Neurofilament heavy chain and chitinase 3-like 1 as markers for monitoring therapeutic response in multiple sclerosis.

AIMS: The aim of this study was to evaluate the association of serum neurofilament heavy chain (sNfH) and chitinase 3-like 1 (sCHI3L1) with treatment response and disease activity in multiple sclerosis (MS). METHODS: This single-center, prospective, observational cohort study was conducted at the MS Centre, University Hospital Ostrava, Czech Republic, from May 2020 to August 2023. sNfH and sCHI3L1 were determined using ELISA. A mixed-effects linear model with a log-transformed outcome variable was applied. RESULTS: We analyzed 459 samples from 57 people with MS. Patients were sampled an average of 8.05 times during 21.9 months of follow-up. Those experiencing a relapse at sampling had a sNfH concentration 50 % higher than those in remission (exp(ß) 1.5, 95 % CI 1.15-1.96). A longer duration of treatment was associated with lower sNfH (exp(ß) 0.95, 95 % CI 0.94-0.96). Patients switched from low- to high-efficacy disease-modifying therapies (DMTs) had higher sNfH than patients treated with low-efficacy DMTs only (exp(ß) 1.95, 95 % CI 1.35-2.81). Higher sCHI3L1 was associated with older age (exp(ß) 1.01, 95 % CI 1.00-1.02) and longer DMT use (exp(ß) 1.01, 95 % CI 1.00-1.02). sCHI3L1 values were not associated with relapse at the time of sampling, renal function, sex, or type of DMT. CONCLUSION: In contrast to sCHI3L1, sNfH may be a potential biomarker for monitoring treatment response and confirming clinical relapse in MS. Further research is needed to determine the long-term dynamics of sNfH and develop related treatment strategies.

Contribution of miRNAs and Other Inflammatory Biomarkers to the Differentiation of Inflammatory and Non-Inflammatory Joint Effusions.

PURPOSE OF THE STUDY The aim of the study was to determine miR-146a-5p, miR-223-3p and miR-23a-3p by an enzyme immunoassay in patients with inflammatory and non-inflammatory joint effusion and to verify the usefulness of these miRNAs as biomarkers of joint inflammation. MATERIAL AND METHODS Synovial fluid (SF) samples were collected from 82 patients. The group consisted of 60 non-inflammatory, 11 inflammatory-non-pyogenic, 11 inflammatory-pyogenic SF. SF miRNA was isolated by RNA Isolation Kit Plasma/Serum. The concentrations of miRNA were determined by enzyme-linked immunosorbent assays (ELISA), C-reactive protein, interleukin-6 and procalcitonin on automatic analyser, presepsin on POCT system, interleukin-1 and human neutrofil defensins 1-3 by ELISA. RESULTS A statistically significant negative correlation was found between miR-146-5p and miR-223-3p, WBC, IL-1ß, IL-6 and CRP (P < 0.05) in all groups; a statistically significant positive correlation was found between miR-223-3p and miR-23a-3p, WBC, PMN, IL-1beta, IL-6 and HNP1-3, as well as a positive correlation of miR-23a-3p with IL-1ß, IL-6 and HNP1-3. A statistically significant difference was found between miR-146a-5p, miR-223-3p and miR-23a-3p and individual SF groups, P = 0.006, P < 0.001, respectively. PMN, WBC, Il-1ß, IL-6, HNP 1-3 predicted the inflammatory processes with excellent diagnostic power (AUC > 0.9). The clinical relevance expressed by effect size was the strongest in miR-223-3p, PMN, IL-1 , HNP 1-3 between non-inflammatory and inflammatory-pyogenic group. CONCLUSIONS Our study quantified the SF miRNA by ELISA. We have shown that miR-146a-5p, miR-223-3p and miR-23a-3p can be an important group of biomarkers for the detection and monitoring of various pathophysiological conditions in synovial fluid, including inflammatory conditions. Key words: miRNA, synovial fluid, inflammatory joint disease, enzyme-linked immunosorbent assay.

[Elevated levels of TFF3 in endometrial cancer patients]. / Zvýsení hladin TFF3 u zen s karcinomem endometria.

AIM: Trefoil peptides are a family of small proteins that are expressed in a site-specific fashion by certain epithelial tissues. These peptides might be used as markers for neoplastic uterine disease. DESIGN: Experimental study. SETTING: Department of Obstetrics and Gynaecology, University Hospital, Medical Faculty, Palacký University, Olomouc; Department of Laboratory Biochemistry, Central Moravian Hospital Trust, Member of Agel holding, Prostejov. METHODS: During the time period from 2012 to 2015 eighty-nine women underwent hysteroscopy and endometrial biopsy for postmenopausal bleeding. Fifty three patients, at the age of (mean ± standard deviation) 63,4 ± 9,5 (33-80) years were diagnosed with endometrial cancer, six patients at the age of 62,9 ± 6,4 (55-74) years were diagnosed with endometrial hyperplasia and thirty patients at the age of 63,3 ± 9,3 (48-62) years diagnosed with endometrial atrophy represented control group. At the day of surgery the venous blood was sampled and subsequently examined for the levels of TFF1, TFF2 and TFF3. RESULTS: TFF3 levels were significantly higher in patients with endometrial carcinoma but not in endometrial hyperplasia subgroup. The levels of TFF1 and TFF2 were not different in selected histopathological subgroups. CONCLUSION: We have shown elevated levels of TFF3 but not of TFF1 and TFF2 in patients with endometrial cancer. TFF1, TFF2 and TFF3 levels were not elevated in patients with endometrial hyperplasia.

Cerebrospinal fluid levels of chromogranin A and phosphorylated neurofilament heavy chain are elevated in amyotrophic lateral sclerosis.

BACKGROUND: Various cerebrospinal fluid (CSF) biomarkers are being studied to improve the sensitivity and specificity of the diagnostic methods for amyotrophic lateral sclerosis (ALS). AIMS OF THE STUDY: The aim of our study was to establish the CSF levels of chromogranin A (CgA) and phosphorylated neurofilament heavy chain (pNF-H) in patients with ALS in order to assess these proteins as possible biomarkers of ALS. METHODS: Cerebrospinal fluid levels of CgA and pNF-H were examined and mutually compared in 15 patients with sporadic ALS and 16 gender- and age-matched controls. RESULTS: Lumbar CSF CgA levels were increased in the patients with ALS compared to the controls (median 235 vs 138, P=.031). Lumbar CSF pNF-H levels were significantly increased in the patients with ALS compared to the control group (median 3091 vs 213, P<.0001). CONCLUSIONS: Identifying CSF biomarkers in ALS is important in order to establish the diagnosis in the early stages of the disease. pNF-H seems to be a good biomarker for the diagnosis of ALS. If confirmed on a larger group of patients, CgA may also become useful in the diagnosis of sporadic ALS.

[The role of trefoil factor family in gynecological disease]. / Význam trifolátu u gynekologických onemocnení.

AIM: Trefoil peptides are a family of small proteins that are expressed in a site-specific fashion by certain epithelial tissues. These peptides appear to be important in mucosal healing processes, in neoplastic disease and in human reproduction. DESIGN: Literature review. SETTING: Department of Obstetrics and Gynaecology, University Hospital, Medical Faculty, Palacký University, Olomouc, Czech Republic; Department of Laboratory Biochemistry, Central Moravian Hospital Trust, Member of Agel holding, Prostejov. METHODS: Literature review. RESULTS: Trefoil peptides are aberrantly expressed by a wide range of human carcinomas and gastrointestinal inflammatory conditions. Outside the gastrointestinal tract, members of this group of peptides have also been identified in the normal hypothalamus and pituitary, and in normal breast tissue where it is responsive to oestrogen stimulation. Evidence of peptide expression has been found in a range of urological, gynaecological, gastrointestinal, pulmonary and breast carcinomas. Furthermore, possible associations between recurrent spontaneous abortion susceptibility and genetic varia-tion in the TFF3 gene were shown.Conclusion In the future, serum levels of trefoil peptides might be used as markers for neoplastic and inflammatory diseases, as well as some defects of reproduction.

Preimplantation genetic diagnosis of X-linked diseases examined by indirect linkage analysis.

BACKGROUND: Many centers of assisted reproduction in the Czech Republic offer preimplantation genetic diagnosis with fluorescent in situ hybridization (FISH) to couples requiring preimplantation genetic diagnosis (PGD) of X-linked diseases. However, this process results in discarding all male embryos and is not able to distinguish a carrier or healthy female embryo in X-linked recessive disorders. OBJECTIVES: The main aim of this study was to summarize a six-year period of PGD of X-linked monogenic diseases using indirect linkage analysis. METHODS AND RESULTS: We wanted to accentuate the advantage indirect analysis of PGD using multiple displacement amplification (MDA) followed by short tandem repeat (STR) analysis. We present forty-six PGD cycles, including pre-case haplotyping (PGH) panel, for fifteen X-linked diseases. Embryo transfer was made thirty-eight times and gravidity was confirmed in thirteen female probands with a success rate of pregnancy calculated at 42 %. CONCLUSIONS: PGD procedure using MDA amplification followed by STR analysis provides help in identifying genetic defects within embryos prior to implantation. The reliability of the method was also supported by high pregnancy rate compared to other publications, which commonly achieved a 30-35 % success rate (Tab. 2, Fig. 1, Ref. 33).

[Implementation of arrays in first trimester prenatal diagnosis]. / Implementace array vysetrení do prenatální diagnostiky v I. trimestru.

OBJECTIVE: Array technology in chorionic villus sampling (CVS) - analysis of clinical benefit and a proposal of a more effective 1st trimester genetic testing policy. DESIGN: Retrospective study. SETTING: Gennet, Center of Medical Genetics and Reproductive Medicine, Prague. MATERIAL AND METHODS: Total of 913 CVS were performed at Gennet between 2010-2014. All 913 samples were tested by QF-PCR rapid test for aneuploidy of chromosomes 13, 18, 21, X and Y and karyotyping following standard long term culture. Microarray analysis (Illumina HumanCytoSNP12 v2.1) was performed on 179 samples with normal result from both - QF-PCR and karyotyping. RESULTS: At 229 samples the common chromosomal aneuploidy was detected using rapid QF-PCR (25% from 911 successful rapid tests). Conventional karyotyping revealed 239 unbalanced chromosome aberrations (27% from 897 successful cultivations). 227/239 (95%) positive karyotypes confirmed QF-PCR finding of common aneuploidies. 10 unbalanced chromosome aberrations were not covered by rapid QF-PCR test. Microarray analysis of samples with normal result from both- QF-PCR and karyotyping- revealed 13 clinically relevant chromosome aberrations (7.5%). CONCLUSION: New policy for chorionic villi testing at Gennet was established. Based on evaluation of the results of karyotyping, array and QF-PCR and analysis of published data we decided to replace karyotyping by microarray analysis in all cases of foetuses with normal results from QF-PCR. More effective detection of pathological and clinically relevant chromosome aberrations in examined foetuses is expected.

Histomorphometric diagnostics of renal osteopathy in chronic dialysis patients at high risk of cardiovascular disease.

UNLABELLED: Chronic kidney disease-mineral and bone disorder (CKD-MBD) ranks among clinically and pathogenetically significant complications in patients with CKD. Numerous factors are involved in its development, and histomorphometric analysis of the bone tissue is still necessary for accurate diagnosis. METHODS: The open, pilot, prospective study aimed at performing a comprehensive histomorphometric bone analysis in 26 dialysis patients and assessing the relationships of different types of CKD-MBD to selected parameters of calcium and phosphate metabolism, densitometry, activity of parathyroid glands, presence of diabetes mellitus, and duration of dialysis treatment. RESULTS: Comparison of the histomorphometric characteristics demonstrated statistically significant correlations between the volume of bone trabeculae and s-procollagen 1 (.754) as well as s-calcitonin (.856). Similarly, there was a positive correlation between the size of tetracycline lines and volume of bone trabeculae (.705) and a strong negative correlation with the thickness of trabeculae (-.442). When assessing the serum levels of s-osteoprotegerin and serum RANKL, there was a correlation with osteoid thickness and bone trabeculae thickness. In case of s-osteoprotegerin, a statistical power was demonstrated in relation to osteoid thickness (.880); in case of s-RANKL, a statistical power was demonstrated in relation to the thickness of trabeculae (.830). When assessing the influence of dialysis duration, relationships to the volume of trabecular bone (.665) and volume of bone trabeculae (.949) were demonstrated. Finally, a relationship between s-1,25-hydroxyvitamin D and s-osteoprotegerin was observed (.739); also the relationships demonstrated were significantly lower volume of bone trabeculae in men (p = 0.067) and lower values of s-osteocalcin and s-procollagen 1 in diabetic patients (p = 0.014). CONCLUSION: The results provide new noninvasive possibilities of CKD-MBD detection that are based on selected serum parameters of bone metabolism. Presented are possibilities of noninvasive assessment of different types of CKD-MBD using serum osteomarkers in relation to comprehensive CKD-MBD histomorphometry.

Pilot study of A-FABP levels as a predictive factor of SPECT results in asymptomatic relatives of patients with cardiovascular disease.

BACKGROUND: A-FABP is a promising link between metabolic syndrome and atherosclerosis. It is not well known whether level of A-FABP predicts results of SPECT. PATIENTS & METHODS: In 82 subjects (53 males) with a median age of 54 years, who were first-degree relatives of patients with cardiovascular disease, the following tests and examinations were performed: A-FABP, calcium score (CS) and SPECT. RESULTS: Subjects with positive and negative SPECT results differed significantly in the noncategorized CS (p = 0.001), uric acid (p = 0.025) and the total cholesterol:high-density lipoprotein ratio (p = 0.043), but not in other parameters (including A-FABP). To predict SPECT results, the best model proved to be a logistic regression model with gender and noncategorized CS as predictors, with an area under the receiver operating characteristic curve of 0.89 (the sensitivity and specificity based on a CS cutoff of 11.1 were 77.78 and 75.34%, respectively). CONCLUSION: The serum level of A-FABP is not a predictor of a positive SPECT result.

[Reccurent pregnancy loss - review]. / Opakované potrácení - prehledový clánek.

OBJECTIVE: Informative review of possible causes and therapy of habitual pregnancy loss and infertility. DESIGN: Review. SETTINGS: Department of Gynecology and Obstetrics, General Faculty Hospital of Charles University, Prague. SUBJECT AND METHOD: The repeated (habitual) loss of pregnancy is defined by three or more spontaneous abortions. Approximately 0,4 to 1% of women are affected. The pregnancy loss is more frequent in women younger than 20 and older than 35 years. The frequency of spontaneous abortions parallels the number of previous pregnancies. The causative treatment of women with recurring abortions is not available, however, it is recommended that such women are evaluated by available methods to eliminate etiological causes of repeated pregnancy losses. CONCLUSIONS: Effective therapy is possible when the diagnostic reason for repeated abortions is determined. Nevertheless, the causes leading to repeated pregnancy losses are identified only in approximately 12% of women. However, alleged and unexplained infertility, resulting in habitual pregnancy losses has a favorable prognosis.

[Is there dependence between the level of adipocyte fatty acid-binding protein and calcium score in asymptomatic relatives of patients with cardiovascular diseases?]. / Existuje závislost mezi hladinou adipocyte fatty acid binding proteinu a kalciovým skóre u asymptomatických príbuzných pacientu s KVO?

UNLABELLED: The objective of our study was to determine a correlation between the level of adipocyte fatty acid-binding protein (A-FABP) (as a possible link between metabolic syndrome and atherosclerosis), the calcium score (CS) and laboratory parameters, including insulin resistance indices in asymptomatic first degree relatives of patients with cardiovascular diseases. SET AND METHODOLOGY: Examination was conducted in 82 persons (53 male) with the average age of 52.79 ± 9.6. The examinations consisted of anthropometric and physical tests (determination of body weight, height, body mass index - BMI and casual blood pressure measurement), laboratory analysis (uric acid, creatinine, lipid panel, insulin, glucose, C-reactive protein, fibrinogen, glycated hemoglobin, adipocyte fatty acid-binding protein - A-FABP) and determination of insulin resistance indices HOMA and QUICKI. Total calcium score (CS) was determined by the Agatston method without the need to administer a contrast agent. RESULTS: The value of the A-FABP level does not show a statistically significant dependence on the categorised CS or on non-categorised CS values. There is a statistically significant positive dependence of the level of A-FABP on the HOMA index (p = 0.00688) and a statistically significant negative dependence on the QUICKI index (p = 0.0068). The A-FABP level is statistically significantly higher in women (p = 0.048), in elder persons (p = 0.043), and in persons with higher BMI values (p = 0.029). Among continuous variables, statistically significant is the difference in the A-FABP level in relation to age (p = 0.002), creatinine (p = 0.026), insulin (p = 0.005), and BMI (p = 0.031). CONCLUSION: Our study confirmed the correlation of the A-FABP level with insulin resistance indices, BMI, age, gender, and insulin and creatinine levels in a group of asymptomatic first degree relatives of patients with cardiovascular diseases. A-FABP could potentially be a marker when determining the risk of CVD; however, this conclusion requires additional clinical trials.

[Medical, legal and ethical aspects of fertility preservation in cancer survivor]. / Medicínské, právní a etické aspekty zachování fertility u onkologických pacientek.

In recent years the number of the young women in fertile age which are oncologically treated is increasing. For these women chemotherapy and radiotherapy introduces potential risk of reproductive dysfunctions. Present techniques of assisted reproduction are offering possibilities to save reproductive functions even after the oncological treatment. As a perspective outlook seems to be frozen premature oocytes with IVM and fertilisation. With these fertility savings methods are naturally coming up some of the ethical and legal issues.

[Reproductive functions in women after cancer therapy]. / Reprodukcní funkce u onkologických pacientek.

Improvement in early diagnostics and treatment options led to an increase in the number of young oncological patients in reproductive age. These young oncological patietns have life-long consequences of treatment, such as infertility, early menopause and sexual dysfunctions. There is the possibility of maintening fertility by assisted reproduction methods. So far, ovarian stimulation followed by ICSI and cryopreservation of embryos seem to be the most successful method. Unfortunately, this method is suitable only for patients with a stable partner where there is no risk of delay because of necessary stimulation of ovulation. For patients without a partner, it is possible to freeze stimulated oocytes. Cryopreservation of immature oocytes followed by in vitro maturation seems to be a very promising method. Freezing ovarial tissues followed by transplantation is at this point only an experimental procedure. The authors present their experience with in vitro maturation of oocytes of 28 women with pregnancy rate 14.3%. Twenty-seven cases of infertility with a high risk of ovarial hyperstimulation syndrome and one case of breast cancer patient before chemotherapy were chosen for IVM.

[Application of SNP array method in prenatal diagnosis]. / Aplikace metody SNP array v prenatální diagnostice.

OBJECTIVES: SNP array (array method using Single Nucleotide Polymorphisms) enables to detect cytogenetically undetectable submicroscopic alterations (microdeletions, microduplications), which could be also causative for ultrasonographic anomalies of fetus. This article describes the principle, advantages, disadvantages and application possibilities of the SNP array method in prenatal diagnosis. The ten month experience with SNP array use in prenatal diagnosis is presented. DESIGN: Prospective study. SETTINGS: Gennet, Prague. MATERIAL AND METHODS: During the period from April 2010 to January 2011 we performed 110 SNP array analyses of fetal DNA: 14 chorionic villi samples (CVS), 88 amniotic fluid samples (AMC), 1 cord blood sample and 7 miscarriage samples. Laboratory tests were carried out on DNA from both cultured and uncultured fetal cells. Examinations were performed in fetuses with sonographic abnormal findings having normal karyotype. In addition 14 fetal cytogenetic abnormalities were solved. SNP array analysis was performed using Illumina InfiniumHD HumanCytoSNP-12 chip. All data were analysed by Illumina KaryoStudio and GenomeStudio software. RESULTS: SNP array analysis was performed in 108 fetuses (only 2 examination failures, 1.8%). In total, we detected CNV (copy number variation) in 29 samples (29/108 = 27%). 15% (16/108) of fetuses with abnormal ultrasound findings were found to carry clinically relevant CNV. Probably benign CNVs were found in 8 samples (8/108 = 7%) and in additional 5 CNVs parental samples have not been analysed yet. Excluding karyotypically abnormal cases clinically relevant CNVs were found in 10% of fetuses (9/94). In all cases with de novo chromosomal aberration the clinical relevancy was clarified (imbalances in 50%). CONCLUSION: Our data suggest that SNP array analysis is a relevant and useful technique in prenatal diagnosis.

Pigment epithelium-derived factor as a new marker of metabolic syndrome in Caucasian population.

Authors present that serum pigment epithelium derived factor (PEDF) is an independent marker of metabolic syndrome in Caucasianpopulation. PEDF was measured with new ELISA sandwich test. J. Clin. Lab. Anal. 24:17-19, 2010. (c) 2010 Wiley-Liss, Inc.

New laboratory markers in diagnosis of alzheimer dementia.

OBJECTIVES: The aim of our work was to assess the role of tau protein, beta amyloid and cystatin C in diagnosis of Alzheimer dementia (AD) and other neurodegenerative diseases (NDs). METHODS: The levels of tau protein, beta amyloid and cystatin C were assessed in a set of 79 patients with ND (38 men and 41 women; aged 22-90 years; mean, 61.6 +/- 15.6 years) and in a control group of 79 subjects with a healthy central nervous system (38 men and 41 women; aged 20-91 years; mean, 61.5 +/- 15.1 years). RESULTS: When compared with the subjects in the control group, a statistically significant decrease in tau protein levels was found in patients with ND, an increase in tau protein levels in patients with AD and an increase in cystatin C cerebrospinal fluid/serum index in the ND + AD group. DISCUSSION: Our work only confirmed the previously reported results in part. Although tau protein seems to be a quite reliable marker of AD, the role of beta amyloid in AD diagnosis remains at the least questionable. In the case of cystatin C, our results would seem to confirm the views of certain authors that cystatin C will probably not become a new 'revolutionary' marker contributing to differential diagnostics.

The assessment of beta amyloid, tau protein and cystatin C in the cerebrospinal fluid: laboratory markers of neurodegenerative diseases.

To assess the role of tau protein, beta-amyloid(1-42) and cystatin C in the diagnostics of Alzheimer dementia (AD) and other neurodegenerative diseases (ND) by comparing to the control groups (CG). The levels of tau protein, beta-amyloid(1-42) and cystatin C were assessed in the set of 69 patients (AD + ND, 33 males, 36 females, aged 22-90, mean 60.5 + 16.1 years), and in a control group of 69 subjects without the affection of the central nervous system (CGAD + CGND, 33 males, 36 females, aged 20-91, mean 60.5 + 16.0 years). Statistically significant increased tau protein levels (P = 0.0001) and index tau/beta-amyloid(1-42) levels (P = 0.0002) were shown in the group of AD patients, compared to the group of ND patients. One-way ANOVA analysis with Bonferonni post hoc test did not show any significant differences of the cystatin C values between any of the compared groups. ROC analysis showed at least one tie between the positive actual state group (AD) and the negative actual state group (ND) by CSF cystatin C and at least one tie between the positive actual state group and the negative actual state group by CSF tau protein. Our study confirmed previously reported results only in part. While tau protein seems to be quite a reliable marker of AD, the role of beta-amyloid(1-42) and cystatin C in AD diagnosis remains at least questionable.

Serum adipocyte-fatty acid binding protein discriminates patients with permanent and temporary body weight loss.

Adipocyte-fatty acid binding protein (A-FABP) is a biomarker of adiposity and metabolic syndrome. The aim of our work was to investigate the effect of weight reduction on serum A-FABP value. In the study, we analyzed a group of 189 probands suffering from obesity (102 women and 87 men; aged 57.3+/-12 years) initially, after a 3-month low-fat diet and once again 3 months after the termination of the diet for serum A-FABP, insulin, glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides. Basal biomarker concentrations were typical of the metabolic syndrome, and moreover A-FABP correlated with Quicki and BMI. We observed a reduction in BMI in 145 subjects who were divided into two subgroups: A-with persistent BMI reduction even after 6 months, B-with BMI reduction after 3 months and its regress after 6 months. Individuals with rise or no BMI difference were signed as subgroup C. In subgroup A, A-FABP level increased and returned to the earlier level (42.3 vs 68.3 vs 37.1 microg/l) and correlated with the markers of the metabolic syndrome. In subgroup B, A-FABP level increased less significantly, however elevated A-FABP level persisted for 6 months (41.9 vs 53.6 vs 50.7 microg/l). Subgroup C (n=54) showed no difference in A-FABP after 3-month diet and after next 3 months. The A-FABP value correlated with the some components of the metabolic syndrome. In conclusion, we describe that serum A-FABP might be a prognostic marker of body weight loss suggesting a preventive therapeutic intervention.

Fibroblast growth factor-19: development, analytical characterization and clinical evaluation of a new ELISA test.

OBJECTIVE: Since fibroblast growth factor 19 (FGF-19) is a potent metabolic regulator that influences glucose and lipid homeostasis, our aim was to develop an ELISA assay for measuring FGF-19 in human serum and to investigate its concentrations in healthy volunteers and patients suffering from metabolic syndrome. MATERIAL AND METHODS: A sandwich ELISA method was developed for quantitative determination of human FGF-19 in serum samples. Blood pressure, waist circumference, FGF-21 serum levels, serum cholesterol, triacylglycerols, HDL-cholesterol, LDL-cholesterol, insulin, glucose, adiponectin, uric acid, creatinine, hs-CRP and calculated BMI and Quicki insulin sensitivity index were measured in 153 healthy volunteers and 66 persons with metabolic syndrome. RESULTS: Neither sex nor age influenced FGF-19 serum concentration in the healthy volunteers. Probands with metabolic syndrome had 65 % lower FGF-19 serum values than the healthy ones (medians 158.6 versus 242.4 ng/L; p<0.01). FGF-19 correlated with glucose (r = -0.35, p<0.01), HDL (r = 0.24, p = 0.045), triacylglycerols (r = -0.19, p = 0.05) and with a number of other risk factors for metabolic syndrome (r = -0.28, p = 0.01). When adjusted to the concentrations of triacylglycerols, BMI and glucose, and finally to all data pertinent to FGF-19 (according to correlation analysis), our data indicate that FGF-19 is an independent marker of metabolic syndrome. CONCLUSIONS: The present study demonstrates the analytical properties of the ELISA FGF-19 assay and its usefulness when studying the metabolic syndrome. Serum concentrations of FGF-19 could be new key predictors of metabolic syndrome and thereby even a new negative risk factor of atherosclerosis.