Analytical and clinical performance of a rapid magnetic immunochromatographic assay for N-terminal pro-B-type natriuretic peptide detection

Abstract

ObjectiveGoldMag® immunochromatography is a novel point-of-care immunoassay platform utilizing quantitative determination of magnetic signals. A N-terminal pro-B-type natriuretic peptide (NT-proBNP) assay has been developed on this system. The objective of this study was to determine whether GoldMag® immunochromatography for NT-proBNP test fulfils the basic requirements of analytical and clinical performance so as to be used as a point-of-care test. MethodsAnalytical performance was performed for the linearity, sensitivity, precision, interference and recovery by Clinical and Laboratory Standards Institute guidelines (CLSI). Clinical evaluation was performed by testing 206 residual serum samples and comparing with Elecsys® proBNP assay (Roche Diagnostics GmbH, Mannheim, Germany). ResultsGoldMag® immunochromatography was able to differentiate concentrations of NT-proBNP from 0.000 to 8,000 pg/mL with a correlation coefficient R2 = 0.9914 and a limit of detection (LOD) of 43 pg/mL. According to statistics, this system exhibited high precision, high recovery, and no interference with lipemia, bilirubinemia, and hemolysis. Correlation analysis showed that the two assays yielded a good correlation with R2 of 0.9860. Bland-Altmananalysis showed a bias offset of 28.98 pg/mL with 95% confidence interval from 6.056 to 72.74 pg/mL for NT-proBNP. ConclusionGoldMag® immunochromatography system for NT-proBNP detection provides high accuracy, reliability, and easy operation. It can be used as a point-of-care test with a great application value in clinical management of chronic and acute heart failure patients.