Sensitivity and specificity of OraScan® toluidine blue mouthrinse in the detection of oral cancer and precancer

Saman Warnakulasuriya, Newell W. Johnson

Journal of Oral Pathology and Medicine · 1996 · 165 citations · 25 references

Concepts

TL;DR

The study employed a ready‑to‑use 1 % toluidine‑blue mouthrinse kit on 102 Asian patients with 145 oral mucosal lesions, with histopathology serving as the reference standard for 87 dye‑retained or dye‑negative lesions. The kit achieved 100 % sensitivity for oral carcinomas, 79.5 % for dysplasias, a 62 % specificity, and identified five dysplastic lesions missed by histology, indicating high sensitivity for invasive cancer and potential utility in high‑risk surveillance.

Abstract

The efficacy of 1% toluidine blue in the identification of oral malignancies and potentially malignant oral lesions was evaluated among a group of Asian patients ( n =102) with undiagnosed oral mucosal lesions and conditions (n=145). The trial, utilizing a ready‐to‐use kit, was controlled by histopathologic evaluation of a total of 87 dye‐retained or dye‐negative lesions. Eighteen oral carcinomas all retained the dye and there were no false negatives, yielding a test sensitivity of 100%. Eight of 39 oral epithelial dysplasias were toluidine blue‐negative, giving a false negative rate of 20.5% and a sensitivity of 79.5% for oral epithelial dysplasias. The specificity of the technique was low (62%). Five dysplastic lesions were detected solely by the kit and this suggests that the method is valuable for surveillance of high‐risk subjects in addition to its remarkable sensitivity in the detection of invasive carcinoma.

References

25