Evidence map›Paper›PMID 32763879›Full record

ArticleJournal of medical Internet research2020

Novel Toilet Paper-Based Point-Of-Care Test for the Rapid Detection of Fecal Occult Blood: Instrument Validation Study.

Hsin-Yao Wang, Ting-Wei Lin, Sherry Yueh-Hsia Chiu, Wan-Ying Lin, Song-Bin Huang, Jason Chia-Hsun Hsieh, Hsieh Cheng Chen, Jang-Jih Lu, Min-Hsien Wu

Open access · goldAbstract readValidation Study
In one paragraph

Article in Journal of medical Internet research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 48% of its field
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

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
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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

9 authors at 3 institutions in 1 country.

Hsin-Yao Wang *Department of Laboratory Medicine, Chang Gung Memorial Hospital at Linkou, Taoyuan City, Taiwan.ORCID 0000-0001-5581-6793
Ting-Wei Lin *Department of Laboratory Medicine, Chang Gung Memorial Hospital at Linkou, Taoyuan City, Taiwan.ORCID 0000-0001-9594-8854
Sherry Yueh-Hsia ChiuDepartment of Health Care Management, College of Management, Chang Gung University, Taoyuan City, Taiwan.ORCID 0000-0002-7207-7088
Wan-Ying LinSyu Kang Sport Clinic, Taipei City, Taiwan.ORCID 0000-0002-2616-9133
Song-Bin HuangSigknow Biomedical Co Ltd, Taipei City, Taiwan.ORCID 0000-0001-7370-3338
Jason Chia-Hsun HsiehDivision of Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou, Taoyuan City, Taiwan.ORCID 0000-0002-5547-409X
Hsieh Cheng ChenSigknow Biomedical Co Ltd, Taipei City, Taiwan.ORCID 0000-0001-6485-3270
Jang-Jih LuDepartment of Laboratory Medicine, Chang Gung Memorial Hospital at Linkou, Taoyuan City, Taiwan.ORCID 0000-0003-4559-268X
Min-Hsien WuPhD Program in Biomedical Engineering, Chang Gung University, Taoyuan City, Taiwan.ORCID 0000-0002-3507-3512
Chang Gung University · TWLinkou Chang Gung Memorial Hospital · TWMing Chi University of Technology · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundColorectal cancer screening by fecal occult blood testing has been an important public health test and shown to reduce colorectal cancer-related mortality. However, the low participation rate in colorectal cancer screening by the general public remains a problematic public health issue. This fact could be attributed to the complex and unpleasant operation of the screening tool.

objectiveThis study aimed to validate a novel toilet paper-based point-of-care test (ie, JustWipe) as a public health instrument to detect fecal occult blood and provide detailed results from the evaluation of the analytic characteristics in the clinical validation.

methodsThe mechanism of fecal specimen collection by the toilet-paper device was verified with repeatability and reproducibility tests. We also evaluated the analytical characteristics of the test reagents. For clinical validation, we conducted comparisons between JustWipe and other fecal occult blood tests. The first comparison was between JustWipe and typical fecal occult blood testing in a central laboratory setting with 70 fecal specimens from the hospital. For the second comparison, a total of 58 volunteers were recruited, and JustWipe was compared with the commercially available Hemoccult SENSA in a point-of-care setting.

resultsAdequate amounts of fecal specimens were collected using the toilet-paper device with small day-to-day and person-to-person variations. The limit of detection of the test reagent was evaluated to be 3.75 µg of hemoglobin per milliliter of reagent. Moreover, the test reagent also showed high repeatability (100%) on different days and high reproducibility (>96%) among different users. The overall agreement between JustWipe and a typical fecal occult blood test in a central laboratory setting was 82.9%. In the setting of point-of-care tests, the overall agreement between JustWipe and Hemoccult SENSA was 89.7%. Moreover, the usability questionnaire showed that the novel test tool had high scores in operation friendliness (87.3/100), ease of reading results (97.4/100), and information usefulness (96.1/100).

conclusionsWe developed and validated a toilet paper-based fecal occult blood test for use as a point-of-care test for the rapid (in 60 seconds) and easy testing of fecal occult blood. These favorable characteristics render it a promising tool for colorectal cancer screening as a public health instrument.

Indexed as

Occult BloodBathroom EquipmentColorectal NeoplasmsFemaleHumansMaleMass ScreeningMiddle AgedPoint-of-Care TestingReproducibility of ResultsSurveys and QuestionnairesVolunteerscancerdetectiondiagnosticfecal occult blood testpaper-based analytical devicespoint-of-care diagnosticspublic healthtestingvalidation

Identifiers

PMID32763879
PMCPMC7472847
OpenAlexW3037647879

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.