scholarly journals Evaluation of the Clinical Performance of the HPV-Risk Assay Using the VALGENT-3 Panel

2017 ◽  
Vol 55 (12) ◽  
pp. 3544-3551 ◽  
Author(s):  
N. J. Polman ◽  
A. Oštrbenk ◽  
L. Xu ◽  
P. J. F. Snijders ◽  
C. J. L. M. Meijer ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Clinical Performance ◽  
Intraepithelial Neoplasia ◽  
Relative Sensitivity ◽  
Hpv Testing ◽  
Abnormal Cytology ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Relative Specificity

ABSTRACTHuman papillomavirus (HPV) testing is increasingly being incorporated into cervical cancer screening. The Validation of HPV Genotyping Tests (VALGENT) is a framework designed to evaluate the clinical performance of various HPV tests relative to that of the validated and accepted comparator test in a formalized and uniform manner. The aim of this study was to evaluate the clinical performance of the HPV-Risk assay with samples from the VALGENT-3 panel and to compare its performance to that of the clinically validated Hybrid Capture 2 assay (HC2). The VALGENT-3 panel comprises 1,300 consecutive samples from women participating in routine cervical cancer screening and is enriched with 300 samples from women with abnormal cytology. DNA was extracted from original ThinPrep PreservCyt medium aliquots, and HPV testing was performed using the HPV-Risk assay by investigators blind to the clinical data. HPV prevalence was analyzed, and the clinical performance of the HPV-Risk assay for the detection of cervical intraepithelial neoplasia grade 3 or worse (CIN3+) and CIN2 or worse (CIN2+) relative to the performance of HC2 was assessed. The sensitivity of the HPV-Risk assay for the detection of CIN3+ was similar to that of HC2 (relative sensitivity, 1.00; 95% confidence interval [CI], 0.95 to 1.05;P= 1.000), but the specificity of the HPV-Risk assay was significantly higher than that of HC2 (relative specificity, 1.02; 95% CI, 1.01 to 1.04;P< 0.001). For the detection of CIN2+, similar results were obtained, with the relative sensitivity being 0.98 (95% CI, 0.93 to 1.02;P= 0.257) and the relative specificity being 1.02 (95% CI, 1.01 to 1.03;P< 0.001). The performance of the HPV-Risk assay for the detection of CIN3+ and CIN2+ was noninferior to that of HC2, with allPvalues being ≤0.006. In conclusion, the HPV-Risk assay demonstrated noninferiority to the clinically validated HC2 by the use of samples from the VALGENT-3 panel for test validation and comparison.

scholarly journals Clinical Evaluation of INNO-LiPA HPV Genotyping EXTRA II Assay Using the VALGENT Framework

2018 ◽  
Vol 19 (9) ◽  
pp. 2704 ◽  
Author(s):  
Lan Xu ◽  
Elizaveta Padalko ◽  
Anja Oštrbenk ◽  
Mario Poljak ◽  
Marc Arbyn
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Linear Array ◽  
Abnormal Cytology ◽  
Specific Detection ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Hpv Genotyping ◽  
Clinical Accuracy ◽  
Hpv Types

In this diagnostic test validation study, we assessed the clinical accuracy and HPV genotyping performance of the INNO-LiPA HPV Genotyping Extra II (INNO-LiPA) within the VALGENT-3 framework. VALGENT is designed to assess the analytical and clinical performance of HPV tests with genotyping capacity. The VALGENT-3 panel comprised 1300 consecutive cervical cell specimens enriched with 300 samples with abnormal cytology obtained from women attending the Slovenian cervical cancer screening programme. The INNO-LiPA allows type-specific detection of 32 HPV types; however, for the clinical accuracy assessment, we considered it as high-risk (hr)HPV positive when at least one of the following HPV types was present: HPV16, HPV18, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV56, HPV58, HPV59, and HPV68. Clinical accuracy for detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) was compared between INNO-LiPA and Hybrid Capture 2 (HC2), which is a standard comparator test for HPV tests used in cervical cancer screening. In addition, hrHPV and type-specific detection HPV types were compared between INNO-LiPA and Linear Array HPV Genotyping Test (Linear Array). The prevalence of hrHPV determined by INNO-LiPA was 17.1% (95% CI, 15.0–19.2%) in the screening population. HrHPV testing with INNO-LiPA had a sensitivity for CIN2+ of 96.9% (95% CI, 92.1–99.1%) which was non-inferior to HC2 (relative sensitivity of 1.01; 95% CI, 0.97–1.04; pn.inf = 0.0002) and a specificity for ≤CIN1 of 85.3% (95% CI, 83.2–87.3%) which was inferior to HC2 (relative specificity of 0.95; 95% CI, 0.93–0.97; pn.inf = 0.9998). Genotyping agreement between INNO-LiPA and Linear Array was excellent for hrHPV, HPV16, HPV18, HPV35, HPV45, HPV58 and HPV59, but good or fair for other HPV types. To conclude, INNO-LiPA demonstrated non-inferior clinical sensitivity but lower specificity compared to HC2 in addition to excellent concordance compared to Linear Array for hrHPV and some genotypes.

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 Screening participation after a false positive result in organized cervical cancer screening: a nationwide register-based cohort study

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Pernille Thordal Larsen ◽  
Susanne Fogh Jørgensen ◽  
Mette Tranberg ◽  
Sisse Helle Njor
Keyword(s):  
Cervical Cancer ◽  
Cohort Study ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
False Positive ◽  
Intraepithelial Neoplasia ◽  
Cervical Cytology ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Screening Participation ◽  
Cancer Screening Participation

Abstract Our aim was to investigate whether receiving a false positive (FP) cervical cytology result affected subsequent cervical cancer screening participation. This Danish nationwide register-based cohort study included 502,380 women aged 22.5–45 attending cervical cancer screening in 2012–2014 with a normal (n = 501,003) or FP (n = 1,377) cytology screening result. A FP result was defined as a cervical cytology showing high grade cytological abnormalities followed by a normal or ‘Cervical Intraepithelial Neoplasia grade 1’ biopsy result. Women were categorized as subsequent participants if they had a cervical cytology within 24–42 months after their last screening or surveillance test. We compared subsequent participation among women with a normal versus a FP result, using odds ratios including 95% confidence intervals. Participation was slightly higher among women with FP results than among women with normal results (71.5% vs. 69.2%, p = 0.058). After adjustment for age and screening history, women with FP results participated significantly more than women with normal results (OR: 1.19, 95% CI 1.06–1.35). Women receiving a FP result did not participate less in subsequent cervical cancer screening than women receiving a normal result. In fact, the use of opportunistic screening seemed to be increased among women receiving a FP result.

scholarly journals Is Primary HPV with Secondary p16/Ki67 Dual-Stain an Alternative HSIL-Risk Detection Strategy in Cervical Cancer Screening for Women under 30 Years?

Diagnostics ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. 2012
Author(s):  
Martyna Trzeszcz ◽  
Maciej Mazurec ◽  
Robert Jach ◽  
Karolina Mazurec ◽  
Zofia Jach ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Age Groups ◽  
Intraepithelial Neoplasia ◽  
Screening Strategy ◽  
Screening Tests ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Predictive Values ◽  
Age Range

Recently, cervical cancer rates elevation has been noted in women aged 20–39 years in regions with a very high human development index (HDI). The onset of cancer elevation rates is observed in the age range of 25–29 years, which should necessitate effective precancer screening in younger age groups, including those <25 years. From 30.066 liquid-based screening tests results (n = 30.066), 3849 liquid-based cytology, 1321 high-risk human papillomavirus (HRHPV) and 316 p16/Ki67 performed in women <30 years were selected. Performance characteristics were calculated for three screening models: primary HRHPV with p16/Ki67 triage, primary cytology with reflex HPV and primary cytology alone. Primary HRHPV with p16/Ki67 triage was significantly more sensitive in high-grade squamous intraepithelial lesion quantified with cervical intraepithelial neoplasia grade 2 or worse [HSIL(CIN2+)] detection than cytology with reflex HRHPV and cytology alone (83.3% vs. 70.8%/45.8%) and had significantly higher diagnostic predictive values (PPV:29.4%/21.3%/22.9%; NPV:91.7%/82.9%/82.2%, respectively at CIN2+ threshold). The number of colposcopies per HSIL(CIN2+) detection indices was 3.4, 4.7 and 4.4, respectively. Primary HPV testing in women <30 years with p16/Ki67 triage of HPV-positive cases might be an effective cervical cancer screening strategy for HSIL(CIN2+) detection with superior diagnostic performance when compared with primary cytology-based models. Women <25 years might also benefit from an introduction to a more sensitive screening approach.

PERFORMANCE OF SMARTPHONE-BASED DIGITAL IMAGES FOR CERVICAL CANCER SCREENING IN A LOW-RESOURCE CONTEXT

2018 ◽  
Vol 34 (3) ◽  
pp. 337-342 ◽  
Author(s):  
Phuong Lien Tran ◽  
Caroline Benski ◽  
Manuela Viviano ◽  
Patrick Petignat ◽  
Christophe Combescure ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Sensitivity And Specificity ◽  
Digital Images ◽  
Healthcare Providers ◽  
Intraepithelial Neoplasia ◽  
Histopathological Diagnosis ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
Low Resource

Objectives:Colposcopes are expensive, heavy, and need specialized technical service, which may outreach the capacity of low-resource settings. Our aim was to assess the performance of smartphone-based digital images for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+).Methods:Human papillomavirus (HPV)-positive women recruited through a cervical cancer screening campaign had VIA/VILI assessment (visual inspection after application of acetic acid/lugol's iodine). Cervical digital images were captured with a smartphone camera, randomly coded with no prior selection and distributed on an online database (Google Forms) for evaluation. Healthcare providers were invited to evaluate the images and identify CIN2+. The gold standard was the histopathological diagnosis. The sensitivity and specificity for the detection of CIN2+ was assessed for each reader and reported with the 95 percent confidence interval (Clopper-Pearson method).Results:One hundred twenty-five consecutive HPV-positive women were included, with 19 CIN2+ (15.2 percent). Forty-five gynecologists completed the assessment, one-third were considered as experts (>50 colposcopies) and two-thirds as novices (<50 colposcopies). The sensitivity and specificity for CIN 2+ detection was 71.3 percent (67.0–75.7 percent) and 62.4 percent (57.5–67.4 percent), respectively. The performance of novices and experts was similar. The readers assessed 73.1 percent of images as acceptable for diagnostic.Conclusion:Smartphone-based digital images, with its high portability, have a great potential for the diagnosis of CIN2+ in low-resource context.

scholarly journals Feasibility and Acceptability of Smartphone-Based Cervical Cancer Screening Among HIV-Positive Women in Western Kenya

2021 ◽  
pp. 686-693
Author(s):  
Chemtai Mungo ◽  
Cirilus Ogollah Osongo ◽  
Jeniffer Ambaka ◽  
Magdalene A. Randa ◽  
Benard Samba ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Intraepithelial Neoplasia ◽  
Screening Methods ◽  
Cervical Intraepithelial Neoplasia Grade ◽  
High Quality ◽  
Middle Income ◽  
Western Kenya ◽  
Low And Middle Income

PURPOSE Adjunct cervical cancer screening methods are under evaluation to improve the diagnostic accuracy of human papillomavirus (HPV)-based screening in low- and middle-income countries. We evaluated the feasibility and acceptability of smartphone-based cervicography among HPV-positive women living with HIV (WLWH) in Western Kenya. METHODS HPV-positive WLWH of 25-49 years of age enrolled in a clinical trial (ClinicalTrials.gov identifier: NCT04191967 ) had digital images of the cervix taken using a smartphone by a nonphysician provider following visual inspection with acetic acid. All participants had colposcopy-directed biopsy before treatment. Cervical images were evaluated by three off-site colposcopists for quality, diagnostic utility, and assigned a presumed diagnosis. We determined the proportion of images rates as low, medium, or high quality, interobserver agreement using Cohen’s Kappa statistic, and the off-site colposcopist’s sensitivity and specificity for diagnosis of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared with histopathology. Acceptability was evaluated using a questionnaire. RESULTS One hundred sixty-four HPV-positive WLWH underwent cervicography during the study period. Mean age was 37.3 years. Images from the first 94 participants were evaluated by off-site colposcopists, with a majority (70.9%) rated as high quality. Off-site colposcopists had a sensitivity ranging from 21.4% (95% CI, 0.06 to 0.43) to 35.7% (95% CI, 0.26 to 0.46) and a specificity between 85.5% (95% CI, 0.81 to 0.90) to 94.9% (95% CI, 0.92 to 0.98) for diagnosis of CIN2+ based compared with histopathology. The majority of women, 99.4%, were comfortable having an image of their cervix taken as part of screening. CONCLUSION Cervicography by a nonphysician provider as an adjunct to HPV-based screening among WLWH in a low- and middle-income country setting is feasible and acceptable. However, low sensitivity for diagnosis of CIN2+ by off-site expert colposcopists highlights the limitations of cervicography.

scholarly journals Clinical Performance of Human Papillomavirus (HPV) Testing versus Cytology for Cervical Cancer Screening: Results of a Large Danish Implementation Study

2020 ◽  
Vol Volume 12 ◽  
pp. 203-213 ◽  
Author(s):  
Louise T Thomsen ◽  
Susanne K Kjær ◽  
Christian Munk ◽  
Kirsten Frederiksen ◽  
Dorthe Ørnskov ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Human Papillomavirus ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Clinical Performance ◽  
Hpv Testing ◽  
Implementation Study

scholarly journals Expanding the upper age limit for cervical cancer screening: a protocol for a nationwide non-randomised intervention study

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e039636
Author(s):  
Mette Tranberg ◽  
Lone Kjeld Petersen ◽  
Klara Miriam Elfström ◽  
Anne Hammer ◽  
Jan Blaakær ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Intervention Study ◽  
Reference Group ◽  
Intervention Group ◽  
Intraepithelial Neoplasia ◽  
Cervical Cytology ◽  
Cervical Intraepithelial Neoplasia Grade

IntroductionCervical cancer screening ceases between the ages of 60 and 65 in most countries. Yet, a relatively high proportion of cervical cancers are diagnosed in women above the screening age. This study will evaluate if screening of women aged 65–69 years may result in increased detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared with women not invited to screening. Invited women may choose between general practitioner (GP)-based screening or cervico-vaginal self-sampling. Furthermore, the study will assess if self-sampling is superior to GP-based screening in reaching long-term unscreened women.Methods and analysisThis population-based non-randomised intervention study will include 10 000 women aged 65–69 years, with no record of a cervical cytology sample or screening invitation in the 5 years before inclusion. Women who have opted-out of the screening programme or have a record of hysterectomy or cervical amputation are excluded. Women residing in the Central Denmark Region (CDR) are allocated to the intervention group, while women residing in the remaining four Danish regions are allocated to the reference group. The intervention group is invited for human papillomavirus-based screening by attending routine screening at the GP or by requesting a self-sampling kit. The reference group receives standard care which is the opportunity to have a cervical cytology sample obtained at the GP or by a gynaecologist. The study started in April 2019 and will run over the next 4.5 years. The primary outcome will be the proportion of CIN2+ detected in the intervention and reference groups. In the intervention group, the proportion of long-term unscreened women attending GP-based screening or self-sampling will be compared.Ethics and disseminationThe study has been submitted to the Ethical Committee in the CDR which deemed that the study was not notifiable to the Committee and informed consent is therefore not required. The study is approved by the Danish Data Protection Regulation and the Danish Patient Safety Authority. Results will be disseminated in peer-reviewed journals.Trial registration numberNCT04114968.

scholarly journals Effect of introducing human papillomavirus genotyping into real-world screening on cervical cancer screening in China: a retrospective population-based cohort study

2021 ◽  
Vol 13 ◽  
pp. 175883592110109
Author(s):  
Binhua Dong ◽  
Huachun Zou ◽  
Xiaodan Mao ◽  
Yingying Su ◽  
Hangjing Gao ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cohort Study ◽  
Human Papillomavirus ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Cox Regression ◽  
Intraepithelial Neoplasia ◽  
Population Based ◽  
Hpv Genotyping ◽  
Cytology Screening

Background: China’s Fujian Cervical Pilot Project (FCPP) transitioned cervical cancer screening from high-risk human papillomavirus (HR-HPV) nongenotyping to genotyping. We investigated the clinical impact of this introduction, comparing performance indicators between HR-HPV genotyping combined with cytology screening (HR-HPV genotyping period) and the previous HR-HPV nongenotyping combined with cytology screening (HR-HPV nongenotyping period). Methods: A retrospective population-based cohort study was performed using data from the FCPP for China. We obtained data for the HR-HPV nongenotyping period from 1 January 2012 to 31 December 2013, and for the HR-HPV genotyping period from 1 January 2014 to 31 December 2016. Propensity score matching was used to match women from the two periods. Multivariable Cox regression was used to assess factors associated with cervical intraepithelial neoplasia of grade 2 or worse (CIN2+). The primary outcome was the incidence of CIN2+ in women aged ⩾25 years. Performance was assessed and included consistency, reach, effectiveness, adoption, implementation and cost. Results: Compared with HR-HPV nongenotyping period, in the HR-HPV genotyping period, more CIN2+ cases were identified at the initial screening (3.06% versus 2.32%; p < 0.001); the rate of colposcopy referral was higher (10.87% versus 6.64%; p < 0.001); and the hazard ratio of CIN2+ diagnosis was 1.64 (95% confidence interval, 1.43–1.88; p < 0.001) after controlling for health insurance status and age. The total costs of the first round of screening (US$66,609 versus US$65,226; p = 0.293) were similar during the two periods. Higher screening coverage (25.95% versus 25.19%; p = 0.007), higher compliance with age recommendations (92.70% versus 91.69%; p = 0.001), lower over-screening (4.92% versus 10.15%; p < 0.001), and reduced unqualified samples (cytology: 1.48% versus 1.73%, p = 0.099; HR-HPV: 0.57% versus 1.34%, p < 0.001) were observed in the HR-HPV genotyping period. Conclusions: Introduction of an HR-HPV genotyping assay in China could detect more CIN2+ lesions at earlier stages and improve programmatic indicators. Evidence suggests that the introduction of HR-HPV genotyping is likely to accelerate the elimination of cervical cancer in China.

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