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Interlaboratory variation for NT-proBNP among Swedish laboratories in an external quality program 2011-2021.

Morgan Lundgren1, Peter Ridefelt1, Mathias Karlsson2

  • 1Department of Medical Sciences, Clinical Chemistry, Uppsala University, Uppsala, Sweden.

Clinical Chemistry and Laboratory Medicine
|March 29, 2023
PubMed
Summary

Standardization of NT-proBNP testing is crucial for accurate heart failure diagnosis. Method variations can lead to different patient treatments, emphasizing the need for common calibrators and reference materials.

Keywords:
brainexternal quality assessmentheart failureinter-laboratory variationnatriuretic peptidestandardization

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Area of Science:

  • Clinical Chemistry
  • Biomarker Analysis
  • Cardiovascular Diagnostics

Background:

  • N-terminal pro-B-type natriuretic peptide (NT-proBNP) is a key biomarker for diagnosing heart failure.
  • Established clinical decision limits for NT-proBNP vary based on clinical context (acute vs. chronic) and international guidelines.
  • Limited standardization across different NT-proBNP assay methods poses a challenge for consistent patient management.

Purpose of the Study:

  • To assess the analytical variability of NT-proBNP assays from different manufacturers.
  • To evaluate the impact of method standardization on clinical decision-making for heart failure.
  • To identify the need for improved standardization in NT-proBNP testing.

Main Methods:

  • Analysis of external quality assessment data for NT-proBNP from Equalis (Sweden) between 2011-2021.
  • Categorization of data by manufacturer and comparison of median values to consensus medians.
  • Calculation of coefficient of variation (CV%) for each manufacturer across different NT-proBNP concentration levels.

Main Results:

  • Roche assays showed median results closest to the consensus median.
  • Total CV for NT-proBNP levels between 0-500 ng/L ranged from 4% to 27%.
  • Significant inter-manufacturer variability was observed, with some methods yielding results substantially above or below the consensus median (e.g., Siemens, Abbott).

Conclusions:

  • The introduction of new NT-proBNP methods since 2017 has decreased inter-manufacturer agreement.
  • Clinical guidelines, often based on specific assay methods (e.g., Roche), may not account for current method-related biases.
  • A common calibrator and standardized reference materials are essential to improve NT-proBNP assay harmonization and ensure reliable clinical application.