摘要
Abstract
Objective: To evaluate the analytical performance of NT-proBNP on POCT (point-of-care testing) device and compare with that of electro-chemiluminescence immunoassay.Methods The precision,linearity,methodology comparison and analytical anti-interference ability of NT-proBNP assay on two POCT devices were evaluated according to the EP documents issued by Clinical and Laboratory Standards Institute (CLSI).In addition,the analytical performance data were compared with the standards declared by the manufacturer.The biological reference intervals were verified according to CLSI C28-A2 document to define whether it could be used in our laboratory.Results The within-run CV (coefficient of variation) and total CV of device A were 6.96%-11.22% and 7.54%-11.75%,respectively,and the linearity range was 98.0 pg/mL-32 924.5 pg/mL.The results of device A were comparable to that of the Roche Cobas e411.Interference in NT-proBNP assay occurred when hemoglobin was over 2747.7mg/L,chyle was over 725.5FTU,free bilirubin was over 180.8 mg/L,and conjugated bilirubin was over 256.9 mg/L.Except one test datum (127pg/mL),all the test data from 50 individuals of various age groups were in the range of biological reference intervals declared by the manufacturer.The within-run CV and total CV of device B were 10.25%-14.23% and ll.46%-14.81%,respectively,and the linearity range was (267.82-8627.28)pg/mL.The results of device B had slight deviation when compared with that of the Roche Cobas e411.Interference of NT-proBNP assay was seen when hemoglobin was over 3490.9mg/L,chyle was over 694.98FTU,free bilirubin was over 172.2mg/L,and conjugated bilirubin was over 303.1 mg/L Except one test datum (305.72pg/mL),all the test data from 50 individuals of various age groups were in the range of biological reference intervals declared by the manufacturer.Conclusions The analytical performance of device A is in the range of standards declared by the manufacturer.The analytical performance of device B is also in the range of standards declared by the manufacturer,except the slight deviations when compared with that of Roche Cobas e411.关键词
即时检验/电化学发光/N末端B型利钠肽原/性能评价Key words
Point-of-care testing/Electro-chemiluminescence/N-terminal precursor of B-type natriuretic peptide/Performance evaluation分类
医药卫生
