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.