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Abstract: Human papillomavirus (HPV)-based screening offers better protection against cervical cancer compared to cytology, but HPV screening assays must adhere to validation requirements of the international guidelines to ensure optimal performance. Allplex HPV HR Detection (Allplex) assay, launched in the late 2022, is a fully automated real-time PCR-based assay utilizing innovative technology that enables quantification and concurrent distinction of 14 high-risk HPV genotypes (HPV16,18,31,33,35,39,45,51,52,56,58,59,66 and 68). We assessed the validity of the Allplex for cervical cancer screening purposes, via comparison to a clinically validated comparator assay (Hybrid Capture 2; HC2), and through assessment of intra-laboratory reproducibility and inter-laboratory agreement. A clinical validation panel comprised of 973 residual ThinPrep samples was obtained from women aged 30-64 years participating in the organized Slovenian screening program, of these 863 were from women undergoing their regular screening visit after a previous negative screen test while 110 were from women with underlying cervical intraepithelial neoplasia grade 2 or worse (CIN2+) lesions. The Allplex's relative clinical sensitivity for detection of CIN2+ and CIN3+ were 1.01 (95%CI;0.98-1.04) and 0.98 (95%CI;0.95-1.02), compared to that of HC2. At recommended thresholds of ≥98% and ≥90%, the Allplex's clinical sensitivity and specificity (p=0.0004 and p=0.02, respectively) were non-inferior to HC2. High intra-laboratory reproducibility and inter-laboratory agreement, both overall (98.1% and 97.9%, respectively) and at genotype level (>98.7%) was observed. In addition, analytical genotype-specific performance of Allplex was compared to that of its predecessor Anyplex HPV HR; high overall agreement was observed (96.3%; kappa value 0.88), with some variations in performance. In conclusion, Allplex met all validation criteria described in the international guidelines on sensitivity, specificity and laboratory reproducibility and can be considered clinically validated for primary cervical cancer screening.
Keywords: Allplex HPV HR, HPV, cervical cancer, genotyping, human papillomaviruses, screening, validation
Published in DiRROS: 11.06.2026; Views: 176; Downloads: 157
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Abstract: Background/Objectives: To assess overall and type-specific HPV vaccine effectiveness in central and eastern Europe (CEE), the age-stratified prevalence of cervical HPV infection was determined among Slovenian women aged 20 to 64 attending a cervical cancer screening program 14 years after implementation of a national HPV vaccination program, which was then compared with 2009-2010 pre-vaccination data using the same methodological approach. Methods: Cervical samples of 4419 women were tested in 2023-2025 using the clinically validated Alinity m HR HPV Assay, and individual HPV types were determined by the Allplex HPV HR Detection assay. Results were compared with 2009-2010 pre-vaccination data generated using the same assay on an age-range matched cohort of women. Results: The overall prevalence of the 14 Alinity-targeted HPV types was 10.0% in 2023-2025 versus 13.3% in 2009-2010 (p < 0.001). HPV16 prevalence declined from 3.5% to 1.5% (p < 0.001), and HPV18 prevalence from 1.1% to 0.5% (p = 0.005). In women aged 20 to 24 with 40% uptake of quadrivalent HPV vaccine, overall HPV prevalence dropped from 25.3% to 12.8% (p < 0.001). No single case of HPV16/HPV18 infection was detected among vaccinated women. Conclusions: The first large-scale, systematic, and methodologically consistent study of HPV vaccine effectiveness in CEE showed a substantial reduction in high-risk HPV prevalence after implementation of the national program, with the greatest decline among women aged 20 to 24, who harbored the highest HPV burden in the pre-vaccination era. These locally acquired data will considerably inform public health strategies on cervical cancer elimination in CEE.
Keywords: HPV, Slovenia, central ane eastern Europe, cervical cancer, prevalence, screening, vaccination
Published in DiRROS: 20.04.2026; Views: 249; Downloads: 170
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Abstract: Background: Ovarian cancer is the deadliest gynecological malignancy, largely due to the advanced stage at diagnosis in most patients. This study investigates whether systemic steroids can serve as biomarkers to distinguish malignant ovarian tumors from non-malignant adnexal masses. Methods: This prospective, single-center observational study included 99 women with adnexal masses who underwent surgery between December 2021 and February 2025. Preoperative serum levels of 17 steroid hormones, including androgens, 11-oxyandrogens, glucocorticoids, and mineralocorticoids, were quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Machine learning was employed to assess the diagnostic potential of these steroids in distinguishing ovarian cancer (n = 43) from non-malignant adnexal masses (n = 56). Results: Patients with ovarian cancer had lower levels of 11β-hydroxy-testosterone (11OHT), 11-keto-testosterone (11KT), and testosterone compared to controls. Using stepwise feature selection, we developed two diagnostic models incorporating three 11-oxyandrogens (11KT, 11OHT, and 11β-hydroxy-androstenedione), patient age, and either cancer antigen 125 (CA-125) or human epididymis protein 4 (HE4) for distinguishing malignant from non-malignant adnexal masses. The model including CA-125 achieved AUC of 0.907, 88.9% sensitivity and 82.0% specificity, while the model including HE4 achieved AUC of 0.911, 94.4% sensitivity and 77.3% specificity as evaluated by cross-validation. Both models significantly outperformed CA-125, HE4, and the Risk of Ovarian Malignancy Algorithm (ROMA) index alone. Conclusion: Patients with ovarian cancer exhibit distinct steroid profiles compared to those with non-malignant adnexal masses. If validated, the models could enhance diagnosis, reducing unnecessary surgeries for benign conditions while ensuring timely treatment for ovarian cancer, particularly when conventional biomarkers are inconclusive.
Keywords: adnexal masses, diagnostic models, machine learning, ovarian cancer, steroids
Published in DiRROS: 10.04.2026; Views: 241; Downloads: 167
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Keywords: rak (medicina), ginekološki raki, ginekologija, onkologija, epidemiologija, histopatologija, preživetje, diagnostika, zdravljenje, kirurgija
Published in DiRROS: 22.01.2026; Views: 453; Downloads: 338
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Abstract: Background: High-grade serous carcinoma (HGSC) is often associated with ascites at presentation. Our objective was to quantify immune cells (ICs) in ascites prior to any treatment was given and evaluate their impact on progression-free survival (PFS) and overall survival (OS). Patients and methods: Forty-seven patients with primary HGSC and ascites were included. Flow-cytometric analysis was performed to detect percentages of CD3+ T cells (CD4+, CD8+, Tregs, and NKT cells), B cells, NK cells (CD56brightCD16- and CD56dimCD16+ subsets), macrophages and dendritic cells (DCs). Furthermore, CD103 expression was analyzed on T cells and their subsets, while PD-1 and PD-L1 expression on all ICs. Cut-off of low and high percentages of ICs was determined by the median of variables, and correlation with PFS and OS was calculated. Results: CD3+ cells were the predominant ICs (median 51%), while the presence of other ICs was much lower (median ≤10%). CD103+ expression was mostly present on CD8+, and not CD4+ cells. PD-1 was mainly expressed on CD3+ T cells (median 20%), lower expression was observed on other ICs (median ≤10%). PD-L1 expression was not detected. High percentages of CD103+CD3+ T cells, PD-1+ Tregs, CD56brightCD16- NK cells, and DCs correlated with prolonged PFS and OS, while high percentages of CD8+ cells, macrophages, and PD-1+CD56brightCD16- NK cells, along with low percentages of CD4+ cells, correlated with better OS only. DCs were the only independent prognostic marker among all ICs. Conclusions: Our results highlight the potential of ascites tumor-immune microenvironment to provide additional prognostic information for HGSC patients. However, a larger patient cohort and longer follow-up are needed to confirm our finBackground: High-grade serous carcinoma (HGSC) is often associated with ascites at presentation. Our objective was to quantify immune cells (ICs) in ascites prior to any treatment was given and evaluate their impact on progression-free survival (PFS) and overall survival (OS). Patients and methods: Forty-seven patients with primary HGSC and ascites were included. Flow-cytometric analysis was performed to detect percentages of CD3+ T cells (CD4+, CD8+, Tregs, and NKT cells), B cells, NK cells (CD56brightCD16- and CD56dimCD16+ subsets), macrophages and dendritic cells (DCs). Furthermore, CD103 expression was analyzed on T cells and their subsets, while PD-1 and PD-L1 expression on all ICs. Cut-off of low and high percentages of ICs was determined by the median of variables, and correlation with PFS and OS was calculated. Results: CD3+ cells were the predominant ICs (median 51%), while the presence of other ICs was much lower (median ≤10%). CD103+ expression was mostly present on CD8+, and not CD4+ cells. PD-1 was mainly expressed on CD3+ T cells (median 20%), lower expression was observed on other ICs (median ≤10%). PD-L1 expression was not detected. High percentages of CD103+CD3+ T cells, PD-1+ Tregs, CD56brightCD16- NK cells, and DCs correlated with prolonged PFS and OS, while high percentages of CD8+ cells, macrophages, and PD-1+CD56brightCD16- NK cells, along with low percentages of CD4+ cells, correlated with better OS only. DCs were the only independent prognostic marker among all ICs. Conclusions: Our results highlight the potential of ascites tumor-immune microenvironment to provide additional prognostic information for HGSC patients. However, a larger patient cohort and longer follow-up are needed to confirm our findings.dings.
Keywords: high-grade serous carcinoma, immune cells, prognostic markers
Published in DiRROS: 26.07.2024; Views: 2216; Downloads: 911
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