Evidence map›Paper›PMID 33741675›Full record

ArticleBMJ open2021

Rapid point-of-care testing for COVID-19: quality of supportive information for lateral flow serology assays.

Patrick Kierkegaard, Anna McLister, Peter Buckle

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In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Patrick KierkegaardNIHR London In Vitro Diagnostics Co-operative, Department of Surgery and Cancer, Imperial College London, London, UK p.kierkegaard@imperial.ac.uk.ORCID http://orcid.org/0000-0001-8600-7956
Anna McListerNIHR London In Vitro Diagnostics Co-operative, Department of Surgery and Cancer, Imperial College London, London, UK.
Peter BuckleNIHR London In Vitro Diagnostics Co-operative, Department of Surgery and Cancer, Imperial College London, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThere is a lack of evidence addressing several important human factors questions pertaining to the quality of supportive information provided by commercial manufacturers that can affect the adoption and use of lateral flow serology assays in practice. We aimed to: (1) identify and assess the quality of information that commercial manufacturers provided for their point-of-care tests (POCTs) and (2) examine the implications of these findings on real-world settings.

designWe used a content analysis methodology in two stages to systematically, code and analyse textual data from documents of commercial manufacturers. A deductive approach was applied using a coding guide based on the validated Point-of-Care Key Evidence Tool (POCKET) multidimensional checklist. An inductive approach was used to identify new patterns or themes generated from our textual analysis.

settingPublicly available supportive information documents by commercial manufacturers for lateral flow serology, were identified and gathered from online searches.

participantsSupportive information documents retrieved from online searches over 3 months (March 2020 to June 2020).

resultsA total of 79 POCTs were identified that met the study inclusion criteria. Using the POCKET coding guide, we found that the quality of information varied significantly between the manufacturers and was often lacking in detail. Our inductive approach further examined these topics and found that several statements were vague and that significant variations in the level of details existed between manufacturers.

conclusionsThis study revealed significant concerns surrounding the supportive information reported by manufacturers for lateral flow serology assays. Information transparency was poor and human factor issues were not properly addressed to mitigate the risk of improper device use, although it should be noted that the results of our study are limited by the data that manufactures were prepared to disclose. Overall, commercial manufacturers should improve the quality and value of information presented in their supporting documentation.

Indexed as

COVID-19 Serological TestingPoint-of-Care TestingCOVID-19DocumentationHumansCOVID-19health services administration & managementinfectious diseasespublic health

Identifiers

PMID33741675
PMCPMC7985936

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.