Winkler M, Christians U, Baumann J, Gonschior A K, Wonigeit K, Pichlmayr R
Klinik für Abdominal- und Transplantationschirurgie, Medizinische Hochschule Hannover, Germany.
Ther Drug Monit. 1996 Dec;18(6):640-6. doi: 10.1097/00007691-199612000-00003.
In a prospective study, we evaluated a novel enzyme-linked immunosorbent assay (ELISA) (Pro-Trac) for determining tacrolimus (FK 506) concentrations in whole blood. Results obtained by the ELISA were compared with those obtained either by microparticle enzyme immunoassay (MEIA) or by high-performance liquid chromatography/mass spectrometry (HPLC-MS). The lower limit of quantitation of the ELISA was 0.5 microgram/L. The within-series coefficient of variation (CV) was < 11%. For spiked blood samples containing different concentrations of tacrolimus, interassay CV was 23.6% at 2.5 micrograms/L; however, at 15 and 60 micrograms/L, interassay CV was 44.9 and 50.8%, respectively. In crossover studies including blood samples from patients after liver, heart, or kidney transplantation, ELISA results correlated with those of the HPLC-MS (r = 0.73) as well as with those generated by MEIA (r = 0.82). The ELISA and MEIA showed 52.3 and 56.2% cross-reactivity with 15-O-demethyltacrolimus, respectively, but only 5.0 and 5.4% cross-reactivity with 13-O-demethyltacrolimus. We conclude that if assay precision in the upper range is improved, the Pro-Trac ELISA might be a valuable alternative to the MEIA for therapeutic drug monitoring of tacrolimus.
在一项前瞻性研究中，我们评估了一种用于测定全血中他克莫司（FK 506）浓度的新型酶联免疫吸附测定法（ELISA）（Pro-Trac）。将ELISA法获得的结果与通过微粒酶免疫测定法（MEIA）或高效液相色谱/质谱法（HPLC-MS）获得的结果进行比较。ELISA法的定量下限为0.5微克/升。批内变异系数（CV）<11%。对于含有不同浓度他克莫司的加标血样，在2.5微克/升时批间CV为23.6%；然而，在15微克/升和60微克/升时，批间CV分别为44.9%和50.8%。在包括肝、心或肾移植患者血样的交叉研究中，ELISA结果与HPLC-MS结果相关（r = 0.73），也与MEIA结果相关（r = 0.82）。ELISA和MEIA对15-O-去甲基他克莫司的交叉反应率分别为52.3%和56.2%，但对13-O-去甲基他克莫司的交叉反应率仅为5.0%和5.4%。我们得出结论，如果提高上限范围内的检测精密度，Pro-Trac ELISA可能是他克莫司治疗药物监测中MEIA的一种有价值的替代方法。
