Analytical performance and clinical results of a fully automated MEIA system for brain natriuretic peptide assay: comparison with a point of care testing method

Clin Chem Lab Med. 2004;42(10):1178-85. doi: 10.1515/CCLM.2004.238.

Abstract

The aim of this study was to evaluate the analytical performance of a recently available immunoassay for brain natriuretic peptide (BNP), based on microparticle enzyme immunoassay (MEIA, AxSYM System, Abbott Laboratories), whose analytical characteristics and clinical results were compared with those of a point of care testing (POCT) method (TRIAGE system, Biosite Diagnostics). The within-run and total imprecision of the MEIA system were 18.4% and 19.8% at 21 ng/l, 8.0% and 14.8% at 183 ng/l, and 5.7% and 14.0% at 319 ng/l, respectively. The detection limit of the MEIA system was tested by repeatedly measuring (n=20) the 0 calibrator in four different runs; a mean +3 SD value of 5.6+/-4.8 ng/l (range 1.8-12.6 ng/l) was obtained. A close linear relationship (MEIA= -22.5+/-1.71 POCT method, R=0.950, n=296) was found (BNP concentration: 5-5500 ng/l), with a significant bias (mean difference: 164.8 ng/l, p<0.0001). Mean BNP concentration measured in 94 reference subjects (57 women and 37 men; mean age 43.5+/-14.0 years) was higher with MEIA than POCT, (25.9+/-32.7 ng/l vs. 11.7+/-8.9 ng/l, p<0.0001). The same trend was observed also in 202 cardiac patients (620.6+/-1082.2 ng/l vs. 386.1+/-594.5 ng/l, p<0.0001). Our data suggest that MEIA and POCT have quite similar analytical performance but different clinical results. Then, different reference values, as well as cut-off values, should be taken into account for the clinical use of these two immunoassays.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Automation
  • Chemistry, Clinical
  • Child
  • Child, Preschool
  • Female
  • Hemoglobins / chemistry*
  • Humans
  • Immunoenzyme Techniques / classification
  • Immunoenzyme Techniques / methods*
  • Infant
  • Male
  • Middle Aged
  • Nanotechnology
  • Natriuretic Peptide, Brain / blood*
  • Natriuretic Peptide, Brain / chemistry
  • Reference Values
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • Hemoglobins
  • Natriuretic Peptide, Brain