Accuracy-based proficiency testing for testosterone measurements with immunoassays and liquid chromatography-mass spectrometry
Accuracy-based proficiency testing for testosterone measurements with immunoassays and liquid chromatography-mass spectrometry
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DOI：
10.1016/j.cca.2017.03.010
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发表时间：
2017-06-01
影响因子：
5
通讯作者：
Vesper, Hubert
中科院分区：
文献类型：
--
作者：
Cao, Zhimin (Tim);Botelho, Julianne Cook;Vesper, Hubert
背景：准确的睾酮测量是正确诊断和治疗患者所必需的。由于矩阵效应和使用非参考测量程序(RMP)定义的评估目标，使用修改后的样本进行测试的能力测试(PT)计划可能会受到限制。基于准确度的PT可以克服这种局限性，但缺乏关于基于准确度的PT的信息及其在睾酮测定评估中实施的可行性。方法：采用16种免疫分析方法和LC-MS/MS方法，对142个NYSDH认证的临床实验室采集的2名男性和2名女性成年供者的未经更改的单一供体人血清进行睾酮检测。结果：4个样本的睾酮靶浓度分别为15.5、30.0、402和498 ng/dl。4个样本的偏差分别为-17.8%~73.1%、3.1%~21.3%、-24.8%~8.6%、-22.1%~6.8%。采用+/-25.1%的总误差目标，这是使用最小允许偏差和不精确度计算的，73%的参与实验室的4个结果中有3个在这些范围内。结论：总睾酮测量的变异性可以影响临床决策。基于准确度的PT通过向实验室、化验制造商和标准化项目提供有关患者护理准确性的可靠数据，可以显著地促进睾酮测试的改进。(C)2017年，由爱思唯尔出版。
Background: Accurate testosterone measurements are needed to correctly diagnose and treat patients. Proficiency Testing (PT) programs using modified specimens for testing can be limited because of matrix effects and usage of non-reference measurement procedure (RMP)-defined targets for evaluation. Accuracy-based PT can overcome such limitations; however, there is a lack of information on accuracy-based PT and feasibility of its implementation in evaluation for testosterone measurements.Methods: Unaltered, single-donor human serum from 2 male and 2 female adult donors were analyzed for testosterone by 142 NYSDH-certified clinical laboratories using 16 immunoassays and LC-MS/MS methods. Testosterone target values were determined using an RMP.Results: The testosterone target concentrations for the 4 specimens were 15.5,30.0, 402 and 498 ng/dl. The biases ranged from -17.8% to 73.1%, 3.1% to 21.3%, -24.8% to 8.6%, and -22.1% to 6.8% for the 4 specimens, respectively. Using a total error target of +/- 25.1%, which was calculated using the minimum allowable bias and imprecision, 73% of participating laboratories had >= 3 of the 4 results within these limits.Conclusions: The variability in total testosterone measurements can affect clinical decisions. Accuracy-based PT can significantly contribute to improving testosterone testing by providing reliable data on accuracy in patient care to laboratories, assay manufacturers, and standardization programs. (C) 2017 Published by Elsevier B.V.