Field evaluation of a rapid antigen test (Panbio™ COVID-19 Ag Rapid Test Device) for COVID-19 diagnosis in primary healthcare centres

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1. 

   ScreenIT

   Mar 1, 2021

   SciScore for 10.1101/2020.10.16.20213850: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IRB: The study was approved by the Hospital Clínico Universitario (HCU) INCLIVA Ethics Committee.
   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 cell culture: Samples collected in UTM were stored at −80°C for up to 2 weeks before being processed for culture.	SARS-CoV-2 suggested: None
   Vero E6 cells, maintained in Modified Eagles Medium (MEM) supplemented with 5% Fetal Bovine Serum (FBS), 1% penicillin/ streptomycin, 0.5 µg/mL Amphotericin B and 1% L-glutamine, were seeded into 96 well …

   SciScore for 10.1101/2020.10.16.20213850: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IRB: The study was approved by the Hospital Clínico Universitario (HCU) INCLIVA Ethics Committee.
   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 cell culture: Samples collected in UTM were stored at −80°C for up to 2 weeks before being processed for culture.	SARS-CoV-2 suggested: None
   Vero E6 cells, maintained in Modified Eagles Medium (MEM) supplemented with 5% Fetal Bovine Serum (FBS), 1% penicillin/ streptomycin, 0.5 µg/mL Amphotericin B and 1% L-glutamine, were seeded into 96 well plates (Thermo Fisher Scientific) at 105 cells/ml and inoculated in triplicate with patient samples (100 µl of a 1:1 dilution in MEM 2% FBS supplemented with antibiotics).	Vero E6 suggested: None
   Software and Algorithms
   Sentences	Resources
   Statistical analyses were performed using SPSS version 25.0 (SPSS, Chicago, IL, USA).	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:

   The main limitation of the current study is the relatively low number of cases in the series (13%); this, however, can be viewed as a strength, as this figure likely represents that found in many community settings worldwide where RAD testing is being increasingly used. In summary, we found the Panbio™ COVID-19 AG Rapid Test Device to perform well as a POC for early diagnosis of COVID-19 in primary healthcare centers. More importantly, our data suggested that patients with RT-PCR-proven COVID-19 testing negative by RAD are unlikely to be infectious. Further studies are warranted to confirm this assumption. The inconsequentiality of false negative RAD results, from a public health perspective [12], would support the implementation of a laboratory diagnostic approach which excluded confirmatory RT-PCR testing for negative RAD tests in non-hospitalized patients, even when the pretest probability is high. This would certainly alleviate laboratory workloads while dealing with RT-PCR supply shortages.

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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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2. Version published to 10.1016/j.cmi.2020.11.004

   Mar 1, 2021
3. 

   Version published to 10.1101/2020.10.16.20213850v1 on medRxiv

   Oct 20, 2020