20S constitutive proteasome, 20S immunoproteasome, and cathepsin S are high-sensitivity and independent markers of immunological activity in relapsing-remitting type of multiple sclerosis.

Research on the markers of autoimmune response in multiple sclerosis (MS) is still of great importance. The aim of our study was the evaluation of plasma 20S constitutive proteasome, 20S immunoproteasome, and cathepsin S concentrations as potential biomarkers of a relapsing-remitting type of MS (RRMS). Surface plasmon resonance imaging (SPRI) biosensors were used for the evaluation of protein concentrations. Plasma 20S constitutive proteasome, 20S immunoproteasome, and cathepsin S concentrations were significantly higher in RRMS patients compared to the control group. All three parameters were characterized by excellent usefulness in differentiating MS patients from healthy individuals (AUC equal to or close to 1.000). The plasma concentration of analyzed parameters was not correlated with severity of disability in the course of RRMS (EDSS value), the number of years from the first MS symptoms, the number of years from MS diagnosis, or the number of relapses within the 24-month observational period. Our study has shown that plasma concentrations of 20S constitutive proteasome, 20S immunoproteasome, and cathepsin S have promising potential in differentiating RRMS patients from healthy individuals. All of the analyzed parameters were found to be independent of the time of MS relapse and the severity of neurological symptoms. Hence, their potential as highly sensitive and independent circulating markers of RRMS suggests a stronger association with immunological activity (inflammatory processes) than with the severity of the disease.

Validation and verification framework and data integration of biosensors and in vitro diagnostic devices: a position statement of the IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MBHLM) and the IFCC Scientific Division.

Advances in technology have transformed healthcare and laboratory medicine. Biosensors have emerged as a promising technology in healthcare, providing a way to monitor human physiological parameters in a continuous, real-time, and non-intrusive manner and offering value and benefits in a wide range of applications. This position statement aims to present the current situation around biosensors, their perspectives and importantly the need to set the framework for their validation and safe use. The development of a qualification framework for biosensors should be conceptually adopted and extended to cover digitally measured biomarkers from biosensors for advancing healthcare and achieving more individualized patient management and better patient outcome.

The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: code of conduct, version 3 - 2023.

Whilst version 2 focussed on the professional conduct expected of a Specialist in Laboratory Medicine, version 3 builds on the responsibilities for ethical conduct from point of planning to point of care. Particular responsibilities that are outlined include: - The need for evidence when planning a new service, providing assurance that a new test does not do harm - Maintaining respect for patient confidentiality, their religious/ethnic beliefs, the need for informed consent to test, agreement on retrospective use of samples as part of governance envelopes in the pre-analytical phase - Ensuring respect for patient autonomy in the response to untoward results generated in the analytical phase - Supporting the safety of patients in the post-analytical phase through knowledge-based interpretation and presentation of results - The duty of candour to disclose and respond to error across the total testing process - Leading initiatives to harmonise and standardise pre-analytical, analytical and post-analytical phases to ensure more consistent clinical decision making with utilisation of demand management to ensure more equitable access to scarce resources - Working with emerging healthcare providers beyond the laboratory to ensure consistent application of high standards of clinical care In identifying opportunities for wider contributions to resolving ethical challenges across healthcare the need is also highlighted for more external quality assurance schemes and ethics-based quality indicators that span the total testing process.

Target association rule mining to explore novel paediatric illness patterns in emergency settings.

BACKGROUND AND AIMS: To assess the hospitalized sick children admitted to the pediatric emergency department (ED) and to find new patterns of clinical and laboratory attributes using association rule mining (ARM). METHODS: In this observational study, 158 children with median (IQR) age 11 months and a PRISM III score of 5 (2-9) were enrolled. Hotspot data mining method was applied to assess clinical attributes, lab investigations and pre-defined outcome parameters of children and their association in sick hospitalized children aged 1 month to 12 years. RESULTS: We obtained 30 rules with value for outcome as discharge is given attributes as follows: duration of hospitalization > 4 days, lactate > 1.2 mmol/L, platelet = 3.67/µL, dur_ventil = 0 h, serum K = 5.2 mmol/L, SBP = 120 mmHg, pCO2 = 41.9 mmHg, PaO2 = 163 mmHg, age = 92 months, heart rate > 114-159 per minute, temperature > 98 °F, GCS (Glasgow Coma Scale) > 7-14, gas K = 4.14 mmol/L, gas Na = 138.1 mmol/L, BUN (Blood Urea Nitrogen) = 18.69 mg/dL, Diagnosis > 1-718, Creatinine = 1.2 mg/dL, serum Na = 148 mmol/L, shock = 2, Glucose = 144 mg/dL, Mg(i) > 0.23 meq/L, BUN > 6.54 mg/dL. CONCLUSION: ARM is an effective data analysis technique to find meaningful patterns using clinical features with actual numbers in pediatric critical illness. It can prove to be important while analysing the association of clinical attributes with disease pattern, its features, and therapeutic or intervention success patterns.

The Academy of the European Federation of Clinical Chemistry and Laboratory Medicine and the European Register of Specialists in Laboratory Medicine: guide to the Academy and the Register, version 4 - 2020.

The 4th version of the guide to the Register for European Specialists in Laboratory Medicine (EuSpLM) established by the European Communities Confederation of Clinical Chemistry and Laboratory Medicine describes the transfer of the register to the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) in 2016, the extension in 2018 of the Register beyond the European Union to Europe and the benefits of membership of the EFLM Academy to which the Register transferred on the Academy's launch in 2019. The Academy offers EuSpLM registrants access to benefits that include reduced registration rates at selected conferences and free subscription to Clinical Chemistry and Laboratory Medicine. With effect from 2020 eligibility was extended to anyone with an interest in laboratory medicine. The updated guide describes the electronically driven processes for individual membership and block enrolment from national societies/organisations, and the stepping stones to recognition as an EuSpLM within the Academy. Whilst eligibility for recognition as an EuSpLM remains largely unchanged new expectations across Europe in education, training, professional regulation and qualifications are reflected in updated criteria. The continuing driver for establishing the Academy and growing the EFLM Register reflects the federation's leadership role in the harmonisation of high quality education and training for those with an interest in laboratory medicine as well as ongoing initiatives to establish a Common Training Framework for Specialists in Laboratory Medicine under EU Directive 2013/55/EC (The Recognition of Professional Qualifications).

A proposed Common Training Framework for Specialists in Laboratory Medicine under EU Directive 2013/55/EC (The Recognition of Professional Qualifications).

European Union (EU) Directive 2013/55/EC (The Recognition of Professional Qualifications) allows Member States to decide on a common set of minimum knowledge, skills and competences that are needed to pursue a given profession through a Common Training Framework. To be adopted the framework must combine the knowledge, skills and competences of at least one third of the Member States. Professionals who have gained their qualifications under a Common Training Framework will be able to have these recognised automatically within the Union. The backbone of the European Federation of Clinical Chemistry and Laboratory Medicine's (EFLM) proposed Common Training Framework for non-medical Specialists in Laboratory Medicine is outlined here. It is based on an Equivalence of Standards in education, training, qualifications, knowledge, skills, competences and the professional conduct associated with specialist practice. In proposing the recognition of specialist practice EFLM has identified 15 EU Member States able to meet Equivalence and in whom the profession and/or its training is regulated (an additional EU Commission requirement). The framework supports and contributes to the Directive's enabling goals for increasing professional mobility, safeguarding consumers and ensuring a more equitable distribution of skills and expertise across the Member States. It represents EFLM's position statement and provides a template for professional societies and/or competent authorities to engage with the EU Commission.

Practice in financial support of third party organised conferences and courses at a national level for health care professionals in Europe.

Background Ethical MedTech prescribes high standards for the participation of the in vitro diagnostics (IVD) industry in third-party organised educational events in terms of charitable donations, educational grants, scholarships and fellowships. We planned a survey to investigate the previous and current practice in terms of cooperation between professionals or professional societies and the IVD industry, as well as plans under the incorporation of the MedTech Europe Code. Methods Different questions, from general information to specific questions related to the practice and knowledge of the new Ethical MedTech Code, were included in two different surveys; for European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) National Societies' (NSs) representatives, and for their (NSs) individual members. Results Twenty-five out of 40 EFLM NS representatives replied; more than half declared that all different types of financial resources were available for supporting the continuing professional education of health care professionals (HCPs). In addition, 322 individual responses collected from 31 NSs, answered that the institutional director (50.3%) or laboratory chief (70.1%) made generally made a decision, without specific criteria. Conclusions The MedTech Europe Code is already adopted or is about to be adopted in numerous EFLM NSs, but most of them have not implemented it as yet. The use of the Code and better communication between IVD companies and HCPs are necessary to guarantee an improved and fair use of financial support, as well as better choices for the organisation and attendance at scientific events.

The European Federation of Clinical Chemistry and Laboratory Medicine syllabus for postgraduate education and training for Specialists in Laboratory Medicine: version 5 - 2018.

Although laboratory medicine practise varies across the European Union's (EU) member states, the extent of overlap in scope is such that a common syllabus describing the education and training associated with high-quality, specialist practise can be identified. In turn, such a syllabus can help define the common set of skills, knowledge and competence in a Common Training Framework (CTF) for non-medical Specialists in Laboratory Medicine under EU Directive 2013/55/EU (The recognition of Professional Qualifications). In meeting the requirements of the directive's CTF patient safety is particularly enhanced when specialists seek to capitalise on opportunities for free professional migration across EU borders. In updating the fourth syllabus, the fifth expands on individual discipline requirements, new analytical techniques and use of statistics. An outline structure for a training programme is proposed together with expected responsibilities of trainees and trainers; reference is provided to a trainee's log book. In updating the syllabus, it continues to support national programmes and the aims of EU Directive 2013/55/EU in providing safeguards to professional mobility across European borders at a time when the demand for highly qualified professionals is increasing in the face of a disparity in their distribution across Europe. In support of achieving a CTF, the syllabus represents EFLM's position statement for the education and training that underpins the framework.

Patient's knowledge and awareness about the effect of the over-the-counter (OTC) drugs and dietary supplements on laboratory test results: a survey in 18 European countries.

Background Nowadays over-the-counter (OTC) drugs and dietary supplements are widely used. Their use can have a significant impact on the validity of laboratory results. The aim of this multicenter European study was to determine the frequency of consumption of various dietary products and OTC drugs among patients and explore their level of knowledge and awareness about the potential impact of various products on laboratory test results. Methods Eighteen European countries participated in this study. The survey was carried out anonymously on a subsequent series of outpatients (n=200) in each participating country. Included were patients who were referred to the laboratory for blood sampling and who voluntarily agreed to participate in the study. The survey included questions about the frequency of consumption of various products, awareness of the importance of informing physicians and laboratory staff about it and information about influence of preanalytical factors in general on laboratory test results. Results In total, 68% of patients were regularly taking at least one OTC drug or dietary supplement. The frequency of patients consuming at least one OTC drug or dietary supplement differed between countries (p=0.001). Vitamins (38%), minerals (34%), cranberry juice (20%), acetylsalicylic acid (ASA) (17%) and omega fatty acids (17%) were the most commonly used in our study. Conclusions The use of various OTC drugs and dietary supplements is highly prevalent in Europe and patients are often not willing to disclose this information to the laboratory staff and ordering physician. The education of both patients and healthcare staff is needed.

Assessment of Early Cardiovascular Risk in Children and Adolescents with Essential Hypertension.

The aim of our study was to investigate some early markers of hypertensive target organ damage in hypertensive children and adolescents, and to detect those showing most prominent clinical significance. We included 100 children with essential hypertension (EH) and 50 age-matched healthy control children, and evaluated left ventricular mass (LVM), intima-media thickness in the carotid arteries (IMT), pulse wave velocity (PWV), microalbuminuria, biochemical parameters and some adipokines. Statistically significant differences between the 2 groups were observed for HDL-cholesterol, LDL-cholesterol, triglycerides, insulin, uric acid, glucose, apolipoprotein A1, and total adiponectin. The mean values of IMT, PWV and LVM were greater in hypertensive children, but only the differences in IMT and LVM were statistically significant. In addition, hypertensive children showed significantly higher values of AoSP (aortic systolic pressure), AoPP (aortic pulse pressure) and AIx@75 (augmentation index corrected for heart rate of 75 b.p.m.). Metabolic syndrome was diagnosed in 31% of hypertensive children. A significant number of children with EH have early target organ changes as well as other risk factors, including metabolic syndrome, especially obese ones. However, IMT, LVM and some parameters of arterial stiffness have been found to be early markers in both obese and non-obese hypertensives. In addition, adipokines and coagulation factors seem to be important in obese hypertensives.

The Impact of Extracorporeal Magnetic Stimulation as Addition to Mirabegron in Overactive Bladder Treatment in Women: A Single-Centre Randomized Sham-Controlled Study.

(1) Background: The purpose of our prospective, single-blinded, randomized, sham-controlled study was to investigate the effect of the additional extracorporeal magnetic stimulation (ExMI) to pharmacological treatment in overactive bladder syndrome (OAB) in women. (2) Methods: We recruited 56 women with OAB, who were allocated into two study groups: the active group received mirabegron 50 mg daily and a total of 16 sessions of ExMI in 8 weeks, whereas the sham group received mirabegron 50 mg daily and sham stimulation following the same treatment protocol. Treatment success was evaluated after 4 and 8 weeks. (3) Results: Both groups experienced significant reduction in daytime urinary frequency, nocturia, and number of weekly incontinence episodes after 8 weeks. There were no statistically significant differences in end-point daytime urinary frequency and nocturia between groups. However, the overall average reduction rate in weekly number of incontinence episodes was 43.7% in treatment group and 24.2% in the control group. The number of urinary incontinence episodes in the treatment and control group was reduced for 3.8 ± 11.8 vs. 2.5 ± 4.3 episodes at week 4 and additional 3.3 ± 6 vs. 0.4 ± 3.2 episodes at week 8, respectively (p = 0.013). Moreover, IIQ-7 score showed a significantly greater score reduction and patients' evaluated improvement of symptoms was higher in the active group. (4) Conclusions: The addition of ExMI to mirabegron in OAB treatment further improves the weekly incontinence episode reduction rate and also leads to grater improvement in symptoms.

New Flow Cytometric Methods for Monitoring STAT5 Signaling Reveal Responses to SARS-CoV-2 Antigen-Specific Stimulation in FOXP3+ Regulatory T Cells also in Patients with Advanced Chronic Lymphocytic Leukemia.

Increased frequency of CD4+CD25+ regulatory T-cells (Treg) has been associated with disease progression in chronic lymphocytic leukemia (CLL). Flow cytometric methods, which allow for the simultaneous analysis of their specific transcription factor Foxp3 and activated STAT proteins, together with proliferation can help to elucidate the signaling mechanisms driving Treg expansion and suppression of FOXP3- conventional CD4+T-cells (Tcon). Herein, we first report a novel approach in which STAT5 phosphorylation (pSTAT5) and proliferation (BrdU-FITC incorporation) could be analyzed specifically in FOXP3+ and FOXP3- responding cells after CD3/CD28 stimulation. The addition of magnetically purified CD4+CD25+ T-cells from healthy donors to cocultured autologous CD4+CD25- T-cells resulted in suppression of Tcon cell cycle progression accompanied by a decrease in pSTAT5. Next, a method using imaging flow cytometry is presented for the detection of cytokine-dependent pSTAT5 nuclear translocation in FOXP3-expressing cells. Finally, we discuss our experimental data obtained by combining Treg pSTAT5 analysis and antigen-specific stimulation with SARS-CoV-2 antigens. Applying these methods on samples from patients revealed Treg responses to antigen-specific stimulation and significantly higher basal pSTAT5 in CLL patients treated with immunochemotherapy. Thus, we speculate that through the use of this pharmacodynamic tool, the efficacy of immunosuppressive drugs and their possible off-target effects can be assessed.

Does leptin cause proximal gastric cancer in the obese? The role of serum leptin in the etiology of proximal gastric cancer.

OBJECTIVES: The aim of the present study was to determine the correlation between obesity, serum levels of leptin and proximal gastric cancer. METHODS: Sixty-four gastric cancer patients operated on with curative intent were included in the study. We determined the correlation between the preoperative serum levels of leptin and the tumor's location. RESULTS: Serum leptin levels were correlated significantly with the proximal third location (p=0.04), gastric outlet obstructing tumors (p<0.0001), CRP levels (p=0.03) and BMI (p<0.0001). Patients with high serum levels of leptin had significantly more intestinal types of gastric cancer (p=0.033) and better differentiation (p=0.009). The linear regression model determined the proximal tumor location (beta: 0.467; p=0.045), BMI (beta: 0.657; p=0.001), high preoperative serum albumin (beta: 0.563; p=0.016) and the presence of pyloric stenosis (beta: 0.525; p=0.006) as related significantly to serum leptin levels. The Cox proportional hazard model identified age (HR: 0.003; 95 % CI: 0-0.794; p=0.041), preoperative serum levels of leptin (HR: 0.125; 95 % CI: 0.018-0.887; p=0.037) and the number of extracted LNs (HR: 0.001; 95 % CI: 0-0.677; p=0.038) as independent prognostic factors. CONCLUSIONS: Serum levels of leptin were significantly elevated in patients with proximal gastric cancer, suggesting that the leptin's effect might be due to its systemic secretion. This might explain the higher incidence of proximal gastric cancer in obese patients. Elevated serum leptin levels were an independent prognostic factor.

UCHL1, besides leptin and fibronectin, also could be a sensitive marker of the relapsing-remitting type of multiple sclerosis.

Research on the markers of immunoregulatory response in multiple sclerosis (MS) is still of great importance. The aim of our study was the evaluation of leptin, fibronectin, and UCHL1 concentrations as potential biomarkers of a relapsing-remitting type of MS (RRMS). Surface Plasmon Resonance Imaging (SPRI) biosensors were used for the evaluation of proteins concentrations in 100 RRMS patients and 46 healthy volunteers. Plasma leptin, fibronectin, and UCHL1 concentrations were significantly higher in RRMS patients compared to the control group (p < 0.001, respectively). UCHL1 concentration evaluation revealed the highest diagnostic sensitivity (100%) and negative predictive value (100%) in differentiating MS patients from healthy individuals. There was no significant difference in the UCHL1 concentrations depending on the patient's sex, the presence of relapse within the last 24 months, and the EDSS value (p > 0.05, respectively). In RRMS patients UCHL1 concentration positively correlated with fibronectin levels (r = 0.3928; p < 0.001). In the current cohort of patients plasma UCHL1 concentration was independent of the time of MS relapse and the severity of neurological symptoms. Thus current study may indicate that plasma UCHL1, besides leptin and fibronectin, also could be a promising high-sensitive potential biomarker of relapsing-remitting type of MS. However, these results should be validated with a larger group of patients, taking into account neuroimaging and cerebrospinal fluid analysis data, and by comparing them to patients with other neurological diseases as a control group.

Artificial intelligence and thyroid disease management: considerations for thyroid function tests.

Artificial intelligence (AI) is transforming healthcare and offers new tools in clinical research, personalized medicine, and medical diagnostics. Thyroid function tests represent an important asset for physicians in the diagnosis and monitoring of pathologies. Artificial intelligence tools can clearly assist physicians and specialists in laboratory medicine to optimize test prescription, tests interpretation, decision making, process optimization, and assay design. Our article is reviewing several of these aspects. As thyroid AI models rely on large data sets, which often requires distributed learning from multi-center contributions, this article also briefly discusses this issue.

Lessons Learned from the COVID-19 Pandemic: Emphasizing the Emerging Role and Perspectives from Artificial Intelligence, Mobile Health, and Digital Laboratory Medicine.

SARS-CoV-2, the new coronavirus causing COVID-19, is one of the most contagious disease of past decades. COVID-19 is different only in that everyone is encountering it for the first time during this pandemic. The world has gone from complete ignorance to a blitz of details in a matter of months. The foremost challenge that the scientific community faces is to understand the growth and transmission capability of the virus. As the world grapples with the global pandemic, people are spending more time than ever before living and working in the digital milieu, and the adoption of Artificial Intelligence (AI) is propelled to an unprecedented level especially as AI has already proven to play an important role in counteracting COVID-19. AI and Data Science are rapidly becoming important tools in clinical research, precision medicine, biomedical discovery and medical diagnostics. Machine learning (ML) and their subsets, such as deep learning, are also referred to as cognitive computing due to their foundational basis and relationship to cognition. To date, AI based techniques are helping epidemiologists in projecting the spread of virus, contact tracing, early detection, monitoring, social distancing, compiling data and training of healthcare workers. Beside AI, the use of telemedicine, mobile health or mHealth and the Internet of Things (IOT) is also emerging. These techniques have proven to be powerful tools in fighting against the pandemic because they provide strong support in pandemic prevention and control. The present study highlights applications and evaluations of these technologies, practices, and health delivery services as well as regulatory and ethical challenges regarding AI/ML-based medical products.

Soluble ST2: A complex and diverse role in several diseases.

The Suppression of Tumorigenicity 2 protein (ST2) is a member of the interleukin (IL) 1 receptor family with transmembrane (ST2L) and soluble (sST2) isoforms that are (over)expressed in several cells in different conditions and following various triggers (e.g. inflammation, stress). The ligand of ST2 is IL-33, which on binding to ST2L results in nuclear signalling and immunomodulatory action in various cells (tumour, immune, heart). sST2, that is released in the circulation, functions as a ¼decoy« receptor of IL-33 and inhibits IL-33/ST2L signalling and beneficial effects. The importance and role of the ST2/IL-33 axis and sST2 have been evaluated and confirmed in several inflammatory, cancer and cardiac diseases. sST2 is involved in homeostasis/pathogenesis of these diseases, as the counterbalance/response on IL-33/ST2L axis activation, which is triggered and expressed during developing fibrosis, tissue damage/inflammation and remodelling. In clinical studies, sST2 has been recognised as an important prognostic marker in patients with cardiac disease, including patients with chronic kidney disease where specific characteristics of sST2 enable better assessment of the risk of End-Stage Renal Disease patients on dialysis. sST2 is also recognised as an important marker for monitoring treatment in heart failure patients. However, accurate measurement and interpretation of ST2 concentration in serum/plasma samples for routine and research applications require the use of appropriate methods and recognition of essential characteristics of both the methods and the analyte that may influence the result. sST2, as one of the most promising disease biomarkers, is deserving of further study and wider application in clinical practice.

EFLM Project "Exchange of Practical Knowledge and Skills in Laboratory Medicine" - EFLMLabX.

BACKGROUND: In many laboratories/institutions of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) there is a need to acquire additional practical knowledge and skills in different fields of Laboratory Medicine (LM).Until now, there were no possibilities, in official and open ways, to find the link to such additional but very important education, which may be obtained in other laboratories in the country or abroad. The aim of this EFLM project is to create and operate a network of medical laboratories willing and able to offer practical training in various fields/aspects of Laboratory Medicine. METHODS: We conducted the survey among EFLM members, with the aim to identify the EFLM members' needs and possibilities to offer different practical training in laboratories in the country or abroad. We created the EFLMLabX website portal within the main EFLM website for offering, searching the practices and establishing direct contacts between applicants and providers institutions. RESULTS: According to the very positive survey results (146 responses) about needs (128) and interest to offer different practices (87) on the field of LM, that we have obtained from EFLM National Societies (28) in 2015, we noted a great interest for training and exchange of practical knowledge and skills in LM amongst EFLM countries. In January 2018 we have launched EFLMLabX portal. Since now we have already 13 providers/partners institutions, from 10 different countries, which offer 17 different practice positions. Four practices are already ongoing and two were already finished. CONCLUSIONS: With this project, according to obtained higher level of knowledge/experience on different field of laboratory diagnostics of general professional population (of EuSpLM), better networks between professionals, experts, and scientists we will gain higher general quality of our profession.

ST2 as a novel prognostic marker in end-stage renal disease patients on hemodiafiltration.

BACKGROUND: Patients with end-stage renal disease (ESRD) are prone to severe heart failure (HF) and to several life-threatening events. Therefore, the ability to assess disease prognosis and the risk of short-term events or death is of great importance. The role of soluble ST2 (sST2) as a potential new prognostic marker in ESRD patients is not yet known. The aim of our study was to assess the prognostic value of sST2 in ESRD patients on hemodiafiltration (HDF) and compare it with NT-proBNP, an established prognostic marker for HF and renal disease. METHODS: 123 ESRD patients on HDF were prospectively followed up from the date of the sST2/NT-proBNP measurement until their death or maximally up to 829days. Patients were divided into a low sST2 group (<35ng/mL) or a high sST2 group (≥35ng/mL) according to their measured sST2 concentration at the start of the study. Kaplan-Meier survival curves, Cox regression model and ROC analyses were used in statistical analysis. RESULTS: During follow-up 32 (26.0%) patients died (all cause mortality). Median (IQR) sST2 serum concentrations of survivors and deceased were 26 (24-29) and 36 (28-59) ng/mL, respectively. The Kaplan-Meier survival analysis showed that survival rate of the high sST2 group was statistically significant lower than of the low sST2 group (P<0.01). Cox regression model for sST2, using a dichotomized (cut-off=35ng/mL, hazard ratio (HR) (95%CI)=2.72 (1.50-4.90), P=0.001) and continuous approach with log-transformed values in univariate (HR (95%CI)=17.35 (4.84-62.22), P<0.001) and multivariate analysis (HR (95%CI)=7.19 (1.89-27.38), P=0.004) showed that sST2 alone and in combination with NT-proBNP can predict all cause mortality. CONCLUSIONS: sST2 has confirmed prognostic value and is independent of renal function and of HDF treatment. It could be useful independent prognostic marker for stratifying ESRD patients on HDF at high risk for life-threatening events, hospitalisation and death, especially in combination with NT-proBNP.

Measurement of anti-Mullerian hormone: performances of a new ultrasensitive immunoassay.

The measurement of anti-Mullerian hormone (AMH) is relevant for the evaluation of primary ovarian insufficiency, success of assisted reproductive therapies, and also to support the diagnosis of polycystic ovary syndrome. Our study demonstrated excellent analytical performances for the Ansh Laboratories AMH immunoassay and an overall good agreement with the AMH Gen II assay. Nevertheless, the two AMH immunoassays are not using the same couple of antibodies and therefore not commutable and the definition of specific reference values and cut-point remains necessary.