高效液相色谱法与单克隆荧光偏振免疫分析法在肝移植和心脏移植患者全血环孢素A测定中的比较

Comparison of high-performance liquid chromatography and monoclonal fluorescence polarization immunoassay for the determination of whole-blood cyclosporin A in liver and heart transplant patients.

作者信息

Taylor P J, Salm P, Norris R L, Ravenscroft P J, Pond S M

机构信息

Department of Clinical Pharmacology, Princess Alexandra Hospital, Woolloongabba, Australia.

出版信息

Ther Drug Monit. 1994 Oct;16(5):526-30. doi: 10.1097/00007691-199410000-00015.

DOI:10.1097/00007691-199410000-00015

PMID:7846754

Abstract

Conflicting conclusions have been drawn from comparisons of high-performance liquid chromatography (HPLC) and the Abbott Diagnostics monoclonal fluorescence polarization immunoassay (mFPIA) for cyclosporin. The aim of this study was to compare whole blood cyclosporin A (CsA) concentrations measured by both mFPIA and HPLC in liver and heart transplant patients. One hundred and twenty-four liver and 62 heart transplant patient samples were assayed by both methods. Assay imprecision for both methods during the studies was < 7% over the range 150-800 micrograms/L. At an HPLC-determined concentration of 100 micrograms/L, mFPIA overestimated CsA by 60% (liver) and 77% (heart). At 300 micrograms/L, the overestimation was 40% (liver) and 45% (heart). On this basis, the mFPIA is not interchangeable with HPLC.

摘要

关于高效液相色谱法（HPLC）和雅培诊断公司的环孢素单克隆荧光偏振免疫分析法（mFPIA）的比较，已经得出了相互矛盾的结论。本研究的目的是比较肝移植和心脏移植患者中通过mFPIA和HPLC测得的全血环孢素A（CsA）浓度。采用这两种方法对124份肝移植患者样本和62份心脏移植患者样本进行了检测。在研究期间，两种方法在150 - 800微克/升范围内的检测不精密度均< 7%。在HPLC测定浓度为100微克/升时，mFPIA对CsA的高估在肝移植患者中为60%，在心脏移植患者中为77%。在300微克/升时，高估分别为40%（肝移植）和45%（心脏移植）。在此基础上，mFPIA与HPLC不可互换。