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Pooled analysis of a self-sampling HPV DNA Test as a cervical cancer primary screening method.
J Natl Cancer Inst 2012; 104(3):178-88JNCI

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.

Authors+Show Affiliations

Department of Epidemiology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22271765

Citation

Zhao, Fang-Hui, et al. "Pooled Analysis of a Self-sampling HPV DNA Test as a Cervical Cancer Primary Screening Method." Journal of the National Cancer Institute, vol. 104, no. 3, 2012, pp. 178-88.
Zhao FH, Lewkowitz AK, Chen F, et al. Pooled analysis of a self-sampling HPV DNA Test as a cervical cancer primary screening method. J Natl Cancer Inst. 2012;104(3):178-88.
Zhao, F. H., Lewkowitz, A. K., Chen, F., Lin, M. J., Hu, S. Y., Zhang, X., ... 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), pp. 178-88. doi:10.1093/jnci/djr532.
Zhao FH, et al. Pooled Analysis of a Self-sampling HPV DNA Test as a Cervical Cancer Primary Screening Method. J Natl Cancer Inst. 2012 Feb 8;104(3):178-88. PubMed PMID: 22271765.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pooled analysis of a self-sampling HPV DNA Test as a cervical cancer primary screening method. AU - Zhao,Fang-Hui, AU - Lewkowitz,Adam K, AU - Chen,Feng, AU - Lin,Margaret J, AU - Hu,Shang-Ying, AU - Zhang,Xun, AU - Pan,Qin-Jing, AU - Ma,Jun-Fei, AU - Niyazi,Mayineur, AU - Li,Chang-Qing, AU - Li,Shu-Min, AU - Smith,Jennifer S, AU - Belinson,Jerome L, AU - Qiao,You-Lin, AU - Castle,Philip E, Y1 - 2012/01/23/ PY - 2012/1/25/entrez PY - 2012/1/25/pubmed PY - 2012/3/27/medline SP - 178 EP - 88 JF - Journal of the National Cancer Institute JO - J. Natl. Cancer Inst. VL - 104 IS - 3 N2 - 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. SN - 1460-2105 UR - https://www.unboundmedicine.com/medline/citation/22271765/Pooled_analysis_of_a_self_sampling_HPV_DNA_Test_as_a_cervical_cancer_primary_screening_method_ L2 - https://academic.oup.com/jnci/article-lookup/doi/10.1093/jnci/djr532 DB - PRIME DP - Unbound Medicine ER -