用于常规临床实践中同时测定血清 Co 和 Cr 的简单而稳健的 ICP-MS 方法。
Simple and robust ICP-MS method for simultaneous determination of serum Co and Cr in routine clinical practice.
机构信息
Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea; Department of Laboratory Medicine, Chonnam National University Medical School and Chonnam National University Hospital, Gwanju, Korea.
Department of Orthopedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
出版信息
Clin Chim Acta. 2015 Jan 15;439:91-6. doi: 10.1016/j.cca.2014.09.019. Epub 2014 Sep 30.
BACKGROUND
Chromium (Cr) and cobalt (Co) metal ions released from orthopedic prostheses, such as metal-on-metal (MoM) bearings, may be related to wear of the bearing surface. These ions may serve as indicators of the in vivo performance of MoM bearing surfaces. We developed a simple and sensitive assay suitable for the simultaneous measurement of serum Cr and Co using inductively coupled plasma-mass spectrometry (ICP-MS) in clinical routine laboratory practice to evaluate analytical performance and clinical utility.
METHODS
We evaluated the linearity, precision, and lower limit of quantification (LOQ) of an ICP-MS method to determine serum Cr and Co concentration in accordance with U.S. Food and Drug Administration guidance for bioanalytical method validation. This method was used to determine the serum Cr and Co levels of 236 clinical samples from 74 patients with MoM hip prosthesis and 51 healthy controls.
RESULTS
The assay showed good linearity (0-20 μg/l, r(2)>0.999) and satisfactory accuracy for all tested concentrations of Cr and Co (%bias, -1.5% to 2.5%, -3.3% to 1.6%, respectively). The CVs for both metal ions were <10% for LOQ (0.02 μg/l Cr, 0.01 μg/l Co) and within 5% for other concentrations (intra- and inter-assay CV, 1.2-2.6 and 1.9-4.4% of Cr; 1.4-2.7 and 1.9-4.7% of Co). The serum Cr and Co concentrations (mean ± SD) were 0.60 ± 0.12 μg/l and 0.29 ± 0.15 μg/l in 51 healthy subjects. In 74 patients (185 serum samples) after HRA (median duration implanted, 48 months; range, 1-138 months), the concentrations of Cr and Co were 2.75 μg/l (range, 0.61-116.80 μg/l) and 1.49 μg/l (range, 0.12-127.80 μg/l), respectively.
CONCLUSIONS
ICP-MS can simultaneously quantify serum Cr and Co levels with suitable analytical performance including a wide analytical range and very low LOQ. This assay will be very useful for evaluating the nutritional status of Cr and Co in healthy humans as well as monitoring the performance of orthopedic prostheses after hip resurfacing arthroplasty.
背景
骨科假体（如金属对金属（MoM）轴承）释放的铬（Cr）和钴（Co）金属离子可能与轴承表面的磨损有关。这些离子可以作为 MoM 轴承表面体内性能的指标。我们开发了一种简单灵敏的测定方法，适用于临床常规实验室实践中使用电感耦合等离子体质谱法（ICP-MS）同时测量血清 Cr 和 Co，以评估分析性能和临床实用性。
方法
我们根据美国食品和药物管理局（FDA）生物分析方法验证指南，评估了 ICP-MS 方法测定血清 Cr 和 Co 浓度的线性、精密度和定量下限（LOQ）。该方法用于测定 74 例 MoM 髋关节假体患者和 51 例健康对照者的 236 例临床样本的血清 Cr 和 Co 水平。
结果
该测定法显示出良好的线性（0-20μg/l，r（2）>0.999），对所有测试浓度的 Cr 和 Co 均具有令人满意的准确性（%偏差，-1.5%至 2.5%，-3.3%至 1.6%）。两种金属离子的 LOQ（0.02μg/l Cr，0.01μg/l Co）的 CV 均<10%，其他浓度的 CV 均<5%（日内和日间 CV，Cr 为 1.2-2.6%和 1.9-4.4%；Co 为 1.4-2.7%和 1.9-4.7%）。51 例健康受试者的血清 Cr 和 Co 浓度（平均值±SD）分别为 0.60±0.12μg/l 和 0.29±0.15μg/l。在 74 例患者（185 份血清样本）接受髋关节表面置换术（植入中位数时间，48 个月；范围，1-138 个月）后，Cr 和 Co 的浓度分别为 2.75μg/l（范围，0.61-116.80μg/l）和 1.49μg/l（范围，0.12-127.80μg/l）。
结论
ICP-MS 可以同时定量血清 Cr 和 Co 水平，具有合适的分析性能，包括宽的分析范围和非常低的 LOQ。该测定法将非常有助于评估健康人群中 Cr 和 Co 的营养状况，以及监测髋关节表面置换术后骨科假体的性能。
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