两种不同原理检测方法测定血清降钙素原的结果比对评估

Comparison and evaluation of the results of two different methods for the determination of serum procalcitonin

目的以VIDAS Brahms双抗体免疫荧光法检测降钙素原(PCT)结果作为参照,对Wondfo干式荧光免疫层析法测定PCT结果进行评估。方法收集72例患者的血清标本,以双盲方式对上述标本分别采用VIDAS和Wondfo仪器进行PCT定量检测,再通过统计学分析评估两种方法测定PCT的一致性。结果两种设备检测的PCT结果高度相关(r=0.987,P<0.01);回归方程:Y=1.069X-0.021,F检验显示回归方程差异有统计学意义(P<0.05);对回归方程的两个系数进行t检验显示,截距(b)则反之差异无统计学意义(P=0.768>0.05),而斜率(a)比较差异有统计学意义(P<0.05)。PCT在定值0.23 ng/ml和0.50 ng/ml时的系统误差(SE%)分别为6.90%和2.70%。结论两种方法检测PCT结果具有高度的相关性,但二者存在一定的比例误差,Wondfo干式荧光免疫层析法检测PCT可以用于临床病情及疗效监控。

Objective To evaluate procalcitonin（PCT） results determined by Wondfo dry fluorescent immunochromatography, with PCT results determined by VIDAS Brahms double antibody immunofluorescence method as a reference. Methods Serum specimens were collected from 72 patients and their PCT was quantitatively detected by VIDAS and Wondfo devices in a double-blind manner. Statistical analysis was used to assess the consistency of the two methods for the determination of PCT. Results The PCT results of the two devices were highly correlated（r=0.987, P〈0.01）; regression equation： Y=1.069X-0.021, F test showed that there was statistically significant difference in regression equation（P〈0.05）. The t test of the two coefficients of the regression equation showed that there was no statistically significant difference in the intercept（b）（P=0.7680.05）, while there was statistically significant difference in slope（a）（P=0.0000.05）. The systematic errors（SE%） of PCT at 0.23 ng/ml and 0.50 ng/ml were respectively 6.90% and 2.70%. Conclusion The PCT results of the two devices are highly correlated, but there is a certain proportion of systematic errors. Wondfo dry fluorescent immunochromatography for determination of PCT can be used for clinical disease and efficacy monitoring.