背景:如果样品矩阵由可交换材料组成,则外部质量评估方案(EQAS)可以提供有关不同测量方法的准确性和可比性的重要信息。这项研究的目的是评估EQAS中使用的阿米替林和去甲替林材料的不同基质的可交换性。
方法:准备能力测试材料(PTM)和含有阿米替林和去甲替林的患者样本,收集,池化,并分发给参与的实验室进行分析。Low,两种药物在液体混合人体中的中等和高浓度,在这项研究中测试了冻干的人血清和冻干的牛血清。PTM结果与患者血清回归线的测量偏差通过将从官方EQAS中报告的结果得出的实验室内平均SD(SDwl)除以谷底来标准化。导致相对残差。可交换性判定极限设定为3SDwl。
结果:有10个实验室参与了这项研究,成立了45对实验室夫妇。所有矩阵类型都在可交换性决策极限之外提供了几个相对残差。与冻干的人和牛血清相比,液体人血清两种药物的相对残差的数量和大小均较低。
结论:用于阿米替林和去甲替林的PTM优选用人血清制备,尽管并不是所有的相对残差都在可交换性决策限制内。
BACKGROUND: External quality assessment schemes (EQAS) can provide important information regarding accuracy and comparability of different measurement methods if the sample matrices are composed of commutable material. The aim of this
study was to assess the commutability of different matrices for the material used in an EQAS for amitriptyline and nortriptyline.
METHODS: Proficiency testing material (PTM) and patient samples containing amitriptyline and nortriptyline were prepared, collected, pooled, and distributed to participating laboratories for analysis. Low, medium and high concentrations of both drugs in liquid pooled human, lyophilized human and lyophilized bovine serum were tested in this
study. The measurement deviation of the PTM results to the patient serum regression line were normalized by dividing trough the average within-laboratory SD (SDwl) derived from the results reported in the official EQAS, resulting in a relative residual. The commutability decision limit was set at 3 SDwl.
RESULTS: With 10 laboratories participating in this
study, 45 laboratory couples were formed. All matrix types delivered several relative residuals outside the commutability decision limit. The number and the magnitude of relative residuals for both drugs were lower for liquid human sera as compared to lyophilized human and bovine sera.
CONCLUSIONS: The PTM used for amitriptyline and nortriptyline is preferably prepared with human serum, although not all relative residuals are within the commutability decision limit.