Certification of creatinine in a human serum reference material by GC-MS and LC-MS

被引:72
作者
Dodder, Nathan G.
Tai, Susan S. -C.
Sniegoski, Lorna T.
Zhang, Nien F.
Welch, Michael J.
机构
[1] NIST, Gaithersburg, MD 20899 USA
[2] NIST, Div Analyt Chem, Gaithersburg, MD 20899 USA
[3] NIST, Stat Engn Div, Gaithersburg, MD 20899 USA
关键词
D O I
10.1373/clinchem.2007.090027
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
Background: To meet recommendations given by the Laboratory Working Group of the National Kidney Disease Education Program for improving serum creatinine measurements, NIST developed standard reference material (SRM) 967 Creatinine in Frozen Human Serum. SRM 967 is intended for use by laboratories and in vitro diagnostic equipment manufacturers for the calibration and evaluation of routine clinical methods. Methods: The SRM was produced from 2 serum pools with different creatinine concentrations. The concentrations were certified using a higher-order isotope-dilution GC-MS method and an isotope-dilution LC-MS method. The LC-MS method is a potential higher-order reference measurement procedure. Results: The GC-MS mean (CV) concentrations were 67.0 (0.9%) mu mol/L for serum pool 1 and 346.1 (0.4 %) mu mol/L for serum pool 2. The LC-MS results were 66.1 (0.2%) mu mol/L and 346.1 (0.2%) mu mol/L, respectively. For serum pool 1, there was a 1.4% difference between the mean GC-MS and LC-MS measurements, and a 0.10% difference for serum pool 2. The results from the 2 methods were combined to give the certified concentrations and expanded uncertainties. Conclusions: The certified concentration (expanded uncertainty) of SRM 967 Was 66.5 (1.8) mu mol/L, for serum pool I (a value close to the diagnostically important concentration of 88.4 mu mol/L) and 346.2 (7.4) mu mol/L for serum pool 2 (a concentration corresponding to that expected in a patient with chronic kidney disease). (c) 2007 American Association for Clinical Chemistry
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页码:1694 / 1699
页数:6
相关论文
共 22 条
[1]  
[Anonymous], [No title captured]
[2]  
Clinical and Laboratory Standards Institute (CLSI), 2005, EP14A2 CLSI, V2nd
[3]  
*CLSI, C37A CLSI
[4]  
COHEN A, 1980, CLIN CHEM, V26, P854
[5]   An application of combining results from multiple methods - statistical evaluation of uncertainty for NIST SRM 1508a [J].
Hornikova, A ;
Zhang, NF ;
Welch, MJ ;
Tai, S .
METROLOGIA, 2006, 43 (03) :205-212
[6]  
*I REF MAT MEAS, 2005, CERT AN BCR 573 BCR
[7]  
*JOINT COMM TRAC L, 2006, DAT HIGH ORD REF MAT
[8]  
*LAB GOV CHEM, 2007, CERT AN ERM ED252A E
[9]  
LIU HK, 2001, AM STAT ASS M ATL GA
[10]   Recommendations for improving serum creatinine measurement: A report from the laboratory working group of the National Kidney Disease Education Program [J].
Myers, GL ;
Miller, WG ;
Coresh, J ;
Fleming, J ;
Greenberg, N ;
Greene, T ;
Hostetter, T ;
Levey, AS ;
Panteghini, M ;
Welch, M ;
Eckfeldt, JH .
CLINICAL CHEMISTRY, 2006, 52 (01) :5-18