Optimal positive cutoff points for careHPV testing of clinician- and self-collected specimens in primary cervical cancer screening

An analysis from rural China

Le Ni Kang, Jose Jeronimo, You Lin Qiao, Fang Hui Zhao, Wen Chen, Melissa Valdez, Xun Zhang, Pooja Bansil, Proma Paul, Ping Bai, Roger Peck, Jing Li, Feng Chen, Mark H. Stoler, Philip E. Castle

Research output: Contribution to journalArticle

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Abstract

careHPV, a lower-cost DNA test for human papillomavirus (HPV), is being considered for cervical cancer screening in low- and middle-income countries. However, not a single large-scaled study exists to investigate the optimal positive cutoff point of careHPV test. We pooled data for 9,785 women participating in two individual studies conducted from 2007 to 2011 in rural China. Woman underwent multiple screening tests, including careHPV on clinician-collected specimens (careHPV-C) and selfcollected specimens (careHPV-S), and Hybrid Capture 2 on clinician-collected specimens (HC2-C) as a reference standard. The primary endpoint was cervical intraepithelial neoplasia grade 3 or more severe (CIN3+) (n =127), and secondary endpoint was CIN2+(n =213). The area under the curves (AUCs) for HC2-C and careHPV-C were similar (0.954 versus 0.948, P=0.166), and better than careHPV-S (0.878; P>0.001 versus both). The optimal positive cutoff points for HC2-C, careHPV-C, and careHPV-S were 1.40, 1.74, and 0.85, respectively. At the same cutoff point, careHPV-C was not significantly less sensitive and more specific for CIN3+than HC2-C, and careHPV-S was significantly less sensitive for CIN3+than careHPV-C and HC2-C. Raising the cutoff point of careHPV-C from 1.0 to 2.0 could result in nonsignificantly lower sensitivity but significantly higher specificity. Similar results were observed using CIN2+endpoint. careHPV using either clinician- or self-collected specimens performed well in detecting cervical precancer and cancer. We found that the optimal cutoff points of careHPV were 2.0 on clinician- collected specimens and 1.0 on self-collected specimens.

Original languageEnglish (US)
Pages (from-to)1954-1961
Number of pages8
JournalJournal of Clinical Microbiology
Volume52
Issue number6
DOIs
StatePublished - 2014
Externally publishedYes

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Early Detection of Cancer
Uterine Cervical Neoplasms
China
Human Papillomavirus DNA Tests
Cervical Intraepithelial Neoplasia
Area Under Curve
Costs and Cost Analysis

ASJC Scopus subject areas

  • Microbiology (medical)
  • Medicine(all)

Cite this

Optimal positive cutoff points for careHPV testing of clinician- and self-collected specimens in primary cervical cancer screening : An analysis from rural China. / Kang, Le Ni; Jeronimo, Jose; Qiao, You Lin; Zhao, Fang Hui; Chen, Wen; Valdez, Melissa; Zhang, Xun; Bansil, Pooja; Paul, Proma; Bai, Ping; Peck, Roger; Li, Jing; Chen, Feng; Stoler, Mark H.; Castle, Philip E.

In: Journal of Clinical Microbiology, Vol. 52, No. 6, 2014, p. 1954-1961.

Research output: Contribution to journalArticle

Kang, LN, Jeronimo, J, Qiao, YL, Zhao, FH, Chen, W, Valdez, M, Zhang, X, Bansil, P, Paul, P, Bai, P, Peck, R, Li, J, Chen, F, Stoler, MH & Castle, PE 2014, 'Optimal positive cutoff points for careHPV testing of clinician- and self-collected specimens in primary cervical cancer screening: An analysis from rural China', Journal of Clinical Microbiology, vol. 52, no. 6, pp. 1954-1961. https://doi.org/10.1128/JCM.03432-13
Kang, Le Ni ; Jeronimo, Jose ; Qiao, You Lin ; Zhao, Fang Hui ; Chen, Wen ; Valdez, Melissa ; Zhang, Xun ; Bansil, Pooja ; Paul, Proma ; Bai, Ping ; Peck, Roger ; Li, Jing ; Chen, Feng ; Stoler, Mark H. ; Castle, Philip E. / Optimal positive cutoff points for careHPV testing of clinician- and self-collected specimens in primary cervical cancer screening : An analysis from rural China. In: Journal of Clinical Microbiology. 2014 ; Vol. 52, No. 6. pp. 1954-1961.
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abstract = "careHPV, a lower-cost DNA test for human papillomavirus (HPV), is being considered for cervical cancer screening in low- and middle-income countries. However, not a single large-scaled study exists to investigate the optimal positive cutoff point of careHPV test. We pooled data for 9,785 women participating in two individual studies conducted from 2007 to 2011 in rural China. Woman underwent multiple screening tests, including careHPV on clinician-collected specimens (careHPV-C) and selfcollected specimens (careHPV-S), and Hybrid Capture 2 on clinician-collected specimens (HC2-C) as a reference standard. The primary endpoint was cervical intraepithelial neoplasia grade 3 or more severe (CIN3+) (n =127), and secondary endpoint was CIN2+(n =213). The area under the curves (AUCs) for HC2-C and careHPV-C were similar (0.954 versus 0.948, P=0.166), and better than careHPV-S (0.878; P>0.001 versus both). The optimal positive cutoff points for HC2-C, careHPV-C, and careHPV-S were 1.40, 1.74, and 0.85, respectively. At the same cutoff point, careHPV-C was not significantly less sensitive and more specific for CIN3+than HC2-C, and careHPV-S was significantly less sensitive for CIN3+than careHPV-C and HC2-C. Raising the cutoff point of careHPV-C from 1.0 to 2.0 could result in nonsignificantly lower sensitivity but significantly higher specificity. Similar results were observed using CIN2+endpoint. careHPV using either clinician- or self-collected specimens performed well in detecting cervical precancer and cancer. We found that the optimal cutoff points of careHPV were 2.0 on clinician- collected specimens and 1.0 on self-collected specimens.",
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AU - Chen, Wen

AU - Valdez, Melissa

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AU - Bansil, Pooja

AU - Paul, Proma

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AU - Peck, Roger

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AU - Chen, Feng

AU - Stoler, Mark H.

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