Troponin T in spinal and bulbar muscular atrophy (SBMA).

Serum biomarkers that might detect clinical progression are currently lacking for Spinal and bulbar muscular atrophy (SBMA), thus limiting the effectiveness of possible future pharmacological trials. Elevation of cardiac troponin T (cTnT) unrelated to myocardial damage in a motor neuron (MN) disease as amyotrophic lateral sclerosis (ALS) was associated to disease severity. We enrolled 47 SBMA patients and 5 Spinal muscular atrophy (SMA) type 3 adult patients as control group; each SBMA patient was evaluated at baseline and at one-year follow-up visit. Demographic and clinical data including functional scores (SBMAFRS) were collected; serum was collected as standard of care and tested for cardiac troponins. Levels of cTnT but not cTnI were increased in SBMA with respect to reference values; unlike other neuromuscular diseases, SMA patients had overall normal cTnT values. Median cTnT concentrations did not change after one year and values were correlated to motor function, particularly with lower limb subdomain, at baseline only. Variations of cTnT and of SBMAFRS were unrelated. The cautiously promising results of cTnT as potential biomarker should undergo a more extensive clinical validation, including studies with longer follow-up period. When evaluating SBMA patients for a potential cardiac damage cTnI testing should be coupled or preferred to cTnT.

Toward a more precise prognostic stratification in acute decompensation of cirrhosis: The Padua model 2.0.

BACKGROUND: The clinical course of acutely decompensated cirrhosis (AD) is heterogeneous. Presepsin (PSP) is a plasmatic biomarker that reflects Toll-like receptor activity and systemic inflammation. We conducted a prospective study to: (1) measure PSP in AD and (2) assess whether PSP in AD can predict the development of acute-on-chronic liver failure (ACLF). METHODS: Patients with AD were prospectively recruited at admission and underwent determination of PSP. In study part 1, we compared PSP in AD versus controls (stable decompensated and compensated cirrhosis). In study part 2, we prospectively followed patients with AD for 1 year and evaluated predictors of ACLF. RESULTS: One hundred and seventy three patients with AD were included (median MELD: 18; CLIF-C AD score: 54). Compared with controls, patients with AD had higher levels of PSP (674 ng/L vs. 310 ng/L vs. 157 ng/L; p < 0.001). In patients with AD, Child-Pugh C and acute kidney injury were associated with higher levels of PSP. During the follow-up, 52 patients developed ACLF (median time from recruitment: 66 days). PSP, CLIF-C AD score, and Child-Pugh stage were independently associated with ACLF. A predictive model combining these variables (Padua model 2.0) accurately identified patients at higher risk of ACLF (AUROC 0.864; 95% CI 0.780-0.947; sensitivity 82.9%, specificity 76.7%). In patients at lower risk of ACLF based on a CLIF-C AD <50, a PSP >674 ng/L could discriminate between two groups at significantly different risk of ACLF. Finally, in patients who did not develop ACLF, baseline PSP was significantly higher in those who progressed toward unstable versus stable decompensated cirrhosis. CONCLUSION: The Padua model 2.0 can be used to identify patients with AD at high risk of ACLF. If these results are validated by external cohorts, PSP could become a new biomarker to improve risk stratification in AD.

Endothelial dysfunction and Mid-Regional proAdrenomedullin: What role in SARS-CoV-2 infected Patients?

BACKGROUND: Endothelial dysfunction, a major complication of SARS-CoV-2 infectionplaying a key-role in multi-organ damage, carries high risk of mortality. AIM: To investigate the potential role of Mid-Regional pro-Adrenomedullin (MR-proADM) in detecting endothelial damage with a view to stratifying the risk of adverse events (length of stay, death, admission in Intensive Care Unit) and/or disease resolution. MATERIALS AND METHODS: In 135 consecutive patients with SARS-CoV-2 infection, MR-proADM was measured in EDTA-K2 plasma samples using B.R.A.H.M.S. KRYPTOR® COMPACT Plus method (Thermo Fisher Scientific, Hennigsdorf, Germany) RESULTS: Patients were subdivided into three groups based on their MR-proADM value (nmol/L): 1 (n = 20, MR-proADM ≤ 0.55); 2 (n = 82, 0.55 < MR-proADM ≤ 1.50); 3 (n = 33, MR-proADM > 1.50). The higher the MR-proADM value, the greater the patients' age, the more frequent the occurrence of pneumonia, the requiring of more aggressive treatment, the longer the hospitalization and the more frequent a fatal event. Significant differences were found between the three groups for MR-proADM, White-blood cell count, Neutrophil count, D-dimer, C-reactive Protein, Procalcitonin and hs-Troponin I. At logistic regression,it was found that MR-proADM and Log10D-dimer were the most significant predictors of adverse events. CONCLUSION: The findings made in the present study highlight the relevance of MR-proADM values in providing clinically useful information, particularly for stratifying COVID-19 patients according to the risk of a more severe form of disease and to the development of adverse events.

Diagnostic and prognostic role of presepsin in patients with cirrhosis and bacterial infection.

OBJECTIVES: Serum biomarkers have suboptimal accuracy for the early diagnosis of bacterial infection (BI) in cirrhosis. The aim of the study was to evaluate the diagnostic and prognostic accuracy of presepsin (PSP) in a cohort of hospitalized patients with cirrhosis. METHODS: All adult cirrhotics admitted between 03.2016 and 06.2019 were consecutively evaluated. PSP was measured using chemiluminescent enzyme immunoassay, and its accuracy was compared with that of common biomarkers. RESULTS: A total of 278 cirrhotic patients for a total of 448 hospitalizations were prospectively collected. Prevalence of BI at admission was 28.3%. Median (range) Log10PSP in the whole cohort was 2.83 (2.48-3.19) ng/L, significantly higher in patients with BI than in patients without (p<0.001). For a cutoff value of 2.87 ng/L, Log10PSP showed sensitivity, specificity and AUC-ROC of 0.66 (95% CI 0.57-0.74), 0.63 (95% CI 0.57-0.68) and 0.69 (95% CI 0.63-0.73), lower than that of C-reactive protein (p=0.002), but similar to procalcitonin (p=0.18) Patients with BI at hospitalization had higher probability of 28-day mortality (sub-hazard ratio [sHR] 2.65;95% CI 1.49-4.70; p=0.001). At multivariate Cox's regression analysis, Log10PSP (sHR 2.4; 95% CI 1.22-4.82; p=0.01) together with age and severity of liver disease, was an independent predictor of short-term mortality. CONCLUSIONS: PSP shows low diagnostic accuracy for BI in cirrhosis, but it is an independent predictor of short-term mortality. PSP may be a biomarker of systemic inflammation, commonly seen in end-stage liver disease.

Cardiac troponin I in SARS-CoV-2-patients: The additional prognostic value of serial monitoring.

BACKGROUND: Major cardiac complications have been described in SARS-CoV-2 patients. The study of cardiac troponin' kinetic release is the recommended approach to differentiate acute from chronic injury, in order to clinically manage different cardiac diseases. AIM: To investigate whether serial measurements of high sensitivity troponin I (hs-cTnI) might provide additional information in SARS-CoV-2 patients's clinical management. METHODS: 113 consecutive patients suffering from microbiology proven SARS-CoV2-infection have been studied. Hs-cTnI has been measured in lithium-heparin plasma samples using STAT High Sensitive Troponin I (Architect i2000, Abbott Diagnostics), being 99th percentiles 16 and 34 ng/L for females and males respectively. RESULTS: In 69 out of 113 patients hs-cTnI has been measured, showing in 31 (45%) values higher than 99th percentiles in at least one occasion. In 50 patients (72%) a kinetic evaluation (at least 2 measurements during 24 h) has been carried out. Patients were subdivided into five groups: 1 (n = 44) and 2 (n = 19) no measurement of hs-cTnI or no monitoring respectively; 3 (n = 15) no significant variations during monitoring; 4 (n = 8) and 5 (n = 27) significant variations with values persistently below or sometimes higher than 99th percentiles, respectively. Group 5 patients had a longer hospital stay (median 37 days, p = 0.0001), a more aggressive disease (6 out of 27, 22%, died), more often need admission to ICU (n = 25, 92.6%, p < 0.0001), and show one or more peak values, sometime preceded by severe hypoxia. CONCLUSIONS: In SARS-CoV-2 patients, hs-cTnI serial monitoring may provide additional data to stratify risk, establish prognosis and gaining epidemiological insight on cardiac involvement in this pandemic disease.

Presepsin in risk stratification of SARS-CoV-2 patients.

BACKGROUND: A severe form of pneumonia, is the leading complication of the respiratory Coronavirus disease 2019 (COVID-19), recently renamed SARS-CoV-2. Soluble cluster of differentiation (CD)14 subtype (sCD14-ST also termed presepsin PSP) is a regulatory factor that modulates immune responses by interacting with T and B cells, useful for early diagnosis, prognosis and risk stratification prediction. METHODS: In 75 consecutive patients suffering from COVID-19 microbiology proven infection, admitted to intensive care unit (ICU, n = 21, 28%) and/or in infectious disease ward (IW, n = 54, 72%), PSP (Pathfast, Mitsubishi, Japan) has been measured in addition to routine laboratory tests performed during the period of hospitalization (from January to March 2020). RESULTS: PSP demonstrates: -statistically significant higher values (Mann-Whitney test) in 6 patients died (median, IQR = 1046, 763-1240; vs 417, 281-678 ng/L, p < 0.05); -statistically significant but poor correlations with CRP (r = 0.59, p < 0.001), LDH (r = 0.52, p < 0.001) and PCT (r = 0.72, p < 0.001) measured at the same day; -a significant relationship between concentrations and ICU stay. In fact patients showing PSP values higher than 250 ng/L (cut-off for risk stratification) did stay in ICU for a significantly longer time (median 17 days, IQR 12-31; p < 0.001) than those exhibiting lower values (median 10 days, IQR 7-18). CONCLUSIONS: The data obtained seems to demonstrate the role of PSP in providing prognostic information in COVID-19 patients, allowing to identify, during the early phase of the monitoring, the patients suffering from a more severe disease which will be hospitalized for a more long time.

Short-term biological variation and diurnal rhythm of cardiac troponin I (Access hs-TnI) in healthy subjects.

BACKGROUND: The availability of high-sensitivity cTnI (hs-cTnI) assays has improved the accuracy of cTn measurements at concentrations around and below the 99th percentile, allowing the evaluation of biological variation. METHODS: cTnI concentrations have been measured in blood samples of 35 reference subjects collected at time 0 (between 8 and 9 AM) and after 1,2,3 and 7 h using a high-sensitive assay (Access hs-TnI). Repeated measure ANOVA and lognormal transformation followed by Nested ANOVA were used to assess differences in cTnI concentration and to estimate biological variation components, respectively. Circadian variability was modelled by sine-wave functions fitting. RESULTS: At time 0, cTnI concentrations were significantly higher than those measured at other times in overall population, as well as in subjects subdivided by biological sex. The concentrations exhibit a strong circadian variability in males and females, with a predicted interval of around 5.4 h (R2 0.949 and 0.999 for males and females, respectively). CONCLUSIONS: Troponin I demonstrates a diurnal rhythm with decreasing values throughout daytime and the peak concentrations in the morning. The circadian variability is statistically significant, but not relevant from a clinical viewpoint. The intra-individual variation (CVI) is lower than that reported in the literature and the index of individuality lower than 0.6 suggests a scarce value of reference interval.

The Effects of Iodine Supplementation in Pregnancy on Iodine Status, Thyroglobulin Levels and Thyroid Function Parameters: Results from a Randomized Controlled Clinical Trial in a Mild-to-Moderate Iodine Deficiency Area.

BACKGROUND: Iodine supplementation during pregnancy in areas with mild-to-moderate iodine deficiency is still debated. METHODS: A single-center, randomized, single-blind and placebo-controlled (3:2) trial was conducted. We enrolled 90 women before 12 weeks of gestation. From enrollment up until 8 weeks after delivery, 52 women were given an iodine supplement (225 ug/day, potassium iodide tablets) and 38 were given placebo. At recruitment (T0), in the second (T1) and third trimesters (T2), and 8 weeks after delivery (T3), we measured participants' urinary iodine-to-creatinine ratio (UI/Creat), thyroid function parameters (thyroglobulin (Tg), TSH, FT3, and FT4), and thyroid volume (TV). The newborns' urinary iodine concentrations were evaluated in 16 cases. RESULTS: Median UI/Creat at recruitment was 53.3 ug/g. UI/Creat was significantly higher in supplemented women at T1 and T2. Tg levels were lower at T1 and T2 in women with UI/Creat ≥ 150 ug/g, and in the Iodine group at T2 (p = 0.02). There was a negative correlation between Tg and UI/Creat throughout the study (p = 0.03, r = -0.1268). A lower TSH level was found in the Iodine group at T3 (p = 0.001). TV increased by +Δ7.43% in the Iodine group, and by +Δ11.17% in the Placebo group. No differences were found between the newborns' TSH levels on screening the two groups. CONCLUSION: Tg proved a good parameter for measuring iodine intake in our placebo-controlled series. Iodine supplementation did not prove harmful to pregnancy in areas of mild-to-moderate iodine deficiency, with no appreciable harmful effect on thyroid function.

Prognostic value of cardiac troponin I assay in hospitalized elderly patients.

BACKGROUND: Cardiac troponin I (cTnI) has been poorly studied in elderly inpatients. AIM: This study wanted to assess factors influencing the increase in cTnI and its prognostic value in hospitalized elderly patients. METHODS: 354 elderly (mean age of 84.8 ± 6.9 years) patients consecutively admitted in the Geriatrics Division in Padua were tested for cTnI levels assay during the hospital stay. Number of subsequent patient deaths at 6 months and 2 years were registered. RESULTS: Of the 354 patients, 27 (7.6%) died in hospital; their levels were not significantly higher or more frequently positive on cTnI than those of the remainder of the sample. 71 (20.01%) patients died within 6 months of being discharged, and in-hospital positive cTnI levels emerged as a mortality risk factor in this group [unadjusted HR 1.13 (1.04-1.23); p = 0.004]. At 2 years, a total of 174 patients (49.2%) had died, but in-hospital pathological cTnI levels were not a mortality risk factor in this group. DISCUSSION: It should be noted that cTnI level was a risk factor for mortality at 6 months but no longer at 2 years after an elderly patient's hospitalization. This finding may relate to patients' limited physiological reserves or be driven by the fact that the elderly tend to receive fewer evidence-based treatments, and to be managed more conservatively than younger patients. CONCLUSIONS: In the multidimensional analysis of older patients, troponin I can be used to stratify patients and assess mortality risk at 6 months, but not at 2 years.

Analytical performance evaluation of the new GEM® Premier™ 5000 analyzer in comparison to the GEM® Premier™ 4000 and the RapidPoint® 405 systems.

AIM OF THE STUDY: Blood gas analysis (BGA) is essential for the diagnosis and management of acid-base imbalances. We evaluated and compared the analytical characteristics of the new GEM® Premier™ 5000 (GP5000) (Instrumentation Laboratory, Bedford, MA, United States) BGA point-of-care (POC) device with those of the GEM® Premier™ 4000 (GP4000) (Instrumentation Laboratory, Bedford, MA, United States) and RapidPoint® 405 (RP405) (Siemens Healthcare, Milan, Italy) POC analyzers. The effect of sample mixing on patient results was also studied. MATERIAL AND METHODS: Quantitative measurement of pH, pCO2, pO2, Na+, K+, Cl-, iCa2+, glucose, lactate, tHb, COHb, MetHb, O2Hb, HHb and Hct were carried out. The imprecision study (IS) and method comparison study (MS) were performed according to CLSI EP guidelines, using respectively internal as well as external quality controls (IS) and whole blood samples collected from the routine analysis (MS). RESULTS: GP5000 demonstrated satisfactory characteristics in the IS showing comparable (GM4000) or even better (RP405) imprecision results than the routine POC devices. Good performance was observed in the MS both using GP4000 and RP405 as reference instruments. Pre-analytical sample management can heavily affect the accuracy of BGA results. In the specimen mixing evaluation, a significant improvement in results accuracy was observed when mixing procedures were more meticulous. CONCLUSIONS: Considering the overall analytical performance observed, the ease of use of the system, the rapid time-to-results and the innovative Intelligent Quality Management technology (iQM2®), GP5000 seems suitable to be used in clinical care for safe patient management. Additionally, effective sample mixing upon draw and before analysis is strongly advisable in order to ensure the most clinically reliable BGA results.

Combined use of the multidimensional prognostic index (MPI) and procalcitonin serum levels in predicting 1-month mortality risk in older patients hospitalized with community-acquired pneumonia (CAP): a prospective study.

BACKGROUND: Several scores and biomarkers, i.e., procalcitonin (PCT), were proposed to stratify the mortality risk in community-acquired pneumonia (CAP). AIM: Evaluating prognostic accuracy of PCT and Multidimensional Prognostic Index (MPI) for 1-month mortality risk in older patients with CAP. METHODS: At hospital admission and at discharge, patients were evaluated by a Comprehensive Geriatric Assessment to calculate MPI. Serum PCT was measured at admission and 1, 3, and 5 days after hospital admission. RESULTS: 49 patients were enrolled. The overall 1-month mortality was 44.5 for 100-persons year. Mortality rates were higher with the increasing of MPI. In survived patients, MPI at discharge showed higher predictive accuracy than MPI at admission. Adding PCT levels to admission MPI prognostic accuracy for 1-month mortality significantly increased. CONCLUSION: In older patients with CAP, MPI significantly predicted 1 month mortality. PCT levels significantly improved the accuracy of MPI at admission in predicting 1-month mortality.

Clinical performance of cardiac Troponin I: A comparison between the POCT AQT90 FLEX and the Dimension Vista analyzer in an emergency setting.

BACKGROUND: Cardiac troponin [cTn (I or T)] is the preferred biomarker for the diagnosis of myocardial infarction (MI). AIM: We studied the analytical performance of the POCT AQT90 FLEX cTnI assay and its diagnostic accuracy, in comparison to the Dimension Vista cTnI method, in patients presenting to the Emergency Department (ED) with suspect of acute coronary syndrome (ACS). METHODS: 786 consecutive patients were enrolled. cTnI was measured at admission to the ED and about 3 and 6 hours later. The imprecision study was carried out using different lots of quality controls (QCs). ROC curve analysis was conducted using discharge diagnoses in order to verify the global diagnostic accuracy. RESULTS: The concentrations measured in the QCs ranging from 0.033 to 1.26µg/L show CVs% ranging from 2.81 to 7.56%, comparable to those declared by the manufacturer. Passing-Bablok and linear regression analysis show a high significant correlation (R2=0.90, p<0.0001); Bland-Altman test describes a statistically significant negative bias (Bias=-0.2336; 95%CI=-0.4217/-0.0456, p=0.0150). ROC curves obtained using Dimension Vista and AQT90 FLEX cTnI assays displayed similar clinical performance being not statistically significant the difference of the corresponding AUC. Comparing sensitivity and specificity of cTnI concentrations obtained from the ROC curve analysis using AQT90 FLEX, we found a "best cut-off" (0.014µg/L) lower than that declared from the manufacturer (0.023µg/L). CONCLUSIONS: The comparison of two different assays of cTnI against a diagnosis of acute MI (AMI) shows that both assays behave equally well with a high degree of sensitivity and specificity. The resulting "best cut-off" suggests that this AQT90 FLEX cTnI concentration could be evaluated as the potentially new "clinically usable" cut-off for AMI/myocardial necrosis diagnoses.

Copeptin decrease from admission to discharge has favorable prognostic value for 90-day events in patients admitted with dyspnea.

BACKGROUND: With patients referred to emergency departments (EDs) for acute dyspnea, emergency physicians should consider all possible diagnoses and assess patients' risk stratification. Copeptin has been shown to have prognostic power for subsequent events, such as death and rehospitalization in patients admitted for dyspnea. The aim of this study was to investigate prognostic role of copeptin variations during hospitalization in patients admitted for dyspnea. METHODS: We conducted a prospective, multicentric, observational study in acute dyspneic patients in three ED centers in Italy. Clinical data and copeptin assessments were performed at admission, and at discharge. A 90-day follow-up was performed. RESULTS: A total of 336 patients were enrolled, and on the basis of final diagnosis distinguished into two groups: acute heart failure and no acute heart failure. Compared to a control group, in all studied population copeptin values at admission resulted in a significantly (p<0.001) higher median (maximum-minimum): 31 (0-905) versus 8 (0-13) pmol/L. Median copeptin value at admission was 42 (0-905) pmol/L in acute heart failure patients and 20 (0-887) pmol/L in no acute heart failure, respectively (p<0.001). In all studied patients and in each group copeptin at admission and discharge showed significant predictive value for 90-day events (p<0.001). Furthermore, in all patients population and in both groups Δ copeptin values from admission to discharge also showed significant predictive value for 90-day events (p<0.001). CONCLUSIONS: In patients admitted for acute dyspnea, admission, discharge and Δ copeptin variations have significant prognostic value from subsequent 90-day death and rehospitalization.

PATHFAST NT-proBNP (N-terminal-pro B type natriuretic peptide): a multicenter evaluation of a new point-of-care assay.

BACKGROUND: The biochemical determination of cardiac natriuretic peptides, primarily brain natriuretic peptide (BNP) and the amino-terminal fragment of its pro-hormone proBNP (NT-proBNP), are reliable tools for diagnosing cardiac disease, establishing prognosis and evaluating the effectiveness of treatment. These biomarkers have proven to be of particular value in the management of chronic and acute heart failure patients, and in the outpatient and the emergency setting. METHODS: A multicenter evaluation was performed to assess the practicability, and the analytical and clinical performance of a new point-of-care testing (POCT) PATHFAST NT-proBNP assay. This is an immunochemiluminescent assay using two polyclonal antibodies in a sandwich test format, and performed with a PATHFAST automated analyzer. RESULTS: The limit of detection (mean+3 SD of the signal of 20 replicates of the zero calibrator obtained in one run) was 0.535 ng/L. An imprecision study, performed in accordance with the CLSI protocol, showed coefficients of variation of 4.0%-6.4% (within-run imprecision), 0.0%-3.4% (between-run imprecision), 5.5%-7.2% (between-day imprecision), 7.6%-8.9% (total imprecision). The method was linear to 28,755 ng/L. Slopes and intercepts ranged from 0.89 to 0.90 and from 10.96 to 22.85, respectively when lithium-heparin plasma samples (n=100) were used to compare the assay under evaluation with the routine laboratory methods (Dimension RxL, Stratus CS). When testing matched samples (n=52), a significant difference was found between the 50th percentile NT-proBNP concentration in K(2)EDTA whole blood, K(2)EDTA plasma, lithium-heparin plasma and serum. No significant interference was observed for NT-proBNP in lipemic (tryglicerides up to 28.54 mmol/L), icteric (total and conjugated bilirubin up to 513 and 13 micromol/L, respectively) or hemolyzed (hemoglobin up to 13.50 g/L) samples. The NT-proBNP concentration in a group of 180 healthy donors was significantly influenced by age and gender. In a selected population of patients (n=56) with acute dyspnea admitted to the emergency department, a marked reduction in cardiac natriuretic peptide concentrations was observed in hospitalized patients suffering from heart failure who had a better prognosis compared with those with a poorer prognosis (NT-proBNP mean Delta change, % from -22 to -71 vs. +9 to -11). CONCLUSIONS: The satisfactory analytical and clinical performance of the PATHFAST NT-proBNP assay, together with its excellent practicability, suggests that it would be a reliable tool in clinical practice, in the emergency setting for point-of-care testing, as well as in the central laboratory.

Precision performance at low levels and 99th percentile concentration of the Access AccuTnl assay on two different platforms.

BACKGROUND: Cardiac troponins currently represent the preferred biomarkers for the detection of myocardial necrosis. The objective of the present study was to compare the performance of the Access AccuTnl assay (Beckman Coulter) measured on two different platforms, the UniCel Dxl 800 and the Access 2 (Beckman Coulter). In particular, the serum cardiac troponin I (cTnl) concentration corresponding to 10% coefficient of variation (CV), the cTnl assay minimum detectable concentration (MDC), and the serum cTnl 99th percentile in healthy subjects were calculated. METHODS: The Access AccuTnl is a paramagnetic particle chemiluminescent immunoassay. Imprecision profiles were determined according to the Clinical and Laboratory Standards Institute EP5-A protocol using serum pools. The MDC was calculated as mean +3 SD of 20 determinations of the zero calibrator during one run. The 99th percentile was determined analyzing serum samples from 679 healthy blood donors (523 males, 156 females; 18-71 years old). RESULTS: cTnl concentrations are given in microg/L. 10% CV values (95% confidence interval, CI) were 0.0577 (0.0467-0.0750) (UniCel Dxl 800) and 0.0486 (0.0255-0.0596) (Access 2). MDC values were 0.011 (UniCel Dxl 800) and 0.012 (Access 2). The 99th percentile (95% CI) value was 0.0340 (0.0298-0.0410). CONCLUSIONS: Our data confirm the reliability of the evaluated cTnl assay and demonstrate the comparability of the cTnl values between the platforms studied.

Recent advances in diagnostic technologies for autoimmune diseases.

The investigation of autoimmunity provides an interest challenge in "omics" research and, particularly, proteome research, as autoimmune diseases are common disorders of unsolved etiology that occur in a wide range of manifestations, in all of which tissues and organs are attacked by the body's own immune system. Autoantibodies are a hallmark of many autoimmune diseases and the presence of autoantibodies is a distinctive and key characteristic of autoimmune diseases. Conventionally, the study of autoimmune response has always been conducted by analysing the presence and/or concentration of individual antibodies in biological fluids. New proteomic techniques allow the simultaneous identification/measurement of different autoantibodies in sera of patients suffering from autoimmune diseases. The possibility of simultaneously measuring a number of correlated analytes appears to be very interesting for analytical reasons (reduced volumes of biological samples, reagents and low costs), logistical/managerial reasons, and pathophysiological reasons (combination of markers in disease-oriented or organ-oriented profiling). In particular, we describe data collected by using high-throughput techniques such as antigen microarrays and mass spectrometry for antibody profiling. While recently collected data demonstrate satisfactory analytical sensitivity and reproducibility, some issues such as standardization and data interpretation have to be solved before the introduction of these new and promising techniques into clinical practice.