scholarly journals Performance of HPV16/18 in Triage of Cytological Atypical Squamous Cells of Undetermined Significance

2019 ◽  
Vol 2019 ◽  
pp. 1-6
Author(s):  
Xiaoqin Cao ◽  
Shuzheng Liu ◽  
Manman Jia ◽  
Hongmin Chen ◽  
Dongmei Zhao ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Predictive Value ◽  
Statistical Tests ◽  
Predictive Values ◽  
Squamous Cells ◽  
Link Type ◽  
Hpv Test ◽  
Undetermined Significance

Context. Human papillomavirus (HPV) testing is widely used in cervical cancer screening in women; however, its efficiency in triaging women with atypical squamous cells of undetermined significance (ASC-US) needs to be validated. Objective. To evaluate the performance of HPV16/18 in the triage of women with ASC-US. Methods. Women presenting for routine cervical cancer screening had cervical specimens collected, with which both liquid-based cytology (LBC) and hrHPVs were examined; those with ASC-US cytology underwent colposcopy. HPV16/18 and 12 other types were tested with domestic hybridization capture and chemiluminescence signal amplification (DH3). Performance characteristics of HPV test (sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) for identification of cervical intraepithelium neoplasma (CIN) grade 2 or worse (CIN2+), and CIN grade 3 or worse (CIN3+)) were determined using standard statistical tests. Results. 317 women with ASC-US were eligible for the study. HrHPV prevalence was 15.77% (50/317); HPV16/18 prevalence was 3.61% (20/317). Sensitivity and specificity of HPV16/18 for detection of CIN 2+ were 64.71% and 97% and 64.29% and 96.37% for detection of CIN 3+, respectively. The positive predictive values (PPVs) and negative predictive values (NPVs) of HPV16/18 were 55.00% and 97.98% for CIN2+ and 45.00% and 98.32% for CIN3+, respectively. Conclusion. HPV16/18 can be considered as an effective method to triage women with ASC-US as its good clinical performance. Trial Registration. This trial is registered with Henan Cancer Hospital Medical Ethics Committee on July 5, 2016 (http://www.anti-cancer.com.cn), with registry no.: 2016037.

Identification of ideal strategy of cervical cancer screening in Japan based on Fukui cervical cancer screening study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e17025-e17025
Author(s):  
Tetsuji Kurokawa ◽  
Akiko Shinagawa ◽  
Yoko Chino ◽  
Motohiro Kobayashi ◽  
Yoshio Yoshida
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Positive Predictive Value ◽  
Cervical Cancer Screening ◽  
Predictive Value ◽  
Screening Method ◽  
Hpv Testing ◽  
Abnormal Cytology ◽  
Predictive Values ◽  
Hpv Status

e17025 Background:The estimated age-standardized incidence rate for cervical cancer is higher in Japan than in North America and the UK. It is important to improve cancer screening. The introduction of HPV testing with cytology for triage of those that test positive for cervical cancer screening has been challenging. The Fukui Cervical Cancer Screening (FCCS) study was designed to determine the best cervical cancer screening method in the Japanese population. We performed a subanalysis using baseline data of FCCS study to determine the performance of cytology, the human papillomavirus (HPV) testing and cotesting with cytology and HPV testing, and to evaluate whether the stratification of HPV16, HPV18, and 12 other hrHPV types appropriately balances risks and harms in the Japanese cancer screening population. Methods:The study enrolled 7,584 women aged 25 years or older undergoing routine screening. All women underwent liquid-based cytology (LBC) and cobas HPV testing. Women with abnormal cytology regardless of the HPV status, women with positive hrHPV results regardless of cytology results, and women randomly selected from among those with normal cytology and negative hrHPV results were referred for colposcopy. Results:The prevalence of hrHPV, HPV16, and HPV18 was 6.8%, 1.2%, and 0.5%, respectively. The estimated sensitivities for cervical intraepithelial neoplasia (CIN) 2 or worse for cytology, HPV testing, and cotesting with cytology and HPV testing were 71%, 92%, and 100%, respectively. The estimated positive predictive values for cytology, HPV testing, and cotesting with cytology and HPV testing were 33%, 21% and 21%, respectively. Using a strategy whereby those with abnormal cytology or positive HPV16 genotype undergo colposcopy and biopsy results in a sensitivity of 85% and a positive predictive value of 33%. This strategy results in improved sensitivity while at the same time maintains the positive predictive value compared to screening with cytology alone. Conclusions:Baseline data from the FCCS study suggests that strategy of using colposcopy for women with abnormal cytology and/or HPV16 positivity appropriately balances risks and harms for Japanese women. Clinical trial information: UMIN000025977.

A Clinical Trial to Verify the Efficiency of the LC-1000 Exfoliative Cell Analyzer as a New Method of Cervical Cancer Screening

2019 ◽  
Vol 63 (5) ◽  
pp. 391-400 ◽  
Author(s):  
Masaru Nakamura ◽  
Masatugu Ueda ◽  
Takashi Iwata ◽  
Kazushige Kiguchi ◽  
Yoshiki Mikami ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Sensitivity And Specificity ◽  
Qualitative Assessment ◽  
Proliferation Index ◽  
Tree Model ◽  
Predictive Values ◽  
Hpv Test ◽  
Cell Analyzer

Objective: The exfoliative cell analyzer, LC-1000 (Sysmex Corporation, Japan), is a medical device that presents the cell proliferation index and 23 research parameters as indicators of cellular proliferative potential. The objective was to evaluate the clinical usability of qualitative assessment by LC-1000 compared with cytology, the human papillomavirus (HPV) test, and histology as gold standard. Study Design: Women that visited 3 sites between July 2015 and March 2017 were registered. The primary endpoint in this study was the comparison between LC-1000 measurement and HPV test for sensitivity and specificity for cervical intraepithelial neoplasia 2+ (CIN2+). A tree model algorithm was newly constructed by a statistical method and its relationship with histological results was evaluated. Results: The sensitivity and specificity of LC-1000 were 78.3 and 74.1%, while those of the HPV test were 94.7 and 85.4%, respectively. A tree model comprising five categories was constructed. The proportion of advanced lesions was higher with the change in the rank classification results from 1 to 5. The positive predictive values of CIN2+ in the categories 4 and 5 were high. Despite the small number of subjects, cancer was undetected in categories 1 and 2. In addition, the comparison with follow-up results in 19 women assessed as CIN1 showed that the rate of progression in the categories 3–5 was 50% (7/14); progression in the categories 1 and 2 was 0% (0/5). Conclusions: LC-1000 may be useful for cervical cancer screening as an index to qualitatively evaluate CIN and cancer based on the changes in characteristics of cells.

The Pittsburgh Cervical Cancer Screening Model: A Risk Assessment Tool

2010 ◽  
Vol 134 (5) ◽  
pp. 744-750
Author(s):  
R. Marshall Austin ◽  
Agnieszka Onisko ◽  
Marek J. Druzdzel
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Disease Risk ◽  
Hpv Vaccination ◽  
Dynamic Bayesian Network ◽  
Adenocarcinoma In Situ ◽  
Test Results ◽  
Hpv Test

Abstract Context.—Evaluation of cervical cancer screening has grown increasingly complex with the introduction of human papillomavirus (HPV) vaccination and newer screening technologies approved by the US Food and Drug Administration. Objective.—To create a unique Pittsburgh Cervical Cancer Screening Model (PCCSM) that quantifies risk for histopathologic cervical precancer (cervical intraepithelial neoplasia [CIN] 2, CIN3, and adenocarcinoma in situ) and cervical cancer in an environment predominantly using newer screening technologies. Design.—The PCCSM is a dynamic Bayesian network consisting of 19 variables available in the laboratory information system, including patient history data (most recent HPV vaccination data), Papanicolaou test results, high-risk HPV results, procedure data, and histopathologic results. The model's graphic structure was based on the published literature. Results from 375 441 patient records from 2005 through 2008 were used to build and train the model. Additional data from 45 930 patients were used to test the model. Results.—The PCCSM compares risk quantitatively over time for histopathologically verifiable CIN2, CIN3, adenocarcinoma in situ, and cervical cancer in screened patients for each current cytology result category and for each HPV result. For each current cytology result, HPV test results affect risk; however, the degree of cytologic abnormality remains the largest positive predictor of risk. Prior history also alters the CIN2, CIN3, adenocarcinoma in situ, and cervical cancer risk for patients with common current cytology and HPV test results. The PCCSM can also generate negative risk projections, estimating the likelihood of the absence of histopathologic CIN2, CIN3, adenocarcinoma in situ, and cervical cancer in screened patients. Conclusions.—The PCCSM is a dynamic Bayesian network that computes quantitative cervical disease risk estimates for patients undergoing cervical screening. Continuously updatable with current system data, the PCCSM provides a new tool to monitor cervical disease risk in the evolving postvaccination era.

scholarly journals Accuracy of Visual Tests for Primary Cervical Cancer Screening in Rural Nepal

2018 ◽  
Vol 56 (214) ◽  
pp. 917-923
Author(s):  
Niresh Thapa ◽  
Muna Maharjan ◽  
Girishma Shrestha ◽  
Narayani Maharjan ◽  
Deborah Lindell ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Negative Predictive Value ◽  
Cervical Cancer Screening ◽  
Predictive Value ◽  
Odds Ratio ◽  
Screening Program ◽  
Diagnostic Odds Ratio ◽  
Screening Tests ◽  
Resource Setting

Introduction: In Nepal, cervical cancer is the most common female cancer. Unfortunately, there is no uniform effective screening system available all around the country. The objective of this study is to evaluate the cytology, Visual Inspection with Acetic Acid and with Lugol’s Iodine alone or in combination to detect a pre-cancerous lesion in rural Nepal.Methods: It is an analytical cross-sectional study. Convenience sampling technique was used to select participants who were apparently healthy, married, non- pregnant women of aged 20-65 years for cervical cancer screening program. Screening tests were performed on all eligible women (n=2143) after socio-demographic and reproductive health data collection. A biopsy was applied as a gold standard test. Cross-tabulations were used to describe the test sensitivity, specificity, positive predictive value, and negative predictive value at a 95% confidence interval. Diagnostic odds ratio was also calculated. Results: A majority, 2143 (94%), of women accepted and participated in this study. The sensitivity vs specificity of cytology, VIA, and VILI was 57.1% vs 98.3%, 71.4% vs 88.8% and 78.6% vs 85.1%, and of the co-testing of ‘Both positive VIA and VILI’ and ‘Either positive VIA or VILI’ was 64.3% vs 85.7% and 90.1% vs 83.7% respectively. Negative predictive value of all tests exceeded 99.7%. Cytology had the highest Diagnostic odds ratio (64.9), followed by the co-test ‘Either positive VIA or VILI’ (27.7).Conclusions: Cervical cancer screening by co-testing ‘Either positive VIA or VILI’ is more useful than cytology; VIA and or VILI are easy, safe, feasible and well-accepted tests in a low resource setting, Nepal.

scholarly journals Evaluating smartphone strategies for reliability, reproducibility, and quality of VIA for cervical cancer screening in the Shiselweni region of Eswatini: A cohort study

PLoS Medicine ◽  
2020 ◽  
Vol 17 (11) ◽  
pp. e1003378
Author(s):  
Ramin Asgary ◽  
Nelly Staderini ◽  
Simangele Mthethwa-Hleta ◽  
Paola Andrea Lopez Saavedra ◽  
Linda Garcia Abrego ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Predictive Value ◽  
Kappa Statistic ◽  
World Health ◽  
Operating Characteristics ◽  
Humanitarian Settings ◽  
The Impact

Background Cervical cancer is among the most common preventable cancers with the highest morbidity and mortality. The World Health Organization (WHO) recommends visual inspection of the cervix with acetic acid (VIA) as cervical cancer screening strategy in resource-poor settings. However, there are barriers to the sustainability of VIA programs including declining providers’ VIA competence without mentorship and quality assurances and challenges of integration into primary healthcare. This study seeks to evaluate the impact of smartphone-based strategies in improving reliability, reproducibility, and quality of VIA in humanitarian settings. Methods and findings We implemented smartphone-based VIA that included standard VIA training, adapted refresher, and 6-month mHealth mentorship, sequentially, in the rural Shiselweni region of Eswatini. A remote expert reviewer provided diagnostic and management feedback on patients’ cervical images, which were reviewed weekly by nurses. Program’s outcomes, VIA image agreement rates, and Kappa statistic were compared before, during, and after training. From September 1, 2016 to December 31, 2018, 4,247 patients underwent screening; 247 were reviewed weekly by a VIA diagnostic expert. Of the 247, 128 (49%) were HIV–positive; mean age was 30.80 years (standard deviation [SD]: 7.74 years). Initial VIA positivity of 16% (436/2,637) after standard training gradually increased to 25.1% (293/1,168), dropped to an average of 9.7% (143/1,469) with a lowest of 7% (20/284) after refresher in 2017 (p = 0.001), increased again to an average of 9.6% (240/2,488) with a highest of 17% (17/100) before the start of mentorship, and dropped to an average of 8.3% (134/1,610) in 2018 with an average of 6.3% (37/591) after the start of mentorship (p = 0.019). Overall, 88% were eligible for and 68% received cryotherapy the same day: 10 cases were clinically suspicious for cancer; however, only 5 of those cases were confirmed using punch biopsy. Agreement rates with the expert reviewer for positive and negative cases were 100% (95% confidence interval [CI]: 79.4% to 100%) and 95.7% (95% CI: 92.2% to 97.9%), respectively, with negative predictive value (NPV) (100%), positive predictive value (PPV) (63.5%), and area under the curve of receiver operating characteristics (AUC ROC) (0.978). Kappa statistic was 0.74 (95% CI; 0.58 to 0.89); 0.64 and 0.79 at 3 and 6 months, respectively. In logistic regression, HIV and age were associated with VIA positivity (adjusted Odds Ratio [aOR]: 3.53, 95% CI: 1.10 to 11.29; p = 0.033 and aOR: 1.06, 95% CI: 1.0004 to 1.13; p = 0.048, respectively). We were unable to incorporate a control arm due to logistical constraints in routine humanitarian settings. Conclusions Our findings suggest that smartphone mentorship provided experiential learning to improve nurses’ competencies and VIA reliability and reproducibility, reduced false positive, and introduced peer-to-peer education and quality control services. Local collaboration; extending services to remote populations; decreasing unnecessary burden to screened women, providers, and tertiary centers; and capacity building through low-tech high-yield screening are promising strategies for scale-up of VIA programs.

PP62 Cost-Effectiveness Of Cervical Cancer Screening In Estonia

2019 ◽  
Vol 35 (S1) ◽  
pp. 49-49
Author(s):  
Triin Võrno ◽  
Kaja-Triin Laisaar ◽  
Terje Raud ◽  
Kai Jõers ◽  
Doris Meigas-Tohver ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cost Effectiveness ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Screening Program ◽  
Pap Test ◽  
Cancer Screening Program ◽  
Hpv Test ◽  
Cervical Cancer Screening Program ◽  
The Cost

IntroductionIn Estonia, organized cervical cancer screening program is targeted at women aged 30–55(59) years and Pap-tests are taken every five years. Since cervical cancer is associated with human papillomavirus (HPV), a number of countries have introduced the HPV-test as the primary method of screening. The objective of this study was to evaluate the cost-effectiveness of organized cervical cancer screening program in Estonia by comparing HPV- and Pap-test based strategies.MethodsFor the cost-effectiveness analysis, a Markov cohort model was developed. The model was used to estimate costs and quality-adjusted life-years (QALYs) of eight screening strategies, varying the primary screening test and triage scenarios, upper age limit of screening, and testing interval. Incremental cost-effectiveness ratios (ICERs) were calculated in comparison to current screening practice as well as to the next best option. Sensitivity analysis was performed by varying one or more similar parameter(s) at a time, while holding others at their base case value. The analysis was performed from the healthcare payer perspective adopting a five percent annual discount rate for both costs and utilities.ResultsIn the base-case scenario, ICER for HPV-test based strategies in comparison to the current screening practice was estimated at EUR 8,596–9,786 per QALY. For alternative Pap-test based strategies ICER was estimated at EUR 2,332–2,425 per QALY. In comparison to the next best option, HPV-test based strategies were dominated by Pap-test based strategies. At the cost-effectiveness threshold of EUR 10,000 per QALY Pap-testing every three years would be the cost-effective strategy for women participating in the screening program from age 30 to 63 (ICER being EUR 3,112 per QALY).ConclusionsDecreasing Pap-test based screening interval or changing to HPV-test based screening can both improve the effectiveness of cervical cancer screening program in Estonia, but based on the current cost-effectiveness study Pap-test based screening every three years should be preferred.

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