Department of Laboratory Medicine, Chang Gung Memorial Hospital at Linkou, Taoyuan City, Taiwan.
PhD Program in Biomedical Engineering, Chang Gung University, Taoyuan City, Taiwan.
J Med Internet Res. 2020 Aug 7;22(8):e20261. doi: 10.2196/20261.
Colorectal 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.
This 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.
The 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.
Adequate 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).
We 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.
粪便潜血检测的结直肠癌筛查一直是一项重要的公共卫生检测手段，已证明可降低结直肠癌相关死亡率。然而，公众对结直肠癌筛查的参与率仍然很低，这是一个存在问题的公共卫生问题。造成这种情况的原因可能是筛查工具的操作复杂且令人不适。
本研究旨在验证一种新型的基于卫生纸的即时检测（即 JustWipe）作为公共卫生工具来检测粪便潜血，并提供从临床验证中评估分析特性中获得的详细结果。
通过重复性和再现性测试验证了卫生纸装置采集粪便标本的机制。我们还评估了测试试剂的分析特性。对于临床验证，我们对 JustWipe 和其他粪便潜血检测进行了比较。第一次比较是在中心实验室环境中，将 70 份粪便标本与典型的粪便潜血检测进行比较。第二次比较中，共招募了 58 名志愿者，在即时检测环境中，将 JustWipe 与市售的 Hemoccult SENSA 进行了比较。
使用卫生纸装置可采集到足够量的粪便标本，且每日和人与人之间的变化很小。测试试剂的检测限评估为每毫升试剂 3.75 µg 的血红蛋白。此外，该测试试剂在不同日期的重复性（100%）和不同使用者之间的再现性（>96%）均较高。在中心实验室环境中，JustWipe 与典型粪便潜血检测的总符合率为 82.9%。在即时检测环境中，JustWipe 与 Hemoccult SENSA 的总符合率为 89.7%。此外，使用方便性问卷调查显示，新型测试工具在操作友好性（87.3/100）、结果读取简便性（97.4/100）和信息有用性（96.1/100）方面得分较高。
我们开发并验证了一种基于卫生纸的粪便潜血检测方法，可用于即时检测粪便潜血，具有快速（60 秒内）和简便的特点。这些有利的特征使其成为结直肠癌筛查的一种有前途的公共卫生工具。
