Nyssen Laurent, Delanaye Pierre, Le Goff Caroline, Peeters Stéphanie, Cavalier Étienne
Department of Clinical Chemistry, University of Liège, CHU Sart-Tilman, 4000 Liège, Belgium.
Department of Nephrology and Hypertension, University of Liège, CHU Sart-Tilman, 4000 Liège, Belgium.
Clin Chim Acta. 2016 Dec 1;463:96-102. doi: 10.1016/j.cca.2016.10.021. Epub 2016 Oct 15.
Chronic kidney disease (CKD) is diagnosed and explored through the determination of the glomerular filtration rate (GFR). Our goal was to develop a simple LC-MS method for the determination in serum of 2 popular GFR markers, contrast agents iohexol and iothalamate, for routine use and comparison studies between the two markers. A similar contrast agent, ioversol, was used as an internal standard and the method underwent a rigorous validation protocol based on β-expectation tolerance intervals.
We adapted the HPLC-UV method from Cavalier et al. to our LC-MS system. Data treatment for the validation was performed using Multiquant 3.0 (Sciex, Framingham, MA, USA) and e.noval 3.0 software (Arlenda, Liège, Belgium).
According to the validation results our method will give accurate and reliable results for concentrations ranging from 6.8 to 250μg/ml for iohexol and 6.15μg/ml to 250μg/ml for iothalamate. In our practice these intervals are sufficient to determine both compounds in most patient samples. Samples with higher detected concentrations can always be diluted into range.
With its internal standard and extensive validation, our method is now ready for routine and clinical research use.
慢性肾脏病（CKD）通过测定肾小球滤过率（GFR）来诊断和评估。我们的目标是开发一种简单的液相色谱-质谱（LC-MS）方法，用于血清中两种常用GFR标志物（造影剂碘海醇和碘他拉酸盐）的测定，以供常规使用以及这两种标志物之间的比较研究。一种类似的造影剂碘佛醇用作内标，该方法基于β-期望耐受区间进行了严格的验证方案。
我们将Cavalier等人的高效液相色谱-紫外（HPLC-UV）方法应用于我们的LC-MS系统。使用Multiquant 3.0（美国马萨诸塞州弗雷明汉市Sciex公司）和e.noval 3.0软件（比利时列日市Arlenda公司）进行验证的数据处理。
根据验证结果，我们的方法对于碘海醇浓度范围为6.8至250μg/ml以及碘他拉酸盐浓度范围为6.15μg/ml至250μg/ml时，将给出准确可靠的结果。在我们的实践中，这些区间足以测定大多数患者样本中的这两种化合物。检测到浓度较高的样本总是可以稀释至范围内。
凭借其内部标准和广泛的验证，我们的方法现已准备好用于常规和临床研究。
