胎盘生长因子荧光免疫层析法检测的临床性能评估

Performance evaluation of placental growth factor by fluorescence immunochromatography

目的:建立胎盘生长因子(placental growth factor,PlGF)荧光免疫层析的检测方法,在此基础上进行分析性能与临床性能评价。方法:鼠抗人PlGF单抗荧光标记、羊抗人PlGF多抗包被硝酸纤维素膜,建立PlGF的荧光免疫层析检测方法,并对其线性范围、准确度、重复性等分析性能进行评价;以电化学发光法为对照,采用136例孕妇血清进行临床性能评价。结果:荧光免疫层析检测方法的线性范围为20.0~9 000.0 pg/mL,准确度为97.98%,重复性、变异系数CV为3.14%(500.0 pg/mL)和2.98%(5 000.0 pg/mL);与电化学发光法具有良好的线性相关性:y=1.032x-5.002(r=0.991);Bland-Altman统计分析显示,荧光免疫层析法检测结果的平均值略高于电化学发光法,但差异无统计学意义(P>0.05)。结论:PlGF荧光免疫层析检测方法的分析性能与临床性能较佳,适合临床应用。

Objective:To establish a fluorescence immunochromatography for placental growth factor(PlGF),evaluate the analysis performance and clinical performance. Methods:Using fluorescent microsphere conjugated-mouse-anti-human PlGF monoclonal antibody,sheep anti-human PlGF polyclonal antibody coated on NC membrane,to establish a fluorescence immunochromatography assay for PlGF,and evaluate the analysis performance,such as linear range,accuracy,repeatability. Using serums of 136 pregnant women,electrochemiluminescence as control,to evaluate the clinical performance. Results:The linear range of fluorescence immunochromatography assay for PlGF was 20.0~9 000.0 pg/mL,accurate was 97.98%,repeatability CV was 3.14%(500.0 pg/mL)and2.98%(5 000.0 pg/mL). The assay had good correlation with electrochemiluminescence:y=1.032 x-5.002(r=0.991). Bland-Altman statistical analysis showed that the average value of fluorescence immunochromatography was slightly higher than that of electrochemiluminescence,without significant difference(P > 0.05). Conclusion:The fluorescence immunochromatography for PlGF has good analysis performance and clinical performance. The assay is suitable for clinical application.