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

Author(s): Wang HY, Lin TW, Chiu SY, Lin WY, Huang SB, Hsieh JC, Chen HC, Lu JJ, Wu MH

Publication: J Med Internet Res, 2020, Vol. 22, Page e20261

PubMed ID: 32763879 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   This study compared sensitivity and specificity of fecal occult blood test results using a novel toilet paper–based point-of-care test (JustWipe) to standard fecal occult blood testing in a central laboratory and to the Hemoccult SENSA Test. Intra-day and inter-individual variations in weight of collected specimen using the JustWipe device as well as limit of detection, intra-assay, and inter-assay repeatability of the JustWipe test were also examined. Fecal specimens were collected from 70 hospitalized patients (diagnosis and patient condition not provided) by nurses, placed in stool collection tubes, and aliquoted in the lab. One aliquot was applied to a fecal occult blood test card and tested using the standard lab test (O-tolidine) and the other aliquot was applied to the JustWipe collection device and tested with the kit reagents (tetramethylbenzidine, hydrogen peroxide, and ethanol). To compare the JustWipe system to the Hemoccult SENSA Test, 58 volunteers collected feces with the toilet paper–based fecal specimen collection device, applied the reagents, and interpreted results themselves after 60 seconds and then collected additional feces stored at room temperature or between 2-8℃ and shipped to the laboratory next day for testing with the Hemoccult SENSA Test. To investigate intra-day and inter-individual variation in specimen collection weight, 18 volunteers collected fecal specimens using the JustWipe device for three consecutive days and sent specimens to the laboratory for testing. Each hemoglobin concentration was tested nine times each collection day. To investigate limit of detection, intra-assay, and inter-assay repeatability of the JustWipe Test, different hemoglobin concentrations (0-15 μg/mL) were applied to the collection area of the device on three different days.

   Summary of Findings:

   The overall agreement between the JustWipe and standard fecal occult blood tests was 82.9% and the positive and negative agreement were 83.9% and 82.1%, respectively. The overall agreement between JustWipe and the Hemoccult SENSA tests was 89.7% and the positive and negative agreement were 80.0% and 94.7%, respectively. For the intra-day variation investigation of the JustWipe collection device, there was no significant difference in the weight of specimens collected on the 3 different days (P=0.12). There was significant inter-patient variation in specimen weight among the 18 volunteers, but this difference was eliminated when three individuals were excluded from statistical analysis (data not provided). The probabilities of positive results were 0% for 0 μg hemoglobin/mL feces over the three days, 100% for 5 μg hemoglobin/mL feces and 15 μg hemoglobin/mL feces for all three days, and 48.8% and 98.8% for 2.26 μg hemoglobin/mL feces and 3.75 μg hemoglobin/mL feces, respectively; thus 3.75 μg hemoglobin/mL feces was defined as the limit of detection (level at which over 95% of specimens tested positive).

   Biospecimens

   • Bodily Fluid - Feces

   Preservative Types

   • None (Fresh)

   Diagnoses:

   • Not specified

   Platform:

   Analyte	Technology Platform
   Protein	Colorimetric assay

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Biospecimen Acquisition	Method of fluid acquisition	Fecal scoop JustWipe toilet paper–based collection device
   Colorimetric assay Specific	Technology platform	Just Wipe toilet paper–based point-of-care test Hemoccult SENSA Test Standard O-tolidine based lab test

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