Analytical performance of the N terminal pro B type natriuretic peptide (NT‐proBNP) assay on the Elecsys™ 1010 and 2010 analysers

Abstract

The Elecsys NT‐proBNP assay is based on two polyclonal antibodies directed at residues 1–21 and 39–50 of the NT‐proBNP molecule. Analytical performance was assessed using NCCLS protocol EP‐5A using three serum pools in a preliminary study then as part of a multicentre evaluation (16 instruments in 8 hospitals). Using pools of 350 pg/l, 8700 pg/l and 13000 pg/l single site within run %CV was 0.7–1.6 (1010) and 1.2–1.5 (2010) and between run CV 5.3–6.7 (1010) and 4.4–5.0 (2010). In the multicentre evaluation within run CV was 1.0–2.5% with total imprecision 1.5–2.5% and between labs imprecision 3.8–4.0%. Functional sensitivity of 50%) and no risk factors, NT‐proBNP values increased with age and were higher in women than men.