The Application of DNA Ploidy Analysis in Large-Scale Population Screening for Cervical Cancer

2021 ◽  
pp. 1-8
Author(s):  
Yulin Guo ◽  
Qiuzi Peng ◽  
Ying Wang ◽  
Lu Li ◽  
Xiaoyun Yi ◽  
...  

<b><i>Objective:</i></b> The objective of this study was to evaluate the application of DNA ploidy analysis in large-scale population screening for cervical cancer. <b><i>Methods:</i></b> From March 2016 to March 2019, eligible subjects were enrolled and recommended to undergo DNA ploidy analysis, the ThinPrep cytology test (TCT), and high-risk human papillomavirus (hrHPV) detection concurrently. Patients with positive results were recommended for colposcopy, and biopsy diagnosis was regarded as the “gold standard.” We compared the test efficiencies of the 3 methods and compared the efficiency and accuracy of the TCT in our hospital and the “2-cancer screening” project in Hubei Province during the same period. <b><i>Results:</i></b> Among 20,574 women, the positive rates of DNA ploidy analysis, cytology, and hrHPV testing were 4.01%, 4.71%, and 16.28%, respectively. The sensitivities of these methods for screening for grade 2+ cervical intraepithelial neoplasia were 0.70, 0.68, and 0.96, and their specificities were 0.79, 0.82, and 0.45, respectively. On comparing DNA ploidy analysis with the TCT, there was no significant difference in the sensitivity, specificity, positive predictive value, negative predictive value, and missed diagnosis rate. In opportunistic screening and the 2-cancer screening project, the positive rates of cytology were 4.71% and 2.87%, respectively. And the efficiency and accuracy of the TCT in opportunistic screening were higher than in the 2-cancer screening project. <b><i>Conclusion:</i></b> Therefore, DNA ploidy analysis, which is of low-cost and does not depend on cytopathologists, can replace cytology and be applied in large-scale population screening for cervical cancer.

2019 ◽  
Vol 2019 ◽  
pp. 1-6
Author(s):  
Xiaoqin Cao ◽  
Shuzheng Liu ◽  
Manman Jia ◽  
Hongmin Chen ◽  
Dongmei Zhao ◽  
...  

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.


2018 ◽  
Vol 56 (214) ◽  
pp. 917-923
Author(s):  
Niresh Thapa ◽  
Muna Maharjan ◽  
Girishma Shrestha ◽  
Narayani Maharjan ◽  
Deborah Lindell ◽  
...  

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.


2020 ◽  
Author(s):  
Lucy Muthoni Mwai ◽  
Mutinda C. Kyama ◽  
Caroline W. Ngugi ◽  
Edwin Walong

AbstractCervical cancer caused mainly by high risk human papillomavirus (HPV) 16 and 18 strains is the second most prevalent cancer of women in Kenya. It is often diagnosed late when treatment is difficult due to very low percentage of women attending screening thus, mortalities remain high. The most available tests in low-and-middle-income countries (LMICs) have relatively low specificity, low sensitivity, require a laboratory setting and huge technical and financial support not readily available. HPV 16/18 E6 oncoprotein has been identified as a potential biomarker in a more specific early diagnosis of cervical cancer. This retrospective cross-sectional study developed a paper-based nanokit with enhanced detection of HPV 16/18 E6 oncoprotein for cervical cancer screening. The HRP labelled antibodies HPV 16 E6/18 E6-HRP (CP15) passively conjugated to citrate stabilized 20nm gold nanoparticles were evaluated for immune sensing mechanism using a recombinant viral HPV E6 protein. The diagnostic accuracy was evaluated using 50 tissue lysates from formalin fixed paraffin embedded cervical biopsy, including control (n=10), Mild Dysplasia (n=10), Cervical intraepithelial neoplasia 3 (CIN3) (n=10), Cervical intraepithelial neoplasia 4 (CIN4) (n=10) and invasive carcinoma (n=10). The molecular technique used was dot blot molecular assay. A positive result was generated by catalytic oxidation of peroxidase enzyme on 3,3’,5,5’-Tetramethylbenzidine (TMB) substrate. The gold nanoparticles were used to enhance the signal produced by peroxidase activity of horseradish peroxidase (HRP) enzyme giving a more sensitive assay as compared to use of non-conjugated antibody. This study provides a significantly high and reliable diagnostic accuracy for precancerous and cancerous lesions with a sensitivity of 90%, a specificity of 90%, a likelihood ratio for positive and negative tests as 9:1 and 1:9 respectively, a Positive Predictive Value of 97.3% and a Negative Predictive Value of 69.2%. This study avails a sensitive, rapid test using paper-based nanotechnology which can be utilised in community-based screening outreaches particularly in low- and middle-income countries.


PLoS Medicine ◽  
2020 ◽  
Vol 17 (11) ◽  
pp. e1003378
Author(s):  
Ramin Asgary ◽  
Nelly Staderini ◽  
Simangele Mthethwa-Hleta ◽  
Paola Andrea Lopez Saavedra ◽  
Linda Garcia Abrego ◽  
...  

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.


1973 ◽  
Vol 45 (3) ◽  
pp. 411-415 ◽  
Author(s):  
R. Fraser ◽  
Sheena Guest ◽  
Jessie Young

1. Two techniques for estimating plasma aldosterone concentration are compared by means of repeated assays of a plasma pool and also by analysis of a wide range of plasma samples. 2. No significant difference was found in the results obtained by the methods. Radioimmunoassay required only one tenth of the volume of plasma needed for the double-isotope derivative method. 3. Its rapidity and relative inexpensiveness makes radioimmunoassay at present the most suitable technique for large-scale population screening.


2020 ◽  
Vol 2 (5) ◽  
pp. e210-e211
Author(s):  
Ioana Alina Cristea ◽  
Florian Naudet

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e17025-e17025
Author(s):  
Tetsuji Kurokawa ◽  
Akiko Shinagawa ◽  
Yoko Chino ◽  
Motohiro Kobayashi ◽  
Yoshio Yoshida

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.


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