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

LIU Junlong;REN Biqiong;XU Fei;LUO Shudi;CHEN Wei;Department of Medical Laboratory,School of Clinical Medicine,Hunan University of Traditional Chinese Medicine;Department of Clinical Laboratory,the Second People's Hospital of Hunan Province;  
Objective To evaluate the performance of domestic latex-enhanced immunoturbidimetric procalcitonin(PCT)diagnostic reagent on ADVIA 2400 system.Methods The precision,accuracy and linear range of latex-enhanced immunoturbidimetric PCT diagnostic reagent was tested by ADVIA 2400 system 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 ADVIA 2400 system,through latexenhanced immunoturbidimetric method,the tested intra-assay precisions of PCT were 5.5% in low quality control and 2.3%in high quality control,respectively.The inter-assay precisions were 6.6%in low quality control and 3.1%in high quality control.The gross precisions were 6.6%in low quality control and 3.9%in high quality control.The linearity in the concentration range of 0.19-49 ng/mL was good(r=0.995 7).The Passing-Bablok regression equation between latex-enhanced turbidimetry method and electrochemistry luminescent method was Y=0.846 X+0.077 2(r=0.989 4).The Kappa values were 0.742,0.893,0.921 respectively,while the cut-off values of the PCT concentrations were 0.5,2.0,10.0 ng/mL,respectively.The sigma value(σ)was 3.5.The quality target indices(QGI)of two PCT concentrations were 0.68 and 2.41 respectively.Conclusion The domestic latex-enhanced immunoturbidimetric PCT reagent meets the performance verification standard on the ADVIA-2400 system,however,this method needs further improvement in precision and accuracy by the six sigma standard.
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