Testing menstrual blood for human papillomavirus during cervical cancer screening in China: cross sectional population based study.

OBJECTIVE

To compare the diagnostic accuracy of minipad collected menstrual blood versus clinician collected cervical samples to test for human papillomavirus (HPV) in the detection of cervical intraepithelial neoplasia grade 2/3 or worse (CIN2+/CIN3+).

DESIGN

Cross sectional population based study.

SETTING

Four urban and three rural communities in Hubei Province, China.

PARTICIPANTS

3068 women aged 20-54 years with regular menstrual cycles, enrolled between September 2021 and January 2025.

INTERVENTIONS: HPV testing using minipad collected menstrual blood, clinician collected cervical samples, and ThinPrep cytology. Women who tested HPV positive by either collection method or by cytology (atypical squamous cells of undetermined significance or worse) were referred for colposcopy directed biopsy sampling.

MAIN OUTCOME MEASURE: Diagnostic accuracy for detecting CIN2+ and CIN3+.

RESULTS

Among 3068 participants, minipad based HPV testing showed a sensitivity of 94.7% (95% confidence interval 80.9% to 99.1%) for CIN2+ detection, comparable to clinician based HPV testing (92.1%, 77.5% to 97.9%; P=1.00). Although minipad HPV testing showed a lower specificity than clinician HPV testing (89.1%, 88.0% to 90.2% v 90.0%, 88.9% to 91.1%; P=0.001), the negative predictive value matched that of clinician HPV testing (99.9%, 99.7% to 100.0% v 99.9%, 99.7% to 100.0%; P=1.00). Both collection methods had a similar positive predictive value (9.9%, 7.1% to 13.5% v 10.4%, 7.4% to 14.3%; P=0.82) and screening efficiency (10.1 v 9.6 referrals per CIN2+ detected; P=0.82).

CONCLUSIONS

Minipad collected menstrual blood showed comparable diagnostic accuracy to clinician collected cervical samples for HPV testing for detecting CIN2+ and CIN3+.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06082765.