JMIR Publications

ABSTRACT

Background:

Colorectal cancer (CRC) screening by fecal occult blood testing (FOBT) has been an important public health test and shown to reduce CRC-related mortality. However, the low participation rate in CRC 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.

Objective:

This study aims to validate a novel toilet paper-based point-of-care test (POCT) (i.e., JustWipe®) as a public health instrument to detect fecal occult blood and provide the detailed result of the evaluation from the analytic characteristic to the clinical verification.

Methods:

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

Results:

The results revealed that specimen collection by the toilet-paper device was able to collect adequate amounts of fecal specimens with small day-by-day and person-to-person variations. The limit of detection of the test reagent was evaluated to be 3.75 µgHb/ml. Moreover, the test reagents also showed high repeatability (100%) on different days and high reproducibility (>96%) among different users. The overall agreement between JustWipe® and a typical FOBT in a central laboratory setting was 82.86%. In the setting of POCTs, the overall agreement of comparison between JustWipe® and Hemoccult SENSA was 89.66%. Moreover, the usability questionnaire showed that the novel test tool could provide high scores in operation friendliness (87.38/100), ease of reading results (97.45/100), and information usefulness (96.14/100).

Conclusions:

In conclusion, we developed and validated a toilet paper-based FOBT. Users could use it as a POCT for the rapid (in 60 seconds) and easy testing of fecal occult blood. These favorable characteristics render it a promising tool for CRC screening as a public health instrument.