Jiajian Wang

and 7 more

Objective: To assess the clinical performance of the human papillomavirus (HPV) 16 18/45 genotype assay (AHPV-GT) combined with age stratification in triaging women with histologic low-grade squamous intraepithelial lesion/cervical intraepithelial neoplasia grade 1 (LSIL [CIN1]) preceded by HPV E6/E7 mRNA assay (Aptima HPV, AHPV) positive/normal or mildly abnormal cytology. Design: Longitudinal study. Setting: Gynaecological clinic in Huzhou Maternity & Child Health Care Hospital, China. Population: Women aged ≥21 years with histologic LSIL (CIN1) preceded by AHPV-positive/normal or mildly abnormal cytology. Methods: Women underwent AHPV-GT testing at baseline and were followed at 6-month intervals for up to 2 years. At each follow-up, women with abnormal cytology or AHPV positivity were referred for colposcopy and then biopsy if indicated. Main outcome measures: The 2-year cumulative incidence rates (CIRs) of CIN3+ stratified by baseline AHPV-GT genotyping. Results: Of 349 eligible women, 25 women (7.2%) progressed, 301 (86.2%) regressed, and 23 (6.6%) persisted during the follow-up. The 2-year CIRs of CIN3+ in AHPV-GT-positive women were both significantly higher than those in AHPV-GT-negative women overall (8.6% vs. 1.7%, P = 0.014) and in the ≥25-year-old group (10.9% vs. 1.5%, P = 0.002) but slightly higher in the 21–24-year-old group ( P > 0.05). Conclusions: AHPV-GT testing with age stratification is effective for triaging women with histologic LSIL (CIN1) preceded by AHPV-positive/normal or mildly abnormal cytology. Immediate treatment is a rational recommendation for women ≥ 25 years old with histologic LSIL (CIN1) preceded by AHPV-GT positivity when good surveillance is not assured.