Association of Results of Four Lateral Flow Antibody Tests with Subsequent SARS-CoV-2 Infection

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1. Version published to 10.1128/spectrum.02468-22

   Oct 26, 2022
2. 

   ScreenIT

   May 25, 2022

   SciScore for 10.1101/2022.05.19.22275126: (What is this?)

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

   Table 1: Rigor

   Ethics	IRB: Ethics: The EDSAB-HOME study was approved by NHS Research Ethics Committee (Health Research Authority, IRAS 284980) on 02/06/2020 and PHE Research Ethics and Governance Group (REGG, NR0198) on 21/05/2020. Consent: All participants gave written informed consent.
   Sex as a biological variable	not detected.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   Study participants: The study population consisted of key workers recruited to the Evaluating Detection of SARS-CoV-2 AntiBodies at HOME (EDSAB-HOME) prospective cohort study (ISRCTN56609224) (27).	ISRCTN56609224 suggested: None
   The AbC-19, OrientGene, and SureScreen devices …

   SciScore for 10.1101/2022.05.19.22275126: (What is this?)

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

   Table 1: Rigor

   Ethics	IRB: Ethics: The EDSAB-HOME study was approved by NHS Research Ethics Committee (Health Research Authority, IRAS 284980) on 02/06/2020 and PHE Research Ethics and Governance Group (REGG, NR0198) on 21/05/2020. Consent: All participants gave written informed consent.
   Sex as a biological variable	not detected.
   Randomization	not detected.
   Blinding	not detected.
   Power Analysis	not detected.

   Table 2: Resources

   Antibodies
   Sentences	Resources
   Study participants: The study population consisted of key workers recruited to the Evaluating Detection of SARS-CoV-2 AntiBodies at HOME (EDSAB-HOME) prospective cohort study (ISRCTN56609224) (27).	ISRCTN56609224 suggested: None
   The AbC-19, OrientGene, and SureScreen devices detect anti-Spike protein antibodies while the Biomerica device detects anti-Nucleoprotein antibodies.	anti-Spike protein suggested: None anti-Nucleoprotein suggested: None
   The OrientGene, SureScreen, Biomerica devices contain separate bands to detect IgG and IgM antibodies, while AbC-19 detects IgG antibodies only.	IgM suggested: None
   For each antibody test, we describe the number of participants who tested positive for SARS-CoV-2, and observed rate per 100 person years, in each of these three periods, stratified by baseline test result.	SARS-CoV-2 suggested: None
   Kaplan-Meier survival curves were also produced, to describe the development of SARS-CoV-2 positivity over time in those who were antibody-positive or antibody-negative according to each test.	antibody-negative suggested: None

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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:

   While this study shows a strong association between lateral flow device results and subsequent SARS-CoV-2 infection, it has several limitations. Firstly, it applies to a historical cohort of unvaccinated individuals. Secondly, lateral flow devices were applied and read using stored plasma, obtained by venesection, in a laboratory setting by trained professionals, rather than relying on measurement in the field by the public using finger-prick technology. This arrangement had the advantage that the subjects did not know their lateral flow device results, minimising potential bias, but leaves open the possibility that performance on finger prick samples might differ from that in the laboratory setting we used. This concern has been addressed for the SureScreen device,, for which data has now been published showing very similar accuracy of the SureScreen device on finger-prick samples taken from individuals and serum samples analysed in a laboratory (24). Finally, some healthcare workers in the cohort received a single vaccine dose in late December 2020 and early January 2021 in the UK, in the final weeks of our follow-up period; it is possible that some individuals acquired protection through vaccination in the last weeks of follow-up, so the true protection associated with LFIA positive tests may be higher than we observed. Lateral flow devices have very different reported accuracy. This is likely to be explicable in part by device design, and in part by selection of samples u...

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

   Identifier	Status	Title
   ISRCTN5660922	NA	NA
   ISRCTN56609224	NA	NA

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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.
   • Thank you for including a protocol registration statement.

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

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   Read the original source
3. 

   Version published to 10.1101/2022.05.19.22275126v1 on medRxiv

   May 22, 2022