Diagnostic Accuracy of SARS-CoV-2 Rapid Antigen Detection Testing in Symptomatic and Asymptomatic Children in the Clinical Setting

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1. Version published to 10.1128/jcm.00991-21

   Aug 18, 2021
2. 

   ScreenIT

   Apr 24, 2021

   SciScore for 10.1101/2021.04.15.21255577: (What is this?)

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

   Table 1: Rigor

   Ethics	Consent: All study participants and/or caregivers provided written informed consent prior to specimen collection. IRB: The study was approved by the local research ethics board (Commission cantonale d’éthique de la recherche #2020-02323).
   Sex as a biological variable	not detected.
   Randomization	not detected.
   Blinding	P-RDT results were read independently by two members of the study team, both being blinded to the result assigned by their pair as well as to the clinical presentation of the participant.
   Power Analysis	The sample size was therefore estimated at 654 participants.

   Table 2: Resources

   Software and Algorithms
   Sentences	Resources
   Data collection: The following data collected at enrolment were …

   SciScore for 10.1101/2021.04.15.21255577: (What is this?)

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

   Table 1: Rigor

   Ethics	Consent: All study participants and/or caregivers provided written informed consent prior to specimen collection. IRB: The study was approved by the local research ethics board (Commission cantonale d’éthique de la recherche #2020-02323).
   Sex as a biological variable	not detected.
   Randomization	not detected.
   Blinding	P-RDT results were read independently by two members of the study team, both being blinded to the result assigned by their pair as well as to the clinical presentation of the participant.
   Power Analysis	The sample size was therefore estimated at 654 participants.

   Table 2: Resources

   Software and Algorithms
   Sentences	Resources
   Data collection: The following data collected at enrolment were managed using RedCap™ managed using REDCap electronic data capture tools hosted at HUG: date of enrolment, number of days post onset of symptoms (DPOS), gender, age, type of symptoms (nasal discharge, cough, dyspnea, dysphagia,	REDCap suggested: (REDCap, RRID:SCR_003445)
   Statistical analyses were processed under SPSS software v23.0	SPSS suggested: (SPSS, RRID:SCR_002865)

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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:

   Our study has several limitations. First, the evaluation was based on one RDT only. Comparative studies have shown similar or reduced performance of other RDTs when compared to the P-RDT6,20. Is it therefore highly unlikely that any RDT would perform significantly better in children than the P-RDT. Second, the study was performed using two different validated RT-PCR assays as gold standards, although 90% of the specimens were tested on the Cobas and standard curves used to calculate VL from Ct values were previously validated and used in several publications6,11,12. Third, the study was conducted in a high prevalence setting. Extrapolating the findings to low prevalence settings must be done with caution. Then, providing that the NPS for P-RDT was always performed after the NPS for RT-PCR, one cannot exclude that the second procedure was more challenging to perform. Finally, we did not evaluate the performance of P-RDT on oropharyngeal, nasal or saliva specimens. However, given the fact that VL is lower in these anatomical compartments when compared to NPS21-24, one can expect even lower sensitivity of P-RDT if used on oropharyngeal, nasal or saliva specimens. In conclusion, this independent study confirms the respective suboptimal sensitivity of P-RDT in symptomatic children, and its poor sensitivity in asymptomatic children at time of sampling, providing additional evidence for cautious routine use of these tests for the detection of SARS-CoV-2, both in symptomatic and asym...

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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 10.1101/2021.04.15.21255577v1 on medRxiv

   Apr 20, 2021