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.