两种检测系统测定降钙素原含量的结果分析

Methodological analysis of results of the procalcitonin by chemiluminescence and electrochemical luminescence method

目的分析化学发光法和电化学发光法定量检测降钙素原(procalcitonin,PCT)的等效性,为临床实验室合理选择降钙素原定量检测方法及试剂盒提供实验依据。方法选取2016年7月—9月收集的某院PCT临床标本50例,分别用两种系统进行检测,比较两种检测系统的敏感度、特异性、阳性预测值、阴性预测值和准确度,分析两组数据的等效性。结果两种检测系统的敏感度和特异性分析显示化学发光法测试PCT有良好的可靠性;F检验P_1=0.424>0.05;t检验P_2=0.214>0.05;相关系数r=0.998>0.90,P_3=0.000;组内相关系数ICC=0.991,P_4=0.000;Bland-Altman法分析监测数据一致性限度值(-0.113,0.461),小于专业界限±0.5。说明两种检测方法测出的两组数据具有等效性。结论两种系统在降钙素原定量检测中具有等效性,即两种测定方法及试剂盒具有等效性。实验结果为临床实验室选择化学发光法定量检测PCT提供了数据支撑。

Objective This paper discussed chemiluminescence method quantitative detection of electrochemical luminescence method two system quantitative detection of procalcitonin the equivalence of the results. The results for choose the procalcitonin quantitative detection methods and kit in our hospital to provide experimental basis.Methods We selected 50 cases clinical specimens PCT in a hospital in July to August 2016, with two kinds of methods for testing respectively, comparing two test results of the system. Statistical software by using F and paired t test, correlation analysis, and Bland - Altman intraclaas correlation coefficient method test, the analysis of two groups results equivalence. Results Two system analysis of sensitivity and specificity showed that the chemil method had reliability; F test P1 = 0.424; t test P2 = 0.214; The correlation coefficient r = 0.998, P3 = 0.000; Intraclass correlation coefficient of the ICC = 0.991, P4 = 0.000; Bland - Ahman method analysis of monitoring data consistency limit values （-0.113,0.461）, less than professional lines ＋0.5. As a result, the two system measure the two groups results with equivalence.Conlusions The two systems in procalcitonin quantitative detection of equivalence, namely, and two methods for determining the kit has the equivalence. Experimental results for the hospital choose method provides data support.