荧光偏振免疫法检测血浆同型半胱氨酸水平的临床评价  

Analytical evaluation of FPIA assay for plasma homocysteine

作　　者：鄢盛恺[1] 宋耀虹[1] 张春玲[2] 方理刚[3] 朱文玲[3] 林其燧[1] 惠汝太 

机构地区：[1]中国医学科学院中国协和医科大学北京协和医院检验科,北京100730 [2]中国医学科学院中国协和医科大学北京协和医院阜外医院 [3]中国医学科学院中国协和医科大学北京协和医院心内科,北京100730

出　　处：《中华检验医学杂志》2001年第1期12-15,共4页Chinese Journal of Laboratory Medicine

基　　金：中国医学科学院北京协和医院科研基金资助

摘　　要：目的　对荧光偏振免疫法 (FPIA)检测血浆同型半胱氨酸 (HCY)进行方法学评价 ,并初步探讨其临床应用价值。方法　系统研究了FPIA法测定HCY的精密度、灵敏度、稀释线性、校准曲线的稳定性及干扰因素 ,并分析了其与高效液相色谱法 (HPLC)检测结果的相关性。同时应用FPIA法测定了北京地区 77名正常人及 6 1例冠心病患者血浆HCY水平。结果　FPIA法检测HCY具有较高的精密度 (总CV为 1.93%～ 3.6 0 % ) ,分析灵敏度为 0 .2 1μmol L ,校准曲线至少可稳定3周 ,稀释标本回收率为 92 .2 8%～ 10 2 .41% ,黄疸、脂血和溶血现象基本不影响测定结果。FPIA法 (X)与HPLC法(Y)具有良好相关性 (Y =0 .977X + 0 .6 90 ,r =0 .992 )。冠心病患者血浆HCY[(16 .83± 6 .70 ) μmol L]明显高于正常人 [(9.6 7± 3 .0 0 ) μmol L](P <0 .0 5 )。结论　FPIA法操作简单、结果准确可靠、自动化程度高 ,且检测速度快 ,具有较高的精密度 。Objectives To evaluate the analytical features of the new automated total homocysteine(HCY) assay using fluorescence polarization immunoassay(FPIA) technology and obtain information about its utility in clinical studies. Methods The parameters like precision, analytical sensitivity, calibration curve stability, dilution recovery of the FPIA assay were determined. The correlation study was also performed versus HPLC method. HCY concentration was determined in 77 healthy individuals and 61 patients with coronary heart disease(CHD) in the Beijing area. Results The FPIA method showed an excellent precision (total CVs : 1.93% ～3.60%) and dilution recovery (92.28% ～102.41%). The minimal detection limit was 0.21 μmol/L. The calibration curve was stable for at least three weeks. There was no interference in the FPIA method for the three pathological plasmas(hyperbilirubinemic, hypertriglyceridemic and hemolyzed plasmas).Linear regression analysis showed a good correlation between the FPIA( X ) and HPLC ( Y ) methods ( Y =0.977 X +0.690, r =0.992). The statistical difference was much higher in patients with CHD compared to healthy individuals [(16.83±6.70) μmol/L vs (9.67±3.00) μmol/L, P <0.05]. Conclusions The FPIA method is reliable, precise, fairly rapid and easy to perform. This method is very useful and suitable for routine determinations of plasma/serum HCY levels in a clinical laboratory.

关 键 词：荧光偏振免疫法 同型半胱氨酸 

分 类 号：R446.6[医药卫生—诊断学]