CMIA、FPIA及MS在全血环孢霉素A浓度监测中的对比分析

目的通过荧光偏振免疫法(FPIA)、化学发光微粒子法(CMIA)和质谱法(MS)对全血环孢霉素A(CsA)谷浓度测定结果的比较,了解3种方法检测结果的差异,以便更加合理地选择CsA浓度监测方式。方法采集分离100例肾移植术后患者稳态浓度的血浆样品,以CMIA、FPIA以及MS法测定CsA浓度,并对3种方法测定结果进行统计分析。结果 FPIA的线性范围在0～800ng/ml,最低检测浓度为43.0ng/ml,而CMIA法测定的线性范围在0～1500ng/ml,最低检测浓度为24.1ng/ml;3种方法中,FPIA法和CMIA法的检测结果与和MS的相关系数r分别为0.96和0.97;FPIA和CMIA法的检测结果均高于MS(P<0.01),但相比FPIA法,CMIA的测定值明显更低,两组数据差异具有统计学意义(P<0.01);Bland-Alman一致性分析显示,CMIA法的测定结果较FPIA法普遍偏低,平均偏差为-76.5ng/ml。结论 CMIA相比FPIA法,灵敏度和特异度更高,是更为客观和理想的CsA血药浓度的检测方法,建议可推广入临床常规监测。

Comparison of FPIA, CMIA or MS for Monitoring Concentration of CsA in Human Whole Blood

Objective To compare fluorescence polarization immunoassay(FPIA),chemiluminescent microparticle immunoassay(CMIA) or mass spectrometry(MS) for detecting concentration of CsA in whole blood in order to choose a more rational way for clinical drug monitoring.Methods We collected 100 cases of steady-state plasma samples and tested concentration of CsA by FPIA,CMIA or MS,then processed the obtained data by statistical analysis.Results Linear detection range of FPIA was 0-800ng/ml and the minimum detectable concentration was 43.0ng/ml,and the linear range of CMIA method was 0-1500ng/ml,with minimum detectable concentration at 24.1ng/ml.Correlation coefficient between FPIA or CMIA and MS was 0.96 and 0.97,respectively.One-way ANOVA analysis showed results obtained from FPIA and CMIA were higher than those from MS,while there was still significant difference between FPIA and CIAM(P<0.01).Bland-Alman consistency analysis manifested CsA concentration tested by CMIA was generally lower,with an mean deviation of-76.5ng/ml.Conclusion Compared to FPIA,CMIA is more sensitive and specific,therefore is a more objective and desirable method for clinical drug monitoring of CsA.