Variations observed for insulin concentrations in an interlaboratory quality control program may be due to interferences between reagents and the matrix of the control materials

被引:4
|
作者
Rigo, Raul Bonnin [1 ]
Panyella, Mariona Garcia [1 ]
Bartolome, Luis Roncero [1 ]
Ramos, Pedro Alia [1 ]
Soria, Pilar Rosel [1 ]
Navarro, Miguel-Angel Moreno [1 ]
机构
[1] Hosp Univ Bellvitge, IDIBELL, Dept Biochem, Hormone & Genet Sect, E-08097 Barcelona, Spain
关键词
immunoassay interferences; quality control programs; insulin; non-conformities UNE-EN-ISO 9001 : 2000;
D O I
10.1016/j.clinbiochem.2007.04.022
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
The present study was carried out to observe the behaviour of insulin concentrations in an interlaboratory quality control program from BioRad Laboratories (Irving, CA) applied to Immulite 2000 (Diagnostics Product Corporation, Los Angeles, CA) for three control materials of Lyphocheck Immumoassay, Plus Control. Insulin was measured for 261 consecutive working days in a year using a solid-phase immunometric chemiluminescent assay; likewise insulin was measured for 55 days during a period of 4 months in a pool of sera obtained from patients with insulin concentrations within the normal range of our laboratory. The results from each control material were classified in three groups according to the closeness among concentrations and time; mean concentrations were significantly different between consecutive groups for the three control materials (p<0.0001). However, no differences were observed in samples from pool sera. The variations observed in insulin concentrations of the control materials may be due to some interferences or matrix effect on the control material caused by the reagents to quantify insulin in the Inumilite 2000. (C) 2007 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.
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页码:1088 / 1091
页数:4
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