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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 the PCT results by Wondfo dry-type fluorescence immunochromatography with VIDAS Brahms double antibody immunofluorescence assay for procalcitonin (PCT) as a reference. Methods Serum samples of 72 patients were collected. The above samples were double-blindly detected by VIDAS and Wondfo apparatus respectively for PCT quantitative analysis. The consistency of PCT was also evaluated by statistical analysis. Results The PCT results of the two devices were highly correlated (r = 0.987, P <0.01). The regression equation was Y = 1.069X-0.021. The F test showed that the regression equation was significantly different (P <0.05) The two tests showed that there was no significant difference in intercept (b) (P = 0.768> 0.05), while the slope (a) was statistically significant (P <0.05). The systematic errors (SE%) for PCT at the 0.23 ng / ml and 0.50 ng / ml values were 6.90% and 2.70%, respectively. Conclusions The two methods are highly correlated with the detection of PCT results, but there is a certain proportion of error between the two methods. Wondfo fluorescence immunochromatography detection of PCT can be used to monitor the clinical status and efficacy of PCT.