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Cited by 21Cervical Cancer and HPV ResearchWomen's cancer prevention and managementReproductive tract infections research

Optimal Positive Cutoff Points for careHPV Testing of Clinician- and Self-Collected Specimens in Primary Cervical Cancer Screening: an Analysis from Rural China

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Kang, Le-Ni, Jeronimo, Jose, Qiao, You-Lin, Zhao, Fang-Hui, Chen, Wen, Valdez, Melissa, Zhang, Xun, Bansil, Pooja +7 more·2014·Journal of Clinical Microbiology
DOI 10.1128/jcm.03432-13PMC PMC4042749
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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 self-collected 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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  • The study supports the conclusion that manufacturer's Cq cutoffs for positivity in HPV assays should always be handled with caution, especially when performing research within different age categories, socioeconomic settings, or types of (self-)sampling.

    “our study supports the assumption of other previous studies which concluded that the, often for specific circumstances validated and optimized, manufacturer’s Cq cutoffs for positivity in HPV assays should always be handled with caution, especially when performing research within different age categories (23), socioeconomic”

    From Comparison between the Roche Cobas 4800 Human Papillomavirus (HPV), Abbott RealTime High-Risk HPV, Seegene Anyplex II HPV28, and Novel Seegene Allplex HPV28 Assays for High-Risk HPV Detection and Genotyping in Mocked Self-Samples (2023) · cites this paper as [23]

    The Discussion says the manufacturer-set careHPV threshold warrants consideration and recommends different cutoffs for clinician- and self-collected specimens. It also says the study could not adequately assess age-specific cutoffs. The paper uses relative light units/cutoff ratios, not Cq cutoffs, and does not establish that manufacturer cutoffs for HPV assays should always be treated cautiously across socioeconomic settings. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

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Cited by

Sorted by citations

Authors
Kang, L.-N., Jeronimo, J., Qiao, Y.-L., Zhao, F.-H., Chen, W., Valdez, M., Zhang, X., Bansil, P., Paul, P., Bai, P., Peck, R., Li, J., Chen, F., Stoler, M. H., & Castle, P. E.
Affiliations
  • Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
  • Program for Appropriate Technology in Health (PATH), Seattle, Washington, USA
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China
  • Program for Appropriate Technology in Health (US)
  • University of Virginia (US)
  • Global Cancer Institute (US)
ORCID
Venue
Journal of Clinical Microbiology
Publisher
American Society for Microbiology
Published
2014-06
Volume
52
Issue
6
Pages
1954-1961
ISSN
  • 0095-1137 (ISSN-L)
  • 1098-660X
DOI
10.1128/jcm.03432-13
PMC
PMC4042749
OpenAlex
W2117654227
Cited by
21
References
1
Citations by year
2026: 3 · 2023: 1 · 2021: 2 · 2020: 5 · 2019: 3 · 2017: 2 · 2016: 1 · 2015: 1 · 2014: 3
FWCI
1.76
Type
journal article
Language
en
Open access
Licence
journals.asm.org/non-commercial-tdm-license (tdm)
Locations
  • Journal of Clinical Microbiology (publishedVersion)
  • PubMed Central (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
human papillomavirus DNA testing, cervical cancer screening, self-collected samples, Hybrid Capture 2, cervical intraepithelial neoplasia, CIN3, CIN2+, sensitivity and specificity, rural China, low- and middle-income countries
MeSH terms
Adult, Aged, Uterine Cervical Neoplasms, China, Female, Humans, Middle Aged, Rural Population, Sensitivity and Specificity, Specimen Handling, Molecular Diagnostic Techniques, Papillomaviridae, Early Detection of Cancer

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