Assessment of twenty-two SARS-CoV-2 rapid antigen tests against SARS-CoV-2: A laboratory evaluation study

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1. 

   ScreenIT

   Dec 19, 2021

   SciScore for 10.1101/2021.12.15.21267691: (What is this?)

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

   Table 1: Rigor

   Ethics	IRB: Ethics: This study was approved by the Royal Melbourne Hospital Research Ethics Committee (QA2020085).
   Sex as a biological variable	not detected.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Cell Line Authentication	not detected.

   Table 2: Resources

   Experimental Models: Cell Lines
   Sentences	Resources
   Virus was grown in Calu-3 cells (Supplementary Appendix) and inactivated by a 50kGy dose of gamma radiation.	Calu-3 suggested: None
   Software and Algorithms
   Sentences	Resources
   Samples were prepared and tested according to methods described in the ‘Guidance For Use of Alternative Protocol’ documentation provided by Abbott.	Abbott suggested: (Abbott, RRID:SCR_010477)
   Analysis was …

   SciScore for 10.1101/2021.12.15.21267691: (What is this?)

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

   Table 1: Rigor

   Ethics	IRB: Ethics: This study was approved by the Royal Melbourne Hospital Research Ethics Committee (QA2020085).
   Sex as a biological variable	not detected.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.
   Cell Line Authentication	not detected.

   Table 2: Resources

   Experimental Models: Cell Lines
   Sentences	Resources
   Virus was grown in Calu-3 cells (Supplementary Appendix) and inactivated by a 50kGy dose of gamma radiation.	Calu-3 suggested: None
   Software and Algorithms
   Sentences	Resources
   Samples were prepared and tested according to methods described in the ‘Guidance For Use of Alternative Protocol’ documentation provided by Abbott.	Abbott suggested: (Abbott, RRID:SCR_010477)
   Analysis was performed using GraphPad Prism (v 9.0) and Stata, and data visualisation was performed using GraphPad Prism (v 9.0) and ggplot (v3.3.5) in Rstudio (v1.4.1717) (16).	GraphPad Prism suggested: (GraphPad Prism, RRID:SCR_002798) Rstudio suggested: (RStudio, RRID:SCR_000432)

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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:

   A limitation of our study, and indeed a limitation of several other laboratory studies assessing antigen test kits, include the use of spiked virus in VTM for kit evaluation, rather than the use of swabs directly placed in manufacturer-provided buffer. However, to try and maximise yield from samples, we tested samples without a freeze-thaw step, as freezing has been shown to reduce yield of infectious virus (18, 28). Although we assessed the analytical characteristics of over twenty assays, a further limitation is that we only evaluated the clinical sensitivity of one antigen test, namely the Abbott PanBio™ COVID-19 Ag test assay. However, recent work has highlighted the widespread use of this kit, with 39 published datasets utilising the Abbott PanBio™ COVID-19 Ag test assay (21), meaning that our findings will have broad applicability and relevance. In summary, our data describe the performance characteristics of 22 antigen test kits against the SARS-CoV-2 Delta variant using a standardised evaluation panel. We demonstrate marked variability between test kits, and variability between reported and observed sensitivities, although most (86.4%) were able to meet WHO recommended minimum standards for detection. In addition, we further corroborate the hypothesis that antigen test positivity generally correlates with positive viral culture and by extension with presence of infectious viral particles) and that a positive antigen test result could be used as an adjunct to determine...

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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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   Results from scite Reference Check: We found no unreliable references.

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   Read the original source
2. 

   Version published to 10.1101/2021.12.15.21267691 on medRxiv

   Dec 16, 2021