McBride J H, Kim S, Rodgerson D O, Reyes A
Department of Pathology and Laboratory Medicine, UCLA School of Medicine, Los Angeles, California 90095-1732, USA.
J Clin Lab Anal. 1998;12(6):337-42. doi: 10.1002/(sici)1098-2825(1998)12:6<337::aid-jcla2>3.0.co;2-d.
In an effort to replace HPLC and FPIA (polyclonal) for whole blood determination of Cyclosporin A (CsA), this study examined the application of FPIA (monoclonal) in patients post cardiac and liver transplantation. The assay had a minimum detectable dose of 15 microg/L, an overall recovery of 97% and was linear to 1200 microg/L, and gave inter-assay precision values of < 5% (CV). On comparing FPIA (monoclonal) and HPLC for 59 cardiac transplant recipient blood samples, a correlation of FPIA (monoclonal) = 1.30 (HPLC) + 36.34, r = 0.96 was obtained. With liver transplant samples (n = 348), the correlation was FPIA (monoclonal) = 1.21 (HPLC) + 42.15, r = 0.98. Correlation on 131 cardiac transplant recipients gave FPIA (monoclonal) = 0.31 FPIA (polyclonal) + 43.97, r = 0.68. It is concluded that when converting from HPLC to FPIA (monoclonal) a positive bias of 21%-30% is observed, and in replacing FPIA (polyclonal) with FPIA (monoclonal), a negative bias of 50%-69% is seen with liver and cardiac patients respectively. These data indicate that therapeutic ranges should be re-established or adjustments in CsA dosing would be necessary.
为了替代高效液相色谱法（HPLC）和荧光偏振免疫分析法（FPIA，多克隆）用于全血中环孢素A（CsA）的测定，本研究检测了FPIA（单克隆）在心脏和肝脏移植术后患者中的应用。该检测方法的最低检测剂量为15μg/L，总回收率为97%，在1200μg/L范围内呈线性，批间精密度值<5%（变异系数）。对59份心脏移植受者血样的FPIA（单克隆）和HPLC进行比较，得到FPIA（单克隆）=1.30（HPLC）+36.34，r=0.96的相关性。对于肝移植样本（n=348），相关性为FPIA（单克隆）=1.21（HPLC）+42.15，r=0.98。对131名心脏移植受者的相关性分析得出FPIA（单克隆）=0.31 FPIA（多克隆）+43.97，r=0.68。得出的结论是，从HPLC转换为FPIA（单克隆）时，观察到21%-30%的正偏差，而用FPIA（单克隆）替代FPIA（多克隆）时，肝脏和心脏患者分别出现50%-69%的负偏差。这些数据表明，应重新确定治疗范围或有必要调整CsA剂量。
