Prime Time for Enzymatic Creatinine Methods in Pediatrics

Cobbaert, Christa; Baadenhuijsen, H.; Weykamp, Cas

doi:10.1373/clinchem.2008.116863

Cited by 88 publications

(72 citation statements)

References 18 publications

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“…However, we have no proof that precision and calibration are linear and performing well between 0 and 36 μmol/L. These low values are however only important in pediatrics [10]. As previously shown, we confirm that precision (random error measurement) of enzymatic methods is high for most of the methods.…”

Section: Discussionmentioning

confidence: 42%

“…Indeed, analytical performances of the enzymatic creatinine measurement are clearly better than for the classical Jaffe methods [10,11]. Interferences such as bilirubin or hemolysis also seem less important with enzymatic methods, as it has been elegantly shown by Cobbaert [10]. According to these previous data, we have focused our work on these enzymatic methods.…”

Section: Discussionmentioning

confidence: 93%

“…This fact is especially relevant in enzymatic methods because the random measurement error is low with these methods [6]. Indeed, analytical performances of the enzymatic creatinine measurement are clearly better than for the classical Jaffe methods [10,11]. Interferences such as bilirubin or hemolysis also seem less important with enzymatic methods, as it has been elegantly shown by Cobbaert [10].…”

Section: Discussionmentioning

confidence: 99%

“…However, the use of these assays is not accurate on an individual patient basis because of the variability of these chromogens. The evaluation of GFR with such methods in everyday practice for children, elderly patients, pregnant women, cancer or anorectic patients who have low creatinine concentrations could lead to a huge overestimation of renal function [10,11]. Furthermore, the measurement of creatinine in urinary samples, which contain no non-creatinine chromogens, does not need a compensation of the calibration.…”

Section: Introductionmentioning

confidence: 99%

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A multicentric evaluation of IDMS-traceable creatinine enzymatic assays

Piéroni

Delanaye

Boutten³

et al. 2011

Clinica Chimica Acta

106

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Chronic kidney disease definition is based on glomerular filtration rate (GFR) estimations which are derived from creatinine-based equations. The accuracy of GFR estimation is thus largely dependent of those of serum creatinine assays. International recommendations highlight the need for traceable creatinine assays. The French Society of Clinical Biochemistry conducted a study for measuring accuracy of creatinine enzymatic methods. This evaluation involved 25 clinical laboratories. Creatinine was measured in serum pools ranging from 35.9 ± 0.9 μmol/L to 174.5 ± 3.1 μmol/L (IDMS determination) using 12 creatinine enzymatic methods. For all creatinine values greater than 74.4 ± 1.4 μmol/L, the bias and imprecision did not exceed 5% and 5.9%, respectively. For the lowest value (35.9 ± 0.9 μmol/L), the bias ranged from −1.8 to 9.9% (with one exception). At this level, the imprecision ranged from 1.9 to 7.8%. The true performances of the assays (couples of bias and relative standard deviation), were evaluated using Monte-Carlo simulations. Most of the assays fall within the maximum Total Error of 12% at all concentrations. This study demonstrates substantial improvements in the calibration, traceability and precision of the enzymatic methods, reaching the NKDEP recommendations. Moreover, most of these assays allowed accurate creatinine measurements for creatinine levels lower than 40 μmol/L.

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Section: Discussionmentioning

confidence: 42%

Section: Discussionmentioning

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

A multicentric evaluation of IDMS-traceable creatinine enzymatic assays

Piéroni

Delanaye

Boutten³

et al. 2011

Clinica Chimica Acta

106

View full text Add to dashboard Cite

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“…There were six analytes for which the minimum quality specifications are not met and manufacturers should strive to improve their performance for these analytes. Standardization of enzyme methods towards IFCC Figure 2 shows improvements reached in analytical performance in the Netherlands for enzymes, creatinine and other analytes after running the type 1 EQA-program for 5 years [44,58]. Additional challenges were demonstrated when lipemic sera were used for testing lipid methodology [59] or high glucose sera in creatinine analysis [60].…”

Section: General Chemistrymentioning

confidence: 99%

The quest for equivalence of test results: the pilgrimage of the Dutch Calibration 2.000 program for metrological traceability

Jansen

Cobbaert

Weykamp

et al. 2018

Clinical Chemistry and Laboratory Medicine (CCLM)

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Calibration 2.000 was initiated 20 years ago for standardization and harmonization of medical tests. The program also intended to evaluate adequate implementation of the In Vitro Diagnostics (IVD) 98/79/EC directive, in order to ensure that medical tests are fit-for-clinical purpose. The Calibration 2.000 initiative led to ongoing verification of test standardization and harmonization in the Netherlands using commutable external quality assessment (EQA)-tools and a type 1 EQA-design, where feasible. National support was guaranteed by involving all laboratory professionals as well as laboratory technicians responsible for EQA and quality officers. A category 1 EQA-system for general chemistry analytes, harmonizers for specific analytes like hGH and IGF-1, and commutable materials for other EQA-sections have been developed and structurally introduced in the EQA-schemes. The type 1 EQA-design facilitates the dialogue between individual specialists in laboratory medicine and the IVD-industry to reduce lot-to-lot variation and to improve standardization. In such a way, Calibration 2.000 sheds light on the metrological traceability challenges that we are facing and helps the laboratory community to get the issues on the table and resolved. The need for commutable trueness verifiers and/or harmonizers for other medical tests is now seen as paramount. Much knowledge is present in the Netherlands and for general chemistry, humoral immunology and protein chemistry, a few endocrinology tests, and various therapeutic drug monitoring (TDM) tests, commutable materials are available. Also the multi sample evaluation scoring system (MUSE) and the category 1 EQA-design offer many possibilities for permanent education of laboratory professionals to further improve the between and within laboratory variation and the test equivalence.

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Time to Rethink the Current Paradigm for Assessing Kidney Function in Drug Development and Beyond

Sharma

Sahasrabudhe

Musib

et al. 2021

Clin Pharma and Therapeutics

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Chronic kidney disease (CKD) is an important health issue that affects ~ 9.1% of the world adult population. Serum creatinine is the most commonly used biomarker for assessing kidney function and is utilized in different equations for estimating creatinine clearance or glomerular filtration rate (GFR). The Cockcroft–Gault formula for adults and “original” Schwartz formula for children have been the most commonly used equations for estimating kidney function during the last 3–4 decades. Introduction of standardized serum creatinine bioanalytical methodology has reduced interlaboratory variability but is not intended to be used with Cockcroft–Gault or original Schwartz equations. More accurate equations (for instance, Chronic Kidney Disease Epidemiology Collaboration (CKD‐EPI) for adults and bedside Schwartz or Chronic Kidney Disease in Children Schwartz equation for children) based on standardized serum creatinine values (and another biomarker—cystatin C) have been introduced and validated in recent years. Recently, the CKD‐EPI equation refitted without a race variable was introduced. Clinical practice guidance in nephrology advocates a shift to these equations for managing health care of patients with CKD. The guidance also recommends use of albuminuria in addition to GFR for CKD diagnosis and management. Significant research with large data sets would be necessary to evaluate whether this paradigm would also be valuable in drug dose adjustments. This article attempts to highlight some important advancements in the field from a clinical pharmacology perspective and is a call to action to industry, regulators, and academia to rethink the current paradigm for assessing kidney function to enable dose recommendation in patients with CKD.

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Prime Time for Enzymatic Creatinine Methods in Pediatrics

Abstract: BACKGROUND:The literature regarding the nonspecificity of applications of the Jaffe (alkaline picrate) reaction for creatinine is generally outdated. We conducted a specificity study to update the nonspecificity information for current Jaffe and enzymatic creatinine assays.

Cited by 88 publications

References 18 publications

A multicentric evaluation of IDMS-traceable creatinine enzymatic assays

A multicentric evaluation of IDMS-traceable creatinine enzymatic assays

The quest for equivalence of test results: the pilgrimage of the Dutch Calibration 2.000 program for metrological traceability

Time to Rethink the Current Paradigm for Assessing Kidney Function in Drug Development and Beyond

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