Key result
Novel ultra-sensitive NT-proBNP test correlates strongly with the standard Elecsys assay.
A novel ultra-sensitive NT-proBNP assay demonstrated highly accurate, rapid (30-min) quantification of NT-proBNP in clinical plasma samples without interference from common endogenous constituents, potentially facilitating earlier heart failure risk detection.
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Supports rapid NT-proBNP testing in practice; extends analytical validation of ultra-sensitive assays toward earlier HF risk detection.
Cardiovascular diseases such as acute myocardial infarction and heart failure accounted for the death of 17.5 million people (31% of all global deaths) in 2015. Monitoring the level of circulating N-terminal proBNP (NT-proBNP) is crucial for the detection of people at risk of heart failure. In this article, we describe a novel ultra-sensitive NT-proBNP test (us-NT-proBNP) that allows the quantification of circulating NT-proBNP in 30 min at 25 °C in the linear detection range of 7.0–600 pg/mL. It is a first report on the application of a fluorescence bead labeled detection antibody, DNA-guided detection method, and glass fiber membrane platform for the quantification of NT-proBNP in clinical samples. Limit of blank, limit of detection, and limit of quantification were 2.0 pg/mL, 3.7 pg/mL, and 7 pg/mL, respectively. The coefficient of variation was found to be less than 10% in the entire detection range of 7–600 pg/mL. The test demonstrated specificity for NT-proBNP without interferences from bilirubin, intra-lipid, biotin, and hemoglobin. The serial dilution test for plasma samples containing various NT-proBNP levels showed the linear decrement in concentration with the regression coefficient of 0.980–0.998. These results indicate that us-NT-proBNP test does not suffer from the interference of the plasma components for the measurement of NT-proBNP in clinical samples.
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Song et al. (2017) studied Individuals undergoing routine health check-up (n=58). us-NT-proBNP test vs. Elecsys NT-proBNP assay was evaluated on Correlation between us-NT-proBNP test and Elecsys NT-proBNP assay (Correlation coefficient 0.899, 95% CI 0.834-0.939, p=<0.0001). The novel ultra-sensitive NT-proBNP test demonstrated a strong correlation (r=0.899) with the standard Elecsys NT-proBNP assay across a linear detection range of 7.0–600 pg/mL.
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