Freire Antonio, Hermida Jesús, Tutor J Carlos
Unidad Monitorización Fármacos, Laboratorio Central, Hospital Clínico Universitario, 15706 Santiago de Compostela, Spain.
Ups J Med Sci. 2008;113(1):103-10. doi: 10.3109/2000-1967-220.
Published data on the performance of the new Dade Behring antibody conjugated magnetic immunoassay (ACMIA) for tacrolimus determination are scarce. The aim of this study was to compare the results obtained using the ACMIA and Abbott microparticle enzyme immunoassay (MEIA), which is the most widely used method for therapeutic tacrolimus monitoring.
Trough tacrolimus concentrations were determined in 305 blood samples from kidney (n=138) and liver (n=167) transplant recipients using the ACMIA and MEIA immunoassays. The MEIA results were corrected for hematocrit values lesser than 30% and higher than 40% (Hermida et al. Clin Lab 2005; 51: 43-45).
The obtained ACMIA within- and between-run variation coefficients (<10.8%) were acceptable. In the comparison between ACMIA and MEIA results in the blood samples studied, the regression equation was: ACMIA=1.02MEIA+0.29 (r=0.912, p<0.001), with an acceptable difference between the means (8.13+/-0.53 ng/mL vs. 7.62+/-0.50 ng/mL). However, in accordance with the well-established interference of the hematocrit on the MEIA results, a highly significant negative correlation between the MEIA/ACMIA ratio and the hematocrit values was obtained (r=-0.585, p<0.001). When the MEIA results were corrected according to the hematocrit (MEIAHtC), the regression with ACMIA levels was: ACMIA=1.08MEIAHtC-0.09 (r=0.926, p<0.001). This equation was analogous to that obtained between ACMIA and MEIA tacrolimus concentrations in the 164 blood samples with hematocrit of 30-40%.
ACMIA is an acceptable option for therapeutic tacrolimus monitoring, with an important decrease in technician time in relation to the widely used MEIA.
关于新型达德拜林抗体结合磁免疫分析(ACMIA)用于测定他克莫司的性能的已发表数据很少。本研究的目的是比较使用ACMIA和雅培微粒酶免疫分析(MEIA)获得的结果,MEIA是治疗性他克莫司监测中使用最广泛的方法。
使用ACMIA和MEIA免疫分析法测定了305份来自肾移植受者(n = 138)和肝移植受者(n = 167)的血样中的他克莫司谷浓度。对低于30%和高于40%的血细胞比容值的MEIA结果进行了校正(Hermida等人,临床实验室,2005年;51:43 - 45)。
获得的ACMIA批内和批间变异系数(<10.8%)是可接受的。在所研究的血样中ACMIA和MEIA结果的比较中,回归方程为:ACMIA = 1.02MEIA + 0.29(r = 0.912,p < 0.001),均值之间的差异可接受(8.13±0.53 ng/mL对7.