Key result
The Dimension RxL NT-proBNP method demonstrated a detection limit of 2.0 ng/L, total imprecision of 2.6-3.6%, and linearity up to 32,650 ng/L, making it suitable for routine heart failure diagnosis.
Why the study?
How does the analytical performance of the Dade Behring Dimension RxL NT-proBNP method compare to the Roche Elecsys 2010 method?
How does the analytical performance of the Dade Behring Dimension RxL NT-proBNP method compare to the Roche Elecsys 2010 method?
The Dimension RxL NT-proBNP method demonstrates acceptable analytical performance and is suitable for routine use in diagnosing heart failure, despite a bias compared to the Elecsys 2010 method.
Supports routine lab adoption of Dimension RxL NT-proBNP; leaves open clinical impact of bias versus Elecsys in heart failure diagnosis.
Methods to quantify B-type natriuretic peptide (BNP) and N-terminal-propeptide (NT-proBNP) in plasma or serum samples are well established. We assessed the analytical performance of the Dimension RxL NT-proBNP method (Dade-Behring). Evaluation of different sample types was carried out. Controls and heparin plasma pools were used to determine the detection limit, precision, and linearity. Sample stability and the effect of interfering substances on the NT-proBNP concentrations were evaluated. Agreement between Dimension RxL and Elecsys 2010 (Roche Diagnostics) NT-proBNP methods was assessed. The influence of age and sex on NT-proBNP concentrations was evaluated in healthy subjects. Heparin plasma should be the matrix of choice. The detection limit was 2.0 ng/L. The total imprecision was 2.6-3.6% for concentrations from 231 to 9471 ng/L; mean NT-proBNP concentrations of 21 and 15 ng/L were associated with coefficients of variation of 9.9% and 14.7%, respectively. The method was linear up to 32,650 ng/L. There was no effect of temperature, freeze-thaw cycles and interfering substances. A bias was detected when Dimension RxL and Elecsys 2010 NT-proBNP methods were compared. Age and sex were significantly and independently related to NT-proBNP concentrations. The Dimension RxL NT-proBNP method, like the Elecsys 2010, is suitable for routine use in the diagnosis of heart failure.
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Serio et al. (2005) studied Heart failure. Dimension RxL NT-proBNP method vs. Elecsys 2010 NT-proBNP method was evaluated on Analytical performance (detection limit, precision, linearity, agreement). The Dimension RxL NT-proBNP method demonstrated a detection limit of 2.0 ng/L, total imprecision of 2.6-3.6%, and linearity up to 32,650 ng/L, making it suitable for routine heart failure diagnosis.
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