Sensitivity and specificity of serum and salivary cyfra21-1 in detecting malignant changes in oral potentially malignant lesions (Diagnostic accuracy study)

Abstract

Aim and objective: To identify the specificity and sensitivity of CYFRA21-1 in differentiating between oral malignancy and oral potentially malignant lesions (PML) and to be able to early diagnose malignant changes in oral lesions. Materials and methods: It was a prospective pilot study. Twenty-eight participants were collected in a convenience series and divided into three groups. Group I: 12 patients suffering from PML. Group II: eight patients with oral squamous cell carcinoma (OSCC). Group III: eight participants with no oral lesions. Serum and salivary CYFRA21-1 levels were measured using enzyme-linked immunosorbent assay and correlated with the histopathological examination to confirm the diagnosis. Results: The OSCC group showed the highest levels of both salivary and serum CYFRA21-1 followed by the group of PML than the control group. The differences in means were statistically significant. At a cutoff value of 0.4 ng/mL, salivary CYFRA21-1 showed 87.5% sensitivity and 100% specificity in differentiating PML from OSCC, with 95% accuracy. Serum CYFRA21-1, at a cutoff value of 1.03 ng/mL showed 100% sensitivity, specificity, and accuracy. Conclusion: Serum and salivary CYFRA21-1 could be considered promising biomarkers for the diagnosis of oral malignancy and could help detect early malignant changes in PML, especially oral lichen planus and leukoplakia.