Study: The Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples

Link to study information: https://clinicaltrials.gov/ct2/show/NCT04071080

Country: Canada

Start date: 2019-08-22

Publications: Mark R. Dube, Gabriel M. Theriault, Paul L. Rheault, Nathalie A. Roy, A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of Oral Fluorescein Disodium and Confirm the Authenticity of Point of Care Urine Samples, Clinical Medicine and Diagnostics, Vol. 10 No. 2, 2020, pp. 27-37. doi: 10.5923/j.cmd.20201002.01.

Abstract: The study provides further evidence that fluorescein disodium has low toxicity in humans. The safety profile of a single oral dose of 100 mg fluorescein disodium in healthy adults was consistent with the previously reported literature. There were no clinically significant differences in vitals, clinical laboratory findings, or AE incidents between baseline and 14 days post-randomization measurements. Furthermore, we show that urine sample authenticity can be ascertained using a fluorophore. The fluorescein assay was performed at four time points (10, 15, 20, and 30 minutes). The sensitivity of the assay was 100% for urine samples taken at or after 15 minutes. The results of this study further the development of fluorescent-based urine specimen identification protocols for clinical use however, future larger trials are required for greater statistical power and to optimize the assay’s cut-off time points. (from the publication by Dube e.a., CC BY).