Diagnostic performance of human papillomavirus DNA cycle threshold values in the detection of high-grade cervical intraepithelial neoplasia.
Cervical cancer remains a major public health burden in low- and middle-income countries, primarily caused by high-risk human papillomavirus (hrHPV) infection. Although HPV DNA testing is highly sensitive, its low specificity necessitates effective triage strategies. Cycle threshold (CT) values from real-time polymerase chain reaction assays reflect viral load and might serve as potential biomarkers for triage; however, their clinical significance remains unclear.
This retrospective cohort study included women aged 25-65 years who tested positive for hrHPV between September 2023 and April 2025 at three Southern Thailand hospitals. All participants had CT values and underwent colposcopy with biopsy. HPV testing was performed using the Allplex HPV HR Detection assay, and diagnostic performance was evaluated using receiver operating characteristic analysis.
Among 677 hrHPV-positive women, 286 met the eligibility criteria, with cervical intraepithelial neoplasia 2 or higher (CIN2+) detected in 56 (19.6%). HPV16, HPV52, and HPV58 were the most common genotypes in CIN2+ cases. CT values were significantly inversely correlated with lesion severity (r = -0.13, P = 0.025). For non-16/18 hrHPV infections, a CT cutoff value of <32.94 improved the area under the curve from 0.54 to 0.65, yielding a sensitivity and specificity of 89% and 41%, respectively.
Cycle threshold values demonstrated modest discriminatory performance. Therefore, they should not be used as the sole biomarkers for triage; rather, they should be used as a supplementary tool to aid in clinical decision-making. Further validation in larger prospective studies is warranted.
This retrospective cohort study included women aged 25-65 years who tested positive for hrHPV between September 2023 and April 2025 at three Southern Thailand hospitals. All participants had CT values and underwent colposcopy with biopsy. HPV testing was performed using the Allplex HPV HR Detection assay, and diagnostic performance was evaluated using receiver operating characteristic analysis.
Among 677 hrHPV-positive women, 286 met the eligibility criteria, with cervical intraepithelial neoplasia 2 or higher (CIN2+) detected in 56 (19.6%). HPV16, HPV52, and HPV58 were the most common genotypes in CIN2+ cases. CT values were significantly inversely correlated with lesion severity (r = -0.13, P = 0.025). For non-16/18 hrHPV infections, a CT cutoff value of <32.94 improved the area under the curve from 0.54 to 0.65, yielding a sensitivity and specificity of 89% and 41%, respectively.
Cycle threshold values demonstrated modest discriminatory performance. Therefore, they should not be used as the sole biomarkers for triage; rather, they should be used as a supplementary tool to aid in clinical decision-making. Further validation in larger prospective studies is warranted.
Authors
Watcharasin Watcharasin, Sirimusika Sirimusika, Atjimakul Atjimakul, Rattanaburi Rattanaburi
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