IMx tacrolimus II assay: is it reliable at low blood concentrations? A comparison with tandem MS/MS
IMx tacrolimus II assay: is it reliable at low blood concentrations? A comparison with tandem MS/MS
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DOI：
10.1016/s0009-9120(02)00338-7
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发表时间：
2002-07-01
影响因子：
2.8
通讯作者：
Soldin, SJ
中科院分区：
文献类型：
--
作者：
Ghoshal, AK;Soldin, SJ
目的：在临床相关范围的低端和高端，比较微粒子酶免疫分析（MEIA）11法和质谱（MS）法测定血液样本中他克莫司浓度。
方法：通过回归分析和差异图分析，将MEIA 11法与我们的串联质谱/质谱（MS/MS）法进行比较。还分析了近期发表的美国病理学家协会（CAP）调查中有关MEIA 11法与MS法比较的数据。
结果：通过回归分析将MEIA 11法与我们的串联MS/MS法进行比较，对于MEIA II测定的他克莫司浓度低于和高于9.0 ng/mL时，相关系数r值分别为0.612和0.829。在低于9 ng/mL时，他克莫司质控品的日间不精密度，MEIA II的变异系数（CV）为12.16，串联MS/MS为7.82。向乙二胺四乙酸（EDTA）全血中加入已知量的他克莫司，MEIA II测定浓度为5.0和17.5 ng/mL时，目标值百分比分别为148和130。差异图显示，在低浓度和高浓度范围，MEIA II的平均偏差分别为43%和36%，存在变异性。对CAP调查的分析表明，当MEIA 11的中位值低于9.0 ng/mL时，MEIA 11的相对正偏差和实验室间变异性更为显著。
结论：我们的结果以及CAP调查数据表明，MEIA 11测定的低于9.0 ng/mL的他克莫司浓度是有问题的，应谨慎解读。（C）2002加拿大临床化学家协会。保留所有权利。
Objectives: To compare tacrolimus concentrations in blood samples using the MEIA 11 and MS methods at the lower and higher ends of the clinically relevant range.Methods: MEIA 11 was compared to our tandem MS/MS procedure by regression and difference plot analysis. Data from recently published CAP surveys comparing MEIA 11 with MS procedures are also analyzed.Results: Comparison of MEIA 11 with our tandem MS/MS procedure by regression analysis yielded r values of 0.612 and 0.829 for tacrolimus concentrations below and above 9.0 ng/mL respectively, as determined by MEIA II. Below 9 ng/mL between day imprecision of tacrolimus controls gave CVs of 12.16 for MEIA II and 7.82 for tandem MS/MS. Addition of known amounts of tacrolimus to EDTA whole blood gave percent target values of 148 and 130 at concentrations of 5.0 and 17.5 ng/mL respectively as determined by MEIA II. Difference plots demonstrated variability in the mean bias for MEIA II of 43% and 36% at the lower and higher concentration ranges respectively. Analysis of the CAP surveys suggested that the relative positive bias and inter-laboratory variability with MEIA 11 was more pronounced when the MEIA 11 median value was below 9.0 ng/mL.Conclusions: Our results along with the CAP survey data suggest that tacrolimus concentrations below 9.0 ng/mL measured by MEIA 11 are questionable and should be interpreted with caution. (C) 2002 The Canadian Society of Clinical Chemists. All rights reserved.