Multicenter comparison of first- and second-generation IMx tacrolimus microparticle enzyme immunoassays in liver and kidney transplantation

被引:8
作者
Brunet, M
Pou, L
Manzanares, C
Palacios, G
Corbella, J
机构
[1] Univ Barcelona, Hosp Clin, Toxicol Serv, E-08036 Barcelona, Spain
[2] Hosp Gen Univ Valle Hebron, Serv Biochem, Madrid, Spain
[3] Hosp 12 Octubre, Serv Biochem, E-28041 Madrid, Spain
[4] Abbott Cient, Dept Sci, Madrid, Spain
关键词
tacrolimus; levels; sensitivity; therapeutic monitoring;
D O I
10.1097/00007691-199812000-00017
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
Tacrolimus is a potent immunosuppressive drug successfully used for baseline and rescue immunosuppression in patients after liver and kidney transplantation. Data from several clinical trials have demonstrated the efficacy of tacrolimus in the prevention of allograft rejection, even at lower concentrations in the therapeutic range (5-15 mu g/L). In fact, some patients with tacrolimus levels at less than 5 mu g/L have excellent hepatic or kidney function. The limit of detection of the IMx Tacrolimus I assay (TAC I; Abbott Laboratories, IL) is only 5 mu g/L and that of the lower tacrolimus calibrator is 10 mu g/L. The second-generation assay uses the same monoclonal antibody and the same IMx technology but offers improved sensitivity, with a dynamic range from 0 mu g/L to 30 mu g/L (lower calibrator, 3 mu g/L). The aim of this multicenter study was to evaluate the new IMx Tacrolimus II assay (TAC II) by assessing its precision, sensitivity, performance, and correlation degree relative to the IMx TAC I assay. The study was performed at three centers in Spain. The within-run coefficients of variation (CVs) obtained for the new assay, using each of the trilevel controls in replicates of 20 during 3 consecutive days, were 8.06%, 4.38% and 5.09% at 5 mu g/L, 11 mu g/L, and 22 mu g/L, respectively. The corresponding between-run CVs obtained measuring each of the three controls in duplicate on 10 consecutive days were 9.54%, 6.38% and 5.75%. The limit of detection, with 97.5% confidence, was 1.22 mu g/L. TAC II results (Y) were compared with those from the original TAC I assay (X) analyzing 293 whole blood samples from liver (n = 145) and kidney (n = 148) transplant recipients. The correlation study with patient samples (using the Passing-Bablock method) was y = 1.056, x + 0.017, r = 0.927. No statistically significant differences were observed between assays (TAC I versus TAC Il) in the mean values obtained far total patients (9.89 +/- 5.42 mu g/L versus 10.49 +/- 5.63 mu g/L), liver patients (9.16 +/- 4.79 mu g/L versus 10.00 +/- 5.20 mu g/L), and kidney patients (10.62 +/- 5.87 mu g/L versus 10.98 +/- 5.99 mu g/L). The new IMx TAC II assay demonstrated the same precision and accuracy that characterized the original assay but showed improved sensitivity to the demands of tacrolimus monitoring in the lower therapeutic range of drug concentrations.
引用
收藏
页码:676 / 679
页数:4
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