Evaluation of four commercial, fully automated SARS-CoV-2 antibody tests suggests a revision of the Siemens SARS-CoV-2 IgG assay

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1. Version published to 10.1515/cclm-2020-1758

   Jan 15, 2021
2. 

   ScreenIT

   Dec 1, 2020

   SciScore for 10.1101/2020.11.27.20239590: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IRB: All procedures performed in the present study involving human participants were in accordance with the ethical standards of the Institutional and/or National Research Committee and with the 1964 Helsinki declaration and its later amendments and were approved by the ethics committee of the Medical University of Innsbruck (ethics commission numbers: 1103/2020, 1167/2020).
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	not detected.

   Table 2: Resources

   Software and Algorithms
   Sentences	Resources
   Anti-SARS-CoV-2 assays: We evaluated the performance of the following fully automated CLIA tests on high throughput …

   SciScore for 10.1101/2020.11.27.20239590: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IRB: All procedures performed in the present study involving human participants were in accordance with the ethical standards of the Institutional and/or National Research Committee and with the 1964 Helsinki declaration and its later amendments and were approved by the ethics committee of the Medical University of Innsbruck (ethics commission numbers: 1103/2020, 1167/2020).
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Sex as a biological variable	not detected.

   Table 2: Resources

   Software and Algorithms
   Sentences	Resources
   Anti-SARS-CoV-2 assays: We evaluated the performance of the following fully automated CLIA tests on high throughput random access analyzers widely available in medical laboratories: Roche Elecsys Anti-SARS-CoV-2 assay on the Cobas e602 platform (Roche Diagnostics, Rotkreuz, Switzerland), Abbott SARS-CoV-2 IgG assay on the Architect i2000SR platform (Abbott Laboratories Abbott Park, IL, USA), Siemens SARS-CoV-2 total (COV2T) and SARS-CoV-2 IgG (COV2G) on the Advia Centaur XP platform (Siemens, Munich, Germany).	Abbott Laboratories suggested: None
   Statistical analyses were performed using MedCalc, version 11.5.1.0 (MedCalc Ltd., Ostend, Belgium) and Excel 2016 (Microsoft, Redmont, USA).	MedCalc suggested: (MedCalc, RRID:SCR_015044)

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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:

   Limitations of our study include differences in the time between disease onset and serological assessment between patients due to the retrospective design of this assay validation study. To avoid potential biases, we constrained our analysis to samples drawn ≥14 days after onset of COVID-19 specific symptoms in SARS-CoV-2 RT-PCR confirmed patients or two weeks after the first positive RT-PCR result in patients for whom no information on symptom onset was available. The median time of 46 days between disease onset and date of the sample used for the sensitivity analysis fits well to the reported plateau of antibody production against SARS-CoV-2 (40). Thus, our study was designed to assess the maximal sensitivity of antibody tests ≥14 days and did not include the early phase of antibody production within the first days of COVID-19. Potential differences between the performances of the evaluated tests in the symptomatic phase of the disease can thus not be excluded. Likewise, the maximum time between disease onset and sampling was 120 days. The duration of antibody production and immunity after a SARS-CoV-2 infection is a major question. For example, in the study of Long et al. 40% of asymptomatic and 13% of symptomatic patients became seronegative in the early convalescent phase (41). Liu et al. found that SARS-CoV-2 antibodies substantially decreased in about 60 days after symptom onset (42). On the other hand, Isho et al. showed that IgG antibodies to SARS-CoV-2 are maintaine...

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   Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
   

   Identifier	Status	Title
   NCT04416100	Recruiting	Development of Interstitial Lung Disease (ILD) in Patients W…

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   Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).

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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 10.1101/2020.11.27.20239590 on medRxiv

   Nov 30, 2020