Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Haute Autorité de Santé. Évaluation du débit de filtration glomérulaire, et du dosage de la créatininémie dans le diagnostic de la maladie rénale chronique chez l'adulte
. [Assessment of glomerular filtration rate and serum creatinine levels in the diagnosis of chronic kidney disease in adults]
. Paris: Haute Autorité de Santé (HAS). 2011 Authors' objectives - To assess the performance of three equations for estimation of GFR: CG, MDRD, CK-DEPI. The equation showing the least bias, best precision and best accuracy compared to the GFR measured by exogenous marker was considered the most useful.
- To assess the analytical performance of methods for measurement of serum creatinine concentrations, compared with a reference method: isotopic dilution mass spectrometry. The analysis was not performed in analyser / reagent pairs but by Jaffé or enzymatic assay methods.
Authors' conclusions Estimation of GFR -
The results in terms of accuracy, a concept that reflects both bias and precision, support the use of the CKD-EPI equation. Statistically significant results were given by a single study in the general population and for GFR> 60 mL/min/1.73m² where P30 accuracy was 84.7% (83.0 to 86.3) for MDRD and 88% (from 86.9 to 89.7) for CKD-EPI.
From the point of view of accuracy, the CKD-EPI equation is superior to the other two equations for screening and monitoring CKD in an adult population, and should be preferred.
Determination of serum creatinine -
The reliability of the enzymatic methods was always better than that of the Jaffé methods:
CV <4% versus CV> 5% for serum creatinine levels less than 80 mmol/L, CV <3.5% versus CV >4.5% for serum creatinine concentration around 150 mmol/L and CV <3% versus CV >4% for serum creatinine concentration around 305 mmol/L.
The analytical performance of the enzymatic methods appeared to be superior to that of the Jaffé methods at low and normal creatinine levels. This superiority decreased as the creatinine concentration increased. The data identified in the literature did not specify the serum creatinine level at which the differences in analytical performance were narrow enough to permit the use of both methods equally without any clinical impact. INAHTA brief and checklist Indexing Status Subject indexing assigned by CRD MeSH Adult; Creatinine; Glomerular Filtration Rate; Humans; Kidney Function Tests; Renal Insufficiency, Chronic Country of organisation France English summary An English language summary is available. Address for correspondence French National Authority for Health, 2, avenue du Stade de France, Saint-Denis La Plaine, FR-93218 Paris France
Tel: +33 1 55 937188 Email: international.affairs@has-sante.fr AccessionNumber 32016000261 Date abstract record published 10/02/2016 |