TS Triage of HR-HPV Positive Population and Its Accuracy Study

A Study on the Application of TS for Triage in HR-HPV Viral Load Positive Population and Accuracy Related Studies

A prospective study assessing TS accuracy in HR-HPV+ women, influencing factors, and 1-year follow-up of false-positives versus biopsy.

The study will be conducted between 2025.01 and 2027.12 and will assess the diagnostic accuracy of TS testing in patients with positive HR-HPV viral loads by means of a prospective controlled study analyzing the factors influencing the false positive/negative results (age/gynecological findings/vaginal microbiota, etc.) and using cervical biopsy as a reference standard for 1 year in cases of TS false positives. The principal investigator will write and publish a paper.

Inclusion Criteria:

1. Patients in our outpatient clinic who have already undergone HPV viral load testing and are awaiting colposcopy, or those who have both HPV viral load test results and TS (Triple Staining) results and are awaiting colposcopy；
2. Informed consent obtained from voluntary participants.

Exclusion Criteria:

1. Patients who are unable to cooperate or have poor compliance;
2. Within four months postpartum;
3. During the first three days of menstruation with heavy flow;
4. Within three months after cervical surgery (including cervical biopsy);
5. Previous radiotherapy in the pelvic region;
6. Currently undergoing chemotherapy or within five weeks after chemotherapy;
7. Clinically evident acute or subacute cervical/vaginal infection;
8. History of photosensitivity disorders, current photodynamic therapy, or exposure to photosensitizing agents;
9. Suspected or confirmed history of alcohol/drug abuse, or any other condition that-in the investigator's judgment-may reduce enrollment feasibility or complicate participation (e.g., frequent job relocation, unstable living conditions leading to high risk of loss to follow-up);
10. Other patients deemed ineligible by the investigators.