Mario Poljak's research while affiliated with Institutul Național de Boli Infecțioase "Prof. Dr. Matei Balș" and other places

Publications (397)

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Evidence suggests that monovalent vaccine formulations are less effective against the Omicron SARS-CoV-2 than against previous variants. In this retrospective cohort study of hospitalized adults with PCR-confirmed COVID-19 during the Delta (October–November 2021) and Omicron (January–April 2022) variant predominant periods in Slovenia, we assessed...
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We advise that only clinically validated HPV assays which have fulfilled internationally accepted performance criteria be used for primary cervical screening. Further, assays should be demonstrated to be fit for purpose in the laboratory in which they will ultimately be performed, and quality materials manuals and frameworks will be helpful in this...
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Background There is limited data on human papillomaviruses (HPV) prevalence in transpeople due to low acceptance rate of screening methods. HPV tests from self-collected urine are gender-neutral, have a high acceptance, and have a comparable accuracy in females to clinician-collected samples. The aim of this study was to evaluate both the HPV preva...
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In 2016, the Hepatitis B and C Public Policy Association (HepBCPPA), gathered all the main stakeholders in the field of hepatitis C virus (HCV) to launch the now landmark HCV Elimination Manifesto, calling for the elimination of HCV in the EU by 2030. Since then, many European countries have made progress towards HCV elimination. Multiple programs...
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Objectives: To analyze phylogenetic relations and assess a role of cross-border clusters in the spread of HIV-1 subtype B across the Balkans, given the general trends of new HIV diagnoses in seven Balkan countries. Design: Retrospective phylogenetic and trend analysis. Methods: In-depth phylogenetic, phylodynamic and phylogeographic analysis p...
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Background Cervical cancer screening coverage is a key monitoring indicator of the WHO cervical cancer elimination plan. We present global, regional, and national cervical screening coverage estimates against the backdrop of the 70% coverage target set by WHO. Methods In this review and synthetic analysis, we searched scientific literature, govern...
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Introduction HSIL or CIN2/3 lesions in HPV-positive women <30 years have high spontaneous regression rates. To reduce overtreatment, biomarkers are needed to delineate advanced CIN lesions that require treatment. We analysed the FAM19A4/miR124-2 methylation test and HPV16/18 genotyping in HPV-positive women <30 years aiming to identify CIN2/3 lesio...
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Background Cervical cancer screening tests that identify DNA of the main causal agent, high-risk human papillomavirus (HPV) types, are more protective than cervical cytology. We systematically reviewed the literature to assess whether tests targeting high-risk HPV (hrHPV) mRNA are as accurate and effective as HPV DNA-based screening tests. Methods...
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The NeuMoDx HPV assay is a novel fully automated, real-time PCR-based assay for the qualitative detection of high-risk human papillomavirus (HPV) DNA in cervical specimens. The assay specifically identifies HPV16 and HPV18 and concurrently detects 13 other high-risk HPV types at clinically relevant infection levels. Following the international guid...
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Several professional societies advise against using real-time Reverse-Transcription PCR (rtRT-PCR) cycle threshold (Ct) values to guide clinical decisions. We comparatively assessed the variability of Ct values generated by six diagnostic approaches by testing serial dilutions of well-characterized isolates of 10 clinically most relevant SARS-CoV-2...
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Introduction In Slovenia national strategies to prevent hepatitis B virus (HBV) infection in children were introduced in the mid-nineties. The aim of the present study was to analyze the epidemiological characteristics of chronic hepatitis B infection in children in Slovenia after the introduction of mandatory HBV vaccination of children and mandat...
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Background & Aims Direct-acting antiviral (DAA) regimens provide a cure in >95% of patients with hepatitis C virus (HCV). Patients who fail therapy may select viruses with drug resistance-associated substitutions (RAS), limiting retreatment options and risking onward resistant virus transmission. SHARED is an international consortium of clinicians...
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The global confrontation with COVID-19 has not only diverted current healthcare resources to deal with the infection but has also resulted in increased resources in the areas of testing and screening, as well as educating most of the global public of the benefits of vaccination. When the COVID-19 pandemic eventually recedes, the opportunity must no...
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We report a case of natural infection with severe acute respiratory syndrome coronavirus 2 transmitted from an owner to a pet ferret in the same household in Slovenia. The ferret had onset of gastroenteritis with severe dehydration. Whole-genome sequencing of the viruses isolated from the owner and ferret revealed a 2-nt difference.
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Stratified mucin-producing intraepithelial lesion (SMILE) is a rare high-grade cervical precancerous lesion designated a variant of adenocarcinoma in situ (AIS) in the WHO classification. We aimed to determine HPV genotypes, immunohistochemical phenotype and mucin presence in SMILE. Between 2010 and 2018, SMILE was diagnosed in 34 out of 6958 (0.5%...
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For more than a decade human papillomavirus (HPV) vaccine have been implemented in most high-income countries, and more recently also in several low- and middle-income countries. The vaccines are safe and their impact and effectiveness in preventing HPV vaccine type infection and associated diseases has been thoroughly established. Currently, the p...
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Objectives To determine the prevalence, viral load, tissue tropism, and genetic variability of novel human papillomavirus (HPV) type 179, which is etiologically associated with sporadic cases of common warts in immunocompromised patients, and phylogenetically related HPV types 135 and 146. Methods The representative collection of 850 HPV-associate...
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Background Only clinically validated HPV assays can be accepted in cervical cancer screening. Objectives To update the list of high-risk HPV assays that fulfil the 2009 international validation criteria (Meijer-2009). Data Sources PubMed/Medline, Embase, Scopus, references from selected studies; published in January 2014-August 2020. Study eligi...
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Background The recently launched Abbott Alinity m HR HPV (Alinity) assay separately identifies high-risk human papillomavirus (hrHPV) genotypes HPV16, HPV18, and HPV45, and reports 11 other genotypes as two aggregates. Methods Clinical and analytical performance of Alinity was compared with the cobas 4800 HPV assay on 4,334 women aged 20-64 years...
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(219/220 words) Abbott’s Alinity m is a recently launched fully integrated, automated molecular analyzer allowing continuous loading of samples and sample-to-result molecular detection of several microorganisms. Manufacturer-independent clinical evaluation of Alinity m SARS-CoV-2 (Alinity) against cobas 6800 SARS-CoV-2 (cobas) as a standard compara...
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Papillomaviruses (PVs) are considered highly species-specific with cospeciation as the main driving force in their evolution. However, a recent increase in the available PV genome sequences has revealed inconsistencies in virus–host phylogenies, which could be explained by adaptive radiation, recombination, host-switching events and a broad PV host...
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Background: To prevent the spread of infectious diseases, several state armies implemented obligatory vaccination programs also practiced in the former Yugoslav National Army (YNA). Iatrogenic hepatitis B virus (HBV) transmissions during vaccinations in the armies were well documented, but to the best of our knowledge, no such study has been perfor...
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Papillomaviruses (PVs) are a diverse group of host species-specific DNA viruses, etiologically linked with various benign and malignant neoplasms of cutaneous and mucosal epithelia. Here, we describe the detection and characterization of the first two PVs naturally infecting Japanese macaques (Macaca fuscata), including the determination of their e...
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Background Neutralization tests (NT) are the gold standard for detecting and quantifying anti-SARS-CoV-2 neutralizing antibodies (NAb), but their complexity restricts them to research settings or reference laboratories. Antibodies against S protein receptor binding domain (RBD) have been shown to confer a neutralizing activity against SARS-CoV-2. A...
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Objectives Seroprevalence surveys provide crucial information on cumulative SARS-CoV-2 exposure. This Slovenian nationwide population study is the first longitudinal 6-month serosurvey using probability-based sample across all age categories. Methods Each participant supplied two blood samples: 1,316 samples in April 2020 (first round) and 1,211 i...
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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 com...
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Introduction: The World Health Organization elimination goal for cervical cancer relies on screening 70% of women at ages 35 and 45, preferentially through molecular HPV testing. The SARS-CoV-2 pandemic has led to an unprecedented demand for molecular tests and platforms. Our objective was to gain insight into the impact of SARS-CoV-2 on the actua...
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Background Accurate anti-SARS-CoV-2 assays are needed to inform diagnostic, therapeutic, and public health decisions. The first manufacturer-independent head-to-head comparison of two rapid high-throughput automated electrochemiluminescence double-antigen sandwich immunoassays targeting total anti-SARS-CoV-2 antibodies against two different viral p...
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High‐grade cervical intraepithelial neoplasia (CIN2 and CIN3) represent a heterogeneous disease with varying cancer progression risks. Biomarkers indicative for a productive human papillomavirus (HPV) infection (HPV E4) and a transforming HPV infection (p16ink4a, Ki‐67 and host‐cell DNA methylation), could provide guidance for clinical management i...
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Aim: To analyze the distribution of high-risk human papillomavirus (HR-HPV) genotypes and the diversity of HPV-16 genomic variants in Croatian women with high-grade squamous intraepithelial lesions (HSIL) and cervical carcinoma. Methods: Tissue biopsy specimens were obtained from 324 women with histopathologically confirmed HSIL or cervical carc...
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Background The incidence and risk factors for the development of high‐grade dysplasia (HG‐D) and laryngeal squamous cell carcinoma (LSCC) were assessed in patients with laryngeal squamous cell papillomas (LSP). Methods Clinical data, human papillomaviruses (HPV) typing, HPV E6/E7 mRNA in situ hybridization, and sequencing of host genes in LSP biop...
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Introduction Human papillomavirus–vaccinated cohorts, irrespective of age, will likely reduce their subsequent screening requirements, thus opening opportunities for global cost reduction and program sustainability. The determinants of uptake and completion of a 3-dose human papillomavirus vaccination program by adult women in a European context we...
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We present a case report of a 64-year-old female patient with a 5-year history of a digital papule that clinically mimicked a common wart but was histologically diagnosed as digital squamous cell carcinoma (DSCC), a rare malignant cutaneous entity etiologically associated with high-risk human papillomaviruses (HR HPVs). This DSCC was positive for H...
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Abstract Objectives Information on the usefulness of screen-and-test strategies of pregnant women for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is lacking. Methods We retrospectively reviewed the Ljubljana Maternity Hospital database and searched for pregnant women, who were admitted to the hospital between March 15 and May 1...
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In human papillomavirus (HPV) cervical cancer screening, cytology is used as triage to counter the low specificity of HPV testing. VALID‐SCREEN is a EU‐multicenter, retrospective study conducted to evaluate the clinical performance of the FAM19A4/miR124‐2 methylation‐based molecular triage test as a substitute or addition to cytology as reflex test...
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Hepatitis C virus (HCV) affects 71 million people worldwide. The development of reliable diagnostic tools in the last 2 decades and recent implementation of highly potent and safe antiviral drug combinations have paved the way to potential elimination of HCV as a public health threat by 2030. This article briefly discusses current and upcoming solu...
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To date, the microbiome, as well as the virome of the Croatian populations of bats, was unknown. Here, we present the results of the first viral metagenomic analysis of guano, feces and saliva (oral swabs) of seven bat species (Myotis myotis, Miniopterus schreibersii, Rhinolophus ferrumequinum, Eptesicus serotinus, Myotis blythii, Myotis nattereri...
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Various polymerase chain reaction- (PCR-) based methods with varying positivity rates were designed to detect the Helicobacter pylori babA2 gene. To compare different primer sets, babA2 prevalence was determined in 279 H. pylori-positive pediatric samples using the 832 bp, 139 bp, and 271 bp PCR primer sets, resulting in 34.0%, 51.3%, and 79.6% pre...
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The age‐standardised incidence of cervical cancer in Europe varies widely (between 3 and 25/100000 women‐years) in 2018. HPV vaccine coverage is low in countries with the highest incidence and screening performance is heterogeneous among European countries. A broad group of delegates of scientific professional societies and cancer organisations end...
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Objectives Accurate population-level assessment of the COVID-19 burden is fundamental for navigating the path forward during the ongoing pandemic, but current knowledge is scant. We conducted the first nationwide population study using a probability-based sample to assess active SARS-CoV-2 infection, combined with a longitudinal follow-up of the en...
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This paper summarises the position of ESGO and EFC on cervical screening based on existing guidelines and opinions of a team of lead experts. HPV test is replacing cytology as this offers greater protection against cervical cancer and allows longer screening intervals. Only a dozen of HPV tests are considered as clinically validated for screening....
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Objectives The first hospital outbreak of carbapenemase-producing Enterobacteriaceae in Slovenia occurred in 2014–2016. Whole genome sequencing was used to analyse the population of carbapenem-resistant Klebsiella pneumoniae collected in Slovenia in 2014–2017, including OXA-48 and/or NDM-1 producing strains from the outbreak. Methods A total of 32...
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Laboratories are currently witnessing extraordinary demand globally for sampling devices, reagents, consumables, and diagnostic instruments needed for timely diagnosis of SARS-CoV-2 infection. To meet diagnostic needs as the pandemic grows, the US Food and Drug Administration (FDA) recently granted several commercial SARS-CoV-2 tests Emergency Use...
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Bats provide important ecosystem services as pollinators, seed dispersers, and/or insect controllers, but they have also been found harboring different viruses with zoonotic potential. Virome studies in bats distributed in Asia, Africa, Europe, and North America have increased dramatically over the past decade, whereas information on viruses infect...
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Background: Human papillomaviruses (HPVs) have been divided into mucosal and cutaneous types according to their primary epithelial tissue tropism. However, recent studies showed the presence of several cutaneous types in mucosal lesions and healthy mucosa from different anatomical sites. Methods: Here, the HPV prevalence and type-specific distri...
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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 widely used in China. VALGENT (VALidation of HPV GENotyping Tests) is an established framework for evaluating HPV tests' clinical performance relative to validated comparators. Th...
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Background Molecular tests for detection of human papillomaviruses (HPV) play a crucial role in the prevention of cervical cancer, including recently announced elimination efforts. HPV testing is a recommended approach for cervical cancer screening of women over 30 and for management of those with precancerous cervical lesions. In addition, they ar...
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In rare cases, equivocal histomorphology (‘deceiving dysplasia’) does not allow immediate diagnosis of cervical high-grade squamous intraepithelial lesion (HSIL). We studied whether these cases are correlated with specific high-risk human papillomavirus (hr HPV) types. During 2011–2017, 39 cases of p16-positive cervical tissue biopsies with unusual...
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Background: Assessment of human papillomavirus (HPV) type-specific viral load (VL) is a valid tool for determining the etiology of HPV-related skin tumors, especially when more than one HPV type is detected within one lesion. Methods: The causative HPV type was determined in 185 fresh-frozen tissue specimens of histologically confirmed common warts...
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Introduction: It has recently been demonstrated that there is a very high prevalence of hepatitis C virus (HCV) infection among hemodialysis patients in Kosovo with HCV subtype 1 being the most prevalent subtype. In this study, we further detail the molecular epidemiology of HCV outbreaks occurring in seven dialysis centers in Kosovo. Methodology...
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Prophylactic human papillomavirus (HPV) vaccines have revolutionarily modified our understanding of and efforts in preventing communicable diseases. Undeniably, all three prophylactic HPV vaccines currently available have excellent safety and have substantially contributed to the control of HPV infections and HPV-related diseases during the past de...
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Introduction: Journal bibliometric indicators are useful tools in assessing the characteristics, development history, and future trending of a particular medical journal. Moreover, they can help potential authors when deciding which journal to submit their work to in order to achieve the highest visibility. Methods: A single journal study of the...
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Molecular epidemiology of HIV-1 infection in treatment-naive HIV-1 infected persons from Croatia was investigated. We included 403 persons, representing 92.4% of all HIV-positive individuals entering clinical care in Croatia in 2014–2017. Overall prevalence of transmitted drug resistance (TDR) was estimated at 16.4%. Resistance to nucleoside revers...
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Background: Scents and odours characterise some microbes when grown in the laboratory, and experienced clinicians can diagnose patients with some infectious diseases based on their smell. Animal sniffing is an innate behaviour, and animals' olfactory acuity is used for detecting people, weapons, bombs, narcotics and food. Objectives: We briefly...
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Alinity m HR HPV is a novel human papillomavirus (HPV) assay that individually identifies genotypes HPV16, HPV18 and HPV45, while reporting 11 other high-risk HPV (hrHPV) genotypes in two aggregates: HPV31/33/52/58 and HPV35/39/51/56/59/66/68. The clinical performance of Alinity for screening of cervical cancer was evaluated in population-based set...
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Background: Point-of-care (POC) tests provide an alternative to traditional laboratory-based diagnostics due to reduced turnaround-times, portability and no need for highly trained laboratory staff. Smartphones can be integrated into POC platforms because of their multifunctionality, enabled by high-quality digital cameras, computer processors, to...
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Background The Hybrid Capture 2 (HC2) High-Risk HPV DNA assay serves as a triage test in the Slovenian national cervical cancer screening programme ZORA. To improve the limited analytical accuracy of HC2 test results near the cut-off value (1.0 relative light units/cut-off (RLU/CO)), we follow an internal protocol of repeating the test on all sampl...
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Helicobacter pylori (H. pylori) is one of the most important human pathogens, infecting approximately half of the global population. Despite its high prevalence, only a subset of H. pylori infected individuals develop serious gastroduodenal pathology. The pathogenesis of H. pylori infection and disease outcome is thus thought to be mediated by an i...
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Mammalian orthoreoviruses with reassortant genomes have recently been detected in various mammals and humans with respiratory, central nervous system, and gastrointestinal symptoms. This study describes the detection of the novel reassortant mammalian orthoreovirus SI-MRV07 in a traveler with gastroenteritis that returned from southeast Asia. The v...
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Background: Drones or unmanned aerial vehicles are autonomous or remotely controlled multipurpose aerial vehicles driven by aerodynamic forces and capable of carrying a payload. Whereas initially used exclusively for military purposes, the use of drones gradually spread into other areas. Given their great flexibility and favourable costs, the use...
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Background: Mobile microbiology is an evolving concept that has the potential to reduce morbidity and mortality associated with infectious diseases on a global level. Molecular methods used in the context of mobile microbiology ensure rapid and accurate etiological diagnostics and allow timely initiation of clinical care. The great majority of pub...
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Background: Cytology-based screening has been a cornerstone of cervical cancer prevention for decades. Following extensive evidence demonstrating higher sensitivity and accuracy, lower variability, and better reproducibility of human papillomavirus (HPV)-based screening compared to conventional or liquid-based cytology, recent European guidelines...
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Widespread adoption of primary human papillomavirus (HPV)‐based screening has encouraged the search for a triage test which retains high sensitivity for the detection of cervical cancer and precancer, but increases specificity to avoid overtreatment. Methylation analysis of FAM19A4 and miR124‐2 genes has shown promise for the triage of high‐risk (h...
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Introduction Sequence-based typing of hepatitis A virus (HAV) is important for outbreak detection, investigation and surveillance. In 2013, sequencing was central to resolving a large European Union (EU)-wide outbreak related to frozen berries. However, as the sequenced HAV genome regions were only partly comparable between countries, results were...
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Introduction: Human papillomavirus (HPV) vaccination was included in the national vaccination program in Slovenia in the 2009/2010 school year. It is recommended for girls attending the sixth grade of primary school only and is fully state funded. Based on the initiative of school medicine specialists, Idrija and Cerkno were the first two municipa...
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BackgroundA steady increase in HIV drug resistance (HIVDR) has been demonstrated globally in individuals initiating first-line antiretroviral therapy (ART). To support effective use of ART and prevent spread of HIVDR, monitoring is essential.AimWe piloted a surveillance system for transmitted HIVDR to assess the feasibility of implementation at the...
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Background: Genotyping for the most carcinogenic human papillomavirus (HPV) types (HPV16/HPV18) can identify high risk of underlying cervical precancer and guide further management. Research design and methods: A pooled analysis was performed of the clinical accuracy of high-risk HPV (hrHPV) testing and HPV16/18 genotyping in triage of women with l...
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Viral metagenomics analysis of samples from bats has been carried out as part of bat rabies surveillance in Croatia. Here, we report the complete genome sequence of a novel circo-like virus isolated from a sample of Miniopterus schreibersii bat guano determined by Illumina next-generation sequencing.
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The purpose of this study was to describe the current practice of mentorship in clinical microbiology (CM) and infectious diseases (ID) training, to identify possible areas for improvement and to assess the factors that are associated with satisfactory mentorship. An international cross-sectional survey containing 35 questions was answered by 317 t...
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Identifying individuals recently infected with HIV has been of great significance for close monitoring of HIV epidemic dynamics. Low HIV sequence ambiguity (SA) has been described as a promising marker of recent infection in previous studies. This study explores the utility of SA defined as a proportion of ambiguous nucleotides detected in baseline...