Systematic differences between BNP immunoassays: comparison of methods using standard protocols and quality control materials

Clin Chim Acta. 2013 Sep 23:424:287-91. doi: 10.1016/j.cca.2013.07.001. Epub 2013 Jul 9.

Abstract

Background: Recent studies suggested that there are marked systematic differences among BNP immunoassays. In this study we compared the BNP data and clinical results obtained with different immunoassays, including a new method (ST-AIA-PACK, TOSOH Corporation).

Methods: BNP was measured on plasma-EDTA samples of healthy subjects (HS, n=126) and patients with heart failure (HF, n=31 NYHA I, II; n=46 NYHA III, IV) using the ST-AIA-PACK and the Triage Biosite (Beckman Coulter) methods. Control samples distributed in the CardioOrmoCheck external quality assessment were also measured with TOSOH and the most used BNP immunoassays in Italy.

Results: TOSOH method showed a good correlation (R=0.976; n=327) but a mean bias (-46.9%) compared to Triage Biosite. On the base of the results obtained in 10 samples of the CardioOrmoCheck study, TOSOH method showed a strict agreement with ADVIA Centaur, while it underestimated BNP in comparison with Triage (-52.5%) and ARCHITECT methods (-39.4%). The agreement of ST-AIA-PACK and Triage Biosite methods for classification of HF patients was tested using 100 ng/L of BNP; the positive agreement between methods was 65%, overall agreement was 73%.

Conclusions: Our results confirm that there are marked differences in measured values among commercial methods for BNP assay.

Keywords: BNP; Heart failure; Immunoassay; Method comparison; Quality control.

Publication types

  • Comparative Study
  • Multicenter Study

MeSH terms

  • Case-Control Studies
  • Heart Failure / blood*
  • Heart Failure / diagnosis
  • Humans
  • Immunoassay / methods
  • Immunoassay / standards*
  • Immunoassay / statistics & numerical data*
  • Italy
  • Laboratories / standards
  • Limit of Detection
  • Natriuretic Peptide, Brain / blood*
  • Observer Variation
  • Quality Control
  • Reproducibility of Results

Substances

  • Natriuretic Peptide, Brain