Pooled analysis of a self-sampling HPV DNA test as a cervical cancer primary screening method
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Authors
Zhao, Fang-Hui
Lewkowitz, Adam K.
Chen, Feng
Lin, Margaret J.
Hu, Shang-Ying
Zhang, Xun
Pan, Qin-Jing
Ma, Jun-Fei
Niyazi, Mayineur
Li, Chang-Qing
Issue Date
2012-01-23
Type
Article
Language
en_US
Keywords
Pooled Analysis , Self-Sampling HPV DNA Test , Cervical Cancer Primary Screening Method
Alternative Title
Abstract
Background:
Worldwide, one-seventh of cervical cancers occur in China, which lacks a national screening program. By evaluating the diagnostic accuracy of self-collected cervicovaginal specimens tested for human papillomavirus (HPV) DNA (Self-HPV testing) in China, we sought to determine whether Self-HPV testing may serve as a primary cervical cancer screening method in low-resource settings.
Methods:
We compiled individual patient data from five population-based cervical cancer–screening studies in China. Participants (n = 13 140) received Self-HPV testing, physician-collected cervical specimens for HPV testing (Physician-HPV testing), liquid-based cytology (LBC), and visual inspection with acetic acid (VIA). Screen-positive women underwent colposcopy and confirmatory biopsy. We analyzed the accuracies of pooled Self-HPV testing, Physician-HPV testing, VIA, and LBC to detect biopsy-confirmed cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) and CIN3+. All statistical tests were two-sided.
Results:
Of 13 004 women included in the analysis, 507 (3.9%) were diagnosed as CIN2+, 273 (2.1%) as CIN3+, and 37 (0.3%) with cervical cancer. Self-HPV testing had 86.2% sensitivity and 80.7% specificity for detecting CIN2+ and 86.1% sensitivity and 79.5% specificity for detecting CIN3+. VIA had statistically significantly lower sensitivity for detecting CIN2+ (50.3%) and CIN3+ (55.7%) and higher specificity for detecting CIN2+ (87.4%) and CIN3+ (86.9%) (all P values < .001) than Self-HPV testing, LBC had lower sensitivity for detecting CIN2+ (80.7%, P = .015), similar sensitivity for detecting CIN3+ (89.0%, P = .341), and higher specificity for detecting CIN2+ (94.0%, P < .001) and CIN3+ (92.8%, P < .001) than Self-HPV testing. Physician-HPV testing was more sensitive for detecting CIN2+ (97.0%) and CIN3+ (97.8%) but similarly specific for detecting CIN2+ (82.7%) and CIN3+ (81.3%) (all P values <.001) than Self-HPV testing.
Conclusions:
The sensitivity of Self-HPV testing compared favorably with that of LBC and was superior to the sensitivity of VIA. Self-HPV testing may complement current screening programs by increasing population coverage in settings that do not have easy access to comprehensive cytology-based screening.
Description
Citation
Zhao, F. H., Lewkowitz, A. K., Chen, F., Lin, M. J., Hu, S. Y., Zhang, X., Pan, Q. J., Ma, J. F., Niyazi, M., Li, C. Q., Li, S. M., Smith, J. S., Belinson, J. L., Qiao, Y. L., & Castle, P. E. (2012). Pooled analysis of a self-sampling HPV DNA Test as a cervical cancer primary screening method. Journal of the National Cancer Institute, 104(3), 178–188. https://doi.org/10.1093/jnci/djr532
Publisher
Journal of the National Cancer Institute