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Evaluation of NT-proBNP assay performance on electro-chemiluminescence immunoassay system / 中华检验医学杂志
Article in Chinese | WPRIM | ID: wpr-421059
Responsible library: WPRO
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.

Full text: Available Index: WPRIM (Western Pacific) Type of study: Practice guideline Language: Chinese Journal: Chinese Journal of Laboratory Medicine Year: 2011 Type: Article

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Full text: Available Index: WPRIM (Western Pacific) Type of study: Practice guideline Language: Chinese Journal: Chinese Journal of Laboratory Medicine Year: 2011 Type: Article