酶放大免疫分析法与二维高效液相色谱法监测万古霉素血药浓度的比较

Comparison of EMIT and 2D-HPLC-UV in the Quantification of Vancomycin in Human Plasma

万古霉素血药浓度个体差异较大,故临床需监测其血药浓度。本文分别建立酶放大免疫分析法(EMIT)、二维高效液相色谱法(2D-HPLC-UV)测定万古霉素血药浓度,2种方法的线性、准确度和精密度均符合生物样品检定要求。60份静脉滴注万古霉素患者的血浆样品测定结果显示,两种方法无统计学差异,且相关性好,回归方程为Y2D-HPLC-UV=0.9670×XEMIT-0.7029,Bland-Altman分析显示两种方法一致性良好。两种方法均可有效且可靠地监测万古霉素血药浓度,临床上应综合考虑监测目的、实验室条件和人员配置等,选择合适的测定方法。

There exist great individual differences in the concentration of vancomycin, so it is necessary to monitor its concentration in clinic. An enzyme multiplied immunoassay technique （EMIT） and a two-di- mensional liquid chromatography coupled with uhraviolet detection method （2D-HPLC-UV） were established to measure the concentration of vancomycin in human plasma. The linear range, accuracy and precision of the two methods satisfied the requirements for bioanalysis. Sixty plasma samples from patients intravenously infused with vancomycin were detected by EMIT and 2D-HPLC-UV, respectively. There were no significant differences in the plasma concentrations of vancomycin detected by EMIT and 2D-HPLC-UV. A good cor- relation was obtained between the two methods. The regression equation was Y2D-HPLC-UV=0.9670XXEMTT-0.7029. Bland-Airman plots analysis showed the two methods were consistent. Both EMIT and 2D-HPLC-UV were effective and reliable in the quantification of vancomycin. The monitoring purpose, laboratory conditions and staffing should be taken into consideration when a method was chosen for monitoring the concentration of vancomycin.