Trueness investigation of routine creatinine assays on nine homogeneous systems in Beijing demonstrates an encouraging outcome that meets clinical requirements

作     者：LIU Yan XU Guo-bin 

作者机构：Department of Clinical Laboratory Peking University First Hospital Beijing 100034 China 

出 版 物：《Chinese Medical Journal》 (中华医学杂志（英文版）)

年 卷 期：2010年第123卷第17期

页      面：2364-2369页

核心收录：

学科分类：0831[工学-生物医学工程（可授工学、理学、医学学位）] 1004[医学-公共卫生与预防医学(可授医学、理学学位)] 07[理学] 08[工学] 0702[理学-物理学] 10[医学] 

基　　金：Ministry of Science and Technology of China [2006AA020909] 

主　　题：creatinine glomerular filtration rate standardization 

摘      要：Background Serum creatinine （Scr） measurement plays a key role in glomerular filtration rate estimation （eGFR）,chronic kidney disease （CKD） diagnosis as well as CKD treatment. However, the test results of Scr from different laboratories vary significantly. In order to get comparable results, the European in vitro diagnostic （IVD） directive requires traceability to reference methods and materials. The purpose of this study was to verify the effect of traceability implementation by investigating the trueness of creatinine measurement on nine homogenous systems in Beijing. Methods Commutable frozen human serum reference material, National Institute of Standards ＆ Technology （NIST） Standard Reference Material （SRM） 967, was used to verify the trueness of Scr measurement results from nine homogeneous analytical systems of seven companies which are the most widely used systems in Beijing＇s third-grade hospitals. The methods referred to the Jaffe＇s and Enzymatic methods. Results from nine routine measurement systems were assessed using two criteria： biological variability and Clinical Laboratory Improvement Amendments＇ 88 （CLIA＇ 88）.We simulated a series of broken lines representing the limits of SD and bias that would produce a relative increase （or decrease） of 10% and 20% in the measurement error when estimating GFR （MEeGFR） using the isotope dilution mass spectrometry （IDMS）-traceable Modification of Diet in Renal Disease （MDRD） Study equation. Results of the College of American Pathologists （CAP） 2008-B LN24 Survey were compared with our investigation results. Results Compared with the total error criteria of biological variability, Ortho （traceable to IDMS） met the minimum acceptable criteria; Roche （Jaffe）, Roche （Enzymatic）, Shino and Daiichi met the desirable criteria at level Ⅰ. At level Ⅱ, Ortho （traceable to gas chromatography/isotope dilution mass spectrometry, GC/IDMS）, Dade Behring and Beckman （traceable to rate Jaffe） met the minimum acceptable criteria; Ro