瑞莱TZ-301型仪器对降钙素原检测能力的临床评价

Evaluation of ReLIA TZ-301 in Procalcitonin detection

目的通过与VIDAS30型仪器比较,评估瑞莱TZ-301型仪器检测降钙素原(PCT)的性能。方法收集自2016年5-11月北京协和医院门诊及住院患者血清标本共305例,其中4例用于精密度分析,40例用于正确度分析,261例用于相关性、医学决定水平处的偏倚、检测能力及区间一致性分析。结果精密度为5.9%～9.9%;正确度百分偏倚为-3.20～-0.01;总体数据相关系数为0.982,斜率为0.866,截距为-0.039,医学决定水平处的预期偏倚为-1.38～0.05;受试者工作特征曲线下面积为0.825,区间数据敏感度为72.7%～87.7%、特异度为88.6%～100.0%。261例标本中共有52个区间分类不一致的标本,其中正偏倚12个,负偏倚40个,主要集中于0.05～0.50及0.50～2.00区间。结论瑞莱TZ-301型仪器检测PCT与VIDAS30型仪器有较好的相关性,各检测区间特异度较高,区间分类不一致的标本主要以负偏倚为主。

Objective To evaluate the performance of ReLIA TZ-301in Procalcitonin(PCT)detection by comparing with VIDAS30.Methods A total of305peripheral blood serum samples from outpatient and inpatient in Peking Union Medical College Hospital(PUMCH)from May to November2016were selected.There are4cases used for precision analysis and40cases for accuracy analysis.261samples were used to verify correlation analysis,bias analysis of medical decision,detection ability analysis and interval consistency analysis.Results The precision rates in different interval were5.9%-9.9%.The percent bias of accuracy was-3.20--0.01.Correlation coefficient r of the totalities was0.982,slope was0.866,intercept was-0.039,the expected bias of medical decision was-1.38-0.05.The area of receiver operating characteristic curve(ROC curve)was0.825.Sensitivity of each interval were72.7%-87.7%,and specificity were88.6%-100.0%.There were52cases of inconsistent samples in the total.The number of positive bias in261cases accounted for12cases,and the number of negative bias accounted for40cases.The most of these datum concentrated in the0.05-0.50and0.50-2.00interval.Conclusion There was a good correlation between ReLIA TZ-301and VIDAS in detecting PCT.The specificity in the each interval was high,and inconsistent samples in each interval were mainly negative bias.