Validity of Toluidine Blue test as a diagnostic tool for high risk oral potentially malignant disorders- a multicentre study in Sri Lanka

J Oral Biol Craniofac Res. 2020 Oct-Dec;10(4):547-551. doi: 10.1016/j.jobcr.2020.08.002. Epub 2020 Aug 19.

Abstract

Introduction: - Early detection plays a major role to reduce the mortality of oral squamous cell carcinoma (OSCC). Many adjunctive techniques have emerged with claims of differentiating high risk oral potentially malignant disorders (OPMDs) from benign lesions. Toluidine blue (TB) test has been established as a diagnostic adjunct in detecting high risk OPMDs and early asymptomatic OSCCs. As majority of OSCC are preceded by OPMDs, recognition of them at an early stage is important in the management of this devastating disease.

Methods: -This study was conducted as a multi-center study prospectively for a period of 2 years. Sixty five patients presented with OPMDs were selected and TB test was performed followed by a biopsy for histopathological confirmation. Criterion validity was assessed with histological diagnosis of the incisional biopsy of the OPMD as a gold standard test verses TB test results.

Results: The sensitivity of the TB test was 68.3% and the specificity 63.1% with a false positive rate of 36.8% and false negative rate of 31.7%. However, the predictive value of the positive test was 80%.

Conclusion: - TB testing might be a potential adjunct diagnostic aid in identifying high risk OPMDs. Further studies with extensive sample size and different demographics are needed to validate our findings.

Keywords: Diagnostic aid; OPMD; OSCC; Prospective; Toluidine blue; Tool; Validation.