scholarly journals Clinical and analytical evaluation of the Alinity m HR HPV assay within the VALGENT-3 framework

2021 ◽  
Author(s):  
Sharonjit K. Dhillon ◽  
Anja Oštrbenk Valenčak ◽  
Lan Xu ◽  
Mario Poljak ◽  
Marc Arbyn
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Screening Program ◽  
Precancerous Lesions ◽  
Cervical Screening ◽  
Relative Sensitivity ◽  
Population Based ◽  
Total Study Population ◽  
Clinical Accuracy

Only clinically validated human papillomavirus (HPV) tests should be used in cervical cancer screening. VALGENT provides a framework to validate new HPV tests. In the VALGENT-3 study, the clinical accuracy of the recently launched Abbott Alinity m HR HPV assay (Alinity m) to detect cervical precancerous lesions was assessed against the standard comparator test (Hybrid Capture 2; HC2) and additionally against two previously validated alternative comparator tests (Abbott RealTime HR HPV and Roche cobas 4800 assays). Validation was conducted using 1,300 consecutive cervical samples from women attending an organized population-based cervical screening program enriched with 300 cytologically abnormal samples. Overall hrHPV test concordance was assessed by kappa values; the concordance for HPV-16 and HPV-18 was assessed for Alinity m, RealTime, and cobas, and the Linear Array (Roche) was used for more detailed genotyping concordance. In the total study population, the relative sensitivity and specificity for CIN2+ and CIN3+ of Alinity m compared to HC2 was 1.02 (95% CI:0.99–1.06) and 1.03 (95% CI:0.99–1.06), respectively. The relative specificity for ≤ CIN1 was 1.01 (95% CI:1.00–1.02) (all pni ≤ 0.001). Alinity m showed non-inferior clinical accuracy among women 30 years or older when cobas or RealTime were used as comparators. HPV genotype-specific concordance between Alinity m and the three comparator tests showed excellent agreement, with kappa values ranging between 0.82 and 1.00. In conclusion, Alinity m fulfils the international accuracy requirements for use in cervical cancer screening and shows excellent HPV genotype-specific concordance with three clinically validated HPV tests.

scholarly journals Cervical Cancer Screening Participation among Women of Russian, Somali, and Kurdish Origin Compared with the General Finnish Population: A Register-Based Study

2020 ◽  
Vol 17 (21) ◽  
pp. 7899
Author(s):  
Esther E. Idehen ◽  
Anni Virtanen ◽  
Eero Lilja ◽  
Tomi-Pekka Tuomainen ◽  
Tellervo Korhonen ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Screening Program ◽  
Cervical Screening ◽  
Well Being ◽  
Migrant Health ◽  
Finnish Population ◽  
Screening Participation ◽  
Cancer Screening Participation

Migrant-origin women are less prone to cervical screening uptake compared with host populations. This study examined cervical cancer screening participation and factors associated with it in the Finnish mass screening program during 2008–2012 in women of Russian, Somali and Kurdish origin compared with the general Finnish population (Finns) in Finland. The study population consists of samples from the Finnish Migrant Health and Well-being Study 2010–2012 and Health 2011 Survey; aged 30–64 (n = 2579). Data from the Finnish screening register linked with other population-based registry data were utilized. For statistical analysis we employed logistic regression. Age-adjusted screening participation rates were Russians 63% (95% CI: 59.9–66.6), Somalis 19% (16.4–21.6), Kurds 69% (66.6–71.1), and Finns 67% (63.3–69.8). In the multiple-adjusted model with Finns as the reference; odds ratios for screening were among Russians 0.92 (0.74–1.16), Somalis 0.16 (0.11–0.22), and Kurds 1.37 (1.02–1.83). Among all women, the substantial factor for increased screening likelihood was hospital care related to pregnancy/birth 1.73 (1.27–2.35), gynecological 2.47 (1.65–3.68), or other reasons 1.53 (1.12–2.08). Screening participation was lower among students and retirees. In conclusion, screening among the migrant-origin women varies, being significantly lowest among Somalis compared with Finns. Efforts using culturally tailored/population-specific approaches may be beneficial in increasing screening participation among women of migrant-origin.

Cervical cancer screening information flow in Northern regional administrative service in Portugal

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
D Portela ◽  
V Cruz ◽  
H Monteiro ◽  
F Tavares
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Information Flow ◽  
Screening Program ◽  
Population Based ◽  
Health Administration ◽  
Screening Programs ◽  
Longitudinal Data Collection ◽  
Northern Regional

Abstract Management of a population-based screening program circuit depends on characteristics and technical barriers of its application and implementation. The aim is to clarify the information flow, to understand and build a vision of cervical screening information flows in Northern Regional Health Administration Portuguese Public System and to identify the constraints among them. A total of 5 cluster meetings were presented and two expert interviews were conducted allowing to present an informational flow and its constraints. Aims addressed in each interview where based on the expertise of the interviewed. Cervical cancer screening program depends on the use of SiiMA application. This is an information system for the management of population-based screening program which involves mainly 3 entities and allows a longitudinal data collection and study. Three main constraints were reported. The time for updating data for the list of eligible women was bigger than accorded reaching up to 3 months delay. A duplicate of records and discharges in hospital care since the discharge was done both in the hospital system and the SiiMA platform manually in order to the woman re-enter the screening program. Pendencies were seen due to other screening programs running in parallel which had to be sorted out manually in the regional level or by the entity involved. The existence of a screening application is vital for the implementation purposes of a screening program. The lack of integration of the systems increases bureaucratic work, costs and causes time delay. To improve the efficiency of digital transformation ensuring the quality of the process it is necessary to adapt the design of the health informatic systems to the daily practice and its wants and needs. The strategies of forcing an ever-increasing number of frameworks have demonstrated not to be so effective. Therefore, it is a cornerstone to understand these flows in order to improve its structure, intervention and optimization. Key messages The existence of a screening digital application is vital but its expanding use arises constraints. Due to the complexity of such programs, a digital strategy is crucial for management and monitoring of the screening at this scale.

scholarly journals Evaluation and Optimization of the Clinical Accuracy of Hybribio's 14 High-Risk HPV with 16/18 Genotyping Assay within the VALGENT-3 Framework

2020 ◽  
Vol 58 (6) ◽  
Author(s):  
Lan Xu ◽  
Anja Oštrbenk Valenčak ◽  
Mario Poljak ◽  
Marc Arbyn
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
High Risk ◽  
Cervical Cancer Screening ◽  
Linear Array ◽  
Clinical Performance ◽  
Total Study Population ◽  
Hpv Genotyping ◽  
Clinical Accuracy ◽  
High Risk Hpv

ABSTRACT Hybribio’s 14 High-Risk HPV with 16/18 genotyping real-time PCR (HBRT-H14) is a human papillomavirus (HPV) assay with approval from the China Food and Drug Administration that is widely used in China. VALGENT (VALidation of HPV GENotyping Tests) is an established framework for evaluating HPV tests’ clinical performance relative to validated comparators. The aim of this study was to assess the clinical accuracy of HBRT-H14 following international validation criteria. Within VALGENT-3, clinical performance of HBRT-H14 was compared with Hybrid Capture 2 (HC2), Linear Array HPV genotyping test (Linear Array), and Cobas 4800 HPV test (Cobas). VALGENT-3 comprised 1,300 consecutive samples and 300 abnormal cytological samples from the Slovenian cervical cancer screening program. Disease was defined as histologically confirmed cervical intraepithelial neoplasia scoring grade 2 or worse (CIN2+) and CIN3+, and two negative cytology results in a row were a proxy for nondisease. In the total study population, relative sensitivity and specificity of HBRT-H14 versus HC2 for detecting CIN2+ were 0.98 (95% confidence interval [CI], 0.94 to 1.03; P noninferiority[Pni] < 0.01) and 0.97 (95% CI, 0.96 to 0.99; Pni = 0.78), respectively. Applying an optimized a posteriori cutoff, defined using Linear Array and Cobas as bridging tests, yielded relative values of 0.98 (95% CI, 0.94 to 1.03; Pni < 0.01) and 1.01 (95% CI, 1.00 to 1.03; Pni < 0.01), respectively. In conclusion, HBRT-H14 was as sensitive but less specific than HC2 for detecting cervical precancer at the predefined cutoff. However, HBRT-H14 fulfilled international accuracy criteria for cervical cancer screening when using an optimized cutoff and might be attractive in low-resource settings given its low cost.

scholarly journals Barriers and attitudes towards cervical cancer screening in primary healthcare in Poland - doctors’ perspective

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Katarzyna Nessler ◽  
Francis Ball ◽  
Sze Kay Florence Chan ◽  
Michal Chwalek ◽  
Anna Krztoń-Królewiecka ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Financial Incentives ◽  
Screening Program ◽  
Population Based ◽  
Pap Smears ◽  
Cross Sectional ◽  
Eu Member States ◽  
Cytology Screening

Abstract Background Healthcare systems have adopted different strategies to reduce the burden of cervical cancer. In Poland, a population-based screening program was implemented in 2006, leading to a downward trend in cervical cancer burden. However, screening rates are still low in relation to other EU member states. In Poland, Pap smears are mainly performed by gynecologists rather than Primary Health Care (PHC) physicians. Little is known about the experiences and attitudes of the latter regarding cervical cancer screening in a PHC setting. Methods A cross-sectional questionnaire-based survey was carried out among 43 PHC physicians from the Malopolska region in Poland. Barriers and attitudes towards cytology in a PHC setting were evaluated. Results Approximately 35% of surveyed physicians reported having experience in performing cytology. Almost 75% of PHC physicians lacked the necessary equipment in their office to perform the screening. None of the studied physicians performed Pap smears in their office at the time. The reasons included: shortage of competence (78.57%) and time (69.05%), the perception of Pap smears as a task for gynecologists (69.05%), the lack of financial incentives (61.90%), and the belief that their patients would be unwilling to undergo the test in their PHC physician’s office (33.33%). More than three quarters (76.74%) declared they would be ready to perform Pap smears if the tests were additionally paid. No significant associations between PHC physicians’ characteristics and their willingness to perform cytology screening were found. Conclusion The primary barrier to perform Pap smears by PHC physicians does not lie in their personal reluctance but in the organization of the healthcare system. Provision of required training and proper funding allocation can likely improve the screening rate of cervical cancer in Poland.

scholarly journals Cervical Cancer Screening Program by Visual Inspection: Acceptability and Feasibility in Health Insurance Companies

2015 ◽  
Vol 2015 ◽  
pp. 1-4 ◽  
Author(s):  
Apollinaire G. Horo ◽  
Judith Didi-Kouko Coulibaly ◽  
Abdoul Koffi ◽  
Boris Tchounga ◽  
Konan Seni ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Health Insurance ◽  
Cancer Screening ◽  
Diagnostic Accuracy ◽  
Cervical Cancer Screening ◽  
Visual Inspection ◽  
Screening Program ◽  
Cervical Screening ◽  
Screening Method ◽  
Insurance Company

Objective. To assess willingness to participate and diagnostic accuracy of visual inspection for early detection of cervical neoplasia among women in a health insurance company.Patients and Method. Cervical cancer screening was systematically proposed to 800 women after consecutive information and awareness sessions. The screening method was visual inspection with acetic acid (VIA) or Lugol’s iodine (VILI).Results. Among the 800 identified women, 640 (82%) have accepted the screening, their mean age was 39 years, and 12.0% of them were involved in a polygamist couple. 28.2% of women had prior cervical screening. VIA has been detected positive in 5.9% of women versus 8.6% for VILI. The sensitivity was 72.9% and specificity was 95.2% for VIA versus 71.2% and 97.3% for VILI respectively. The histological examination highlighted a nonspecific chronic cervicitis in 4.6%, CIN1 lesions in 5.91%, and CIN2/3 in 1.2% of the cases.Conclusion. Cervical cancer screening by visual inspection showed appropriate diagnostic accuracy when used to detect early cervical lesions. It is a simple and easy to perform method that could be introduced progressively in the health insurance policy while waiting for a national screening program.

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