乳胶增强免疫比浊PCT试剂在ADVIA 2400系统应用的性能评估及与电化学发光系统一致性研究

Analytical evaluation of latex-enhanced immunoturbidimetric PCT reagent on ADVIA2400 system and the consistency of ADVIA2400 system and electrochemistry luminescent system

目的评价国产乳胶增强免疫比浊法降钙素原(PCT)诊断试剂在西门子ADVIA 2400系统上应用的性能。方法参考美国临床实验室标准化委员会(CLSI)指南对乳胶增强免疫比浊法PCT诊断试剂在西门子ADVIA 2400系统检测的精密度、准确度及线性范围进行性能验证,同时与参考方法(电化学发光法)进行一致性比较。结果乳胶增强免疫比浊法在西门子ADVIA 2400系统上测定PCT低值和高值质控品的批内精密度分别为5.5%、2.3%,批间精密度分别为6.6%、3.1%,总精密度分别为6.6%、3.9%。PCT浓度在0.19～49ng/mL范围的线性良好(r=0.995 7)。乳胶增强比浊法与电化学发光法的Passing-Bablok回归方程为Y=0.846 X+0.0772(r=0.989 4)。两种方法在cut-off值分别为0.5、2.0、10.0ng/mL时的Kappa值分别为0.742、0.893、0.921,西格玛(σ)值为3.5,两方法在低、高PCT浓度处的质量目标指数(QGI)分别为0.68、2.41。结论国产乳胶增强免疫比浊PCT试剂在ADVIA-2400系统上应用符合性能验证标准,但采用六西格玛标准,该方法在精密度和准确度方面尚需进一步改进。

Objective To evaluate the performance of domestic latex-enhanced immunoturbidimetric procalcitonin(PCT)diagnostic reagent on ADVIA2400system.Methods The precision,accuracy and linear range of latex-enhanced immunoturbidimetric PCT diagnostic reagent was tested by ADVIA2400system in reference to CLSI guide.At the same time,the consistency of this method was compared with the reference method,which was electrochemistry luminescent method.Results On Siemens ADVIA2400system,through latex-enhanced immunoturbidimetric method,the tested intra-assay precisions of PCT were5.5%in low quality control and2.3%in high quality control,respectively.The inter-assay precisions were6.6%in low quality control and3.1%in high quality control.The gross precisions were6.6%in low quality control and3.9%in high quality control.The linearity in the concentration range of0.19-49ng/mL was good(r=0.9957).The Passing-Bablok regression equation between latex-enhanced turbidimetry method and electrochemistry luminescent method was Y=0.846X+0.0772(r=0.9894).The Kappa values were0.742,0.893,0.921respectively,while the cut-off values of the PCT concentrations were0.5,2.0,10.0ng/mL,respectively.The sigma value(σ)was3.5.The quality target indices(QGI)of two PCT concentrations were0.68and2.41respectively.Conclusion The domestic latex-enhanced immunoturbidimetric PCT reagent meets the performance verification standard on the ADVIA-2400system,however,this method needs further improvement in precision and accuracy by the six sigma standard.