Anti-Spike Protein Assays to Determine SARS-CoV-2 Antibody Levels: a Head-to-Head Comparison of Five Quantitative Assays

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1. Version published to 10.1128/spectrum.00247-21

   Sep 3, 2021
2. 

   ScreenIT

   Mar 15, 2021

   SciScore for 10.1101/2021.03.05.21252977: (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 was reviewed and approved by the Ethics Committee of the Medical University of Vienna (EK1066/2021). Consent: All participants provided written informed consent to donate blood for the evaluation of diagnostic test systems (EK404/2012).
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   IgG (DiaSorin TriS IgG) chemiluminescence immunoassay (CLIA) quantifies IgG antibodies against a trimeric S-protein antigen on a DiaSorin LIAISON (DiaSorin, Stillwater, USA).	a trimeric S-protein suggested: None
   The Virion\Serion ELISA (enzyme-linked …

   SciScore for 10.1101/2021.03.05.21252977: (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 was reviewed and approved by the Ethics Committee of the Medical University of Vienna (EK1066/2021). Consent: All participants provided written informed consent to donate blood for the evaluation of diagnostic test systems (EK404/2012).
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   IgG (DiaSorin TriS IgG) chemiluminescence immunoassay (CLIA) quantifies IgG antibodies against a trimeric S-protein antigen on a DiaSorin LIAISON (DiaSorin, Stillwater, USA).	a trimeric S-protein suggested: None
   The Virion\Serion ELISA (enzyme-linked immunosorbent assay) agile SARS-CoV-2 IgG (Serion IgG) (Institut Virion-Serion, Wuerzburg, Germany) was analyzed on a FilterMax F5 Multiplate Reader (Molecular Devices, San José, USA) and quantifies IgG antibodies against total S-protein between 3 and 250 U/mL.	Serion IgG suggested: None total S-protein between 3 suggested: None
   If applicable, binding antibody units per milliliter (BAU/mL), which are traceable to the WHO International Standard for anti-SARS-CoV-2 immunoglobulin, were calculated by applying the following conversion factors, as suggested by the manufacturers: Roche , Abbott S , DiaSorin TriS , Serion .	anti-SARS-CoV-2 immunoglobulin, suggested: None
   We excluded prior SARS-CoV-2 infection by using the Roche Elecsys® SARS-CoV-2 ECLIA on the cobas® e801 analyzer (Roche), which detects total antibodies to the viral nucleocapsid antigen.	viral nucleocapsid antigen. suggested: None
   Software and Algorithms
   Sentences	Resources
   It quantifies IgG-type antibodies against the RBD of the viral S-protein on an Abbott ARCHITECT platform (Abbott, Abbott Park, USA) between 21.0 and 40,000.0 AU/mL.	Abbott suggested: (Abbott, RRID:SCR_010477)
   All analyses were performed using MedCalc 19.6 (MedCalc, Ostend, Belgium), and graphs were drawn using GraphPad 9 (GraphPad, La Jolla, USA).	MedCalc suggested: (MedCalc, RRID:SCR_015044) GraphPad suggested: (GraphPad Prism, RRID:SCR_002798)

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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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

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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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3. 

   Version published to 10.1101/2021.03.05.21252977 on medRxiv

   Mar 8, 2021