循环增强荧光分析仪及配套降钙素原定量检测试剂盒的分析性能评价

Evaluation of analytical performance of cyclic enhanced fluorescence analyzer and its supporting quantitative PCT detection ki

目的:对一款新近研发的循环增强荧光分析仪及配套降钙素原(PCT)试剂盒进行系统性的性能评价,并对新版美国临床实验室标准协会(CLSI)文件的适用性进行验证。方法:依据目前最新版CLSI文件(EP5-A3、C28-A3和EP9-A3),对国产的循环增强荧光分析仪及配套PCT定量检测试剂盒与进口Roche公司COBASe411电化学发光免疫分析仪及其配套PCT试剂分别检测人血标本中的PCT含量进行对比评价,验证循环增强荧光分析仪及配套PCT试剂盒的低值血清质控品批内变异系数(CV)、检测偏差、整体符合率以及批间偏差等分析性能。结果:循环增强荧光分析仪低值血清质控品批内CV为6.5%,实验室内总CV为8.7%,高值血清质控品批内CV为5.3%,实验室内总CV为8.0%;血清临床可报告范围为0.032~827 ng/ml;健康人群血清PCT第95百分位为0.047 ng/ml,全血PCT第95百分位为0.066 ng/ml;血红蛋白(500 mg/dl)、胆红素(10 mg/ml)和甘油三酯(500 mg/dl)对血清检测结果的偏差均<15%;检测全血、血浆及血清PCT与Roche检测血浆PCT整体符合率分别为91.1%、95.5%及93.3%;3个批号的循环增强荧光分析仪试剂批间偏差均<15%。结论:循环增强荧光分析仪检测系统的各项分析性能良好,可用于医学实验室进行常规PCT标本检测。

Objective:To systematically evaluate the performances of a newly developed cyclic enhanced fluorescence analyzer and its supporting pro-calcitonin(PCT)kit,and to verify the applicability of the new files of Clinical and Laboratory Standards Institute(CLSI).Methods:According to the currently latest edition of CLSI files(EP5-A3,C28-A3 and EP9-A3),the domestic cyclic enhanced fluorescence analyzer and its supporting quantitative PCT detection kit,and the COBAS e411 electrochemical luminescence immune analyzer and its supporting PCT reagent were adopted to respectively detect PCT contents in human blood specimens,and the results of them were compared and evaluated.The analytical performances included within-run coefficient of variation(CV),detection bias,overall coincidence rate and between-run bias of quality control of serum with low value of cyclic enhanced fluorescence analyzer and its supporting quantitative PCT kit were further verified.Results:The within-run CV and total CV of laboratory of cyclic enhanced fluorescence analyzer were 6.5% and 8.7% for quality control of serum with low value,and those of that were 5.3% and 8.0% for quality control of serum with high value.The clinical reportable range of serum was 0.032~827 ng/ml in this analyzer,and the 95 th percentile of serum PCT of healthy population was 0.047 ng/ml,and the 95 th percentile of whole blood PCT was 0.066 ng/ml.The biases of hemoglobin(500 mg/dl),bilirubin(10 mg/ml)and triglyceride(500 mg/dl)were less than 15% in the interference experiment for the detection results of serum.The overall coincidence rates of cyclic enhanced fluorescence analyzer with Roche instrument were 91.1%,95.5% and 93.3% in detecting PCT of whole blood,plasma and serum,respectively.And the bias of 3 batches of reagents of cyclic enhanced fluorescence analyzer were less than 15%.Conclusion:The performance of each analysis of the detection system of cyclic enhanced fluorescence analyzer is favorable,which can be used in the detection of routine PCT specimen in medical laboratory.