降钙素原量子点荧光免疫层析检测法的方法学评价

Evaluation on the analytical performance of quantum dots fluorescence immunochromatographic for the determination of procalcitonin

目的评价量子点荧光免疫层析法检测血清降钙素原(PCT)的方法学性能。方法精密度评价采用美国临床和实验室标准协会(CLSI)提供的标准化文件用户对精密度和偏倚的评估(EP15-A3)方案,分析测量范围评价采用CLSI EP6-A2方案,生物参考区间评价采用CLSI C28-A2方案,对比实验选择120份新鲜血清标本,分别在梅里埃mini Vidas检测系统(参比系统),深圳金准生物检测系统(实验系统)上检测,评价其阳性符合率、阴性符合率、假阳性率、假阴性率、诊断符合率、Kappa一致性。结果量子点荧光免疫层析法在低、高两个浓度水平处重复性变异系数(CV)分别为4.96%、4.70%,期间变异系数(CV)分别为6.81%,9.68%;在0.1327～93.2917浓度范围内结果呈线性;选取的20份正常标本,结果均小于0.25ng/ml;以参比系统为准,在0.25ng/ml、0.50ng/ml、2.0ng/ml临界值时其阳性符合率、阴性符合率、假阳性率、假阴性率、诊断符合率分别为98.33%、75.00%、25.00%、1.67%、86.67%,100.00%、85.90%、14.10%、0.00%、90.83%,100.00%、97.96%、2.04%、0.00%、98.33%,kappa值分别为0.73、0.81、0.95。结论量子点荧光免疫层析法检测血清降钙素原(PCT)的检测性能符合临床检测的要求。

Objective To evaluate the methodological performance of quantum dot fluorescence immunochromatography assay for the detection of serum procalcitonin（PCT）. Methods The EP15-A3,EP6-A2 and C28-A2 schemes provided by the Clinical and Laboratory Standards Institute（CLSI） were used to evaluate the precision,linearity and biological reference range of the detection system. The serum samples of 120 patients were collected and tested on the experimental system-mini VIDAS immunofluorescence analyzer-and the reference system respectively,to evaluate the positive coincidence rate,negative coincidence rate,false positive rate,false negative rate,diagnostic coincidence rate and Kappa consistency. Results Quantum dot fluorescence immunochromatography at therepeatability coefficient in low and high concentration levels（CV） were 4.96% and 4.70%,while the coefficient of variation（CV） were 6.81% and9.68%,respectively;in the concentration range of 0.1327～93.2917 was linear;20 normal specimens were selected,the results are less than 0.25 ng/ml;in reference the system is quasi 0.25 ng/ml,0.50 ng/ml,2.0 ng/ml in the critical value of the positive and negative consistent rate,false positive rate,false negative rate and diagnostic accuracy were 98.33%,75%,25%,1.67%,86.67%,100%,85.90%,14.10%,0%,90.83%,100%,97.96%,2.04%,0%,98.33%,respectively. The K values were 0.73,0.81 and 0.95. Conclusion The detection performance of serum procalcitonin（PCT） by quantum dot fluorescence immunochromatography assay meets the requirements of clinical testing.