Pooled analysis of a self-sampling HPV DNA test as a cervical cancer primary screening method

Fang Hui Zhao, Adam K. Lewkowitz, Feng Chen, Margaret J. Lin, Shang Ying Hu, Xun Zhang, Qin Jing Pan, Jun Fei Ma, Mayineur Niyazi, Chang Qing Li, Shu Min Li, Jennifer S. Smith, Jerome L. Belinson, You Lin Qiao, Philip E. Castle

Research output: Contribution to journalArticle

102 Citations (Scopus)

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 = 13140) 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 13004 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.

Original languageEnglish (US)
Pages (from-to)178-188
Number of pages11
JournalJournal of the National Cancer Institute
Volume104
Issue number3
DOIs
StatePublished - Feb 8 2012
Externally publishedYes

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Human Papillomavirus DNA Tests
Early Detection of Cancer
Uterine Cervical Neoplasms
Cell Biology
Acetic Acid
Physicians
China
Biopsy
Sensitivity and Specificity
Colposcopy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Pooled analysis of a self-sampling HPV DNA test as a cervical cancer primary screening method. / 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; Li, Shu Min; Smith, Jennifer S.; Belinson, Jerome L.; Qiao, You Lin; Castle, Philip E.

In: Journal of the National Cancer Institute, Vol. 104, No. 3, 08.02.2012, p. 178-188.

Research output: Contribution to journalArticle

Zhao, FH, Lewkowitz, AK, Chen, F, Lin, MJ, Hu, SY, Zhang, X, Pan, QJ, Ma, JF, Niyazi, M, Li, CQ, Li, SM, Smith, JS, Belinson, JL, Qiao, YL & Castle, PE 2012, '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, pp. 178-188. https://doi.org/10.1093/jnci/djr532
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 ; Li, Shu Min ; Smith, Jennifer S. ; Belinson, Jerome L. ; Qiao, You Lin ; Castle, Philip E. / Pooled analysis of a self-sampling HPV DNA test as a cervical cancer primary screening method. In: Journal of the National Cancer Institute. 2012 ; Vol. 104, No. 3. pp. 178-188.
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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 = 13140) 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 13004 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.",
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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.

PY - 2012/2/8

Y1 - 2012/2/8

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 = 13140) 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 13004 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.

AB - 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 = 13140) 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 13004 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.

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