A new HPV-DNA test for cervical-cancer screening in developing regions: a cross-sectional study of clinical accuracy in rural China
Abstract
Background A new test (careHPV; QIAGEN, Gaithersburg, MD, USA) has been developed to detect 14 high-risk types of carcinogenic human papillomavirus (HPV) in about 2.5 h, to screen women in developing regions for cervical intraepithelial neoplasia (CIN). We did a cross-sectional study to assess the clinical accuracy of careHPV as a rapid screening test in two county hospitals in rural China. Methods From May 10 to June 15, 2007, the careHPV test was done locally by use of self-obtained vaginal and provider-obtained cervical specimens from a screening population-based set of 2530 women aged 30 to 54 years in Shanxi province, China. All women were assessed by visual inspection with acetic acid (VIA), Digene High-Risk HPV HC2 DNA Test (HC2), liquid-based cytology, and colposcopy with directed biopsy and endocervical curettage as necessary. In 2388 women with complete data, 441 women with negative colposcopy, but unsatisfactory or abnormal cytology or who were positive on HC2 or the new careHPV test, were recalled for a second colposcopy, four-quadrant cervical biopsies, and endocervical curettage. An absence of independence between the tests was not adjusted for and the Bonferroni correction was used for multiple comparisons. Findings Complete data were available for 2388 (94.4%) women. 70 women had CIN2+ (moderate or severe CIN or cancer), of whom 23 had CIN3+. By use of CIN2+ as the reference standard and area-under-the-curve analysis with a two-sided alpha error level of 0.008…
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Testing for HPV is a simple, low-cost technology that reduces cervical cancer incidence and related mortality when directly coupled with outpatient cryotherapy treatment for women testing HPV positive.
“Testing for HPV is a simple, low-cost technology that has been shown to reduce the cervical cancer incidence and related mortality when directly coupled with outpatient cryotherapy treatment for women testing HPV positive [2, 9, 10].”
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- Authors
- Qiao, Y.-L., Sellors, J. W., Eder, P. S., Bao, Y.-P., Lim, J. M., Zhao, F.-H., Weigl, B., Zhang, W.-H., Peck, R. B., Li, L., Chen, F., Pan, Q.-J., & Lorincz, A. T.
- Affiliations
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- Program for Appropriate Technology in Health (US)
- Queen Mary University of London (GB)
- Corresponding author
- Sellors, John W
- Venue
- The Lancet Oncology
- Publisher
- Elsevier BV
- Published
- 2008-10
- Volume
- 9
- Issue
- 10
- Pages
- 929-936
- ISSN
- 1470-2045 (ISSN-L)
- OpenAlex
- W1990879009
- Cited by
- 471
- References
- 1
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 5 · 2023: 22 · 2022: 10 · 2021: 13 · 2020: 20 · 2019: 21 · 2018: 17 · 2017: 33 · 2016: 19 · 2015: 37 · 2014: 46 · 2013: 44 · 2012: 51
- FWCI
- 31.03
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet Oncology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Cervical Cancer and HPV Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Women's cancer prevention and management
- Life Sciences › Immunology and Microbiology › Microbiology › Reproductive tract infections research
- Keywords
- HPV testing, cervical cancer screening, cervical intraepithelial neoplasia, high-risk HPV, rapid screening test, rural China, diagnostic accuracy, sensitivity and specificity, visual inspection with acetic acid, cervical specimens, developing regions, Shanxi Province, county hospitals
- MeSH terms
- Adult, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, China, Cross-Sectional Studies, DNA, Viral, Female, Humans, Mass Screening, Middle Aged, Predictive Value of Tests, ROC Curve, Sensitivity and Specificity, Biomarkers, Tumor, Rural Health Services, Papillomavirus Infections, Alphapapillomavirus
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