Comparative performance of SARS-CoV-2 lateral flow antigen tests and association with detection of infectious virus in clinical specimens: a single-centre laboratory evaluation study

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1. Version published to 10.1016/s2666-5247(21)00143-9

   Sep 1, 2021
2. 

   ScreenIT

   Mar 15, 2021

   SciScore for 10.1101/2021.02.27.21252427: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IRB: All studies were performed in accordance with the UK Policy Framework for Health and Social Care Research and with specific Research Ethics Committee approval (REC 20/SC/0310).
   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

   Antibodies
   Sentences	Resources
   Primary antibody (murinized anti-N 3009) was incubated at a final concentration of 2 ug/mL in 1% milk for 45 minutes at room temperature, before washing twice with PBS and incubating with secondary antibody (goat-anti-mouse IgG HRP-linked, Cell Signaling Technology, 1:2000) in 1% milk for …

   SciScore for 10.1101/2021.02.27.21252427: (What is this?)

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

   Table 1: Rigor

   Institutional Review Board Statement	IRB: All studies were performed in accordance with the UK Policy Framework for Health and Social Care Research and with specific Research Ethics Committee approval (REC 20/SC/0310).
   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

   Antibodies
   Sentences	Resources
   Primary antibody (murinized anti-N 3009) was incubated at a final concentration of 2 ug/mL in 1% milk for 45 minutes at room temperature, before washing twice with PBS and incubating with secondary antibody (goat-anti-mouse IgG HRP-linked, Cell Signaling Technology, 1:2000) in 1% milk for 45 minutes at room temperature.	anti-N suggested: (Wesley CS; J Cell Biol. 2000 Cat# N, RRID:AB_2570096) IgG HRP-linked, Cell Signaling Technology, suggested: None
   Rapid antibody tests: Presence of IgM and IgG antibodies in matched serums was assessed using the lateral flow immunoassay (LFIA) COVID-19 IgG/IgM rapid test cassette (SureScreen).	IgG suggested: None IgG/IgM rapid test cassette (SureScreen) suggested: None
   Experimental Models: Cell Lines
   Sentences	Resources
   For plaque assays, VTM was 10-fold serially diluted and applied to Vero.E6 cells in 12-well plates, in a volume of 500 ul per well, and incubated for 1 hour at 37°C. 500 ul of pre-warmed overlay (0.1% agarose in DMEM supplemented with 2% FCS, pen/strep and amphotericin B) was then applied to each well, and cultures were incubated for 72 hours at 37°C, before fixing with 4% formaldehyde.	Vero.E6 suggested: JCRB Cat# JCRB1819, RRID:CVCL_YQ49)
   Software and Algorithms
   Sentences	Resources
   Statistical Analyses: Expected binomial exact 95% confidence intervals were calculated on Prism 8.0 using Wilson/Brown statistical analysis.	Prism suggested: (PRISM, RRID:SCR_005375)

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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:

   We therefore recommend that regular testing be emphasised, and that tests are deployed in populations where the limitations of these tests are understood and/or manageable. In certain in-patient situations, LFDs can also be used to make early, rapid decisions about patient management, with appropriate isolation pending confirmatory SARS-CoV-2 PCR testing. This approach has recently been successful in hospital LFD pilot studies, with the use of such devices preventing the cohorting of asymptomatic and/or infectious individuals with uninfected patients while awaiting PCR results.26 At the other end of the disease course, LFDs could also be useful for determining if persistently PCR positive individuals pose a transmission risk, potentially in tandem with rapid antibody testing.27 Although the LFDs are very easy to use, the correct sampling, reading and interpretation of the result are essential to their success in mass screening situations.1 In particular, one must take into account training and familiarity with swabbing when deploying devices to the general public as compared with a trained healthcare worker in a hospital/clinic-based setting. It is also easy to underestimate the importance of correctly recognising a positive band. We found that some tests gave clearer results than other, as illustrated by the number of borderline results seen in Figure 1 and 2. Removing this element of subjectivity, for example through the use of an smartphone application to read/capture the ...

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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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   Read the original source
3. 

   Version published to 10.1101/2021.02.27.21252427 on medRxiv

   Mar 2, 2021