VIDAS定量检测降钙素原的性能评价

Evaluation Performance of Quantitative Procalcitonin Test on the VIDAS Instrument

目的评价VIDAS定量检测降钙素原（PCT）的性能。方法根据美国临床和实验室标准化协会（NCCLS）的要求，分析法国生物梅里埃公司全自动免疫分析系统（VIDAS）检测降钙素原的精密度、准确度、线性范围等性能。结果高质控物（Control1）、低质控物（Control2）及混合血浆的批内精密度cV分别为1．93％、2．28％和2．01％；批间精密度CV分别为3．57％、4．02％和3．62％；总重复性为6．96％，准确度为98％。此次评估线性范围为0．05～200ng／mL，仪器在此范围内线性良好（r=0．999）；血红蛋白（0．347mmol／L），三酰甘油（2mmol／L），胆红素（0．574mmol／L）对检测结果的影响度均小于厂家给定的批内批变异率（％）；50例健康者血清标本进行PCT正常参考值验证，均符合原试剂说明书提供的参考之。结论VIDAS定量检测PCT的准确度、精密度、线性均较好，无携带污染率，检测简便易行，自动化程度高，尤其适用急症检测。

Objective To evaluate the performance of the quantitative procalcitonin test on the VIDAS instrument. Methods According to the standard of the NCCI.S documents, the quality of the quantitative procalcitonin test on the VIDAS instrument were investigatedResults Intra 2 assay precision of high level control,low level control and mixed plasma was 1.93 %, 2.28 %, and 2.01% respectively. Extra 2 assay precision of high level control, low level control and mixed plasma was 3.57%, 4.02%,and 3.62% respectively. Total reproducibility was 6.96%, The meas- urement range is from 0.05 to 200ng/mL, It showed good linearity during this range. The influence of hemoglobin, triglyeride,bilirubin were less than the given efficient of variation. 50 tested healthy plasma validated the given reference range was used in their lab. Conclusion Quantitative procalcitonin test on the VIDAS instrument has good accu racy,precision and linearity. Its convenience,automation is suitable for individual test in emergency.