SARS-CoV-2 suggested: None
   Visualization of plaques was obtained with an immunocytochemical …

   SciScore for 10.1101/2020.08.01.20166546: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IRB: The study protocol (number 23307) was approved by the Ethics Committee of the University-Hospital, Padova.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	, 21 autoimmune patients, 8 pregnant women) were included in the study (Table 1).
   Cell Line Authentication	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   In the same samples, a high-throughput PRNT method was developed for the fast and accurate quantification of neutralizing antibodies in plasma samples collected from patients exposed to SARS-CoV-2.	SARS-CoV-2 suggested: None
   Visualization of plaques was obtained with an immunocytochemical staining method using an anti-dsRNA monoclonal antibody (J2, 1:10,000; Scicons) for 1 hour, followed by 1-hour incubation with peroxidase-labeled goat anti-mouse antibodies (1:1000; DAKO) and a 7-minute incubation with the True Blue™ (KPL) peroxidase substrate.	anti-dsRNA suggested: (Millipore Cat# MABE1134, RRID:AB_2819101) J2 suggested: (US Biological Cat# U1000-87M, RRID:AB_2210756) anti-mouse suggested: None
   Experimental Models: Cell Lines
   Sentences	Resources
   Fifty microliters of the virus–serum mixtures were added to confluent monolayers of Vero E6 cells, in 96-wells plates and incubated for 1 hour at 37□°C, in a 5% CO2 incubator.	Vero E6 suggested: None
   Software and Algorithms
   Sentences	Resources
   ; SARS-CoV-2 IgG, Abbott Laboratories, IL, USA) and one enzyme-linked immunosorbent assay (ELISA) (ENZY-WELL SARS-CoV-2 IgG, Diesse Diagnostica Senese, Siena, Italy).	Abbott Laboratories suggested: None
   The GraphPad Prism version 8.4.1 for Windows (GraphPad Software, LLC) was employed to evaluate plaque reduction neutralization test results, using non-parametric tests (Kruskall-Wallis test and Spearman’s correlation).	GraphPad Prism suggested: (GraphPad Prism, RRID:SCR_002798) GraphPad suggested: (GraphPad Prism, RRID:SCR_002798)
   Stata v13.1 (Statacorp, Lakeway Drive, TX, USA) was used to evaluate the assays’ clinical performances.	Statacorp 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:

   The present paper has limitations: first, neutralizing antibodies were tested in a limited number of samples the procedure being very complex; second, COVID-19 positive patients were selected retrospectively on the basis of available leftover samples; therefore NPV and PPV could be overestimated. Finally, the relationship between IgM antibodies and neutralizing activity should be studied further in a larger series of patients. In conclusion, although the performances of SARS-CoV-2 antibody immunoassays are of analytical and clinical value, they could be enhanced by considering the test purposes, emphasizing sensitivity in the screening and specificity in the second-line testing. In addition, a further search should be made for a better dynamic range and a stronger correlation with respect to antibody neutralization activity, in order to, above all, obtain information needed for effective passive antibody therapy and vaccine development against SARS-CoV-2 virus.

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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 10.1016/j.ebiom.2020.103101

   Dec 1, 2020
3. 

   Version published to 10.1101/2020.08.01.20166546 on medRxiv

   Aug 4, 2020