J Gynecol Oncol.  2017 Sep;28(5):e66. 10.3802/jgo.2017.28.e66.

Prospective comparison of hybrid capture 2 and SPF₁₀-LiPA for carcinogenic human papillomavirus detection and risk prediction of cervical cancer: a population-based cohort study in China

• Dong L
• Feng RM
• Zhang L
• Xu XQ
• Zhao XL
• Wang MZ
• Qiao YL
• Zhao FH

• KMID: 2413226
• DOI: http://doi.org/10.3802/jgo.2017.28.e66

Abstract

OBJECTIVE
To investigate the extent of the cross-reactivity of hybrid capture 2 (HC2) assay and evaluate the potential effect of cross-reactivity on the long-term risk for cervical cancer and precancers.
METHODS
Based on the Shanxi Province Cervical Cancer Screening Study-I (SPOCCS-I) cohort from 2005 to 2014 in Shanxi, China, SPF₁₀-line probe assay (LiPA) was performed in all 598 HC2 positive and 300 random-selected HC2 negative cervical specimens. Ten-year cumulative incidence rate (CIR) of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) of these two tests was evaluated using Kaplan-Meier methods. Possible human papillomavirus (HPV) types to be cross-reacted by HC2 were also analyzed.
RESULTS
The overall agreement between HC2 and SPF₁₀-LiPA for detecting carcinogenic HPV was 73.27%. The highest 10-year cumulative risk of CIN2+ was observed in both HC2 positive and LiPA-carcinogenic HPV positive women (25.70%; 95% confidence interval [CI]=23.55%-27.91%), followed by HC2 positive but LiPA-non-carcinogenic HPV positive women (9.97%; 95% CI=8.57%-11.50%), HC2 negative but LiPA-carcinogenic HPV positive (2.56%; 95% CI=2.44%-2.70%) and HC2 positive but LiPA-HPV negative (1.85%; 95% CI=1.78%-1.92%) women. The proportion of cross-reactivity of HC2 with untargeted carcinogenic types was 8.9%, most of which were attributable to HPV26, 73, 82, 69, 71, 53, 11, 43, and 54.
CONCLUSION
The noticeable high risk of CIN2+ in women infected with cross-reacted non-carcinogenic HPV and low risk in those with miss-to-detective carcinogenic HPV supported an overall good clinical performance of HC2 for a general cervical cancer screening.

Keyword

Human papillomavirus; Cervical Intraepithelial Neoplasia; Cumulative Incidence; Cohort Study; Assay

MeSH Terms

Adult
Cervical Intraepithelial Neoplasia/diagnosis/virology
Cervix Uteri/virology
China
Cohort Studies
Cytological Techniques
DNA Probes
DNA, Viral/*analysis
Early Detection of Cancer/methods
Female
Genotype
Humans
Middle Aged
Papillomaviridae/*genetics/isolation & purification
Papillomavirus Infections/*diagnosis
Prospective Studies
Risk Factors
Sensitivity and Specificity
Uterine Cervical Neoplasms/diagnosis/*virology
DNA Probes
DNA, Viral