Percutaneous Gastrostomies: Associated Complications in PUSH vs. PULL Techniques over 12 Years in a Referral Centre.

Objectives: To compare complications associated with percutaneous gastrostomies performed using PUSH and PULL techniques, whether endoscopic (PEG) or radiological (PRG), in a tertiary-level hospital. Methods: This was a prospective observational study. Adult patients who underwent percutaneous PULL or PUSH gastrostomy using PEG or PRG techniques at the Virgen del Rocio University Hospital and subsequently followed up in the Nutrition Unit between 2009-2020 were included. X2 tests or Fisher's test were used for the comparison of proportions when necessary. Univariate analysis was conducted to study risk factors for PRG-associated complications. Results: n = 423 (PULL = 181; PUSH = 242). The PULL technique was associated with a higher percentage of total complications (37.6% vs. 23.8%; p = 0.005), exudate (18.2% vs. 11.2%; p = 0.039), and irritation (3.3% vs. 0%; p = 0.006). In the total sample, there were 5 (1.1%) cases of peritonitis, 3 (0.7%) gastrocolic fistulas, and 1 (0.2%) death due to complications associated with gastrostomy. Gender, age, and different indications were not risk factors for a higher number of complications. The most common indications were neurological diseases (35.9%), head and neck cancer (29%), and amyotrophic lateral sclerosis (17.2%). Conclusions: The PULL technique was associated with more total complications than the PUSH technique, but both were shown to be safe techniques, as the majority of complications were minor.

Adherence and impact of an oral nutritional supplement enriched in leucine, EVOO, EPA and DHA, and beta-glucans on the coverage of energy and protein requirements in patients with cancer and malnutrition: Alisenoc study.

OBJECTIVE: The aim of this study was to evaluate the impact of an enhanced ONS (enriched in EPA, DHA, leucine, and beta-glucans) on the dietary intake of cancer patients. METHODS: A randomized, double-blind, parallel, controlled, and multicenter clinical trial was conducted in patients with cancer and malnutrition. The trial compared prescribed dietary advice and two packs per day, for 8 weeks, of a hypercaloric (400 kcal/pack) and hyperproteic ONS (20 g/pack) with fiber and specific ingredients (leucine, EPA and DHA, and beta-glucans) (enhanced-ONS) versus an isocaloric and isoproteic formula (standard-ONS) without specific ingredients. Food intake was assessed with a 3-day dietary survey, and adherence to the supplement with a patient self-completed diary. RESULTS: Thirty-seven patients completed the intervention period. The combined intervention of dietary advice and ONS managed to increase the energy intake of the overall cohort by 792.55 (378.57) kcal/day, protein by 40.72 (19.56) g/day. Increases in energy and nutrient intakes were observed in both groups, both in dietary intake and associated exclusively with the supplement. The group that received the enhanced-ONS ingested a greater volume of product when there was a greater severity of malnutrition; a tumor location in the head, neck, upper digestive area, liver, or pancreas; more advanced stages of the tumor; or the receipt of more than one antineoplastic treatment. CONCLUSION: The use of an enhanced-ONS helps meet the nutritional requirements of cancer patients, especially those who have a more compromised clinical condition, with high adherence, good tolerance, and acceptance.

Ultrasound Muscle Evaluation for Predicting the Prognosis of Patients with Head and Neck Cancer: A Large-Scale and Multicenter Prospective Study.

Head and neck cancer (HNC) is a prevalent and aggressive form of cancer with high mortality rates and significant implications for nutritional status. Accurate assessment of malnutrition in patients with HNC is crucial for optimizing treatment outcomes and improving survival rates. This study aimed to evaluate the use of ultrasound techniques for predicting nutritional status, malnutrition, and cancer outcomes in patients with HNC. A total of 494 patients with HNC were included in this cross-sectional observational study. Various tools and body composition measurements, including muscle mass and adipose tissue ultrasound evaluations, were implemented. Using regression models, we mainly found that high levels of RF-CSA (rectus femoris cross-sectional area) were associated with a decreased risk of malnutrition (as defined with GLIM criteria (OR = 0.81, 95% CI: 0.68-0.98); as defined with PG-SGA (OR = 0.78, 95% CI: 0.62-0.98)) and sarcopenia (OR = 0.64, 95% CI: 0.49-0.82) after being adjusted for age, sex, and BMI. To predict the importance of muscle mass ultrasound variables on the risk of mortality, a nomogram, a random forest, and decision tree models were conducted. RF-CSA was the most important variable under the random forest model. The obtained C-index for the nomogram was 0.704, and the Brier score was 16.8. With an RF-CSA < 2.7 (AUC of 0.653 (0.59-0.77)) as a split, the decision tree model classified up to 68% of patients as possessing a high probability of survival. According to the cut-off value of 2.7 cm2, patients with a low RF-CSA value lower than 2.7 cm2 had worse survival rates (p < 0.001). The findings of this study highlight the importance of implementing ultrasound tools, for accurate diagnoses and monitoring of malnutrition in patients with HNC. Adipose tissue ultrasound measurements were only weakly associated with malnutrition and not with sarcopenia, indicating that muscle mass is a more important indicator of overall health and nutritional status. These results have the potential to improve survival rates and quality of life by enabling early intervention and personalized nutritional management.

Explainability as the key ingredient for AI adoption in Industry 5.0 settings.

Explainable Artificial Intelligence (XAI) has gained significant attention as a means to address the transparency and interpretability challenges posed by black box AI models. In the context of the manufacturing industry, where complex problems and decision-making processes are widespread, the XMANAI platform emerges as a solution to enable transparent and trustworthy collaboration between humans and machines. By leveraging advancements in XAI and catering the prompt collaboration between data scientists and domain experts, the platform enables the construction of interpretable AI models that offer high transparency without compromising performance. This paper introduces the approach to building the XMANAI platform and highlights its potential to resolve the "transparency paradox" of AI. The platform not only addresses technical challenges related to transparency but also caters to the specific needs of the manufacturing industry, including lifecycle management, security, and trusted sharing of AI assets. The paper provides an overview of the XMANAI platform main functionalities, addressing the challenges faced during the development and presenting the evaluation framework to measure the performance of the delivered XAI solutions. It also demonstrates the benefits of the XMANAI approach in achieving transparency in manufacturing decision-making, fostering trust and collaboration between humans and machines, improving operational efficiency, and optimizing business value.

Gastrostomies: experience and complications with three modalities in a tertiary centre over a 26-year period.

Objectives: To describe the complications associated with the different gastrostomy techniques [endoscopic (PEG), radiologic (PRG), and surgical (SG)] performed in the last 26 years in a terciary hospital. Methods: Retrospective observational study. Patients who underwent gastrostomy at the Virgen del Rocío University Hospital between 1995 and 2021 were included. For PEG, the PULL technique was performed until 2018 and subsequently the PUSH technique predominantly. For PRG, a pigtail catheter was used until 2003, a balloon catheter between 2003 and 2009, and a balloon catheter with gastropexy between 2015 and 2021. For SG, the conventional technique (CSG) was performed until 2009 and since then the laparoscopic assisted percutaneous gastrostomy (PLAG) technique. Descriptive analysis was performed obtaining the median and quartiles of the quantitative variables [P50 (P25-P75)] and the frequency for the qualitative variables [n (%)].The comparison of complications between patients who underwent different techniques was performed with Fisher's test. Results: n = 1,070 (PEG = 608, PRG = 344, SG = 118). The three most frequent indications were head and neck tumors, neurological diseases and gastroesophageal tumors. The percentage of patients who had any complication was 48.9% (PEG-PULL), 23.7% (PEG-PUSH), 38.5% (pigtail PRG), 39.2% (balloon PRG), 29.7% (balloon with gastropexy PRG), 87.3% (CSG), and 41.26% (PLAG). 2 (0.18%) patients died from gastrostomy-related complications. 18(1.68%) presented with peritonitis and 5 (0.4%) presented with gastrocolic fistula. The rest of the complications were minor. Conclusion: Gastrostomy in any of its modalities is currently a safe procedure with a low rate of complications, most of which are minor.

Bioavailability and systemic transport of oleanolic acid in humans, formulated as a functional olive oil.

Evidence of the pharmacological activity of oleanolic acid (OA) suggests its potential therapeutic application. However, its use in functional foods, dietary supplements, or nutraceuticals is hindered by limited human bioavailability studies. The BIO-OLTRAD trial is a double-blind, randomized controlled study with 22 participants that received a single dose of 30 mg OA formulated as a functional olive oil. The study revealed that the maximum serum concentration of OA ranged from 500 to 600 ng mL-1, with an AUC0-∞ value of 2862.50 ± 174.50 ng h mL-1. Furthermore, we discovered a physiological association of OA with serum albumin and triglyceride-rich lipoproteins (TRL). UV absorption spectra showed conformational changes in serum albumin due to the formation of an adduct with OA. Additionally, we demonstrated that TRL incorporate OA, reaching a maximum concentration of 140 ng mL-1 after 2-4 hours. We conjecture that both are efficient carriers to reach target tissues and to yield high bioavailability.

Mortalidad atribuible al consumo de tabaco en la Provincia de Buenos Aires. Estimación a partir de las Encuestas Nacionales de Factores de Riesgo / Mortality Attributable to Tobacco Consumption in the Province of Buenos Aires. Estimation from the National Surveys of Risk Factors

RESUMEN Introducción : El consumo de tabaco es la principal causa de defunción por enfermedades no transmisibles como las cardiopatías, las neumopatías y el cáncer. Estimar la mortalidad atribuida al consumo de tabaco dependiente de su prevalencia se basa en el conocimiento previo del número de fumadores, exfumadores y no fumadores en la población. Estos datos provienen de las cuatro Encuestas Nacionales de Factores de Riesgo (ENFR). Objetivos : El presente trabajo pretende mostrar la carga de mortalidad por consumo de tabaco en la Provincia de Buenos Aires en los períodos de relevamiento de las cuatro ENFR (2005-2009-2013-2018). Material y métodos : La mortalidad atribuible fue calculada utilizando un método dependiente de la prevalencia, y asumiendo los riesgos asociados al consumo en las 19 causas clasificadas como asociadas al tabaquismo según el estudio Cancer Prevention Study II (CPSII). Las defunciones fueron agrupadas en períodos equivalentes a los relevamientos de cada ENFR. Las fracciones atribuibles del CSPII se aplicaron entonces calculando las defunciones absolutas y atribuibles de mortalidad por causa y sus agrupamientos: tumores, circulatorias y respiratorias. Resultados : Globalmente, para todas las edades de 18 años y más, se pasó de una prevalencia de tabaquismo del 29,5% en 2005 al 23,1% en 2018 (reducción absoluta de 6,4% y porcentual del 21,7%). De las 18 255 muertes producidas por enfermedades cardiovasculares coincidentes con los cuatro relevamientos, 6293 fueron atribuibles al tabaquismo (34,4%), frente al 68% de las muertes por tumores y el 40% de las muertes de causa respiratoria. Conclusión : Se hace necesario fortalecer aún medidas para reducir la exposición al tabaco.

ABSTRACT Background : Tobacco consumption is the leading cause of death from non-communicable diseases, such as heart disease, lung disease and cancer. Estimating prevalence-based mortality attributed to tobacco consumption is based on prior knowledge of the number of smokers, ex-smokers, and non-smokers in the population. These data derive from the four National Surveys of Risk Factors (Encuestas Nacionales de Factores de Riesgo, ENFR). Objectives : This study aims to show the burden of mortality due to tobacco consumption in the Province of Buenos Aires in the assessed periods of the four ENFRs (2005, 2009, 2013, 2018). Methods : Mortality attributable to tobacco consumption was estimated by using a prevalence-based method and assuming the risks associated with smoking in the 19 causes classified as associated with smoking, in accordance with the Cancer Prevention Study II (CPSII). The deaths were grouped into periods equivalent to those relevant to each ENFR. The CSPII attributable fractions were then applied by estimating the absolute deaths and attributable fractions of mortality by cause and groupings: tumours, circulatory diseases and respiratory diseases. Results : Overall, in persons aged 18 years or older, there was a decrease in smoking prevalence from 29.5% in 2005 to 23.1% in 2018 (an absolute reduction of 6.4% and a percentage reduction of 21.7%). A total of 6293 out of 18 255 deaths from cardiovascular diseases in the four surveys were attributed to smoking, that is, 34.4%, compared to 68% of deaths from tumours and 40.0% of deaths from respiratory diseases. Conclusion : It is necessary to further strengthen measures to reduce exposure to tobacco.

Detection of a novel 16.3 variant allele at locus DYS533 in R1b males inhabiting southern South America: A 19-nucleotide insertion explains its origin based on Sanger sequencing results.

We typed 1541 Y-STR haplotypes from reference samples along forensic casework investigations. In three haplotypes, we detected a variant allele designed as 16.3 at locus DYS533. This was confirmed by amplification using two commercial kits. Sanger sequencing revealing a novel motif corresponding to [TATC]12 repeats with a 19-bp insertion in the flanking upstream region. We propose its origin as an insertion at - 9.1 upstream of the repeat motifs. We searched other local databases and found this allele in various geographical areas of Argentina and neighbouring countries. The haplotypes share a common core of 10 Y-STRs (DYS389-I/13; DYS389-II/30; DYS19/14; DYS481/22; DYS438/12; DYS437/16; DYS635/23; DYS392/13; DYS393/13; GATA H4/11) and belong to the R1b haplogroup. This 16.3 allele is restricted to southern South America, which allows us to propose a local and relatively recent origin. The sequence described herein constitutes a novelty that could be considered in future criteria for the nomenclature of STRs based on massively parallel sequencing.

Percutaneous Radiology Gastrostomy (PRG)-Associated Complications at a Tertiary Hospital over the Last 25 Years.

OBJECTIVES: We aimed to describe and compare the complications associated with different percutaneous radiologic gastrostomy (PRG) techniques. METHODS: A retrospective and prospective observational study was conducted. Patients who underwent a PRG between 1995-2020 were included. TECHNIQUES: A pigtail catheter was used until 2003, a balloon catheter without pexy was used between 2003-2009 and a balloon catheter with gastropexy was used between 2015-2021. For the comparison of proportions, X2 tests or Fisher's test were used when necessary. Univariate analysis was performed to study the risk factors for PRG-associated complications. RESULTS: n = 330 (pigtail = 114, balloon-type without pexy = 28, balloon-type with pexy = 188). The most frequent indication was head and neck cancer. The number of patients with complications was 44 (38.5%), 11 (39.2%) and 54 (28,7%), respectively. There were seven (25%) cases of peritonitis in the balloon-type without-pexy group and 1 (0.5%) in the balloon-type with-pexy group, the latter being the only patient who died in the total number of patients (0.3%). Two (1%) patients of the balloon-type with-pexy group presented with gastrocolic fistula. The rest of the complications were minor. CONCLUSIONS: The most frequent complications associated with the administration of enteral nutrition through PRG were minor and the implementation of the balloon-type technique with pexy has led to a decrease in them.

miR-579-3p Controls Hepatocellular Carcinoma Formation by Regulating the Phosphoinositide 3-Kinase-Protein Kinase B Pathway in Chronically Inflamed Liver.

Chronic liver inflammation causes continuous liver damage with progressive liver fibrosis and cirrhosis, which may eventually lead to hepatocellular carcinoma (HCC). Whereas the 10-year incidence for HCC in patients with cirrhosis is approximately 20%, many of these patients remain tumor free for their entire lives. Clarifying the mechanisms that define the various outcomes of chronic liver inflammation is a key aspect in HCC research. In addition to a wide variety of contributing factors, microRNAs (miRNAs) have also been shown to be engaged in promoting liver cancer. Therefore, we wanted to characterize miRNAs that are involved in the development of HCC, and we designed a longitudinal study with formalin-fixed and paraffin-embedded liver biopsy samples from several pathology institutes from Switzerland. We examined the miRNA expression by nCounterNanostring technology in matched nontumoral liver tissue from patients developing HCC (n = 23) before and after HCC formation in the same patient. Patients with cirrhosis (n = 26) remaining tumor free within a similar time frame served as a control cohort. Comparison of the two cohorts revealed that liver tissue from patients developing HCC displayed a down-regulation of miR-579-3p as an early step in HCC development, which was further confirmed in a validation cohort. Correlation with messenger RNA expression profiles further revealed that miR-579-3p directly attenuated phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) expression and consequently protein kinase B (AKT) and phosphorylated AKT. In vitro experiments and the use of clustered regularly interspaced short palindromic repeats (CRISPR)/Cas9 technology confirmed that miR-579-3p controlled cell proliferation and cell migration of liver cancer cell lines. Conclusion: Liver tissues from patients developing HCC revealed changes in miRNA expression. miR-579-3p was identified as a novel tumor suppressor regulating phosphoinositide 3-kinase-AKT signaling at the early stages of HCC development.

Debate 2: Legislación del consumo de tabaco en España. ¿Está siendo eficaz? A favor / Debate 285Legislation on smoking in Spain. Is it being effective? For

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Hepatitis C virus deep sequencing for sub-genotype identification in mixed infections: A real-life experience.

BACKGROUND: The effectiveness of the new generation of hepatitis C treatments named direct-acting antiviral agents (DAAs) depends on the genotype, subtype, and resistance-associated substitutions present in individual patients. The aim of this study was to evaluate a massive sequencing platform for the analysis of genotypes and subtypes of hepatitis C virus (HCV) in order to optimize therapy. METHODS: A total of 84 patients with hepatitis C were analyzed. The routine genotyping methodology for HCV used at the study institution (Versant HCV Assay, LiPA) was compared with a deep sequencing platform (454/GS-Junior and Illumina MiSeq). RESULTS: The mean viral load in these HCV patients was 6.89×106±7.02×105. Viral genotypes analyzed by LiPA were distributed as follows: 26% genotype 1a (22/84), 55% genotype 1b (46/84), 1% genotype 1 (1/84), 2.5% genotype 3 (2/84), 6% genotype 3a (5/84), 6% genotype 4a/c/d (5/84). When analyzed by deep sequencing, the samples were distributed as follows: 27% genotype 1a (23/84), 56% genotype 1b (47/84), 8% genotype 3a (7/84), 5% genotype 4d (4/84), 2.5% genotype 4f (2/84). Six of the 84 patients (7%) were infected with more than one subtype. Among these, 33% (2/6) failed DAA-based triple therapy. CONCLUSIONS: The detection of mixed infection could explain some treatment failures. Accurate determination of viral genotypes and subtypes would allow optimal patient management and improve the effectiveness of DAA therapy.

Valoración de un método de dilución para la resolución de resultados no valorables en la detección de Chlamydia trachomatis y Neisseria gonorrhoeae con la plataforma cobas 4800 / Evaluation of a dilution method for non-evaluable results in the detection of Chlamydia trachomatis and Neisseria gonorrhoeae with the Cobas 4800 platform

Introducción: Un porcentaje variable de muestras analizadas por el equipo cobas 4800 pueden dar un resultado invalidado por inhibición de la PCR o erróneo al no extraerse el ADN correctamente con el test cobas 4800 CT/NG. Método: Valoración de un protocolo de agitación y dilución de la muestra original (exudado u orina) en un total de 116 muestras. Para analizar la sensibilidad de este método, 100 muestras (exudados y orinas) con resultado conocido fueron retestadas. Resultados: Un 98,3% (114/116) de las muestras se resolvieron con este protocolo con un 100% de concordancia al consultar con datos clínicos, tinción de Gram y otras muestras analizadas en paralelo del mismo paciente. Discusión: Los datos indican que no hay pérdida de sensibilidad con este protocolo, por lo que los usuarios de esta plataforma podrían usarlo sin necesidad de métodos alternativos (AU)

Introduction: A variable percentage of samples analysed using the Cobas 4800 assay can give an invalid result by PCR inhibition or erroneous due to incorrect DNA extraction with the Cobas 4800 CT/NG test. Method: An analysis was performed using the vortex agitation and dilution protocol on the original sample (swab or urine) for a total of 116 samples. In order to analyse the sensitivity of this method, 100 samples (swabs and urine) with known results were retested. Results: A total of 98.3% (114/116) of the samples analysed were resolved with this protocol with 100% agreement after reviewing clinical data, Gram stain, and other samples analysed in parallel from the same patient. Discussion: The data indicate no loss of sensitivity with this protocol; thus Cobas 4800 users could use this method without the need for alternative methods (AU)

Candida albicans Germ-Tube Antibody: Evaluation of a New Automatic Assay for Diagnosing Invasive Candidiasis in ICU Patients.

Testing for Candida albicans germ-tube antibody IFA IgG assay (CAGTA) is used to detect invasive candidiasis infection. However, most suitable assays lack automation and rapid single-sample testing. The CAGTA assay was adapted in an automatic monotest system (invasive candidiasis [CAGTA] VirClia® IgG monotest (VirClia®), a chemiluminescence assay with ready-to-use reagents that provides a rapid objective result. CAGTA assay was compared with the monotest automatic VirClia® assay in order to establish the diagnostic reliability, accuracy, and usefulness of this method. A prospective study with 361 samples from 179 non-neutropenic critically ill adults patients was conducted, including 21 patients with candidemia, 18 with intra-abdominal candidiasis, 84 with Candida spp. colonization, and 56 with culture-negative samples, as well as samples from ten healthy subjects. Overall agreement between the two assays (CAGTA and VirCLIA) was 85.3%. These assays were compared with the gold-standard method to determine the sensitivity, specificity as well as positive and negative predictive values. In patients with candidemia, values for CAGTA and VirCLIA assays were 76.2 versus 85.7%, 80.3 versus 75.8%, 55.2 versus 52.9%, and 91.4 versus 94.3%, respectively. The corresponding values in patients with intra-abdominal candidiasis were 61.1 versus 66.7%, 80.3 versus 75.8%, 45.8 versus 42.9%, and 88.3 versus 89.3%, respectively. No differences were found according to the species of Candida isolated in culture, except for Candida albicans and C. parapsilosis, for which VirClia® was better than CAGTA. According to these results, the automated VirClia® assay was a reliable, rapid, and very easy to perform technique as tool for the diagnosis invasive candidiasis.

Liver damage and senescence increases in patients developing hepatocellular carcinoma.

BACKGROUND AND AIM: Most patients with a hepatocellular carcinoma (HCC) have an underlying chronic liver inflammation, which causes a continuous damage leading to liver cirrhosis and eventually HCC. However, only a minority of cirrhotic patients develop HCC. To assess a possible differential impact of liver inflammation in patients developing HCC versus patients remaining tumor-free, we designed a longitudinal study and analysed liver tissue of the same patients (n = 33) at two points in time: once when no HCC was present and once several years later when an HCC was present. As a control group, we followed cirrhotic patients (n = 37) remaining tumor-free over a similar time frame. METHODS: We analysed cell damage and senescence of hepatocytes by measuring γ-H2AX positivity, p16INK4 and p21WAF/Cip1 expression, nuclear size, and telomere length. RESULTS: γ-H2AX positivity, p16INK4 and p21WAF/Cip1 expression, in the first liver biopsy was similar in patients developing HCC later on and cirrhotic patients remaining tumor free. In contrast, γ-H2AX positivity, p16INK4 and p21WAF/Cip1 expression, was significantly higher in the second non-tumoral liver biopsy of HCC patients than in the control patients. Consequently, the individual increase in γ-H2AX positivity, p16INK4 and p21WAF/Cip1 expression, from the first biopsy to the second biopsy was significantly higher in patients developing HCC than in patients remaining tumor free. In addition, changes in nuclear size and telomere length revealed a more pronounced cell aging in patients developing HCC than in patients remaining tumor free. CONCLUSIONS: Hepatocytes from patients developing HCC go through more pronounced cell damage and senescence in contrast to cirrhotic patients remaining tumor free.

Evaluation of a dilution method for non-evaluable results in the detection of Chlamydia trachomatis and Neisseria gonorrhoeae with the Cobas 4800 platform. / Valoración de un método de dilución para la resolución de resultados no valorables en la detección de Chlamydia trachomatis y Neisseria gonorrhoeae con la plataforma cobas 4800.

INTRODUCTION: A variable percentage of samples analysed using the Cobas 4800 assay can give an invalid result by PCR inhibition or erroneous due to incorrect DNA extraction with the Cobas 4800 CT/NG test. METHOD: An analysis was performed using the vortex agitation and dilution protocol on the original sample (swab or urine) for a total of 116 samples. In order to analyse the sensitivity of this method, 100 samples (swabs and urine) with known results were retested. RESULTS: A total of 98.3% (114/116) of the samples analysed were resolved with this protocol with 100% agreement after reviewing clinical data, Gram stain, and other samples analysed in parallel from the same patient. DISCUSSION: The data indicate no loss of sensitivity with this protocol; thus Cobas 4800 users could use this method without the need for alternative methods.

Clinical and epidemiological characterisation of lymphogranuloma venereum in southwest Spain, 2013-2015.

OBJECTIVES: Lymphogranuloma venereum (LGV) infections caused by Chlamydia trachomatis L serovars have emerged in 2003 in Europe among HIV-positive men having sex with men (MSM). Our aim was to evaluate LGV prevalence and predictors in a high-risk population attending to two STI clinics in the southwest of Spain between December 2013 and April 2015. METHODS: Screening of C. trachomatis using commercial kits was carried out, followed by real-time pmpH-PCR discriminating LGV strains, and finally ompA gene was sequenced for phylogenetic reconstruction. RESULTS: A total of 6398 samples were tested, of which, 594 (9.3%) were C. trachomatis-positive specimens and successfully typed by pmpH PCR. Five hundred and eighty-one samples contained non-LGV and 13 (2.2%; 95% CI 1.3% to 3.7%) samples had LGV. One hundred and sixty-six (27.9%; 95% CI 24.5% to 31.7%) CT-positive results were found in MSM. All C. trachomatis LGV types were found in rectal samples from MSM (13/166, 7.8%; 95% CI 4.5% to 13.0%). Of these, five (38.5%; 95% CI 17.7% to 64.5%) patients were asymptomatic and 11 (84.6%; 95% CI 57.8% to 95.7%; p<0.001) were also HIV positive. Successful treatment of LGV was achieved in all patients including 11/13 (84.6%) who received single-dose azithromycin. All of the L types were confirmed to be genotype L2b with ompA PCR and sequencing. CONCLUSIONS: This analysis shows that LGV infections are occurring in MSM in southwest Spain, where no data about LGV have been described before, reinforcing the need for screening and genotyping for LGV. LGV should be taken into account when considering treatment and management of rectal C. trachomatis infections, including in asymptomatic HIV-positive MSM. Larger studies on appropriate treatment for asymptomatic LGV infection are needed.

Performance of the HSV OligoGen kit for the diagnosis of herpes simplex virus type 1 and 2.

PCR methods are nowadays between the most rapid and sensitive methods for screening and diagnosing herpes simplex virus (HSV) type 1 and 2. The aim of this study was to analyze the reliability, accuracy, and usefulness of the new assay HSV OligoGen kit in comparison with the Roche LightCycler HSV ½ Qual Kit assay for the detection of HSV in clinical samples. For this analysis, a prospective study was designed for detection of HSV-1 and HSV-2 including 110 ulcer specimens, 48 urine, 48 endocervical, 43 cerebral spinal fluids, 4 urethral and 3 pharyngeal swabs that were sent from a regional STI clinic or an Intensive Clinical Unit, both in Seville, Spain. In comparison to the Roche LightCycler HSV ½ Qual Kit assay, sensitivity, specificity, positive and negative predicative values, and kappa value for HSV detection using the HSV OligoGen kit were 96.2%, 100%, 100%, 98.3%, and 0.97 for HSV-1, respectively. For HSV-2, the corresponding values were 98.3%, 100%, 100%, 99.5%, and 0.98, respectively. Statistical data obtained in this study confirms the usefulness and reliable results of this new assay.

Comparison of the CT OligoGen kit with cobas 4800 assay for detection of Chlamydia trachomatis / Comparación del kit CT OligoGen con el ensayo Cobas 4800 para la detección de Chlamydia trachomatis

INTRODUCTION: A prospective study was designed to assess the performance of the new CT OligoGen kit and the cobas 4800 assay for detection of Chlamydia trachomatis. METHODS: A set of samples that included urine samples (n = 212), endocervical (n = 167), rectal (n = 53), pharyngeal (n = 7) and urethral swabs (n = 3). The samples were sent from a regional sexually transmitted diseases (STD) clinic in Seville, Spain, and were collected from 261 men and 181 women. Discordant results were re-analyzed and clinical data and other tests were reviewed in order to resolve them. RESULTS: Sensitivity, specificity, positive predicative value (PPV), negative predictive value (NPV) and kappa value for C. trachomatis detection using the CT OligoGen kit were 98.5%, 100%, 100%, 95.4% and 0.97, respectively. Conclusions This new kit had a high sensitivity, specificity, PPV and NPV for C. trachomatis, therefore the performance profile confirms the usefulness and reliable results of this new assay

INTRODUCCIÓN: Se diseñó un estudio prospectivo para evaluar las características del nuevo kit CT OligoGen en comparación con el test cobas 4800 para la detección de Chlamydia trachomatis. MÉTODOS: Se analizaron una serie de muestras que incluían orinas (n = 212), exudados endocervicales (n = 167), rectales (n = 53), faríngeos (n = 7) y uretrales (n = 3). Estas muestras provenían de un centro de infecciones de transmisión sexual (Sevilla) y pertenecían a 261 hombres y 181 mujeres. Los resultados discordantes se reanalizaron y revisaron historias clínicas y otras pruebas para resolverlas. RESULTADOS: Los valores de sensibilidad, especificidad, valor predictivo positivo (VPP) y negativo (VPN) y valor kappa para el kit CT OligoGen fue 98,5%, 100%, 100%, 95,4% and 0,97, respectivamente. CONCLUSIONES: Este nuevo kit tuvo una alta sensibilidad, especificidad, VPP y VPN para la detección de C. trachomatis, por lo que esta evaluación confirma su utilidad y fiabilidad

Comparison of the CT OligoGen kit with cobas 4800 assay for detection of Chlamydia trachomatis.

INTRODUCTION: A prospective study was designed to assess the performance of the new CT OligoGen kit and the cobas 4800 assay for detection of Chlamydia trachomatis. METHODS: A set of samples that included urine samples (n=212), endocervical (n=167), rectal (n=53), pharyngeal (n=7) and urethral swabs (n=3). The samples were sent from a regional sexually transmitted diseases (STD) clinic in Seville, Spain, and were collected from 261 men and 181 women. Discordant results were re-analyzed and clinical data and other tests were reviewed in order to resolve them. RESULTS: Sensitivity, specificity, positive predicative value (PPV), negative predictive value (NPV) and kappa value for C. trachomatis detection using the CT OligoGen kit were 98.5%, 100%, 100%, 95.4% and 0.97, respectively. CONCLUSIONS: This new kit had a high sensitivity, specificity, PPV and NPV for C. trachomatis, therefore the performance profile confirms the usefulness and reliable results of this new assay.