Evaluation of the EMIT Mycophenolic Acid Assay from Dade Behring

被引:29
作者
Vogl, M
Weigel, G
Seebacher, G
Griesmacher, A
Laufer, G
Müller, MM
机构
[1] Ludwig Boltzmann Inst Cardiosurg Res, Vienna, Austria
[2] Univ Vienna, Dept Cardiothorac Surg, Vienna, Austria
关键词
Mycophenolic Acid Assay; heart transplant recipients; Emit; HPLC;
D O I
10.1097/00007691-199912000-00010
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 Emit Mycophenolic Acid Assay, a new homogeneous enzyme immunoassay far the quantitative analysis of mycophenolic acid (MPA) in human plasma, was evaluated and compared to a high-performance liquid chromatography (HPLC) method. Coefficients of variation (CV) of the within-run imprecision (n = 10) varied from 2.5% to 4.4% and from 1.3% to 4.9% for the Emit and the HPLC, respectively. The CV's of between-day imprecision (n = 10) ranged from 7.9% to 10.8% for the Emit and from 4.7% to 12.1% for the HPLC. Mean recoveries were 95.6% and 100.1% for Emit and HPLC, respectively. Serial dilution of a patient pool demonstrated a linear relationship between expected (x) and measured (y) concentrations: Emit, y = 0.998x + 0.086; HPLC, y = 1.006x - 0.016. The detection limit and the lower limit of quantification were 0.087 mg/L and 0.20 mg/L for Emit. The detection limit for HPLC was 0.08 mg/L using a signal-to-noise ratio of three. Sample stability under various storage conditions was satisfactory, although storage at -20 degrees C is recommended for storage longer than one day. No cross-reactivity from the major metabolite mycophenolic acid glucuronide (MPAG) was found. A correlation study on 261 patient samples yielded the following regression equation (bivariate Deming procedure): Emit = 1.012HPLC + 0.244, r = 0.970.
引用
收藏
页码:638 / 643
页数:6
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