Publications by authors named "Martina Zaninotto"

162 Publications

Corrigendum to: Understanding and managing interferences in clinical laboratory assays: the role of laboratory professionals.

Clin Chem Lab Med 2021 Mar 1;59(5):1005. Epub 2021 Mar 1.

Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy.

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http://dx.doi.org/10.1515/cclm-2021-0212DOI Listing
March 2021

Clinical relevance of biological variation of cardiac troponins.

Clin Chem Lab Med 2020 Nov 26. Epub 2020 Nov 26.

Dipartimento di Medicina di Laboratorio, Azienda Ospedaliera Universitaria di Padova, and Dipartimento di Medicina - Università di Padova, Padova, Italy.

The high-sensitivity immunoassays for cardiac troponin I (hs-cTnI) and cardiac troponin T (hs-cTnT) are recommended by all the most recent international guidelines as gold standard laboratory methods for the detection of myocardial injury and diagnosis of acute myocardial infarction (AMI). In this review article, the Authors aimed at discussing the relevant biochemical, physiological, and clinical issues related to biological variability of cTnI and cTnT. Cardiac troponins, measured with hs-cTn methods, show a better clinical profile than the other cardio-specific biomarkers (such as the natriuretic peptides, BNP and NT-proBNP). In particular, the hs-cTn methods are characterized by a low intra-individual index of variation (<0.6) and reduced analytical imprecision (about 5% CV) at the clinical cut-off value (i.e., the 99th percentile URL value). Moreover, recent studies have reported that differences between two hs-cTn measured values (RCV) >30% can be considered statistically significant. These favourable biological characteristics and analytical performance of hs-cTn methods significantly improved the accuracy in the diagnostic process of acute coronary syndromes (ACS) in patients admitted to emergence department. In addition, several studies have demonstrated the clinical usefulness of cardiovascular risk evaluation with hs-cTn methods in some groups of patients with clinical conditions at high cardiovascular risk (such as systemic hypertension, severe obesity, diabetes mellitus, renal insufficiency, and chronic obstructive pulmonary disease). However, screening programs in the general population with hs-cTn methods for cardiovascular risk stratification require further investigation to define the optimal target populations, timing of measurement, and preventive interventions.
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http://dx.doi.org/10.1515/cclm-2020-1433DOI Listing
November 2020

Chest pain management and biomarkers: the lack of trust in cardiac troponins measurement.

Diagnosis (Berl) 2020 Dec 21. Epub 2020 Dec 21.

Department of Laboratory Medicine, University Hospital, Padova, Italy.

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http://dx.doi.org/10.1515/dx-2020-0156DOI Listing
December 2020

Effectiveness of In-Hospital Cholecalciferol Use on Clinical Outcomes in Comorbid COVID-19 Patients: A Hypothesis-Generating Study.

Nutrients 2021 Jan 14;13(1). Epub 2021 Jan 14.

Internal Medicine, Department of Medicine, University Hospital AOUI, 37134 Verona, Italy.

Little information is available on the beneficial effects of cholecalciferol treatment in comorbid patients hospitalized for COVID-19. The aim of this study was to retrospectively examine the clinical outcome of patients receiving in-hospital high-dose bolus cholecalciferol. Patients with a positive diagnosis of SARS-CoV-2 and overt COVID-19, hospitalized from 15 March to 20 April 2020, were considered. Based on clinical characteristics, they were supplemented (or not) with 400,000 IU bolus oral cholecalciferol (200,000 IU administered in two consecutive days) and the composite outcome (transfer to intensive care unit; ICU and/or death) was recorded. Ninety-one patients (aged 74 ± 13 years) with COVID-19 were included in this retrospective study. Fifty (54.9%) patients presented with two or more comorbid diseases. Based on the decision of the referring physician, 36 (39.6%) patients were treated with vitamin D. Receiver operating characteristic curve analysis revealed a significant predictive power of the four variables: (a) low (<50 nmol/L) 25(OH) vitamin D levels, (b) current cigarette smoking, (c) elevated D-dimer levels (d) and the presence of comorbid diseases, to explain the decision to administer vitamin D (area under the curve = 0.77, 95% CI: 0.67-0.87, < 0.0001). Over the follow-up period (14 ± 10 days), 27 (29.7%) patients were transferred to the ICU and 22 (24.2%) died (16 prior to ICU and six in ICU). Overall, 43 (47.3%) patients experienced the combined endpoint of transfer to ICU and/or death. Logistic regression analyses revealed that the comorbidity burden significantly modified the effect of vitamin D treatment on the study outcome, both in crude ( = 0.033) and propensity score-adjusted analyses ( = 0.039), so the positive effect of high-dose cholecalciferol on the combined endpoint was significantly amplified with increasing comorbidity burden. This hypothesis-generating study warrants the formal evaluation (i.e., clinical trial) of the potential benefit that cholecalciferol can offer in these comorbid COVID-19 patients.
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http://dx.doi.org/10.3390/nu13010219DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7828675PMC
January 2021

Vitamin K and Osteoporosis.

Nutrients 2020 Nov 25;12(12). Epub 2020 Nov 25.

Department of Medicine, University Health Network, University of Toronto, 200 Elizabeth Street, Eaton North 7-221, Toronto, ON M5G 2C4, Canada.

Vitamin K acts as a coenzyme of carboxylase, catalyzing the carboxylation of several vitamin K dependent proteins. Beyond its well-known effects on blood coagulation, it also exerts relevant effects on bone and the vascular system. In this review, we point out the relevance of an adequate vitamin K intake to obtain sufficient levels of carboxylated (active form) vitamin K dependent proteins (such as Osteocalcin and matrix Gla protein) to prevent bone health. Another bone-related action of Vitamin K is being a ligand of the nuclear steroid and xenobiotic receptor (SXR). We also discuss the recommended intake, deficiency, and assessment of vitamin K. Furthermore, we review the few available studies that have as pre-specified outcome bone fractures, indicating that we need more clinical studies to confirm that vitamin K is a potential therapeutic agent for bone fractures.
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http://dx.doi.org/10.3390/nu12123625DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7760385PMC
November 2020

Sevelamer Use, Vitamin K Levels, Vascular Calcifications, and Vertebral Fractures in Hemodialysis Patients: Results from the VIKI Study.

J Bone Miner Res 2021 Mar 3;36(3):500-509. Epub 2020 Dec 3.

Division of Nephrology, Department of Medicine, Columbia University Irving Medical Center, New York City, NY, USA.

Hyperphosphatemia is a risk factor for vascular calcifications (VCs), which are part of the chronic kidney disease-mineral and bone disorders (CKD-MBD). Vitamin K-dependent proteins such as matrix Gla protein (MGP) and bone Gla proteins (BGP, or osteocalcin) can inhibit VCs and regulate bone mineralization. In this analysis of the Vitamin K Italian (VIKI) study, the relationship between vitamin K status, vertebral fractures (VFs) and VCs in 387 hemodialysis (HD) patients with (N = 163; 42.1%) or without N = 224; 57.9%) sevelamer was evaluated. Levels of vitamin K vitamers K1 and K2 or menaquinones (MK; MK4-7), total and undercarboxylated (uc) forms for both BGP and MGP were determined. Although no differences in clinical characteristics were noted, lower levels of MK4 (0.45 versus 0.6 ng/mL, p = .01) and a greater MK4 deficiency was observed in sevelamer-treated patients (13.5% versus 5.4%, p = .005). Multivariate logistic regression revealed that MK4 deficiency was associated with sevelamer use (odds ratio [OR] = 2.64, 95% confidence interval [CI] 1.25-5.58, p = .011) and aortic calcification (OR = 8.04, 95% CI 1.07-60.26, p = .04). In the same logistic model, sevelamer amplified the effect of total BGP levels on the odds of VFs in patients with total BGP <150 μg/L compared with those with total BGP ≥150 μg/L (OR = 3.15, 95% CI 1.46-6.76, p = .003). In contrast, there was no such effect in those untreated (total BGP <150 μg/L versus total BGP ≥150 μg/L: OR = 1.21, 95% CI 0.66-2.23, p = .54]; p = .049 for effect modification by sevelamer). Sevelamer may interfere with MK4 levels in HD patients and interact with low BGP levels to increase bone fractures in CKD patients. © 2020 American Society for Bone and Mineral Research (ASBMR).
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http://dx.doi.org/10.1002/jbmr.4214DOI Listing
March 2021

The combined measurement of high-sensitivity cardiac troponins and natriuretic peptides: a useful tool for clinicians?

J Cardiovasc Med (Hagerstown) 2020 Dec;21(12):953-963

Laboratory of Cardiovascular Endocrinology and Cell Biology, CNR-Regione Toscana, Foundation, G. Monasterio and Scuola Superiore Sant'Anna, Pisa, Italy.

: An enormous amount of experimental and clinical evidence has clearly shown that the measurement of cardio-specific biomarkers is able to significantly and independently improve the diagnostic accuracy and risk stratification in cardiovascular diseases. Furthermore, many recent studies have reported that the measurement of cardio-specific biomarkers has a positive impact also on the management and outcome of patients with cardiovascular diseases. Considering the significant and independent information associated with cardio-specific biomarkers, several studies have recently reported that the combined dosage of natriuretic peptides and cardiac troponins may be convenient not only for the diagnosis, prognosis, and treatment of heart disease, but also for general screening of the population for individuals with high cardiovascular risk. Due to the higher cost of cardio-specific biomarkers compared with other laboratory tests, the clinical adequacy of the combined measurement of natriuretic peptides and cardiac troponins must be carefully evaluated. Consequently, an increase in the clinical use of a laboratory test should be based not only on the favorable pathophysiological characteristics of a biomarker, but also on the high performance of the methods used for biomarker dosing. The purpose of this review is to discuss the clinical relevance and the possible cost efficiency of the combined dosage of natriuretic peptides and cardiac troponins in some clinical conditions, in particular those most frequently observed in patients with critical illnesses admitted to the emergency room.
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http://dx.doi.org/10.2459/JCM.0000000000001022DOI Listing
December 2020

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

Clin Chim Acta 2020 Dec 1;511:75-80. Epub 2020 Oct 1.

Department of Laboratory Medicine, University Hospital of Padova, Padova, Italy; Department of Medicine-DIMED, Medical School, University of Padova, Padova, Italy.

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 2000, 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.
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http://dx.doi.org/10.1016/j.cca.2020.09.036DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7527277PMC
December 2020

Vitamin K and Kidney Transplantation.

Nutrients 2020 Sep 5;12(9). Epub 2020 Sep 5.

Nephrology Unit, ASST Fatebenefratelli Sacco, 20157 Milano, Italy.

The assessment of the vitamin K status and its effects on clinical outcomes in kidney transplantation (KT) patients has sparked interest, but it is still largely unfulfilled. In part, this is due to difficulties in laboratory measurements of vitamin K, especially K2 vitamers. Vitamin K status is currently best assessed by measuring undercarboxylated vitamin-K-dependent proteins. The relative contribution of vitamin K1 and K2 to the health status of the general population and CKD (chronic kidney disease) patients, including KT patients, is also poorly studied. Through a complete and first review of the existing literature, we summarize the current knowledge of vitamin K pathophysiology and its potential role in preventing KT complications and improving organ survival. A specific focus is placed on cardiovascular complications, bone fractures, and the relationship between vitamin K and cancer. Vitamin K deficiency could determine adverse outcomes, and KT patients should be better studied for vitamin K assessment and modalities of effective therapeutic approaches.
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http://dx.doi.org/10.3390/nu12092717DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7551925PMC
September 2020

Cardiotoxic effects and myocardial injury: the search for a more precise definition of drug cardiotoxicity.

Clin Chem Lab Med 2020 Aug 26;59(1):51-57. Epub 2020 Aug 26.

Scuola Superiore Sant'Anna e Fondazione CNR - Regione Toscana G. Monasterio, Pisa, Italy.

Drug-induced cardiotoxicity is a major clinical problem; cardiotoxic drugs may induce both cardiac dysfunction and myocardial injury. Several recent studies reported that cardiac troponins measured with high-sensitivity methods (hs-cTn) can enable the early detection of myocardial injury related to chemotherapy or abuse of drugs that are potentially cardiotoxic. Several authors have some concerns about the standard definition of cardiotoxicity, in particular, regarding the early evaluation of chemotherapy cardiotoxicity in cancer patients. Several recent studies using the hs-cTn assay indicate that myocardial injury may precede by some months or years the diagnosis of heart failure (HF) based on the evaluation of left ventricular ejection fraction (LVEF). Accordingly, hs-cTn assay should considered to be a reliable laboratory test for the early detection of asymptomatic or subclinical cardiotoxic damage in patients undergoing cancer chemotherapy. In accordance with the Fourth Universal Definition of Myocardial Infarction and also taking into account the recent experimental and clinical evidences, the definition of drug-cardiotoxicity should be updated considering the early evaluation of myocardial injury by means of hs-cTn assay. It is conceivable that the combined use of hs-cTn assay and cardiac imaging techniques for the evaluation of cardiotoxicity will significantly increase both diagnostic sensitivity and specificity, and also better prevent chemotherapy-related left ventricular (LV) dysfunction and other adverse cardiac events. However, large randomized clinical trials are needed to evaluate the cost/benefit ratio of standardized protocols for the early detection of cardiotoxicity using hs-cTn assay in patients receiving chemotherapy for malignant diseases.
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http://dx.doi.org/10.1515/cclm-2020-0566DOI Listing
August 2020

Evidence on clinical relevance of cardiovascular risk evaluation in the general population using cardio-specific biomarkers.

Clin Chem Lab Med 2020 Jul 21;59(1):79-90. Epub 2020 Jul 21.

Dipartimento di Medicina di Laboratorio, Azienda Ospedaliera Universitaria di Padova, Padova, Italy.

In recent years, the formulation of some immunoassays with high-sensitivity analytical performance allowed the accurate measurement of cardiac troponin I (cTnI) and T (cTnT) levels in reference subjects. Several studies have demonstrated the association between the risk of major cardiovascular events and cardiac troponin concentrations even for biomarker values within the reference intervals. High-sensitivity cTnI and cTnT methods (hs-cTn) enable to monitor myocardial renewal and remodelling, and to promptly identify patients at highest risk ofheart failure. An early and effective treatment of individuals at higher cardiovascular risk may revert the initial myocardial remodelling and slow down heart failure progression. Specific clinical trials should be carried out to demonstrate the efficacy and efficiency of the general population screening by means of cost-benefit analysis, in order to better identify individuals at higher risk for heart failure (HF) progression with hs-cTn methods.
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http://dx.doi.org/10.1515/cclm-2020-0310DOI Listing
July 2020

Harmonization of two hs-cTnI methods based on recalibration of measured quality control and clinical samples.

Clin Chim Acta 2020 Nov 9;510:150-156. Epub 2020 Jul 9.

S.C. Laboratorio Analisi, A.O. Ordine Mauriziano di Torino, Torino, Italy.

Background: The study aim was to evaluate whether is possible to harmonize the results of two hs-cTnI methods using a recalibration procedure based on linear regression models and measured values of external quality assessment (EQA) and clinical samples.

Methods: A two-step experimental approach was used. The preliminary step was performed using 16 EQA samples. The harmonization procedure was then validated by using 2530 heparinized plasma samples collected by 12 Italian University and Regional Hospitals from apparently healthy volunteers and patients admitted to emergency department with cardiac diseases. Two hs-cTnI methods were tested: Architect Stat High Sensitive Troponin-I, and the Access hs-cTnI using DxI platform. Linear regression models based on mean values measured with the two hs-cTni methods were used.

Results: A significant reduction in the measurement bias between the two methods was found after recalibration procedure. The agreement between-methods improved of about 2.5 folds after recalibration, as assessed by reduction in mean CV values from 38.4% (SD 25.9%) before recalibration to 15.0% (SD 10.6%) after recalibration for hs-cTnI values ≤ 500 ng/L (n = 13, P = 0.0111 by non-parametric test for paired data).

Conclusions: A recalibration procedure based on means of measured concentrations with hs-cTnI methods, which use monoclonal antibodies with similar binding characteristics, can be used to significantly reduce systematic bias and so to improve harmonization between methods. The results of this study can aid laboratorians and clinicians to better compare the concentrations respectively measured with the Architect and Access hs-cTnI methods.
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http://dx.doi.org/10.1016/j.cca.2020.07.009DOI Listing
November 2020

Is pasireotide-induced diabetes mellitus predictable? A pilot study on the effect of a single dose of pasireotide on glucose homeostasis.

Pituitary 2020 Oct;23(5):534-542

Endocrinology Unit, Department of Medicine DIMED, University-Hospital of Padova, Via Ospedale Civile 105, 35128, Padova, Italy.

Introduction: Pasireotide (PAS) is an effective treatment for Cushing's disease (CD) but its use is burdened by an associated high incidence of diabetes mellitus (DM). The aim of this study was to examine the effect of a single subcutaneous injection of PAS on glucose metabolism in CD, and to identify predictors of DM onset.

Methods: Fifteen patients with CD (13 females, 2 males; median age 43 years [IQR 34-50]) were submitted to an acute PAS test (600 µg s.c.), measuring glucose, insulin, C-peptide, GIP, glucagon, GLP-1, ACTH, and cortisol at the baseline and every 30 min for 2 h. Then they were treated twice daily with PAS 600 µg, and followed up with clinical and hormone assessments for a median of 6 months [2-13].

Results: PAS prompted a significant decrease in all hormonal parameters considered except for glycemia, which increased (as expected), reaching the highest value at 120' (p < 0.0001). Overall, 9/15 patients developed DM within 2 months of starting PAS therapy. There were no differences in age, weight, visceral adiposity, HOMA index, fasting glucose or severity of CD between patients who developed DM and those who did not. Baseline fasting glucagon levels were higher in the DM patients (17.95 [12.45-20.54] vs. 10.53 [8.11-12.33] pmol/L, p = 0.0256), and so were GIP and HbA1c levels (37 [5.5-39.5] vs. 29 [27-31.8] mmol/mol, p = 0.0008). Glucose at 120' was also significantly higher in the DM patients (9.5 [8.65-11.95] vs. 6.85 [4.48-9] mmol/L, p = 0.012).

Conclusions: PAS was rapidly able to suppress insulin and incretin secretion, with a subsequent rise in glucose levels into the diabetic range. It also induced a significant inhibition of glucagon production. The patients at higher risk of DM during PAS therapy were those with higher glucagon levels, HbA1c > 34.5 mmol/mol, and a glucose peak after PAS administration > 9 mmol/L. CD patients with these features given PAS therapy should therefore be monitored more carefully.
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http://dx.doi.org/10.1007/s11102-020-01055-xDOI Listing
October 2020

High-sensitivity cardiac troponin I and T methods for the early detection of myocardial injury in patients on chemotherapy.

Clin Chem Lab Med 2021 Feb 22;59(3):513-521. Epub 2020 May 22.

Dipartimento di Medicina di Laboratorio, Azienda Ospedaliera Universitaria di Padova, and Dipartimento di Medicina - Università di Padova, Padova, Italy.

Important advances achieved in pharmacological cancer treatment have led progressively to a reduction in mortality from many forms of cancer, and increasing numbers of previously incurable patients can now hope to become cancer-free. Yet, to achieve these improved outcomes a high price has been paid in terms of untoward side effects associated with treatment, cardio-toxicity in particular. Several recent studies have reported that cardiac troponin assay using high-sensitivity methods (hs-cTn) can enable the early detection of myocardial injury related to chemotherapy or abuse of drugs that are potentially cardiotoxic. Several authors have recently suggested that changes in hs-cTn values enable the early diagnosis of cardiac injury from chemotherapy, thus potentially benefitting cancer patients with increased troponin values by initiating early cardioprotective therapy. However, large randomised clinical trials are needed in order to evaluate the cost/benefit ratio of standardised protocols for the early detection of cardiotoxicity using the hs-cTn assay in patients treated with chemotherapy.
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http://dx.doi.org/10.1515/cclm-2020-0362DOI Listing
February 2021

Overweight-obesity is associated with decreased vitamin K2 levels in hemodialysis patients.

Clin Chem Lab Med 2021 Feb 8;59(3):581-589. Epub 2020 May 8.

National Research Council (CNR), Institute of Clinical Physiology (IFC), Pisa, Italy.

Objectives: Obesity is an important risk factor for morbidity and mortality. Vitamin K2 is involved in the production of bone and matrix amino acid g-carboxy-glutamic acid (Gla) proteins (vitamin K-dependent proteins [VKDPs]), regulating bone and vascular calcification (VC). Bone Gla protein (BGP) is involved both in bone mineralization and VCs. We assessed the relationships between vitamin K levels and body mass index (BMI) according to the hypothesis that the impact of BMI on mortality is partly driven by low vitamin K levels.

Methods: The Vitamin K Italian (VIKI) study included 387 hemodialysis patients from 18 dialysis centers in Italy. We determined plasma levels of bone markers: vitamin K levels, VKDPs, vitamin 25(OH)D, alkaline phosphatase (ALP), parathyroid hormone (PTH), calcium (Ca), phosphorus (P) and routine biochemistry. BMI was classified into the following categories: underweight (BMI < 18.5 kg/m), normal weight (18.5 ≤ BMI < 25 kg/m), overweight (25 ≤ BMI < 30 kg/m) and obese (BMI ≥ 30 kg/m).

Results: 45.2% of patients were overweight or obese. Stratification by BMI demonstrated lower median menaquinone-7 (MK7)/triglycerides levels in obese patients (0.42 ng/mg [0.19, 0.87], p = 0.005). BGP levels were lower in overweight and obese patients (152 mcg/L [83.2, 251] and 104 mcg/L [62.7, 230], p = <0.001). Furthermore, there was an inverse correlation between MK7/triglycerides levels and BMI (regression coefficient β = -0.159; p = 0.003). In multiple linear regression, there was an inverse relationship between BGP levels and BMI (β = - 0.119; p = 0.012).

Conclusions: These data are the first to report an inverse relationship between Vitamin K2 levels and BMI in hemodialysis patients. Further studies are needed to confirm these findings and to determine if lower levels of Vitamin K are related to greater morbidity and mortality in this at-risk population.
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http://dx.doi.org/10.1515/cclm-2020-0194DOI Listing
February 2021

Efficacy of weekly administration of cholecalciferol on parathyroid hormone in stable kidney-transplanted patients with CKD stage 1-3.

Clin Chem Lab Med 2020 May 5;59(2):343-351. Epub 2020 May 5.

Department of Medicine, Clinica Medica 1, University of Padova, Padova, Italy.

Objectives: Kidney transplant (KTx) recipients frequently have deficient or insufficient levels of serum vitamin D. Few studies have investigated the effect of cholecalciferol in these patients. We evaluated the efficacy of weekly cholecalciferol administration on parathyroid hormone (PTH) levels in stable KTx patients with chronic kidney disease stage 1-3.

Methods: In this retrospective cohort study, 48 stable KTx recipients (37 males, 11 females, aged 52 ± 11 years and 26 months post-transplantation) were treated weekly with oral cholecalciferol (7500-8750 IU) for 12 months and compared to 44 untreated age- and gender-matched recipients. Changes in levels of PTH, 25(OH) vitamin D (25[OH]D), serum calcium, phosphate, creatinine and estimated glomerular filtration rate (eGFR) were measured at baseline, 6 and 12 months.

Results: At baseline, clinical characteristics were similar between treated and untreated patients. Considering the entire cohort, 87 (94.6%) were deficient in vitamin D and 64 (69.6%) had PTH ≥130 pg/mL. Serum calcium, phosphate, creatinine and eGFR did not differ between groups over the follow-up period. However, 25(OH)D levels were significantly higher at both 6 (63.5 vs. 30.3 nmol/L, p < 0.001) and 12 months (69.4 vs. 30 nmol/L, p < 0.001) in treated vs. untreated patients, corresponding with a significant reduction in PTH at both 6 (112 vs. 161 pg/mL) and 12 months (109 vs. 154 pg/mL) in treated vs. untreated patients, respectively (p < 0.001 for both).

Conclusions: Weekly administration of cholecalciferol can significantly and stably reduce PTH levels, without any adverse effects on serum calcium and renal function.
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http://dx.doi.org/10.1515/cclm-2020-0282DOI Listing
May 2020

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

Clin Chim Acta 2020 Aug 22;507:161-163. Epub 2020 Apr 22.

Department of Laboratory Medicine, University-Hospital, Padova, Italy; Department of Medicine - DIMED, University of Padova, Italy.

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.
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http://dx.doi.org/10.1016/j.cca.2020.04.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7175898PMC
August 2020

PTH: Redefining Reference Ranges in a Healthy Population-The Role of Interfering Factors and the Type of Laboratory Assay.

Int J Endocrinol 2020 21;2020:1053719. Epub 2020 Feb 21.

Endocrinology Unit, Department of Medicine (DIMED), University of Padua, Padua, Italy.

. Parathyroid hormone (PTH) is a linear peptide constituted by 84 amino acids and active in its 1-84 form, but a wide range of PTH forms produced by its post-transcriptional modifications are present in blood. Many assays with different specificities are commercially available. The aim of our study was to compare a 2 and 3 generation in healthy population in order to better define the reference range in the healthy population residing in our region. . 108 subjects (53 females and 55 males) referring to the transfusion donor were enrolled in the study centre in April 2016 and underwent PTH levels measurements with a 3 generation kit (chemiluminescent immunoassay DiaSorin Liaison) and with a 2 generation kit (immunoradiometric assay Total Intact PTH Assay (Coated Tube), Scantibodies). Also calcium, phosphate, creatinine, and 25OHD3 were measured. A questionnaire on lifestyle and dietary habits was obtained.

Results: The median PTH values obtained with the 2 generation assay and the whole 3 generation assay were 20.26 pg/ml and 23.11 pg/ml, respectively. Bland-Altman method showed substantial concordance between the two PTH assays, although with an overestimation of the 3 generation method over the 2 generation method. There was no correlation between 3 generation PTH and 25OHD3 and creatinine. Calcium was negatively correlated with PTH only when measured with 3 generation kit.

Conclusions: On the basis of our data, obtained from healthy subjects, we can conclude that the reference range used by our laboratory was too narrow and was necessary to reestablish normal ranges according to our population. This is useful to avoid hyperparathyroidism misdiagnosis.
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http://dx.doi.org/10.1155/2020/1053719DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7054804PMC
February 2020

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

Clin Chim Acta 2020 May 5;504:163-167. Epub 2020 Feb 5.

Department of Laboratory Medicine, University-Hospital, Padova, Italy; Department of Medicine, University of Padova, Italy.

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 (R 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 (CV) is lower than that reported in the literature and the index of individuality lower than 0.6 suggests a scarce value of reference interval.
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http://dx.doi.org/10.1016/j.cca.2020.02.004DOI Listing
May 2020

An international multi-center serum protein electrophoresis accuracy and M-protein isotyping study. Part II: limit of detection and follow-up of patients with small M-proteins.

Clin Chem Lab Med 2020 03;58(4):547-559

Division of Clinical Biochemistry and Immunology, Department of Laboratory Medicine and Pathology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA.

Background Electrophoretic methods to detect, characterize and quantify M-proteins play an important role in the management of patients with monoclonal gammopathies (MGs). Significant uncertainty in the quantification and limit of detection (LOD) is documented when M-proteins are <10 g/L. Using spiked sera, we aimed to assess the variability in intact M-protein quantification and LOD across 16 laboratories. Methods Sera with normal, hypo- or hyper-gammaglobulinemia were spiked with daratumumab or elotuzumab, with concentrations from 0.125 to 10 g/L (n = 62) along with a beta-migrating sample (n = 9). Laboratories blindly analyzed samples according to their serum protein electrophoresis (SPEP)/isotyping standard operating procedures. LOD and intra-laboratory percent coefficient of variation (%CV) were calculated and further specified with regard to the method (gel/capillary electrophoresis [CZE]), gating strategy (perpendicular drop [PD]/tangent skimming [TS]), isotyping (immunofixation/immunosubtraction [ISUB]) and manufacturer (Helena/Sebia). Results All M-proteins ≥1 g/L were detected by SPEP. With isotyping the LOD was moderately more sensitive than with SPEP. The intensity of polyclonal background had the biggest negative impact on LOD. Independent of the method used, the intra-laboratory imprecision of M-protein quantification was small (mean CV = 5.0%). Low M-protein concentration and high polyclonal background had the strongest negative impact on intra-laboratory precision. All laboratories were able to follow trend of M-protein concentrations down to 1 g/L. Conclusions In this study, we describe a large variation in the reported LOD for both SPEP and isotyping; overall LOD is most affected by the polyclonal immunoglobulin background. Satisfactory intra-laboratory precision was demonstrated. This indicates that the quantification of small M-proteins to monitor patients over time is appropriate, when subsequent testing is performed within the same laboratory.
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http://dx.doi.org/10.1515/cclm-2019-1105DOI Listing
March 2020

An international multi-center serum protein electrophoresis accuracy and M-protein isotyping study. Part I: factors impacting limit of quantitation of serum protein electrophoresis.

Clin Chem Lab Med 2020 03;58(4):533-546

Division of Clinical Biochemistry and Immunology, Department of Laboratory Medicine and Pathology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA.

Background Serum protein electrophoresis (SPEP) is used to quantify the serum monoclonal component or M-protein, for diagnosis and monitoring of monoclonal gammopathies. Significant imprecision and inaccuracy pose challenges in reporting small M-proteins. Using therapeutic monoclonal antibody-spiked sera and a pooled beta-migrating M-protein, we aimed to assess SPEP limitations and variability across 16 laboratories in three continents. Methods Sera with normal, hypo- or hypergammaglobulinemia were spiked with daratumumab, Dara (cathodal migrating), or elotuzumab, Elo (central-gamma migrating), with concentrations from 0.125 to 10 g/L (n = 62) along with a beta-migrating sample (n = 9). Provided with total protein (reverse biuret, Siemens), laboratories blindly analyzed samples according to their SPEP and immunofixation (IFE) or immunosubtraction (ISUB) standard operating procedures. Sixteen laboratories reported the perpendicular drop (PD) method of gating the M-protein, while 10 used tangent skimming (TS). A mean percent recovery range of 80%-120% was set as acceptable. The inter-laboratory %CV was calculated. Results Gamma globulin background, migration pattern and concentration all affect the precision and accuracy of quantifying M-proteins by SPEP. As the background increases, imprecision increases and accuracy decreases leading to overestimation of M-protein quantitation especially evident in hypergamma samples, and more prominent with PD. Cathodal migrating M-proteins were associated with less imprecision and higher accuracy compared to central-gamma migrating M-proteins, which is attributed to the increased gamma background contribution in M-proteins migrating in the middle of the gamma fraction. There is greater imprecision and loss of accuracy at lower M-protein concentrations. Conclusions This study suggests that quantifying exceedingly low concentrations of M-proteins, although possible, may not yield adequate accuracy and precision between laboratories.
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http://dx.doi.org/10.1515/cclm-2019-1104DOI Listing
March 2020

Percentile transformation and recalibration functions allow harmonization of thyroid-stimulating hormone (TSH) immunoassay results.

Clin Chem Lab Med 2020 Sep;58(10):1663-1672

Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy.

Background The comparability of thyroid-stimulating hormone (TSH) results cannot be easily obtained using SI-traceable reference measurement procedures (RPMs) or reference materials, whilst harmonization is more feasible. The aim of this study was to identify and validate a new approach for the harmonization of TSH results. Methods Percentile normalization was applied to 125,419 TSH results, obtained from seven laboratories using three immunoassays (Access 3rd IS Thyrotropin, Beckman Coulter Diagnostics; Architect System, Abbott Diagnostics and Elecsys, Roche Diagnostics). Recalibration equations (RCAL) were derived by robust regressions using bootstrapped distribution. Two datasets, the first of 119 EQAs, the second of 610, 638 and 639 results from Access, Architect and Elecsys TSH results, respectively, were used to validate RCAL. A dataset of 142,821 TSH values was used to derive reference intervals (RIs) after applying RCAL. Results Access, Abbott and Elecsys TSH distributions were significantly different (p < 0.001). RCAL intercepts and slopes were -0.003 and 0.984 for Access, 0.032 and 1.041 for Architect, -0.031 and 1.003 for Elecsys, respectively. Validation using EQAs showed that before and after RCAL, the coefficients of variation (CVs) or among-assay results decreased from 10.72% to 8.16%. The second validation dataset was used to test RCALs. The median of between-assay differences ranged from -0.0053 to 0.1955 mIU/L of TSH. Elecsys recalibrated to Access (and vice-versa) showed non-significant difference. TSH RI after RCAL resulted in 0.37-5.11 mIU/L overall, 0.49-4.96 mIU/L for females and 0.40-4.92 mIU/L for males. A significant difference across age classes was identified. Conclusions Percentile normalization and robust regression are valuable tools for deriving RCALs and harmonizing TSH values.
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http://dx.doi.org/10.1515/cclm-2019-1167DOI Listing
September 2020

Evaluation of analytical performance of immunoassay methods for cTnI and cTnT: From theory to practice.

Adv Clin Chem 2019 27;93:239-262. Epub 2019 Aug 27.

Department of Laboratory Medicine, University Hospital, Padova, Italy.

Current guidelines worldwide recommend cardiac troponins I (cTnI) and T (cTnT) as the biomarkers of choice for the differential diagnosis of acute coronary syndrome (ACS), and the measurement of the 99th upper reference population limit (URL) value for cardiac troponins, with an imprecision of ≤10 CV%. Measuring the 99th URL of cTnI and cTnT is a challenging analytical task due to low biomarker concentrations present in healthy subjects. Therefore, since the year 2006, several manufacturers have established new generation cTnI and cTnT immunoassays with an improved analytical sensitivity in accordance with the quality specifications described in international guidelines, the more recent of which state that only immunoassays that meet the required quality specifications should be considered "high-sensitivity" methods. For the early diagnosis of ACS, and for the stratification of cardiovascular risk in cardiac patients and the general population, high-sensitivity methods should be employed. It is therefore important for laboratory professionals and clinicians to gain a thorough understanding of the analytical performances of immunoassay methods for cTnI and cTnT, especially at low to normal concentration ranges. The aim of the present study was to analyze critical aspects related to definition, analytical performance, pathophysiological interpretations, and the clinical relevance of high-sensitivity cardiac troponin assays.
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http://dx.doi.org/10.1016/bs.acc.2019.07.005DOI Listing
December 2019

Understanding and managing interferences in clinical laboratory assays: the role of laboratory professionals.

Clin Chem Lab Med 2020 02;58(3):350-356

Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy.

The recently raised concerns regarding biotin interference in immunoassays have increased the awareness of laboratory professionals and clinicians of the evidence that the analytical phase is still vulnerable to errors, particularly as analytical interferences may lead to erroneous results and risks for patient safety. The issue of interference in laboratory testing, which is not new, continues to be a challenge deserving the concern and interest of laboratory professionals and clinicians. Analytical interferences should be subdivided into two types on the basis of the possibility of their detection before the analytical process. The first (type 1) is represented by lipemia, hemolysis and icterus, and the second (type 2), by unusual constituents that are not undetectable before analysis, and may affect the matrix of serum/plasma of individual subjects. Type 2 cannot be identified with current techniques when performing the pre-analytical phase. Therefore, in addition to a more careful evaluation and validation of the method to be used in clinical practice, the awareness of laboratory professionals should be raised as to the importance of evaluating the quality of biological samples before analysis and to adopt algorithms and approaches in the attempt to reduce problems related to erroneous results due to specific or non-specific interferences.
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http://dx.doi.org/10.1515/cclm-2019-0898DOI Listing
February 2020

Osteoporosis in Systemic Autoinflammatory Diseases: A Case-Control Study.

Front Endocrinol (Lausanne) 2019 18;10:636. Epub 2019 Sep 18.

Rheumatology Unit, Department of Medicine DIMED, University of Padova, Padova, Italy.

To assess if patients affected by systemic autoinflammatory diseases (SAIDs) present an increased risk of osteoporosis (OP). Forty adults patients referred to the Rheumatology Unit of Padova University Hospital affected by Familial Mediterranean Fever (FMF), TNF-Receptor Associated Periodic Syndrome (TRAPS), and Mevalonate Kinase Deficiency (MKD) and 40 healthy subjects were enrolled. Blood and urine samples were collected in order to define phosphocalcic metabolism, including Receptor activator of nuclear factor kappa-B ligand (RANKL) and osteoprotegerin (OPG), and among inflammatory markers serum amyloid A (SAA). Femur and lumbar dual-energy X-ray absorptiometry (DXA) scans were performed and Trabecular Bone Score (TBS) was calculated on DXA lumbar images. We did not observe a statistically significant difference between Bone Mineral Density (BMD) and TBS of patients compared to controls. Also, the values of phosphocalcic metabolites in patients did not statistically differ from those in controls. However, SAA and OPG levels were significantly higher in patients compared to healthy subjects ( = 0.0244 and = 0.0064, respectively). Patients of our cohort affected by FMF, TRAPS, and MKD do not present an increased risk of OP compared to the healthy controls. TBS and BMD are similar between the two groups underlining a preserved bone quality in patients. High OPG levels could suggest a protective role and a bone re-balancing action in response to an inflammatory background. Finally, it should be taken into account a modulatory role played by a pro-inflammatory cytokine such as SAA on bone homeostasis.
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http://dx.doi.org/10.3389/fendo.2019.00636DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6759948PMC
September 2019

Serological Biomarkers in Early Axial Spondyloarthritis During 24-Months Follow Up (Italian Arm of Space Study).

Front Med (Lausanne) 2019 7;6:177. Epub 2019 Aug 7.

Rheumatology Unit, Department of Medicine-DIMED, University of Padova, Padova, Italy.

The study aimed to evaluate biomarkers facilitating early axial-spondyloarthritis (axSpA) diagnosis and disease activity and imaging indices correlated. Seventy-five patients with low back pain (LBP) (≥3 months, ≤2 years, onset ≤45 years) participating in the Italian arm of the SpondyloArthritis-Caught-Early (SPACE) study underwent a physical examination, questionnaires, laboratory tests, spine, and sacroiliac joints (SIJ) X-rays and magnetic resonance imaging (MRI) at baseline and during a 24-months follow-up. Two expert rheumatologists formulated axSpA diagnosis and assessed fulfillment of Assessment of SpondyloArthritis International Society (ASAS) criteria. Disease activity and physical functioning were assessed using imaging, clinical, and serological indices. Spine and SIJ MRI and X-rays were scored independently by 2 readers following the (SPARCC), mSASSS, and mNY-criteria. Patients were classified in accordance to ASAS criteria as: 21 patients classified according to axSpA imaging arm; 29 patients classified according to axSpA clinical ± imaging arm; 25 patients not fulfilling ASAS criteria. At baseline biomarker levels were not significantly increased in any of the patient groups. Instead, a significant decrease of all functional and disease activity indices from baseline to 24 months was observed in all the three groups. In the same period, there were no significant variation in the serological markers values within each group. The correlations between IL-17 and IL-23 and clinical and functional indices were not significant. On the other hand, significant correlations were found between IL-22 and Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Patient Global Score (BASG1), Health Assessment Questionnaire (HAQ), Visual Analog Scale (VAS pain); MMP3 and mSASSS; MMP3 and hsCRP. Although not significantly higher in any of the cohorts, IL-22, MMP3, and hsCRP values correlated with some disease activity indices and with mSASSS. Further studies are warranted to confirm these preliminary findings.
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http://dx.doi.org/10.3389/fmed.2019.00177DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6692922PMC
August 2019

Free light chains in cerebrospinal fluid of multiple sclerosis patients negative for IgG oligoclonal bands.

Clin Chim Acta 2019 Sep 21;496:117-120. Epub 2019 Jun 21.

Department of Laboratory Medicine, University-Hospital of Padova, Via Giustiniani 2, 35128 Padova, Italy.

The detection of IgG oligoclonal bands (OCBs) in cerebrospinal fluid (CSF) is, as yet, the recommended biochemical marker for the diagnosis of multiple sclerosis (MS). Aim of this study was to investigate the behaviour of free light chains (FLC) in OCBs negative (OCBs-) MS patients compared with that in OCBs positive (OCBs+) MS patients and in a control group (CG) of subjects without cerebrospinal inflammatory disease. At multiple comparisons between the three groups, statistically significant differences (p < .001 for all) were found for κFLC. Conversely, λFLC values evidenced a greater overlapping in the three groups. Receiver operating characteristics (ROC) curves made with κFLC values, evidenced the greater differences of areas under curves (AUCs) between OCBs- and OCBs+ (AUCs: κFLC 0.98, QκFLC 0.98, κFLC index 0.96) with respect to the differences between OCBs- and CG (AUCs: κFLC 0.77, QκFLC 0.86, κFLC index 0.77): indeed >50% of MS OCBs- subjects studied evidenced the same values of κFLC, QκFLC and κFLC index found in CG. Conversely, if the aim is to select MS subjects while avoiding undertaking the more complex isoelectrofocusing test, values with absolute specificity for MS (QκFLC = 15, sensitivity = 0.76 and κFLCindex = 3.09, sensitivity = 0.72) could be used. The values found in this study call for confirmation with data from more subjects, including those with other CSF inflammatory diseases. Anyway, the most important finding was that, for some OCBs- subjects, κFLC are more effective than OCBs in diagnosing MS.
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http://dx.doi.org/10.1016/j.cca.2019.06.016DOI Listing
September 2019

Head-to-head comparison of plasma cTnI concentration values measured with three high-sensitivity methods in a large Italian population of healthy volunteers and patients admitted to emergency department with acute coronary syndrome: A multi-center study.

Clin Chim Acta 2019 Sep 13;496:25-34. Epub 2019 Jun 13.

Department of Laboratory Medicine, University-Hospital, Padova, Italy.

Background: The study aim is to compare cTnI values measured with three high-sensitivity (hs) methods in apparently healthy volunteers and patients admitted to emergency department (ED) with acute coronary syndrome enrolled in a large multicentre study.

Methods: Heparinized plasma samples were collected from 1511 apparently healthy subjects from 8 Italian clinical institutions (mean age: 51.5 years, SD: 14.1 years, range: 18-65 years, F/M ratio:0.95). All volunteers denied chronic or acute diseases and had normal values of routine laboratory tests. Moreover, 1322 heparinized plasma sample were also collected by 9 Italian clinical institutions from patients admitted to ED with clinical symptoms typical of acute coronary syndrome. The reference study laboratory assayed all plasma samples with three hs-methods: Architect hs-cTnI, Access hs-cTnI and ADVIA Centaur XPT methods. Principal Component Analysis (PCA) was also used to analyze the between-method differences among hs-cTnI assays.

Results: On average, a between-method difference of 31.2% CV was found among the results of hs-cTnI immunoassays. ADVIA Centaur XPT method measured higher cTnI values than Architect and Access methods. Moreover, 99th percentile URL values depended not only on age and sex of reference population, but also on the statistical approach used for calculation (robust non-parametric vs bootstrap).

Conclusions: Due to differences in concentrations and reference values, clinicians should be advised that plasma samples of the same patient should be measured for cTnI assay in the same laboratory. Specific clinical studies are needed to establish the most appropriate statistical approach to calculate the 99th percentile URL values for hs-cTnI methods.
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http://dx.doi.org/10.1016/j.cca.2019.06.012DOI Listing
September 2019

Glycated albumin as a glycaemic marker in patients with advanced chronic kidney disease and anaemia: a preliminary report.

Scand J Clin Lab Invest 2019 Sep 9;79(5):293-297. Epub 2019 May 9.

a Institute of Clinical Biochemistry, Clinical Molecular Medicine and Laboratory Medicine, Department of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo , Palermo , Italy.

: The association between glycated albumin (GA) and glycaemic status has not been fully described in patients with advanced chronic kidney disease (CKD) in relation to anaemia. The aim of this study was to evaluate the relationship between GA and fasting plasma glucose (FPG) and HbA1c in patients with advanced CKD and to evaluate the influence of anaemia in such relationship. : Patients with CKD stage 4 or 5 were included in the study. eGFR was calculated by the CKD-EPI creatinine equation. Plasma GA was measured by an enzymatic method. : Eighty-one patients were included in the study, 46 (57%) were males; the mean age was 67 ± 14 years. HbA1c was correlated with Hb ( = 0.39;  = .0003), and no significant correlation was detected between plasma GA and serum albumin ( = .82). A significant association between FPG and GA ( = 0.41;  < .0001), and between FPG and HbA1c ( = 0.42;  < .0001) was detected in the whole study population. Patients with moderate/severe anaemia had lower HbA1c than patients with no anaemia, while both FPG and GA were comparable between the two groups. Multivariate regression analysis showed that GA was a significant predictor of FPG in patients with moderate/severe anaemia while HbA1c did not ( = 0.55;  < .0001 for the model). : GA, alone or in combination with other biomarkers, can be considered for the evaluation of glycaemic status in patients with advanced CKD and severe anaemia.
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http://dx.doi.org/10.1080/00365513.2019.1613673DOI Listing
September 2019

Evaluation of reproducibility of the cTnT immunoassay using quality control samples.

Clin Chim Acta 2019 Aug 22;495:269-270. Epub 2019 Apr 22.

Istituto di Fisiologia Clinica del CNR and CNR Spin-off QualiMedLab, Pisa, Italy. Electronic address:

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http://dx.doi.org/10.1016/j.cca.2019.04.068DOI Listing
August 2019