Validation of a new HPV self-sampling device for cervical cancer screening: The Cervical and Self-Sample In Screening (CASSIS) study

El‐Zein, Mariam; Bouten, Sheila; Louvanto, Karolina; Gilbert, Lucy; Gotlieb, Walter H.; Hemmings, Robert; Behr, Marcel A.; Franco, Eduardo L.

doi:10.1016/j.ygyno.2018.04.004

Cited by 18 publications

(32 citation statements)

References 23 publications

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“…The higher cross-sectional accuracy of HPV testing over cytology screening has been demonstrated previously (31). Our results are also in agreement with more recent studies, including one based on this study population (21). A randomized study (2013)(2014)(2015) in Sweden, which compared the detection rate of histologically defined CIN2 þ in women performing repeated self-sampling of vaginal fluid for HPV testing (n ¼ 17,997) to those performing screening by conventional cytology (n ¼ 18,393 women), found that HPV self-sampling detected more than twice as many women with CIN2 þ than cytology (32).…”

Section: Discussionsupporting

confidence: 93%

“…Another key strength is the use of a recently validated selfsampling device (21). Notwithstanding, further studies are warranted in healthy screening populations that will additionally allow for evaluations of operational and system-related barriers to HPV self-sampling.…”

Section: Discussionmentioning

confidence: 99%

“…Detailed methods of the CASSIS study including recruitment, eligibility screening, and data collection have been described previously (21). Briefly, a total of 1,217 women ages between 16 and 70 years took part in this cross-sectional study between June 2015 and April 2016.…”

Section: Study Design and Populationmentioning

confidence: 99%

“…Given that one of the fundamental advantages of HPV testing is that it can be done with self-collected vaginal specimens, two central questions of HPV self-sampling relate to its diagnostic accuracy and the performance and acceptability of the sampling device. Several studies that compared vaginal self-sampling with cervical physician-sampling found high concordance for HPV detection (1,(11)(12)(13)(14)(15)(16)(17)(18) and comparable clinical accuracy to detect high-grade cervical intraepithelial neoplasia (CIN) and cancers, provided that validated assays are used (17,(19)(20)(21)(22). In a recent meta-analysis of 56 accuracy studies, the pooled relative sensitivity of high-risk HPV (hrHPV) assays (based on PCR) on self-collected versus physician-collected samples was 99% for CIN2 þ or CIN3 þ , and the positive predictive values (PPV) for either histologic endpoint were not significantly lower for self-collected samples (22).…”

Section: Introductionmentioning

confidence: 99%

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Predictive Value of HPV Testing in Self-collected and Clinician-Collected Samples Compared with Cytology in Detecting High-grade Cervical Lesions

El‐Zein

Bouten

Louvanto

et al. 2019

Cancer Epidemiology, Biomarkers &Amp; Prevention

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Background: Self-sampling has become an attractive proposition now that human papillomavirus (HPV) primary testing is being incorporated into cervical cancer screening programs worldwide. We compared predictive values of HPV testing based on self-and physician-collected samples, and cytology, in detecting high-grade cervical intraepithelial neoplasia (CIN).Methods: The Cervical And Self-Sample In Screening (CASSIS) study enrolled 1,217 women ages 16-70 years prior to scheduled colposcopies. Vaginal specimens were self-collected using the validated HerSwab device. Cervical specimens were collected by gynecologists. Specimens were tested for presence of high-risk HPV (hrHPV) by the Cobas 4800 HPV test. We estimated positive predictive values (PPV) and negative predictive values (NPV) and 95% confidence intervals (CI) for a subset of women (n ¼ 700) who underwent cervical biopsy and cytology at the actual CASSIS visit.Results: hrHPV was detected in 329 women (47%) with HerSwab and in 327 (46.7%) with physician sampling. Respective values for HPV16/18 were 119 (17%) and 121 (17.3%). On histology, 134 women had CIN1, 49 had CIN2, 48 had CIN3, 5 had CIN2/CIN3, and 3 had cancers. PPVs for CIN2 þ of any hrHPV were 28% (95% CI, 23.2-33.1) and 29.7% (95% CI, 24.8-34.9) for HerSwab and physician samples, respectively. Corresponding values for HPV16/18 were 43.7% (95% CI, 34.6-53.1) and 43.8% (95% CI, 34.8-53.1). PPV of cytology (ASC-USþ) was 26.6% (95% CI, 21.6-32.0). Corresponding NPVs (same order as PPVs) were 96.4% (95% CI, 93.9-98.1), 97.8% (95% CI, 95.6-99), 90.9% (95% CI, 88.2-93.1), 91% (95% CI, 88.4-93.2), and 94.7% (95% CI, 91.8-96.8).Conclusions: Our results confirm that HPV self-sampling has comparable performance with a physician-collected sample in detecting cervical lesions.Impact: HPV self-sampling has the potential to increase coverage in cervical cancer screening.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Section: Study Design and Populationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Predictive Value of HPV Testing in Self-collected and Clinician-Collected Samples Compared with Cytology in Detecting High-grade Cervical Lesions

El‐Zein

Bouten

Louvanto

et al. 2019

Cancer Epidemiology, Biomarkers &Amp; Prevention

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“…The HPV samples were collected using HerSwab kits, a self-collection sampling method 32 34 35. If a participant was willing to provide a sample, instructions and graphical materials were provided and the participant collected the sample in a separate, private room from the CHWs.…”

Section: Methodsmentioning

confidence: 99%

HPV self-sampling acceptability in rural and indigenous communities in Guatemala: a cross-sectional study

et al. 2019

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IntroductionCervical cancer disproportionately burdens low-income and middle-income countries (LMICs) such as Guatemala. Self-collection testing for human papillomavirus (HPV) has been suggested as a form of cervical cancer screening to facilitate access in LMICs. This study assessed and compared the acceptability of self-collection HPV testing in two rural, indigenous and ethnically distinct communities in Guatemala: Santiago Atitlán, Sololá and Livingston, Izabal.MethodsAll participants, women between the ages of 18 and 60, completed a questionnaire. Eligible participants were also asked to self-collect a vaginal sample and complete a questionnaire regarding comfort and acceptability. Self-collected samples were tested for high-risk HPV using the real-time PCR Hybribio kit.ResultsIn the indigenous community of Santiago Atitlán, of 438 age-eligible participants, 94% completed self-collection. Of those, 81% found it comfortable and 98% were willing to use it as a form of screening. In the multiethnic (Afro-Caribbean, indigenous) community of Livingston, of 322 age-eligible participants, 53% chose to self-collect. Among those who took the test, 83% found it comfortable and 95% were willing to use it as a form of screening. In Livingston, literacy (can read and/or write vs cannot read or write) was higher in women who chose to self-collect (prevalence ratio 2.25; 95% CI 1.38 to 3.68). Ethnicity, history of screening and reproductive history were not associated with willingness to self-collect in Livingston. Women in Santiago reported less prior use of healthcare than women in Livingston. Overall, 19% (106/549) of samples tested positive for high-risk HPV.ConclusionAmong women willing to self-collect in rural and indigenous communities in Guatemala, self-collection for HPV testing is highly acceptable. However, willingness to try self-collection might vary across communities and settings. Women from a community that used less healthcare were more likely to choose self-collection. Further research is necessary to determine what factors influence a woman’s choice to self-collect.

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Evaluation of a novel vaginal cells self‐sampling device for human papillomavirus testing in cervical cancer screening: A clinical trial assessing reliability and acceptability

Yang,

Chang,

Chou

et al. 2024

Bioengineering & Transla Med

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Cervical cancer is a significant public health concern, particularly in low‐ and middle‐income countries where resources for prevention and treatment are limited. Routine screening, such as the Papanicolaou test (Pap smears) and human papillomavirus (HPV) testing, plays a crucial role in the early detection and prevention of cervical cancer. However, the participation rate in cervical cancer screening programs remains below optimal levels due to various factors. This study aimed to evaluate the reliability and acceptability of the HygeiaTouch Self Sampling Kit for Women in collecting vaginal samples for HPV typing, comparing the results with samples collected by physicians. The study included 1210 women aged 21–65 from three medical centers in Taiwan. The findings indicated that the self‐sampling kit was as effective as physician‐collected specimens in terms of obtaining valid samples and identifying HPV. The agreement between the two methods was 88%, with a κ value of 0.75. Furthermore, the study assessed the mechanical characteristics of the self‐sampling applicator through tensile, bending, and torque tests, and determined that it was safe for intravaginal use. Additionally, the study evaluated the safety and satisfaction of self‐sampling and found a low rate of adverse events (0.7%) and high levels of satisfaction (over 90%) among participants. Overall, we demonstrated that the HygeiaTouch Self Sampling Kit for Women is a reliable and acceptable device for HPV testing and cervical screening, providing a convenient, safe, and effective alternative for women.

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Validation of a new HPV self-sampling device for cervical cancer screening: The Cervical and Self-Sample In Screening (CASSIS) study

Cited by 18 publications

References 23 publications

Predictive Value of HPV Testing in Self-collected and Clinician-Collected Samples Compared with Cytology in Detecting High-grade Cervical Lesions

Predictive Value of HPV Testing in Self-collected and Clinician-Collected Samples Compared with Cytology in Detecting High-grade Cervical Lesions

HPV self-sampling acceptability in rural and indigenous communities in Guatemala: a cross-sectional study

Evaluation of a novel vaginal cells self‐sampling device for human papillomavirus testing in cervical cancer screening: A clinical trial assessing reliability and acceptability

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