Evaluation of a Rapid Antigen Test To Detect SARS-CoV-2 Infection and Identify Potentially Infectious Individuals

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1. Version published to 10.1128/jcm.00896-21

   Aug 18, 2021
2. 

   ScreenIT

   Apr 8, 2021

   SciScore for 10.1101/2021.03.30.21254624: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	Consent: For quality control, an RADT was simultaneously performed after verbal consent. IRB: Upon approval by the Institutional Review Board of the University of Cologne, results were retrospectively analyzed including clinical data retrieved from a symptoms diary webtool that all individuals registering for a SARS-CoV-2 test are asked to complete.
   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

   Experimental Models: Cell Lines
   Sentences	Resources
   SARS-CoV-2 Culture: Vero E6 cells (ATCC CRL-1586) were cultured in complete medium (CM) consisting …

   SciScore for 10.1101/2021.03.30.21254624: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	Consent: For quality control, an RADT was simultaneously performed after verbal consent. IRB: Upon approval by the Institutional Review Board of the University of Cologne, results were retrospectively analyzed including clinical data retrieved from a symptoms diary webtool that all individuals registering for a SARS-CoV-2 test are asked to complete.
   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

   Experimental Models: Cell Lines
   Sentences	Resources
   SARS-CoV-2 Culture: Vero E6 cells (ATCC CRL-1586) were cultured in complete medium (CM) consisting of Dulbecco’s modified Eagle Medium (DMEM; Thermo Fisher Scientific-Gibco, Waltham, MA) supplemented with 10% fetal calf serum (FCS; GE Healthcare, Chicago, IL), 200 units/ml Penicillin, 200 µg/ml Streptomycin, 0.25	Vero E6 suggested: None
   Software and Algorithms
   Sentences	Resources
   AMP Kit running on the Alinity m (Abbott, Illinois, USA) was used for 63 (3.11%) specimens targeting the viral N-and RdRp-genes according to the manufacturer’s instructions.	Abbott suggested: (Abbott, RRID:SCR_010477)
   µg/ml Amphotericin B, 2 mM L-Glutamine and 1 mM sodium pyruvate (all by Thermo Fisher Scientific-Gibco, Waltham, MA) at 37°C in an incubator with 5% CO2.	Thermo Fisher Scientific-Gibco suggested: None
   Data analysis was performed using Microsoft Excel 16.44 (Microsoft)	Microsoft Excel suggested: (Microsoft Excel, RRID:SCR_016137)
   GraphPad Prism 9 (GraphPad Software, Inc.)	GraphPad suggested: (GraphPad Prism, RRID:SCR_002798)
   ), Python 3.8.3, and R 3.6.3.	Python suggested: (IPython, RRID:SCR_001658)

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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, however, is subject to some limitations. Although the examined single-center study population was large, our cohort might not be considered representative of the general population due to young age and disproportionate gender distribution. The data on symptoms and their duration are only reliable to a limited extent, since they were retrospectively analyzed from mostly self-reported symptoms entered into a web tool. Furthermore, instead of a nasal swab, we used an oro-and nasopharyngeal swab to investigate RADT performance, which impedes the feasibility for the general public. In combating overdispersed SARS-CoV-2 transmission, rapid detection and isolation of highly infectious individuals is a primary goal (8, 9, 36–40). In our investigation the Standard Q RADT was able to reliably detect high viral load as well as all culture positive samples. Therefore, this test could be used as a fast surrogate marker for viral cultivation in order to identify and prevent SARS-CoV-2 transmissions by highly infectious individuals. Although less sensitive than RT-qPCR, RADT could compensate for this disadvantage through easy and feasible mass screenings (8, 41). Furthermore, one might suspect that RT-qPCR positive, but RADT negative individuals do not pose a high risk of transmissions, since all samples remained culture negative in our experimental setup. However, individual results must be interpreted with caution as SARS-CoV-2 infection could remain undetected in early stages...

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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.
   • Thank you for including a protocol registration statement.

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3. 

   Version published to 10.1101/2021.03.30.21254624 on medRxiv

   Apr 6, 2021