Evaluation of NT-proBNP assay performance on electro-chemiluminescence immunoassay system
10.3760/cma.j.issn.1009-9158.2011.12.025
- VernacularTitle:电化学发光免疫法检测NT-proBNP的分析性能评价
- Author:
Xiuming ZHANG
;
Dongmei WEN
;
Weijia WANG
;
Fei LI
;
Lijuan KAN
;
Haizhong YAN
;
Minghuan SUO
;
Nengliang OUYANG
- Publication Type:Journal Article
- Keywords:
Natriuretic peptide,brain;
Electrochemistry;
Luminescence;
Immunoassay;
Evaluation study
- From:
Chinese Journal of Laboratory Medicine
2011;34(12):1152-1157
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate analytical performance of NT-proBNP on Electro-Chemiluminescence Immunoassay system.MethodsThe precision,accuracy,limit of blank ( LoB ),limit of detection (LoD),functional sensitivity (FS),analytical measure range (AMR),maximal dilution rate,clinical reportable range(CRR) and the analytical anti-interference ability of NT-proBNP were evaluated according to EP documents issued by CLSI and related references.The analytical performance data were compared to quality standards declared by the manusfacturers.According to CLSI C28-A2,80 healthy volunteers,aged from 18 to 74, were chosen and divided into 4 groups on average for biological reference intervals verification.Results The within-run CV and total CV were 1.1％ -2.2％and 1.5％ -2.9％ respectively.The deviations from controls distributed by National Center for Clinical Laboratory and affiliated calibrators were 2.7％ -5.9％ and 2.7％ -7.5％,respectively.The results of LoB,LoD and FS were 2.5,7.8 and 8.8 pg/ml,respectively.AMR was 8 -35 126 pg/ml,and the most suitable dilution rate was 1∶ 2,so the CRR was 9 -70 252 pg/ml.428 μmol/L bilirubin,2 g/L haematoglobin and 2 200 FIU chyle didn't interfere with the NT-proBNP assay.Moreover,almost all the data from different age groups were in the range of biological reference intervals declared by the manusfacturers, except one test data (167 pg/ml).Conclusions The analyticalperformance of NT-proBNP analyzed on Roche Cobas E601electrochemiluminescence immunoassay systemisconsistentwiththestandarlswhichmanufacturershas proclaimed.The establishment of LoD,FS,maximal dilution and CRR for NT-proBNP assay could provide the quality assurance for clinical use and the biological reference intervals declared by manusfacturers could meet the clinical needs.
