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Objectives: Primary human papillomavirus (HPV) testing by clinician-collection is endorsed by U.S. guideline organizations for cervical cancer screening, but uptake remains low and insights into patients' understanding are limited. This study aims to primarily address patient awareness of primary HPV screening by clinician-collection and acceptance of primary HPV screening by clinician- and self-collection, and secondarily assess factors associated with awareness and acceptance. Setting: Primary care practices affiliated with an academic medical center. Methods: A cross-sectional survey study of screening-eligible women aged 30–65 years was conducted to assess awareness and acceptability of primary HPV screening. We analyzed bivariate associations of respondent characteristics with awareness of primary HPV screening by clinician-collection, willingness to have clinician- or self-collected primary HPV testing, and reasons for self-collection preference. Results: Respondents (n = 351; response rate = 23.4%) reported cervical cancer screening adherence of 82.8% but awareness of clinician-collected primary HPV as an option was low (18.9%) and only associated with HPV testing with recent screening (p = 0.003). After reviewing a description of primary HPV screening, willingness for clinician-collected (81.8%) or home self-collected (76.1%) HPV testing was high, if recommended by a provider. Acceptability of clinician-collected HPV testing was associated with higher income (p = 0.009) and for self-collection was associated with higher income (p = 0.002) and higher education (p = 0.02). Higher education was associated with reporting self-collection as easier than clinic-collection (p = 0.02). Women expected self-collection to be more convenient (94%), less embarrassing (85%), easier (85%), and less painful (81%) than clinician-collection. Conclusions: Educational interventions are needed to address low awareness about the current clinician-collected primary HPV screening option and to prepare for anticipated federal licensure of self-collection kits. Informing women about self-collection allows them to recognize benefits which could address screening barriers. [ABSTRACT FROM AUTHOR]

Objectives: In this study, we aimed to validate the performance of the PAX1 and JAM3 methylation (PAX1m/JAM3m) test as a triage tool for detecting cervical intraepithelial neoplasia grade 3 or worse (CIN3 +) in non-16/18 high-risk human papillomavirus-positive patients (non-16/18 hrHPV +). Methods: The triage performance of liquid-based cytology (LBC) and the PAX1m/JAM3m test for detecting CIN3 + were compared. Results: In total, 1851 participants had cervical histological outcomes and were included in the analysis. The sensitivity/specificity of the LBC test results with atypical squamous cells of undetermined significance or worse (LBC ≥ ASCUS) and the PAX1m/JAM3m test were 90.1%/26.7% and 84.8%/88.5%, respectively. PAX1m/JAM3m(+) had the highest diagnostic AUC (0.866, 95% confidence interval (CI) 0.837–0.896) in the whole cohort. All cancers (n = 20) were detected by PAX1m/JAM3m(+). Compared with LBC ≥ ASCUS, PAX1m/JAM3m(+) reduced the number of patients who needed referral for colposcopy by 57.21% (74.66% vs. 17.45%). The odds ratios for detecting CIN3 + by LBC ≥ ASCUS and PAX1m/JAM3m(+) were 3.3 (95% CI 2.0–5.9) and 42.6 (27.1–69.6), respectively (p < 0.001). The combination of LBC ≥ ASCUS or PAX1m/JAM3m(+) slightly increased the diagnostic sensitivity (98.0%, 95% CI: 95.8–100%) and referral rate (77.09%) but reduced the diagnostic specificity (24.8%, 22.7–26.8%). Conclusions: In non-16/18 hrHPV(+) women, PAX1m/JAM3m was superior to cytology for detecting CIN3 +. Compared with LBC ≥ ASCUS, PAX1m/JAM3m(+) reduced the number of significant referrals to colposcopy without compromising diagnostic sensitivity. [ABSTRACT FROM AUTHOR]

Copyright of Turkiye Klinikleri Journal of Nursing Sciences is the property of Turkiye Klinikleri and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Salud Pública de México is the property of Instituto Nacional de Salud Publica and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Introduction/Objectives: Despite U.S. Preventive Services Task Force and American Cancer Society endorsement of primary HPV screening, limited published data shows low uptake. Primary Aim: Assess cervical cancer screening rates over time, particularly primary HPV test uptake, among patients in a midwestern practice. Secondary Aim: Evaluate associations between sociodemographics and screening adherence. Methods: Cross-sectional study. Qualifying subjects and type of screening test used were identified by applying ICD-9, ICD-10, lab test, and CPT codes to the Unified Data Platform. Sociodemographics were found through the electronic health record. Results: Primary HPV uptake represented <1% of annual screening from 1/2017 to 1/2022. On 1/1/2022, only 55% of 21 to 29 year old and 63% of 30 to 65 year old were up to date with screening among the studied population. For 21 to 29 year old, compared with White women, Black women were 28% less likely to be screened [RR = 0.72 (0.66-0.79)]. Compared with never-smokers, current smokers were 9% less likely to be screened [RR = 0.91 (0.87-0.96)], past smokers were 14% more likely [RR = 1.14 (1.09-1.2)]. Among 30 to 65 year old, compared with White women, Black women were 14% less likely to be screened [RR = 0.86 (0.81-0.9)]. Compared with never-smokers, current smokers were 21% less likely to be screened [RR = 0.79 (0.77-0.81)], past smokers were 6% less likely [RR = 0.94 (0.92-0.95)]. Jointly considering race, ethnicity, smoking status, Charlson score, and rurality, findings were similar for 21 to 29 year old; Black women were screened less than White women [RR = 0.73 (0.67-0.79)]; current smokers [RR = 0.9 (0.85-0.94)] and past smokers [RR = 1.12 (1.06-1.17)] were screened less than never smokers. For 30 to 65 year old, Black women were screened less than White women [RR = 0.83 (0.79-0.88)]; current smokers [RR = 0.8 (0.78-0.81)] and past smokers [RR = 0.95 (0.93-0.96)] were screened less than never smokers. Conclusions: Screening rates remained below the Healthy People 2030 goal of 79.2% over time, particularly for younger Black women and current smokers, with minimal use of primary HPV screening. [ABSTRACT FROM AUTHOR]

Background: The World Health Organization (WHO) call for cervical cancer elimination includes increasing global cervical screening coverage. HPV-based self-collection (HPV-SC) is a promising screening model for low- and middle-income countries (LMICs), and while digital technology, such as cellphones, can be used to streamline HPV-SC, there is limited data on digital technology penetration in LMICs. Determining women's cellphone access is critical to understanding the feasibility of using cellphones to support HPV-SC. Methods: This study is a secondary analysis of a larger clinical trial. Participants of a cluster-randomized trial comparing HPV-SC models in Uganda completed a survey, including questions about demographics, cellphone access/ownership, prior cervical cancer screening (CCS), and willingness to receive CCS information by text. A logistic regression model was used to determine adjusted rates of cellphone ownership using survey variables as factors. Results: Of 2019 participants, 76.1% owned a cellphone. In non-cellphone owners (n = 483), 82.4% had daily cellphone access and 7.3% had no access. Compared to non-cellphone owners, cellphone owners were significantly older, more educated, closer to major health centers, more likely to have prior CCS, and more willing to receive a CCS text. In the logistic regression model, the aforementioned variables were all significantly associated with the odds of owning a cellphone. Conclusions: As health care systems consider adopting HPV-SC, it is imperative to understand digital technology penetration. The majority of participants were cellphone owners and were willing to receive CCS information by text; however, significant socioeconomic and demographic differences remain between cellphone owners and non-owners. Further investigation is needed to understand whether HPV-SC using cellphones is feasible in similar settings. Trial registration: ISRCTN, 12767014. ClinicalTrials.gov, NCT04000503. [ABSTRACT FROM AUTHOR]

Sexual minority men are at increased risk for anal squamous cell carcinoma. Our objective was to compare screening engagement among individuals randomized to self‐collect an anal canal specimen at home or to attend a clinic appointment. Specimen adequacy was then assessed for human papillomavirus (HPV) DNA genotyping. A randomized trial recruited cisgendered sexual minority men and transgender people in the community and assigned them to use a home‐based self‐collection swabbing kit or attend a clinic‐based swabbing. Swabs were sent for HPV genotyping. The proportions of participants completing screening in each study arm and the adequacy of their specimens for HPV genotyping were assessed. Relative risks were estimated for factors associated with screening. A total of 240 individuals were randomized. Age (median, 46 years) and HIV status (27.1% living with HIV) did not differ by study arm. A total of 89.2% and 74.2% of home‐arm and clinic‐arm individuals returned the swab, respectively (P =.003), difference between groups, 15.0% (95% CI 5.4%‐24.6%). Among black individuals, 96.2% and 63.2% in the home and clinic arms screened (P =.006). Among individuals with HIV, 89.5% and 51.9% in the home and clinic arms screened (P <.001). Self‐collected swabs and clinician‐collected swabs were comparable in adequacy for HPV genotyping (96.3% and 93.3%, respectively). People at highest risk for anal cancer may be more likely to screen if they are able to self‐collect swabs at home rather than attend a clinic. [ABSTRACT FROM AUTHOR]

PURPOSE This study aimed to evaluate the potential of machine learning-based models for predicting carcinogenic human papillomavirus (HPV) oncogene types using radiomics features from magnetic resonance imaging (MRI). METHODS Pre-treatment MRI images of patients with cervical cancer were collected retrospectively. An HPV DNA oncogene analysis was performed based on cervical biopsy specimens. Radiomics features were extracted from contrast-enhanced T1-weighted images (CE-T1) and T2-weighted images (T2WI). A third feature subset was created as a combined group by concatenating the CE-T1 and T2WI subsets. Feature selection was performed using Pearson's correlation coefficient and wrapper-based sequential-feature selection. Two models were built with each feature subset, using support vector machine (SVM) and logistic regression (LR) classifiers. The models were validated using a five-fold cross-validation technique and compared using Wilcoxon's signed rank and Friedman's tests. RESULTS Forty-one patients were enrolled in the study (26 were positive for carcinogenic HPV oncogenes, and 15 were negative). A total of 851 features were extracted from each imaging sequence. After feature selection, 5, 17, and 20 features remained in the CE-T1, T2WI, and combined groups, respectively. The SVM models showed 83%, 95%, and 95% accuracy scores, and the LR models revealed 83%, 81%, and 92.5% accuracy scores in the CE-T1, T2WI, and combined groups, respectively. The SVM algorithm performed better than the LR algorithm in the T2WI feature subset (P = 0.005), and the feature sets in the T2WI and the combined group performed better than CE-T1 in the SVM model (P = 0.033 and 0.006, respectively). The combined group feature subset performed better than T2WI in the LR model (P = 0.023). CONCLUSION Machine learning-based radiomics models based on pre-treatment MRI can detect carcinogenic HPV status with discriminative accuracy. [ABSTRACT FROM AUTHOR]

Purpose: Prevalence of cervical high-risk human papillomavirus (hrHPV) infection varies greatly. Data on distribution of hrHPV infection constitute important evidence for decision-making when implementing HPV testing into cervical cancer screening programs. We estimate the prevalence of cervical hrHPV infection in a large sample of women in a middle-income country and explore variation by age, community marginalization and region in women using public cervical cancer screening services. Methods: Records covering 2010–2017 from a registry of hrHPV test results (Hybrid Capture 2 and polymerase chain reaction) in 2,737,022 women 35–64 years were analyzed. In this observational study, 32 states were categorized into five geographical regions and classified by degree of marginalization. We stratified by test type and estimated crude and adjusted prevalence and rate ratios and used Poisson models and joinpoint regression analysis. Results: Prevalence was higher in women 35–39 years, at 10.4% (95% CI 10.3–10.5) and women 60–64 years, at 10.1% (95% CI 10.0–10.3). Prevalence was higher in the southeast, at 10.5% (95% CI 10.4–10.6). Women living in less marginalized areas had a significantly higher prevalence, at 10.3% (95% CI 10.2–10.4) compared to those in highly marginalized areas, at 8.7% (95% CI 8.5–8.7). HPV16 infection was detected in 0.92% (2,293/23,854) of women and HPV18 infection was detected in 0.39% (978/23,854) of women. Conclusion: Understanding the distribution of HPV prevalence has value as evidence for developing policy in order to improve cervical cancer screening strategies. These results will constitute evidence to allow decision makers to better choose where to focus those resources that they do have. [ABSTRACT FROM AUTHOR]

The World Health Organization recommends high‐risk human papillomavirus (hrHPV)‐based screening for women 39 to 49 years, based on the greater accuracy of hrHPV‐based screening for cervical cancer detection. Many cervical cancer screening programs have incorporated hrHPV testing and multiple early cervical cancer detection strategies have been evaluated, mostly under controlled conditions. However, there are few evaluations of combined hrHPV and cytology strategies post‐implementation at the population level. Our study sought to estimate the relative yield of hrHPV testing compared to cervical cytology, as a primary screening test for cervical intraepithelial neoplasia grade 2+ (CIN2+), used at the population level. We analyzed screening data from Mexico's public cervical cancer prevention program from 2010 to 2015 in women 35 to 64 years. The study population consisted of two cohorts: one from a total of 2 881 962 cytology‐based screening tests and another from a total of 2 004 497 hrHPV‐based screening tests, which are concurrent in time. We performed a relative yield analysis using Poisson regression models to compare the effectiveness of hrHPV testing for CIN2+ with cervical cytology. A total of 4 886 459 records were analyzed, including 23 999 biopsies; 0.12% (n = 6166) had a CIN2+ histologic diagnosis. hrHPV testing with cytological triage detects twice as many CIN2+ cases as screening using cytology alone. [ABSTRACT FROM AUTHOR]

Objectives: The natural history of HPV-related oropharyngeal squamous cell carcinoma (OPSCC) is still largely unknown. Since reports of second primary tumors (SPTs) in patients with HPV-related OPSCCs are increasing, a multifocal HPV infection, hinting a «virus-induced field effect», has been hypothesized. This study aimed to investigate the HPV-prevalence in normal appearing oropharyngeal tissue in patients with OPSCCs. Materials and Methods: 49 OPSCC patients undergoing panendoscopy were prospectively enrolled. Tumor specimens and biopsies of normal appearing oropharyngeal tissue adjacent to and distant from the index OPSCC underwent histopathological examination, p16INK4A immunohistochemical staining, HPV DNA and mRNA-detection. Patient characteristics and follow-up data on SPTs were obtained. Results: 26 of 49 (53%) OPSCC were positive for HPV DNA and p16INK4A. HPV mRNA was detected in 23 of 26 (88%) of these tumor samples. HPV DNA was detected in 36% adjacent mucosa and in 17% distant mucosa samples and only in patients with an HPV-related index OPSCC. HPV mRNA could not be detected in tumor-free distant and adjacent mucosa samples. No evidence of association between HPV detection in normal appearing mucosa and development of second primary tumors was found. Conclusions: HPV was detectable but not transcriptionally active in adjacent/distant tumor-free oropharyngeal tissue. This suggests that a multifocal HPV infection, hinting a «virus-induced fielcd cancerization», may not be pertaining to HPV-related OPSCC. [ABSTRACT FROM AUTHOR]

Background: Cervical cancer disproportionately affects women ≥65 years, especially those not screened regularly. Speculum use is a key barrier.Aim: To assess if offering non-speculum clinician-taken sampling and self-sampling increases uptake for lapsed attenders aged 50-64 years.Design and Setting: Pragmatic randomised control trial conducted at 10 general practices in East London, UK.Method: Participants were 784 women aged 50-64 years, last screened 6-15 years before randomisation. Intervention participants received a letter offering the choice of non-speculum clinician- or self-sampling. Control participants received usual care. The main outcome measure was uptake within 4 months.Results: Screening uptake 4 months after randomisation was significantly higher in the intervention arm: 20.4% (n = 80/393) versus 4.9% in the control arm (n = 19/391, absolute difference 15.5%, 95% confidence interval [CI] = 11.0% to 20.0%, P<0.001). This was maintained at 12 months: intervention 30.5% (n = 120/393) versus control 13.6% (n = 53/391) (absolute difference 17.0%, 95% CI = 11.3% to 22.7%, P<0.001). Conventional screening attendance within 12 months was very similar for both intervention 12.7% (n = 50/393) and control 13.6% (n = 53/391) arms. Ethnic differences were seen in screening modality preference. More White women opted for self-sampling (50.7%, n = 38/75), whereas most Asian and Black women and those from other ethnic backgrounds opted for conventional screening.Conclusion: Offering non-speculum clinician-taken sampling and self-sampling substantially increases uptake in older lapsed attendee women. Non-speculum clinician sampling appeals to women who dislike the speculum but still prefer a clinician to take their sample. Providing a choice of screening modality may be important for optimising cervical screening uptake. [ABSTRACT FROM AUTHOR]

Aim: Type‐specific persistent infection (TSPI) of human papillomavirus (HPV) is reportedly associated with a high risk of residual/recurrent disease after local treatment for cervical intraepithelial neoplasia (CIN). This study aimed to evaluate whether HPV genotyping is more accurate in detecting residual/recurrent disease than HPV DNA testing and identify which HPV genotype can predict a high risk of residual/recurrent disease. Methods: We retrospectively reviewed patient outcomes and results of HPV DNA testing and genotyping at 6–12 months after local treatment for CIN2/3 for 439 women. We investigated residual/recurrent disease occurrence according to the TSPI and new infections. Sensitivity, specificity, and positive and negative predictive values (PPV and NPV, respectively) of the two testing methods for predicting residual/recurrent diseases were also evaluated. Results: Eighty‐five (19.4%) patients were positive for HPV DNA testing after treatment, of which 74 (87.1%) had TSPI. Residual/recurrent disease was identified in 34 (7.7%) patients, of which 30 were positive for HPV DNA testing and had TSPI of HPV16, 18, 31, 33, 52, and 58 (six HPV genotypes). The sensitivity and NPV of HPV DNA testing and TSPI were equal at 88.2% and 98.9%, respectively. The specificity and PPV of TSPI were higher than those of HPV DNA testing (89.1% vs. 86.4%, 40.5% vs. 35.2%, respectively). Furthermore, the TSPI of the six HPV genotypes further improved specificity (90.6%) and PPV (44.1%) with the same sensitivity and NPV. Conclusion: HPV genotyping is more useful than HPV DNA testing for determining TSPI, especially of the six HPV genotypes. [ABSTRACT FROM AUTHOR]

Copyright of Journal of International Obstetrics & Gynecology is the property of TianJin Medical Information Center and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Randomized controlled trials have shown a higher sensitivity and longer negative predictive value of high-risk human papillomavirus (HPV) testing than cytology for cervical cancer screening; however, little is known about the effectiveness of HPV testing in middle-income countries. Understanding the characteristics of HPV testing may increase the priority of HPV testing in health policies. The study aims to evaluate the effectiveness of HPV testing in the national cervical cancer screening programme in China. Methods: We performed a nationwide, population-based study using individual data from the national cervical cancer screening programme in rural China between 2015 and 2017. The analyses included 1,160,981 women aged 35–64 years who underwent cytology alone or high-risk HPV testing with cytology or genotyping triage. The main outcome was cervical intraepithelial neoplasia 2 or worse (CIN2+). We used multivariate logistic regressions and performed sensitivity analyses with propensity score matching to compare the screening positive, colposcopy referral, detection rate, and positive predictive value (PPV). Results: The screening positive rates for HPV testing and cytology were 10.1% and 4.0%, respectively. The per protocol colposcopy referral rate of HPV testing was significantly lower than that of cytology (3.5% vs 4.0%), and this difference was mostly due to the low referral threshold of cytology (≥ASC-US). Overall, HPV testing detected more CIN2+ (5.5 vs. 4.4 per 1000, adjusted odds ratio [aOR]=1.18, 95% confidence interval 1.11–1.25) and had a higher PPV (13.8% vs 10.9%, aOR 1.29, 95% CI 1.21–1.37) than cytology. The colposcopy referrals of HPV testing in comparison to cytology differed by income status; it significantly increased in lower-middle-income areas (3.7% vs 3.1%, aOR 1.21, 95% CI 1.17–1.25) and significantly decreased in upper-middle-income areas (3.4% vs 4.9%, aOR 0.69, 95% CI 0.67–0.71). Sensitivity analyses demonstrated the reliability and robustness of the results. Conclusions: The introduction of HPV testing could improve both the CIN2+ detection rate and efficiency of cervical cancer screening programme, supporting the introduction of primary screening with high-risk HPV testing in China. Further study is needed to investigate the long-term effect of this change. [ABSTRACT FROM AUTHOR]

Background: Randomized controlled trials have shown a higher sensitivity and longer negative predictive value of high-risk human papillomavirus (HPV) testing than cytology for cervical cancer screening; however, little is known about the effectiveness of HPV testing in middle-income countries. Understanding the characteristics of HPV testing may increase the priority of HPV testing in health policies. The study aims to evaluate the effectiveness of HPV testing in the national cervical cancer screening programme in China.Methods: We performed a nationwide, population-based study using individual data from the national cervical cancer screening programme in rural China between 2015 and 2017. The analyses included 1,160,981 women aged 35-64 years who underwent cytology alone or high-risk HPV testing with cytology or genotyping triage. The main outcome was cervical intraepithelial neoplasia 2 or worse (CIN2+). We used multivariate logistic regressions and performed sensitivity analyses with propensity score matching to compare the screening positive, colposcopy referral, detection rate, and positive predictive value (PPV).Results: The screening positive rates for HPV testing and cytology were 10.1% and 4.0%, respectively. The per protocol colposcopy referral rate of HPV testing was significantly lower than that of cytology (3.5% vs 4.0%), and this difference was mostly due to the low referral threshold of cytology (≥ASC-US). Overall, HPV testing detected more CIN2+ (5.5 vs. 4.4 per 1000, adjusted odds ratio [aOR]=1.18, 95% confidence interval 1.11-1.25) and had a higher PPV (13.8% vs 10.9%, aOR 1.29, 95% CI 1.21-1.37) than cytology. The colposcopy referrals of HPV testing in comparison to cytology differed by income status; it significantly increased in lower-middle-income areas (3.7% vs 3.1%, aOR 1.21, 95% CI 1.17-1.25) and significantly decreased in upper-middle-income areas (3.4% vs 4.9%, aOR 0.69, 95% CI 0.67-0.71). Sensitivity analyses demonstrated the reliability and robustness of the results.Conclusions: The introduction of HPV testing could improve both the CIN2+ detection rate and efficiency of cervical cancer screening programme, supporting the introduction of primary screening with high-risk HPV testing in China. Further study is needed to investigate the long-term effect of this change. [ABSTRACT FROM AUTHOR]

Purpose The study aimed to evaluate the diagnostic accuracy of polymerase chain reaction-based high-risk human papillomavirus (HPV) assays on self-collected vaginal and urine samples for detection of precancerous cervical lesions in referral population. Materials and Methods Women referred for colposcopy following abnormal cytology, were included this study. A total of 314 matched urine, vaginal, and cervical samples were collected. All samples were tested for HPV DNA using the RealTime HR-S HPV and Anyplex II HPV 28 assays. Primary endpoints were sensitivity for cervical intraepithelial neoplasia (CIN) 2+/CIN3+ and specificity for

Objective: We aim to compare the cost‐effectiveness of the old cytology programme with the new high‐risk human papillomavirus (hrHPV) screening programme, using performance indicators from the new Dutch hrHPV screening programme. Design: Model‐based cost‐effectiveness analysis. Setting: The Netherlands. Population: Dutch 30‐year‐old unvaccinated females followed up lifelong. Methods: We updated the microsimulation screening analysis (MISCAN) model using the most recent epidemiological and screening data from the Netherlands. We simulated both screening programmes, using the screening behaviour and costs observed in each programme. Sensitivity analyses were performed on screening behaviour, utility losses and discount rates. Main outcome measures: Cervical cancer incidence and mortality rates, number of screening tests and repeat tests, colposcopy referrals by lesion grade, costs from a societal perspective, quality‐adjusted life years (QALYs) gained and cost‐effectiveness. Results: The new Dutch cervical cancer screening programme decreased the cervical cancer mortality by 4% and the incidence by 1% compared with the old programme. Colposcopy referrals of women without cervical intra‐epithelial neoplasia grade 2 or worse, increased by 172%, but 13% more QALYs were still achieved. Total costs were reduced by 21%, mainly due to fewer screening tests. Per QALY gained, the hrHPV programme cost 46% less (€12,225) than the cytology programme (€22,678), and hrHPV‐based screening remained more cost‐effective in all sensitivity analyses. Conclusions: The hrHPV‐based screening programme was found to be more effective and cost‐effective than the cytology programme. Alternatives for the current triage strategy should be considered to lower the number of unnecessary referrals. First results after implementation confirm that HPV screening is more cost‐effective than cytology screening. First results after implementation confirm that HPV screening is more cost‐effective than cytology screening. [ABSTRACT FROM AUTHOR]

Koilocytes are considered a common cytopathological effect in patients with human papillomavirus (HPV) infection. Thus, we aimed to elucidate whether koilocytes are common to all HPV infections. Liquid‐based cytology samples from 651 patients with abnormal Papanicolaou (Pap) test results were used to analyze the presence of koilocytes and HPV genotype. HPV genotype was determined in complete liquid cytology samples and microdissected cell samples from Pap smear slides using the uniplex E6/E7 polymerase chain reaction method, which can detect 39 mucosal HPV genotypes. Koilocytes were found in 29.3% (191) of all patients. Logistical regression analysis of diverse HPV genotypes revealed that infections with low‐risk HPV types (HPV‐6b, HPV‐40, HPV‐42, HPV‐61, HPV‐74, HPV‐89, and HPV‐90), probably high‐risk HPV types (HPV‐53 and HPV‐66), and high‐risk types (HPV‐39 and HPV‐56) were significantly associated with the presence of koilocytes. However, HPV‐16, HPV‐18, and HPV‐52, which have higher oncogenic potential, were not found to be associated with koilocytes. These results were confirmed by HPV genotyping using microdissected koilocytes in 27 patients.Most common high‐risk types belonging to α‐9 and α‐7 genotypes appear to rarely induce koilocytic changes. Therefore, koilocytes may provide additional useful information for predicting the risk of progression to high‐grade lesions. Research Highlights: The koilocytic change is a cytopathologic effect of particular HPV genotypes.HPV‐16, HPV‐18, and HPV‐52, which have higher oncogenic potential, rarely induce the koilocytic change.The strength of the present study was the use of samples in which various HPV genotypes were comprehensively detected with high sensitivity without any cross‐reactivity for each type through uniplex E6/E7 PCR.Koilocytes in Papanicolaou smears from cytologic tests performed to triage women with high‐risk HPV‐positive after HPV testing have the potential to provide a key manifestation for predicting a low risk of progression to high‐grade lesions. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate experiences and reactions after receiving a mailed, unsolicited human papillomavirus self-sampling kit and identify psychosocial correlates of using kits. Methods: Survey participants were underscreened women aged 30–64 who were mailed human papillomavirus kits as part of a pragmatic trial at Kaiser Permanente Washington, a United States integrated health care system. Six months after the mailing, we invited kit returners and non-returners to complete a web survey that measured psychosocial factors (e.g. cervical cancer/human papillomavirus knowledge, attitudes toward screening), experiences, and reactions to kits. We compared responses between kit returners and non-returners. Results: Comparing 116 kit returners (272 invited) and 119 non-returners (1083 invited), we found no clinically significant differences in psychosocial factors. Overall, survey respondents showed knowledge gaps in human papillomavirus natural history (82% did not know human papillomavirus infection can clear on its own) and interpreting human papillomavirus test results (37% did not know a human papillomavirus-negative result indicates low cancer risk). Kit returners found kits convenient and easy to use (>90%). The most common reason for non-return was low confidence in ability to correctly use a kit, although many non-returners (49%) indicated that they would consider future use. Women reported low trust in human papillomavirus testing to identify women at high risk for cervical cancer (52% in returners, 42% in non-returners). Conclusions: Screening programs could improve uptake and acceptability of human papillomavirus self-sampling through outreach materials that emphasize the high efficacy of human papillomavirus testing for cervical cancer screening and educate patients about how to interpret results. [ABSTRACT FROM AUTHOR]

Background: Cervical cancer is almost entirely preventable through vaccination and screening, yet remains one of the 'gravest threats to women's lives' according to the World Health Organization. Specific high-risk subtypes of human papillomavirus (HR-HPV) are well-established as the primary cause of cervical cancer. Uganda has one of the highest cervical cancer incidence rates in the world (54.8 per 100,000) as a result of limited screening access and infrastructure. The integration of a self-collected cervical cancer screening program using HPV testing within existing community-based primary health care services could increase access to screening and reduce cervical cancer rates among Ugandan women.Methods: Using a pragmatic, sequential, cluster randomized trial design; we will compare the effectiveness of two cervical cancer screening models for self-collected HPV testing: 1) community health worker recruitment (door-to-door); and 2) community health meetings. In Mayuge district, Uganda, 31 villages are randomized to one of two treatment arms. Due to the nature of this trial, blinding is not possible. Women are eligible to participate if they have no previous history of hysterectomy or treatment for cervical cancer or pre-cancer and are aged 25-49 years old. All participants receive an integrated package of cervical cancer screening and education. Samples are tested for HPV using GeneXpert point of care testing. All women who test positive for HR-HPV types are referred to a designated health centre for follow-up inspection by Visual Inspection with Acetic acid (VIA) and treatment with thermal ablation. The primary outcome for the trial is the number of women who attend follow-up for VIA screening at a designated Health Centre after a positive HR-HPV test out of all women screened per arm. Secondary outcomes include: cervical cancer screening knowledge; patient-reported experience measures for self-collected cervical cancer screening; and HPV incidence.Discussion: Results from this study will inform the national scale-up of cervical cancer screening in Uganda, aligning with the World Health Organization's target of achieving cervical cancer elimination through the pillar of increased HPV screening coverage.Trial Registration: ISRCTN, ISRCTN12767014. Registered 14 May 2019, https://doi.org/10.1186/ISRCTN12767014; clinicaltrials.gov, NCT04000503; Registered 27 June 2019, https://clinicaltrials.gov/ct2/show/NCT04000503 PROTOCOL VERSION: January 8, 2020, version 1. [ABSTRACT FROM AUTHOR]

Based on emerging data and current knowledge regarding high-risk human papillomavirus (hrHPV) testing as a primary screening for cervical cancer, the Korean Society of Obstetrics and Gynecology and the Korean Society of Gynecologic Oncology support the following scientific facts: Compared to cytology, hrHPV screening has higher sensitivity and detects more cases of high-grade cervical intraepithelial neoplasia. Qualified hrHPV testing can be considered as an alternative primary screening for cervical cancer to the current cytology method. The starting age of primary hrHPV screening should not be before 25 years because of possible overtreatment in this age, which has a high human papillomavirus (HPV) prevalence but rarely progresses to cancer. The screening interval should be no sooner than every 3 years and no longer than every 5 years. Before the introduction of hrHPV screening in Korea, research into comparative effectiveness of primary hrHPV screening for cervical cancer should be conducted to determine the appropriate HPV assay, starting age, and screening interval. [ABSTRACT FROM AUTHOR]

Background: The objective of the study is to comparatively evaluate performance of human papillomavirus (HPV) hybrid capture 2 (HC2) and cytology as triage tests among visual inspection after application of 3-5% acetic acid (VIA) screen positive women, thus aiming to reduce the referral burden. Methods: The community-based cross sectional cervical cancer screening with VIA was conducted among women aged between 30 and 65, residing in selected low socio-economic areas of Mumbai, India, during October 2010-March 2017. After obtaining informed consent, delivering health education and collecting socio-demographic data, participants were offered VIA screening by trained primary health workers. The VIA screen positive women underwent cytology, HPV HC2 and diagnostic colposcopy at nodal hospital. Women with positive colposcopy underwent cervical biopsies. Results: 231 VIA positive women underwent cytology and HPV HC2 test, followed by colposcopy. Cervical biopsies were obtained in 83 cases. The sensitivity and specificity in detecting ≥ CIN 2 were 77.8 and 92.3 for HC2 and 66.7 and 98.2 for cytology. The false positivity and negativity rates were 7.7 and 22.2 for HC2 and 1.8 and 33.3 for cytology. Conclusions: HPV HC2 reduces referrals to larger extent and misses fewer cases compared to cytology, thus appearing a better triage test among VIA positive women. [ABSTRACT FROM AUTHOR]

Objective: We explored patient perspectives after a positive human papillomavirus (HPV) self-sampling result to describe experiences and information needs for this home-based screening modality. Materials and Methods: We recruited women who tested high-risk (hr) HPV positive during a pragmatic trial evaluating mailed hrHPV self-sampling kits as an outreach strategy for women overdue for Pap screening in a U.S. integrated health care system. Telephone interviews were conducted from 2014 to 2017. Five independent coders analyzed transcripts using iterative content analysis. Results: Forty-six women (61% of invited; median age 55.5 years) completed a semistructured interview. Six themes emerged: (1) convenience of home-based screening, (2) intense feelings and emotions after receiving positive kit results, (3) importance of seeing provider and discussing kit results, (4) information seeking from various sources, (5) confusion about purpose and meaning of HPV versus Pap tests, and (6) concern that HPV self-sampling is inaccurate when the subsequent Pap test is normal. Conclusions: Although women liked the kit's convenience, discussion about discordant home HPV and in-clinic Pap results led them to question the accuracy of HPV self-sampling. Patient–provider communication around home HPV kits is more complex than for reflex or cotesting because clinician-collected Pap results are unknown at the time of the positive kit result. Patients need education about differences between HPV and Pap tests and how they are used for screening and follow-up. To reassure patients and keep them interested in self-sampling, education should be provided at multiple time points during the screening process. [ABSTRACT FROM AUTHOR]

Objectives: To assess the clinical and cost-effectiveness of human papillomavirus (HPV) primary screening triage with p16/Ki-67 dual stain cytology compared to cytology. Methods: We conducted an Excel®-based budget impact model to estimate the preinvasive and invasive cervical cancer cases identified, mortality rate, direct medical costs, qualityadjusted life years (QALYs) and the incremental cost-effectiveness analysis of two strategies from the healthcare payer perspective. The study population is a cohort of women 30-65 years of age presenting for cervical screening. Results: HPV primary screening triage with p16/Ki-67 dual stain showed higher sensitivity without losing specificity compared to conventional Pap smear. The improving the screening performance leads to decrease the prevalence of precancerous lesion, annual incidence and mortality of cervical cancer. The incidence of cervical cancer case detected by new algorithm compared with conventional method were 31,607 and 38,927, respectively. In addition, the new algorithm was more effective and more costly (average QALY 24.03, annual cost $13,262,693) than conventional cytology (average QALY 23.98, annual cost $7,713,251). The incremental cost-effective ratio (ICER) per QALY gained was $1,395. The sensitivity analysis showed if the cost of cytology and HPV test increased three times, the ICER would fall to $303/QALY gained and increased to $4,970/QALY gained, respectively. Conclusion: Our model results suggest that screening by use of HPV genotyping test as a primary screening test combined with dual stain cytology as the triage of HPV positive women in Thai population 30-65 years old is expected to be more cost-effective than conventional Pap cytology. [ABSTRACT FROM AUTHOR]

Aim of the study: The present study aims to estimate the prevalence and distribution of HPV genotypes and identify related risk factors among Turkish women. Material and methods: 11 624 Turkish women attending our gynaecological clinic and expressing a desire for access to cervical cancer screening were assessed during the years 2014-2016. Cervical specimens were collected and transported using the HC2 HPV DNA Collection Device (consisting of a cervical brush and digene Specimen Transport Medium). Results: Among these 11 624 individuals, positive HPV test results were obtained for 325 (2.79%), and negative results were observed for 11 299 (97.2%). The vast majority of patients were between the 3rd and 5th decades and the mean age of the patients was 44 ±9.12 (range 27-66). Among the HPV-positive women, 205 were positive for a single HPV type (205/325 = 63.1% of HPV infections; 205/11624 = 1.76% of all samples) and 120 were positive for multiple types (120/325 = 36.9% of HPV infections; 120/11624 = 1.03% of all samples). The four most prevalent high-risk types were HPV 16, 31, 51 and 52, with frequencies of 11.25%, 7.83%, 6.06% and 3.16%, respectively. Conclusions: There appears to be geographic variation in the distribution of HPV genotypes. In this study, the four most prevalent high-risk types were HPV 16, 31, 51 and 52, with frequencies of 11.25%, 7.83%, 6.06% and 3.16%, respectively. [ABSTRACT FROM AUTHOR]

Objective: Infection with high-risk genotypes of human papillomavirus (HR-HPV) is the major cause of invasive cervical cancers. HPV-16 and HPV-18 are known to be responsible for two-thirds of all invasive cervical carcinomas, followed by HPV-45, -31, and -33. Current guidelines only differentiate HPV-16/18 (+) by recommending direct colposcopy for treatment. We tried to evaluate whether there are differences in risk among 12 non-16/18 HRHPV genotypes in this study. Methods: The pathology archive database records of 1,102 consecutive gynecologic patients, who had results for cervical cytology and histology and for HPV testing, as determined by HPV 9G DNA chip, were reviewed. Results: Among the 1,102 patients, 346 were non-16/18 HR-HPV (+) and 231 were HPV-16/18 (+). We calculated the odds ratios for ≥cervical intraepithelial neoplasia 2 (CIN 2) of 14 groups of each HR-HPV genotype compared with a group of HR-HPV (-) patients. Based on the odds ratio of each genotype, we divided patients with non-16/18 HR-HPV genotypes (+) into two groups: HPV-31/33/35/45/52/58 (+) and HPV-39/51/56/59/66/68 (+). The age-adjusted odds ratios for ≥CIN 2 of the HPV-31/33/35/45/52/58 (+) and HPV-39/51/56/59/66/68 (+) groups compared with a HR-HPV (-) group were 11.9 (95% CI, 7.6 to 18.8; p<0.001) and 2.4 (95% CI, 1.4 to 4.3; p<0.001), respectively, while that of the HPV-16/18 (+) group was 18.1 (95% CI, 11.6 to 28.3; p=0.003). Conclusion: The 12 non-16/18 HR-HPV genotypes can be further categorized (HPV- 31/33/35/45/52/58 vs. HPV-39/51/56/59/66/68) by risk stratification. The HPV-31/33/35/45/52/58 genotypes might need more aggressive action. Large scale clinical trials or cohort studies are necessary to confirm our suggestion. [ABSTRACT FROM AUTHOR]

Purpose: The authors aimed to detect immediate risk of having high grade squamous lesions (HSIL) in atypical squamous cells of uncertain significance(AS-CUS) and concomitant high-risk human papillomavirus (HrHPV) testing as negative [HrHPV(negative)ASCUS]. Materials and Methods: The authors performed immediate/baseline colposcopy on concomitant HrHPV (negative)AS-CUS cases. Pap tests were evaluated with liquid-based cytology (LBC) and HrHPV detection was performed in LBC material with PCR. Colposcopic diagnoses and biopsy results were compared with Pap test and HrHPV test results. Results: There were 104 patients over a oneyear period. In all, 84 cases were included. Colposcopic biopsies revealed low grade squamous intraepithelial lesion (LSIL) in 19 cases (23%) and HSIL in three cases (4%). Intrauterine device use and smoking were significantly correlated with presence of HSIL (p = 0.005 and p = 0.007 respectively). Conclusion: Similar data in literature, 4% of ASC-US-HrHPV (negative) cases are expected to have HSIL in follow-up periods less than six months. The present authors believe clinicians should be more open with their patients about limitations of Pap-HPV testing. [ABSTRACT FROM AUTHOR]

Background: It is well acknowledged that HPV testing should not be performed at young age and at short intervals. Cytological screening practices have shown that over-screening, i.e., from a younger age and at shorter intervals than recommended, is hard to avoid. We quantified the consequences of a switch to primary HPV screening for over-screened women, taking into account its higher sensitivity but lower specificity than cytology.Methods: The health effects of using the HPV test instead of cytology as the primary screening method were determined with the MISCAN-Cervix model. We varied the age women start screening and the interval between screens. In the sensitivity analyses, we varied the background risk of cervical cancer, the HPV prevalence, the discount rate, the triage strategy after cytology, and the test characteristics of both cytology and the HPV test.Results: For women screened 5 yearly from age 30, 32 extra deaths per 100,000 simulated women were prevented when switching from primary cytology to primary HPV testing. For annual screening from age 20, such a switch resulted in 6 extra deaths prevented. It was associated with 9,044 more positive primary screens in the former scenario versus 76,480 in the latter. Under all conditions, for women screened annually, switching to HPV screening resulted in a net loss of quality-adjusted life years.Conclusion: For over-screened women, the harms associated with a lower test specificity outweigh the life years gained when switching from primary cytology to primary HPV testing. The extent of over-screening should be considered when deciding on inclusion of primary HPV screening in cervical cancer screening guidelines. [ABSTRACT FROM AUTHOR]

Background: HPV FOCAL is a randomized trial (ISRCTN79347302, registered 20 Apr 2007) comparing high-risk (hr) HPV testing vs. liquid-based cytology (LBC) for cervical cancer screening of women aged 25-65. We compared the Digene Hybrid Capture® 2 High-Risk HPV DNA Test® (HC2) and the Roche cobas® 4800 HPV Test (COBAS) for primary screening.Methods: Women (n=6,172) were screened at baseline by HC2 and COBAS and by LBC 24 months later. We assessed HPV genotyping and reflex LBC for colposcopy triage of baseline HPV positive women.Results: Overall HC2/COBAS agreement was 96.1% (kappa 0.75) and positive agreement was 77.5%. Baseline CIN2 and CIN3+ rates based on HPV screening were 8.6/1,000 and 6.6/1,000 respectively; 24 month rates were 0.7/1,000 and 0.4/1,000 (LBC screening). HC2 and COBAS were concordant positive for 91% of round 1 CIN2 and 98% of CIN3+. CIN3+ was significantly associated with HPV 16 (Odds Ratio [OR] 5.11; 95% confidence interval [CI] 2.30, 11.37), but not HPV 18 (OR 2.62; 95% CI 0.73, 9.49), vs. non-HPV 16/18 HPV at baseline. There was no significant association between HPV genotype and CIN2. CIN3+ was significantly more likely for high-grade (OR 5.99; 95% CI 2.53, 14.18), but not low-grade (OR 0.54; 95% CI 0.20, 1.49), vs. negative LBC. No significant association was observed between LBC grade and CIN2. HPV 16 and 18 were associated with 33% of CIN2 and 68% of CIN3+ identified at baseline.Conclusions: For hrHPV positive women, abnormal reflex LBC is appropriate for colposcopy triage. In addition, immediate referral of women with HPV 16/18 and normal cytology may allow for earlier detection of CIN2+ lesions which would not be detected until after follow-up testing. [ABSTRACT FROM AUTHOR]

BACKGROUND: Persistent infection with high risk human papillomavirus (hrHPV) types causes cervical cancer but most women who test positive are at very low risk of neoplasia. Strategies are needed which can retain high sensitivity of hrHPV testing but reduce the number of false-positives. We showed previously that a combination DNA methylation triage assay for HPV types 16, 18 and 31 and human gene EPB41L3 was useful to identify high grade cervical lesions. OBJECTIVE: Assess whether measurement of DNA methylation in HPV type 33 can improve the previous classifier. METHODS: A London colposcopy referral group of 1493 women of whom 556 (37%) had histologically-confirmed CIN (cervical intraepithelial neoplasia) 2 or 3 that included 114 HPV33 positive women with methylation measured for three L2 CpGs 5557, 5560 and 5566. Discrimination performance was assessed for the new classifier S5, built by adding HPV33 to the earlier classifier. RESULTS: HPV33 methylation measurement improved prediction among HPV33 positive women. Receiver operating characteristic analyses showed an area under the curve (AUC) for HPV33 methylation of 0.68 (95% CI 0.57-0.78). The earlier risk score was significantly improved by HPV33 methytlation (AUC = 0.82 vs 0.80;P < 0.001). For 90% sensitivity the specificity for CIN2/3 was 49% (95% CI 46-52%). CONCLUSIONS: Measurement of HPV33 DNA methylation contributes independent diagnostic information to EPB41L3 and HPV16, HPV18 and HPV31, and is superior to genotyping. Other HPV and human methylation target regions might be useful to further improve S5. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the prognostic implication of human papillomavirus (HPV) viral load in cervical cancer patients who underwent radical hysterectomy. Methods: We conducted a retrospective review of patients with stage IA2 through stage IIIA cervical carcinoma who underwent radical hysterectomy at Sun Yat-sen University Cancer Center between January 2005 and December 2009. Patients who had undergone preoperative hybrid capture 2 testing to detect HPV DNA were included. A total of 346 patients positive for HPV DNA were enrolled and stratified into two groups according to the median HPV viral load. Results: HPV viral load was significantly correlated with lymphovascular space invasion (p=0.026) and deep stromal invasion (p=0.024). However, other factors, such as age, stage, histologic grade, histologic type, lymph node metastasis, and tumor size, were not significantly associated with viral load. Low HPV viral load was correlated with poor disease-free survival in univariate analysis (p=0.037) and multivariate analysis (p=0.027). There was no significant difference in overall survival with regard to initial HPV viral load. Conclusion: Low initial HPV viral load may be a poor prognostic factor for cervical cancer patients who have undergone radical hysterectomy. [ABSTRACT FROM AUTHOR]

Testing for high-risk (hr) types of human papillomavirus (HPV) is highly sensitive as a screening test of high-grade cervical intraepithelial neoplastic (CIN2/3) disease, the precursor of cervical cancer. However, it has a relatively low specificity. Our objective was to develop a prediction rule with a higher specificity, using combinations of human and HPV DNA methylation. Exfoliated cervical specimens from colposcopy-referral cohorts in London were analyzed for DNA methylation levels by pyrosequencing in the L1 and L2 regions of HPV16, HPV18, HPV31 and human genes EPB41L3, DPYS and MAL. Samples from 1,493 hrHPV-positive women were assessed and of these 556 were found to have CIN2/3 at biopsy; 556 tested positive for HPV16 (323 CIN2/3), 201 for HPV18 (73 CIN2/3) and 202 for HPV31 (98 CIN2/3). The prediction rule included EPB41L3 and HPV and had area under curve 0.80 (95% CI 0.78-0.82). For 90% sensitivity, specificity was 36% (33-40) and positive predictive value (PPV) was 46% (43-48). By HPV type, 90% sensitivity corresponded to the following specificities and PPV, respectively: HPV16, 38% (32-45) and 67% (63-71); HPV18, 53% (45-62) and 52% (45-59); HPV31, 39% (31-49) and 58% (51-65); HPV16, 18 or 31, 44% (40-49) and 62% (59-65) and other hrHPV 17% (14-21) and 21% (18-24). We conclude that a methylation assay in hrHPV-positive women might improve PPV with minimal sensitivity loss. [ABSTRACT FROM AUTHOR]

BACKGROUND Recent proposals to lengthen the interval in cervical cancer screening highlight the importance of the accurate interpretation of screening tests. Tumor debris present in Papanicolaou (Pap) tests from women with invasive cancer is known to hamper interpretation. The current study evaluated limiting factors in Pap tests from women with invasive cervical cancer. METHODS A total of 3003 women with the spectrum of cervical lesions who had ThinPrep (Hologic Inc, Marlborough, Mass) Pap and human papillomavirus (HPV) genotyping tests performed were grouped by their most severe histologic diagnosis. Cytologic and HPV results were analyzed by cross-sectional analysis. RESULTS The unsatisfactory rate of cytology specimens from patients with cancer (3.1%) was significantly higher than those from patients with cervical intraepithelial neoplasia of type 3 or less (0.8%) ( P < .001). The percentage of samples with qualified adequacy was 34.8% in specimens from patients with cancer compared with only 3.6% from specimens from those without cancer ( P < .001). The unsatisfactory and qualified adequacy rates were higher in squamous cancers compared with adenocarcinomas. However, adenocarcinomas were identified less frequently than squamous cancers (37.0% vs 61.7%) in the Pap tests. HPV tests were positive in 84.4% of unsatisfactory cases including 8 of 9 cancer cases, although 8.5% of cancers tested negative for HPV. CONCLUSIONS Unsatisfactory and suboptimal ThinPrep Pap tests were increased in cancer cases compared with lesser histologic diagnoses. This was found to be particularly true for squamous cancers. Specimens from adenocarcinomas had fewer adequacy problems but were less frequently recognized as malignant. HPV tests were positive in the majority of unsatisfactory Pap tests in women with carcinoma, suggesting that HPV testing in women aged > 30 years can help to identify high-risk women with unsatisfactory Pap tests. Cancer (Cancer Cytopathol) 2014;122:694-701. © 2014 American Cancer Society. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of the study was to assess the effectiveness of repeat cytology with and without additional high-risk human papilloma virus (hrHPV) testing after atypical squamous cells of undetermined significance/low-grade squamous intraepithelial lesion (ASC-US/LSIL) screening results. Methods: In the Netherlands, ASC-US/LSIL is triaged by repeat cytology at 6 months or repeat cytology at 6 months with additional hrHPV testing. ASC-US/LSIL results from 13,734 screenees in 2008 were extracted from 'Dutch Pathology Registry' including cytology, histology, and/or HPV follow-up results. Proportions of compliance, repeat cytology, referral, and detected cervical intraepithelial neoplasia (CIN) were assessed. Results: With additional hrHPV testing, 46.8 % was send back to regular screening at 6 months, 28.6 % needed second repeat cytology, and 24.6 % was referred for colposcopy. Without additional hrHPV testing, this was 0.0, 76.1, and 23.9 %, respectively. With additional hrHPV testing, significantly higher proportions of persisting ASC-US/LSIL; compliance with repeat/referral advices; and histological detection of CIN0 (no CIN or cancer), CIN1, and CIN2 were found but equal proportions CIN3+. Conclusions: Additional hrHPV testing shortens follow-up without altering CIN3+ detection. Detection of CIN0, CIN1, and CIN2 was higher, presumably by hrHPV-driven biased cytology and detection bias. Restricting additional hrHPV testing to older women, reading cytology without knowledge of hrHPV status, and addition of more specific triage tests could further improve the effectiveness of additional hrHPV testing. [ABSTRACT FROM AUTHOR]

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Most uterine cervical cancers are caused by the persistent infection of the high-risk human papillomavirus (hrHPV). Thus, the hrHPV-DNA test, which examines specimens from the cervix, is the standard screening method as well as cytology in western countries. Urine sampling for the hrHPV-DNA test would be easier and help improving screening rates. This study prospectively investigated the concordance between urine and cervical hrHPV tests for patients with atypical squamous cells of undetermined significance (ASC-US) in cervical cytology. We recruited 338 women with the cytologic diagnosis of ASC-US and performed hrHPV-DNA tests to both samples from the uterine cervix and first void urine, using the Cobas 4800 system. In all hrHPV genotypes, the simple concordance rate was 90.8% (307/338) and the Kappa statistic value was 0.765, which shows substantial concordance. The positive concordance rate was 70.5% (74/105), which was the rate excluding women who had negative results in both tests. When limited to types 16 and 18, the simple concordance rate was 98.8% (334/338), and the Kappa statistical value was calculated to be 0.840, which showed almost perfect concordance. The positive concordance rate resulted in 81.8% (18/22). We conclude that the urine hrHPV-DNA test could substitute the cervical test in women with ASC-US. [ABSTRACT FROM AUTHOR]