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Abstract

Background/purpose: Oral squamous cell carcinoma (OSCC) remains a global health issue, particularly in underserved settings such Taiwan where access to early diagnosis is limited. DNA ploidy-based oral cytology has shown strong diagnostic performance, but its applicability across populations require evaluation.

Materials and methods: In this prospective feasibility study, brush and oral rinse samples were collected from patients with OSCC, low-grade dysplasia, reactive lesions, and normal mucosa. DNA cytometry was performed to quantify ploidy profiles. Diagnostic performance was evaluated using published algorithm and cohort-specific thresholds derived from stratified 10-fold cross-validation.

Results: A total of 118 patients were included (50 OSCC, 41 normal, 22 reactive lesions, and 5 low-grade dysplasia). Applying the published algorithm to brushing samples yielded high sensitivity (0.97), but much poor specificity (0.27), highlighting cohort-specific limitations. New thresholds were therefore derived using 10-fold cross-validation based on the percentage of abnormal cells. Among 82 adequate brush samples, a threshold of 3.7% abnormal cells achieved 0.75 sensitivity 0.75 and 0.86 specificity. For 95 adequate rinse samples, a 1.4% threshold yielded 0.77 sensitivity and 0.80 specificity. Thresholds based on non-diploid cells performed worse. Covariate-adjusted logistic regression further improved sensitivity to 0.94 (brush) and 0.87 (rinse). In 105 paired samples, rinse testing demonstrated fewer inadequate samples (12.5% vs. 22.5%) and higher cell yield.

Conclusion: This is the first study assessing automated DNA cytology in an areca nut-prevalent population. Findings emphasize the need for population-specific calibration and support rinse-based cytology as a scalable self-administered screening approach. Large multicenter validation is warranted.

Publication Date

2026

Received Date

May 06 2026

Accepted Date

June 25 2026

Final Revision Date

June 24 2026

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