CAJ | 학술논문

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61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%～3.60%)，分析灵敏度为0.21 μmol/L，校准曲线至少可稳定3周，稀释标本回收率为92.28%～102.41%，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+0.690，r=0.992)。冠心病患者血浆HCY［(16.83±6.70) μmol/L］明显高于正常人［(9.67±3.00) μmol/L］(P<0.05)。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，非常适合普通实验室应用。
목적대형광편진면역법(FPIA)검측혈장동형반광안산(HCY)진행방법학평개，병초보탐토기림상응용개치。방법계통연구료FPIA법측정HCY적정밀도、령민도、희석선성、교준곡선적은정성급간우인소，병분석료기여고효액상색보법(HPLC)검측결과적상관성。동시응용FPIA법측정료북경지구77명정상인급61례관심병환자혈장HCY수평。결과 FPIA법검측HCY구유교고적정밀도(총CV위1.93%～3.60%)，분석령민도위0.21 μmol/L，교준곡선지소가은정3주，희석표본회수솔위92.28%～102.41%，황달、지혈화용혈현상기본불영향측정결과。FPIA법(X)여HPLC법(Y)구유량호상관성(Y=0.977X+0.690，r=0.992)。관심병환자혈장HCY［(16.83±6.70) μmol/L］명현고우정상인［(9.67±3.00) μmol/L］(P<0.05)。결론FPIA법조작간단、결과준학가고、자동화정도고，차검측속도쾌，구유교고적정밀도，비상괄합보통실험실응용。
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=0.977X +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.