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See detailInter-method variability in bone alkaline phosphatase measurement : clinical impact on the management of dialysis patients
CAVALIER, Etienne ULg; Souberbielle, Jean-Claude; GADISSEUR, Romy ULg et al

in Clinical Biochemistry (in press)

BACKGROUND: Bone-specific alkaline phosphatase (BAP) is now recommended to assess bone turnover in hemodialysis (HD) patients. However, little is known about potential variability between methods ... [more ▼]

BACKGROUND: Bone-specific alkaline phosphatase (BAP) is now recommended to assess bone turnover in hemodialysis (HD) patients. However, little is known about potential variability between methods available to measure BAP. METHODS: We measured BAP in 76 HD patients with six different assays (Beckman-Coulter Ostase IRMA, Beckman-Coulter Ostase Access, IDS iSYS Ostase, IDS Ostase enzyme immunoassay, DiaSorin Liaison Ostase and Quidel MicroVue BAP). RESULTS: We observed a high correlation between all the assays ranging from 0.9948 (IDS iSYS vs. IDS EIA) to 0.9215 (DiaSorin Liaison vs. Quidel MicroVue). However, using the regression equations, the equivalent concentration of a Beckman-Coulter Access value of 10μg/L can range from 7.7 to 14.4μg/L and of 20μg/L can range from 16.9 to 27.9μg/L with other assays. According to Beckman-Coulter Access, 13%, 50% and 37% of the patients presented BAP values ≤10, between 10 and 20 and ≥20μg/L, respectively. Discrepancies are observed when other assays are used (concordance from 10 to 100%). CONCLUSIONS: Analytical problems leading to inter-method variation should be overcome to improve the usefulness of this marker in clinical practice. According to correlation results, recalibration of BAP assays is necessary but should not be a major issue. [less ▲]

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See detailCalibration and precision of serum creatinine and plasma cystatin C measurement: impact on the estimation of glomerular filtration rate
DELANAYE, Pierre ULg; CAVALIER, Etienne ULg; Cristol, Jean-Paul et al

in Journal of Nephrology (in press)

Serum creatinine (SCr) is the main variable for estimating glomerular filtration rate (GFR). Due to interassay differences, the prevalence of chronic kidney disease (CKD) varies according to the assay ... [more ▼]

Serum creatinine (SCr) is the main variable for estimating glomerular filtration rate (GFR). Due to interassay differences, the prevalence of chronic kidney disease (CKD) varies according to the assay used, and calibration standardization is necessary. For SCr, isotope dilution mass spectrometry (IDMS) is the gold standard. Systematic differences are observed between Jaffe and enzymatic methods. Manufacturers subtract 0.30 mg/dl from Jaffe results to match enzymatic results (‘compensated Jaffe method’). The analytical performance of enzymatic methods is superior to that of Jaffe methods. In the original Modification of Diet in Renal Disease (MDRD) equation, SCr was measured by a Jaffe Beckman assay, which was later recalibrated. A limitation of this equation was an underestimation of GFR in the high range. The Chronic Kidney Disease Epidemiology (CKD-EPI) consortium proposed an equation using calibrated and IDMS traceable SCr. The gain in performance was due to improving the bias whereas the precision was comparable. The CKD-EPI equation performs better at high GFR levels (GFR[60 ml/ min/1.73 m2). Analytical limitations have led to the recommendation to give a grade ([60 ml/min/1.73 m2) rather than an absolute value with the MDRD equation. By using both enzymatic and calibrated methods, this cutoff-grade could be increased to 90 ml/min/1.73 m2 (with MDRD) and 120 ml/min/1.73 m2 (with CKD-EPI). The superiority of the CKD-EPI equation over MDRD is analytical, but the precision gain is limited. IDMS traceable enzymatic methods have been used in the development of the Lund– Malmo¨ (in CKD populations) and Berlin Initiative Study equations (in the elderly). The analytical errors for cystatin C are grossly comparable to issues found with SCr. Standardization is available since 2011. A reference method for cystatin C is still lacking. Equations based on standardized cystatin C or cystatin C and creatinine have been proposed. The better performance of these equations (especially the combined CKD-EPI equation) has been demonstrated. [less ▲]

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See detailStandardization of DiaSorin and Roche automated third generation PTH assays with an international standard: impact on clinical populations
CAVALIER, Etienne ULg; DELANAYE, Pierre ULg; LUKAS, Pierre ULg et al

in Clinical Chemistry & Laboratory Medicine (2014), 52(8), 1137-41

Background: Standardization of parathyroid hormone (PTH) assays is a major issue, especially in hemodialyzed (HD) patients. Two automated third generation PTH assays (Roche Elecsys and DiaSorin Liaison ... [more ▼]

Background: Standardization of parathyroid hormone (PTH) assays is a major issue, especially in hemodialyzed (HD) patients. Two automated third generation PTH assays (Roche Elecsys and DiaSorin Liaison) are now available. These assays are specific for the (1-84) PTH and do not cross-react with the (7-84) fragment, contrary to second generation (intact) assays. We aimed to calibrate the two methods against the WHO International PTH Standard (IS) 95/646 to see if the two assays could provide comparable results in a population of healthy subjects, HD patients and patients suffering from primary hyperparathyroidism (PHP). Methods: We selected 79 healthy subjects and two populations of patients presenting PTH disorders: 56 HD and 27 PHP patients. We reconstituted the IS in a pool of human serum containing undetectable levels of 1-84 PTH and prepared 13 serum standards ranging from 0 to 2000 pg/mL. The standards were run on the two instruments to calibrate the assays on the IS. The different populations were run before and after restandardization. Results: As these kits were differently calibrated, the results obtained after restandarization were significantly different. Restandardization process improved concordance between assays and, taking the analytical variability of the two kits into account, the results could be considered to be similar. Conclusions: Restandardization of automated third generation PTH assays with the WHO 1-84 PTH Standard significantly reduces inter-method variability. Reference ranges and raw values are totally transposable from one method to the other in healthy subjects, but also in diseased patients, e.g., with HD or those suffering from PHP. [less ▲]

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See detailAltération de la fonction rénale chez le patient âgé, comment gérer?
KRZESINSKI, Jean-Marie ULg; DELANAYE, Pierre ULg

in Revue Médicale de Liège (2014), 69(5-6), 287-293

From age 30 onwards, kidney function physiologically decreases although this deterioration cannot yet be called chronic kidney disease. The latter appears in those exposed to cardiovascular risk factors ... [more ▼]

From age 30 onwards, kidney function physiologically decreases although this deterioration cannot yet be called chronic kidney disease. The latter appears in those exposed to cardiovascular risk factors associated with inflammation and oxidative stress. A diffuse atherosclerosis then develops Patients with a decreased glomerular filtration rate, especially below the threshold of 45 ml/min, are characterised by a poor physical heath and by cognitive disorders, leading to frailty. In these conditions, a management strategy to reduce the increased risk of acute kidney injury should be outlined and the need for renal replacement therapy be considered. One must try to maintain the best possible quality of life, promoting in some situations a conservative approach. [less ▲]

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See detailCan we use circulating biomarkers to monitor bone turnover in CKD haemodialysis patients? Hypotheses and facts
DELANAYE, Pierre ULg; Souberbielle, Jean-Claude; Lafage-Proust, Marie-Hélène et al

in Nephrology Dialysis Transplantation (2014), 29(5), 997-1004

Assessing bone turnover is a key diagnostic tool in the global management of chronic kidney disease-mineral and bone disorder (CKD-MBD). Since bone biopsy is invasive and cannot be repeated in clinical ... [more ▼]

Assessing bone turnover is a key diagnostic tool in the global management of chronic kidney disease-mineral and bone disorder (CKD-MBD). Since bone biopsy is invasive and cannot be repeated in clinical practice and because bone histomorphometry is less available due to the lack of specialized laboratories, we will focus on potential biomarkers used to assess and monitor bone turnover. After briefly reviewing the pathophysiology of bone turnover in CKD and haemodialysis patients, we will focus on the strengths and limitations of the now recommended biomarkers, i.e. parathormone and bone-specific alkaline phosphatase. We will consider the clinical and also the biological aspects of the topic and also insist on the use of these biomarkers for the monitoring, and the follow-up of the turnover in haemodialysis subjects. Finally, we will discuss some of the most promising, but still not recommended, emerging biomarkers. [less ▲]

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See detailCan we use circulating biomarkers to monitor bone turnover in CKD haemodialysis patients? Hypotheses and facts
DELANAYE, Pierre ULg; Souberbielle, Jean-Claude; Lafage-Proust, Marie-Hélène et al

in Nephrology Dialysis Transplantation (2014), 29(5), 997-1004

Assessing bone turnover is a key diagnostic tool in the global management of chronic kidney disease-mineral and bone disorder (CKD-MBD). Since bone biopsy is invasive and cannot be repeated in clinical ... [more ▼]

Assessing bone turnover is a key diagnostic tool in the global management of chronic kidney disease-mineral and bone disorder (CKD-MBD). Since bone biopsy is invasive and cannot be repeated in clinical practice and because bone histomorphometry is less available due to the lack of specialized laboratories, we will focus on potential biomarkers used to assess and monitor bone turnover. After briefly reviewing the pathophysiology of bone turnover in CKD and haemodialysis patients, we will focus on the strengths and limitations of the now recommended biomarkers, i.e. parathormone and bone-specific alkaline phosphatase. We will consider the clinical and also the biological aspects of the topic and also insist on the use of these biomarkers for the monitoring, and the follow-up of the turnover in haemodialysis subjects. Finally, we will discuss some of the most promising, but still not recommended, emerging biomarkers. [less ▲]

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See detailThe Third/Second Generation PTH Assay Ratio as a Marker for Parathyroid Carcinoma: Evaluation Using an Automated Platform
CAVALIER, Etienne ULg; BETEA, Daniela ULg; SCHLECK, Marie-Louise ULg et al

in Journal of Clinical Endocrinology and Metabolism (2014), 99(3), 453-7

Background: Parathyroid carcinoma (PCa) is rare and often difficult to differentiate initially from benign disease. Because PCa oversecretes amino PTH that is detected by third-generation but not by ... [more ▼]

Background: Parathyroid carcinoma (PCa) is rare and often difficult to differentiate initially from benign disease. Because PCa oversecretes amino PTH that is detected by third-generation but not by second-generation PTH assays, the normal generation PTH ( 1) is inverted in PCa (ie, 1). Objective: The objective of the investigation was to study the utility and advantages of automated generation PTH ratio measurements using the Liaison XL platform over existing manual techniques. Setting: The study was conducted at a tertiary-referral academic center. Design: This was a retrospective laboratory study. Subjects: Eleven patients with advanced PCa (mean age 56.0 y). The controls were patients with 1°-hyperparathyroidism (n 144;meanage 53.8 y), renal transplantation (n 41;meanage 50.6 y), hemodialysis (n 80; mean age 65.2 y), and healthy elderly subjects (n 40; mean age 72.6 y). Results: The median (interquartile range) generation PTH ratio was 1.16 (1.10 –1.38) in the PCa group, which was significantly higher than the control groups: 0.74 (hemodialysis, 0.71–0.75), 0.77 (renal transplant, 0.73–0.79), 0.80 (healthy elderly, 0.74–0.83), and 0.76 (1°-hyperparathyroidism, 0.74–0.78). An inverted -generation PTH ratio ( 1) was seen in 9 of 11 PCa patients (81.8%) and in 7 of 305 controls (2.3%), 3 of 80 hemodialysis (3.8%), and 4 of 144 1°-hyperparathyroidism patients (2.8%). Of four PCa patients who had a normal PTH ratio with the manual method, two had an inverted -generation PTH ratio with the automated method. Conclusions: Study of the -generation PTH ratio in large patient populations should be feasible using a mainstream automated platform like the Liaison XL. The current study confirms the utility of the inverted -generation PTH ratio as a marker of PCa (sensitivity: 81.8%; specificity: 97.3%). [less ▲]

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See detailDetection of decreased glomerular filtration rate in intensive care units: serum cystatin C versus serum creatinine
DELANAYE, Pierre ULg; CAVALIER, Etienne ULg; Morel, Jérôme et al

in BMC Nephrology (2014), 15(9), 1471-2369

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See detailEnzymatic creatinine assays allowestimation of glomerular filtration rate in stages 1 and 2 chronic kidney disease using CKD-EPI equation
Kuster, Nils; Cristol, Jean-Paul; CAVALIER, Etienne ULg et al

in Clinica Chimica Acta (2014), 428

The National Kidney Disease Education Program group demonstrated that MDRD equation is sensitive to creatinine measurement error, particularly at higher glomerular filtration rates. Thus, MDRD-based eGFR ... [more ▼]

The National Kidney Disease Education Program group demonstrated that MDRD equation is sensitive to creatinine measurement error, particularly at higher glomerular filtration rates. Thus, MDRD-based eGFR above 60 mL/min/1.73 m2 should not be reported numerically. However, little is known about the impact of analytical error on CKD-EPI-based estimates. This study aimed at assessing the impact of analytical characteristics (bias and imprecision) of 12 enzymatic and 4 compensated Jaffe previously characterized creatinine assays on MDRD and CKD-EPI eGFR. In a simulation study, the impact of analytical error was assessed on a hospital population of 24 084 patients. Ability using each assay to correctly classify patients according to chronic kidney disease (CKD) stages was evaluated. For eGFR between 60 and 90 mL/min/1.73 m2, both equations were sensitive to analytical error. Compensated Jaffe assays displayed high bias in this range and led to poorer sensitivity/specificity for classification according to CKD stages than enzymatic assays. As compared to MDRD equation, CKD-EPI equation decreases impact of analytical error in creatinine measurement above 90 mL/min/1.73 m2. Compensated Jaffe creatinine assays lead to important errors in eGFR and should be avoided. Accurate enzymatic assays allow estimation of eGFR until 90 mL/min/1.73 m2 with MDRD and 120 mL/min/1.73 m2 with CKD-EPI equation. [less ▲]

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See detailPINP in renal impaired patients: the assay matters
CAVALIER, Etienne ULg; DELANAYE, Pierre ULg

Poster (2013, November 08)

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See detailModification of diet in renal disease versus chronic kidney disease epidemiology collaboration equation to estimate glomerular filtration rate in obese patients
BOUQUEGNEAU, Antoine ULg; Vidal-Petiot, Emanuelle; Vrtovsnik, François et al

in Nephrology Dialysis Transplantation (2013), 28(4), 122-130

Background Obesity is a recognized risk factor for both the development and progression of chronic kidney disease (CKD). Accurate estimation of glomerular filtration rate (GFR) is thus important in these ... [more ▼]

Background Obesity is a recognized risk factor for both the development and progression of chronic kidney disease (CKD). Accurate estimation of glomerular filtration rate (GFR) is thus important in these patients. We tested the performances of two creatinine-based GFR estimates, the Modification of Diet in Renal Disease (MDRD) and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations, in an obese population. Methods Patients with body mass index (BMI) > 30 kg/m2 were included. The reference method for measured GFR (mGFR) was 51Cr-EDTA (single-injection method, two blood samples at 120 and 240 min). Both indexed and non-indexed results were considered. Serum creatinine was measured using the IDMS-traceable compensated Jaffe method. Mean bias (eGFR–mGFR), precision (SD around the bias) and accuracy within 30% (percentage of estimations within 30% of mGFR) were calculated for both equations. Results The population included 366 patients (185 women) from two different areas. Mean age was 55 ± 14 years, and mean BMI was 36 ± 7 kg/m2. Mean mGFR was 56 ± 26 mL/min/1.73 m2 (71 ± 35 mL/min without indexation). In the total population, mean bias was +1.9 ± 14.3 and +4.6 ± 14.7 mL/min/1.73 m2 (P < 0.05), and accuracy 30% was 80 and 76% for the MDRD and CKD-EPI equations (P < 0.05), respectively. In patients with mGFR > 60 mL/min/1.73 m2, mean bias was +4.6 ± 18.4 and +9.3 ± 17.2 mL/min/1.73 m2 (P < 0.05), and accuracy 30% was 81 and 79% (NS) for the MDRD and CKD-EPI equations, respectively. Conclusions The CKD-EPI equation did not outperform the MDRD study equation in this population of obese patients [less ▲]

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See detailStaging chronic kidney disease and estimating glomerular filtration rate: an opinion paper about the new international recommendations
DELANAYE, Pierre ULg; CAVALIER, Etienne ULg

in Clinical Chemistry & Laboratory Medicine (2013), 51(10), 1911-1917

Abstract: In January 2013, the international recommendations <br />of the KDIGO (for “ Kidney Disease: Improving <br />Global Outcomes ” ) to define chronic kidney disease <br />(CKD) and classify ... [more ▼]

Abstract: In January 2013, the international recommendations <br />of the KDIGO (for “ Kidney Disease: Improving <br />Global Outcomes ” ) to define chronic kidney disease <br />(CKD) and classify patients in CKD stages have been published. <br />In this opinion article, we will review and discuss <br />the most important guidelines proposed about CKD staging <br />and glomerular filtration rate (GFR) estimating. In <br />particular, we question the choice of fixed knot values <br />at 60 mL/min/1.73 m ² to define CKD. We also question <br />the strategies proposed to measure and use cystatin C <br />results. [less ▲]

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See detailThe applicability of eGFR equations to different populations
DELANAYE, Pierre ULg; Mariat, Christophe

in Nature Reviews Nephrology (2013), 9

The Cockcroft–Gault equation for estimating glomerular filtration rate has been learnt by every generation of medical students over the decades. Since the publication of the Modification of Diet in Renal ... [more ▼]

The Cockcroft–Gault equation for estimating glomerular filtration rate has been learnt by every generation of medical students over the decades. Since the publication of the Modification of Diet in Renal Disease (MDRD) study equation in 1999, however, the supremacy of the Cockcroft–Gault equation has been relentlessly disputed. More recently, the Chronic Kidney Disease Epidemiology (CKD-EPI) consortium has proposed a group of novel equations for estimating glomerular filtration rate (GFR). The MDRD and CKD-EPI equations were developed following a rigorous process, are expressed in a way in which they can be used with standardized biomarkers of GFR (serum creatinine and/or serum cystatin C) and have been evaluated in different populations of patients. Today, the MDRD Study equation and the CKD-EPI equation based on serum creatinine level have supplanted the Cockcroft–Gault equation. In many regards, these equations are superior to the Cockcroft–Gault equation and are now specifically recommended by international guidelines. With their generalized use, however, it has become apparent that those equations are not infallible and that they fail to provide an accurate estimate of GFR in certain situations frequently encountered in clinical practice. After describing the processes that led to the development of the new GFR-estimating equations, this Review discusses the clinical situations in which the applicability of these equations is questioned. [less ▲]

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See detailCholecaciferol in haemodialysis patients: a randomized, double-blind, proof-of-concept and safety study
DELANAYE, Pierre ULg; WEEKERS, Laurent ULg; WARLING, Xavier et al

in Nephrology Dialysis Transplantation (2013), 28(7), 1779-1786

Background. The role of cholecalciferol supplementation in end-stage renal disease (ESRD) patients has been questioned. The objective of this randomized double-blinded study is to assess whether ... [more ▼]

Background. The role of cholecalciferol supplementation in end-stage renal disease (ESRD) patients has been questioned. The objective of this randomized double-blinded study is to assess whether cholecalciferol therapy can increase serum 25-hydroxyvitamin D [25(OH)D] levels in haemodialysed patients and the safety implications of this therapy on certain biological parameters and vascular calcifications score. Methods. Forty-three haemodialysis patients were randomized to receive placebo or cholecalciferol (25 000 IU) therapy every 2 weeks. The biological parameters, serum calcium, phosphorus, 25(OH)D and parathormone (PTH) levels, were monitored monthly for 12 consecutive months. Vascular calcifications were assessed by lateral X-ray radiography. Results. At baseline, the mean serum 25(OH)D levels were low and similar in both groups. Thirty patients (16 treated and 14 placebo) completed the study: 11 patients died (5 placebo and 6 treated), 1 patient dropped out and 1 patient was transplanted (both from the placebo group). After 1 year, the percentage of 25(OH)D deficient patients was significantly lower in the treated group. None of the patients developed hypercalcaemia. The PTH levels tended to increase over the study period under placebo and to decrease in the cholecalciferol group. The median changes in PTH levels from baseline to 1 year were statistically different between the two groups [+80 (−58 to 153) and −115 (−192 to 81) under placebo and cholecalciferol treatment, respectively, P = 0.02].The calcification scores increased equivalently in both groups (+2.3 per year). Conclusions. Cholecalciferol is effective and safe, and does not negatively affect calcium, phosphorus, PTH levels and vascular calcifications. Additional studies are needed to compare the impacts of nutritional and active vitamin D agents on vascular calcification and mortality. [less ▲]

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