Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study

Article activity feed

1. Version published to 10.1016/j.xcrm.2020.100062

   Aug 1, 2020
2. 

   ScreenIT

   Jun 9, 2020

   SciScore for 10.1101/2020.05.31.20114520: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IRB: Ethical approval: The protocol was approved by the East of England - Essex Research Ethics Committee. Consent: Verbal informed consent was obtained from all participants or in the case of participants without capacity, from a consultant nominee who was involved in their clinical care but independent from the research team (see supplemental).
   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
   The primary study outcomes for the implementation study was the median time from admission to definitive bed placement comparing SAMBA assay period …

   SciScore for 10.1101/2020.05.31.20114520: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IRB: Ethical approval: The protocol was approved by the East of England - Essex Research Ethics Committee. Consent: Verbal informed consent was obtained from all participants or in the case of participants without capacity, from a consultant nominee who was involved in their clinical care but independent from the research team (see supplemental).
   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
   The primary study outcomes for the implementation study was the median time from admission to definitive bed placement comparing SAMBA assay period with the pre-implementation period.	SAMBA suggested: (Samba, RRID:SCR_006557)
   Analyses was done using STATA version 13.	STATA suggested: (Stata, RRID:SCR_012763)

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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: The assay validation component was limited by the fact that the same swab could not be tested on the two platforms being compared. This raised an issue of two separate samples being tested on the two assays. Nonetheless, we identified only 2 cases where the sampling explained discrepant results. In addition, the SAMBA II SARS-CoV-2 test is not able to give viral load or cycle threshold values for more nuanced analysis. Results of the validation can be generalized to hospitalized suspects of COVID-19 with symptom of disease, but we did not assay validity in asymptomatic or outpatients with mild symptoms. Similarly, our results included dual swabs of the oral and naso-pharynx and should be interpreted with those methods mind. The implementation study was a non-randomized, controlled pre-post intervention design, and thus the effects seen cannot be fully causally attribute to the implementation of the assay. However, our findings are plausible, consistent across multiple measures, and process measures (e.g. turnaround time) are supportive of the more downstream measures assessed. Moreover, for our primary outcome, we conducted multivariable adjustment including clinical and demographic indicators, which demonstrated a persistent benefit in hazard of time to emergency room discharge. Moreoever, the implementation phase took place six weeks into the UK lockdown, at a time when the rate of new infections had reduced substantially across the country. Nonetheless, the st...

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

   Identifier	Status	Title
   NCT04326387	Recruiting	Evaluation of Novel Diagnostic Tests for COVID-19

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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.
   • No funding statement was detected.
   • No protocol registration statement was detected.

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   Read the original source
3. 

   Version published to 10.1101/2020.05.31.20114520 on medRxiv

   Jun 2, 2020