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.

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.

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.

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.

Dynamics of Human Papillomavirus and Cervical Cancer Screening

2011 ◽  
Vol 07 (04) ◽  
pp. 243
Author(s):  
Channa E Schmeink ◽  
Leon FAG Massuger ◽  
Willem JG Melchers ◽  
Ruud LM Bekkers ◽  
◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Cervical Carcinoma ◽  
Participation Rate ◽  
Productive Infection ◽  
High Grade ◽  
Screening Guidelines ◽  
Hpv Test

Primary screening based on detection of human papillomavirus (HPV) has proved to be more sensitive than cytology for the detection of high-grade cervical intraepithelial neoplasia (CIN). Self-sampling for specimen collection may also improve the participation rate, especially in the non-responder group. However, HPV is highly prevalent and therefore HPV detection has a lower specificity in cervical cancer screening than cytology. In addition to the clinically validated HPV test, HPV dynamics should be taken into account. It is important to identify women with a chronic productive infection likely to cause, or to already have caused, high-grade CIN or cervical carcinoma, and to limit overtreatment of women with a transient infection. Furthermore, the introduction of the HPV vaccine is likely to lower the incidence of CIN and cervical carcinoma, which will lower the positive predictive value of cervical cancer screening. This potential impact needs to be taken into account when planning for future screening guidelines.

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.

scholarly journals Clinical validation of Anyplex™ II HPV HR Detection according to the guidelines for HPV test requirements for cervical cancer screening

2016 ◽  
Vol 76 ◽  
pp. 36-39 ◽  
Author(s):  
A.T. Hesselink ◽  
R. Sahli ◽  
J. Berkhof ◽  
P.J.F. Snijders ◽  
M.L. van der Salm ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Clinical Validation ◽  
Hpv Test ◽  
Test Requirements

scholarly journals Evaluation of the SureX HPV Genotyping Test for the Detection of High-Risk HPV in Cervical Cancer Screening

2020 ◽  
Author(s):  
Baojun Wei ◽  
Ping Mei ◽  
Shengkai Huang ◽  
Xueting Yu ◽  
Tong Zhi ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
High Risk ◽  
Cervical Cancer Screening ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Agreement Rate ◽  
Hpv Genotyping ◽  
Hpv Test ◽  
Hpv Types ◽  
High Risk Hpv

Abstract Background: The SureX HPV genotyping test (SureX HPV test), which targets the human papillomavirus (HPV) E6/E7 genes was compared with the Cobas 4800 and Venus HPV tests for detecting 14 high-risk HPV (HR-HPV) types in clinical referral and follow-up patients to evaluate its value for cervical cancer screening.Methods: Two different populations were enrolled in the study. The first population comprised 185 cases and was used for comparing the SureX HPV test (Health, China) with the Cobas 4800 test (Roche, USA). The second population comprised 290 cases and was used for comparing the SureX HPV test (Health, China) with the Venus HPV test (Zhijiang, China). Polymerase chain reaction (PCR) sequencing was performed for further confirmation of discordant results.Results: In the first population, the overall agreement rate was 95.3% for 14 High-Risk HPV types. Eight discordant cases were confirmed by PCR sequencing, which showed that the agreement rates were 75.0% between the SureX HPV test and PCR sequencing and 25.0% between the Cobas 4800 test and PCR sequencing (P<0.01). In the second population, the overall agreement rate was 94.5%. Thirteen discordant cases were confirmed by PCR sequencing, which showed that the agreement rates were 76.9% between the SureX HPV test and PCR sequencing and 23.1% between the Venus HPV test and PCR sequencing (P<0.01). With cervical intraepithelial neoplasia grade 2+ (CIN2+) as the reference standard, the sensitivity values of the SureX HPV test and the Venus HPV test were 93.5% and 92.0%, (P>0.05), while the specificity values were 43.3% and 46.7%, respectively (P>0.05).Conclusion: The SureX HPV test had good consistency with both the Cobas 4800 and Venus HPV tests for 14 HR-HPV types. In addition, it avoided some false negatives and false positives. Therefore, the SureX HPV test can be used for cervical cancer screening.

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