Evidence map›Paper›PMID 34609947›Full record

ArticleJMIR human factors2021

Usability of an At-Home Anterior Nares SARS-CoV-2 RT-PCR Sample Collection Kit: Human Factors Feasibility Study.

Laura E Strong, Irene Middendorf, Michelle Turner, David K Edwards V, Varun Sama, Joshua Mou, K Colleen Adams

Abstract read
In one paragraph

Article in JMIR human factors, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Article
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

7 authors.

Laura E StrongExact Sciences Corporation, Madison, WI, United States.ORCID https://orcid.org/0000-0001-8415-2500
Irene MiddendorfExact Sciences Corporation, Madison, WI, United States.ORCID https://orcid.org/0000-0002-7059-7178
Michelle TurnerExact Sciences Corporation, Madison, WI, United States.ORCID https://orcid.org/0000-0002-4362-7247
David K Edwards VExact Sciences Corporation, Madison, WI, United States.ORCID https://orcid.org/0000-0003-2708-9562
Varun SamaExact Sciences Corporation, Madison, WI, United States.ORCID https://orcid.org/0000-0002-7085-9369
Joshua MouExact Sciences Corporation, Madison, WI, United States.ORCID https://orcid.org/0000-0002-2729-7364
K Colleen AdamsExact Sciences Corporation, Madison, WI, United States.ORCID https://orcid.org/0000-0003-2375-1483

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundReadily available testing for SARS-CoV-2 is necessary to mitigate COVID-19 disease outbreaks. At-home collection kits, in which samples are self-collected without requiring a laboratory or clinic visit and sent to an external laboratory for testing, can provide convenient testing to those with barriers to access. They can prevent unnecessary exposure between patient and clinical staff, increase access for patients with disabilities or remote workers, and decrease burdens on health care resources, such as provider time and personal protective equipment. Exact Sciences developed an at-home collection kit for samples to be tested to detect SARS-CoV-2 that includes an Instructions for Use (IFU) document, which guides people without prior experience on collecting a nasal swab sample. Demonstrating successful sample collection and usability is critical to ensure that these samples meet the same high-quality sample collection standards as samples collected in clinics.

objectiveThe aim of this study was to determine the usability of a SARS-CoV-2 at-home nasal swab sample collection kit.

methodsA human factors usability study was conducted with 30 subjects without prior medical, laboratory, or health care training and without COVID-19 sample self-collection experience. Subjects were observed while they followed the IFU for the at-home sample collection portion of the SARS-CoV-2 test in a setting that simulated a home environment. IFU usability was further evaluated by requiring the subjects to complete a survey, answer comprehension questions, provide written feedback, and respond to questions from the observer about problems during use.

resultsAll 30 subjects successfully completed the sample collection process, and all 30 samples were determined by reverse transcription-polymerase chain reaction (RT-PCR) testing to meet quality standards for SARS-CoV-2 testing. The subjects' written feedback and comments revealed several recommendations to improve the IFU.

conclusionsThe study demonstrated the overall usability of an at-home SARS-CoV-2 collection kit. Various feedback mechanisms provided opportunities to improve the wording and graphics for some critical tasks, including placing the label correctly on the tube. A modified IFU was prepared based on study outcomes.

Indexed as

at-home collection kitCOVID-19COVID-19 testingfeasibility studiesSARS-CoV-2self-collectionusability study

Identifiers

PMID34609947
PMCPMC8673714

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Registered trials

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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.