Funding information
Zhejiang Province Public Welfare Technology Application Research Project (LGF19H160001); Zhejiang Provincial Medicine and Health Science and Technology Project (2023KY322) and Huzhou Science and Technology Plan (2022GZ38).
Performance of human papillomavirus (HPV) 16 and 18/45 genotyping combined with age stratification in the triaging of women with histologic low-grade squamous intraepithelial lesions preceded by HPV oncogenic mRNA-positive/normal or mildly abnormal cytology: A longitudinal study
Abstract
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.