Pooled Analysis of a Self-Sampling HPV DNA Test as a Cervical Cancer Primary Screening Method

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

doi:10.1093/jnci/djr532

Cited by 148 publications

(132 citation statements)

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“…Based on these data, we suggest that increasing the cutoff point for careHPV-C to 2.0 may represent a good trade-off for LMICs where there are limited numbers of clinical personnel to provide the necessary clinical management. Although HPV tests on self-collected specimens would not perform as well as the tests on clinician-collected specimens, it could be used as a complementary tool for the current cervical cancer screening programs to reach women who cannot access clinics (17). We observed a moderate sensitivity of 83.46% and specificity of 86.49% in detecting CIN3ϩ at 1.0 positive cutoff point by careHPV-S. Increasing the cutoff point resulted in significant reductions in sensitivity.…”

Section: Discussionmentioning

confidence: 73%

“…Although the use of self-collected specimens decreases the sensitivity for cervical precancer and cancer compared to clinically collected specimens (17,18), its sensitivity is superior to that of visual inspection with acetic acid (VIA) and conventional cytology in detecting cervical precancer and cancer (17,19). Furthermore, self-sampling does not require a clinic visit for specimen collection and thus might be used to increase population coverage (17,20).…”

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confidence: 99%

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

et al. 2014

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d 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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Section: Discussionmentioning

confidence: 73%

mentioning

confidence: 99%

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

et al. 2014

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“…The samples were also tested with the clinically validated hrHPV GP5ϩ/6ϩ primer-mediated PCR assay (Diassay, Rijswijk, Netherlands). With this, detection of DNA from 14 hrHPV genotypes, i.e., HPV 16,18,31,33,35,39,45,51,52,56,58,59, 66, and 68, can be determined (46). Briefly, 10 l of DNA was amplified with the biotin-labeled GP5ϩ/6ϩ primer set.…”

Section: Methodsmentioning

confidence: 99%

“…For the comparison of the two collection systems, only the 14 hrHPV types 16,18,31,33,35,39,45,51,52,56,58,59, 66, and 68 were evaluated. Comparing the presence of hrHPV between the samples, results were classified as identical, concordant, or discordant.…”

Section: Methodsmentioning

confidence: 99%

Dry Storage and Transport of a Cervicovaginal Self-Sample by Use of the Evalyn Brush, Providing Reliable Human Papillomavirus Detection Combined with Comfort for Women

et al. 2012

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dPrimary screening using high-risk human papillomavirus (hrHPV) detection has been suggested as a way of improving cervical cancer prevention. Women currently not attending screening (nonresponders) are more likely to participate when given the opportunity of self-sampling for hrHPV testing. The Evalyn Brush is a new cervicovaginal self-sampling device, developed specifically to meet women's demands, which is user-friendly and easy to use. The aims of this study were to investigate agreement of hrHPV detection by two PCR methods between the Evalyn Brush and physician-obtained samples and to study women's acceptance of this self-sampling device. Each of 134 women visiting the gynecology outpatient clinic collected a self-obtained sample (self-sample) and completed a questionnaire. The brush was stored dry. After self-sampling, a trained physician obtained a conventional cervical cytology specimen in ThinPrep medium. HrHPV detection was performed using the SPF 10 -DEIA-LiPA 25 and GP5؉/6؉-LQ-test. The overall agreement for hrHPV detection using SPF 10 -DEIA-LiPA 25 between the self-sample and the physician-taken sample was 85.8% (kappa value, 0.715; 95% confidence interval [CI], 0.597 to 0.843; P ‫؍‬ 1.000). The overall agreement for hrHPV detection using GP5؉/6؉-LQ between the self-sample and the physician-taken sample was 86.6% (kappa value, 0.725; 95% CI, 0.607 to 0.843; P ‫؍‬ 0.815). Ninety-eight percent of the women rated their experience as good to excellent. Moreover, 95% of women preferred self-sampling to physician sampling. Self-sampling using the dry Evalyn Brush system is as good as a physician-taken sample for hrHPV detection and is highly acceptable to women. To validate this self-sampling device for clinical use, a large screening cohort should be studied. C ervical cytology screening programs have significantly decreased the incidence and mortality of cervical cancer. Primary screening using high-risk human papillomavirus (hrHPV) detection has been found to be more sensitive than conventional cervical cytology for detecting cervical precancer (11,34,41,42). All data argue for the implementation of hrHPV testing as a primary test in cervical cancer screening, and the Health Council in the Netherlands has advised the Minister of Health to implement primary screening with hrHPV detection as a way of improving cervical cancer prevention (24).Cervical cancer incidence is higher among women who do not respond (nonresponders) or have no access to cervical screening programs than in screened women. A substantial number of nonresponders participate in screening when given the opportunity of self-sampling for hrHPV testing (1, 19). Self-sampling for hrHPV therefore has the potential to reduce cervical cancer incidence, especially among nonresponders (5).Cervicovaginal self-collected samples (self-samples) have proved to be as reliable as physician-obtained cervical samples for the detection of hrHPV (9, 22, 37-39, 44-45, 50). Studies on HPV selfsampling have used a great variety of collection devices, such a...

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“…Thus, HPV testing may improve the prevention of cervical precursor lesions to a greater extent than cytology. 13,36,43,44 All of the HSILs observed using cytology were found to be positive for hr-HPV. Among the identified LSILs, 55.3% were positive for hr-HPV.…”

Section: Discussionmentioning

confidence: 98%

Can the careHPV test performed in mobile units replace cytology for screening in rural and remote areas?

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Fregnani

Possati-Resende

et al. 2016

Cancer Cytopathology

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Pooled Analysis of a Self-Sampling HPV DNA Test as a Cervical Cancer Primary Screening Method

Cited by 148 publications

References 40 publications

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

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

Dry Storage and Transport of a Cervicovaginal Self-Sample by Use of the Evalyn Brush, Providing Reliable Human Papillomavirus Detection Combined with Comfort for Women

Can the careHPV test performed in mobile units replace cytology for screening in rural and remote areas?

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