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Quality Specifications for BNP and NT-proBNP as Cardiac Biomarker Assays

The Committee on Standardization of Markers of Cardiac Damage of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) published quality specifications for BNP and NT-proBNP as cardiac biomarkers assays in 2005. The recommendations proposed were intended for use by manufacturers of commercial assays, by clinical laboratories using those assays, by clinical trial groups and research investigators, and by regulatory agencies, such as the FDA. The main objectives of these recommendations were as follows:

  • • The manufacturers should endorse and then consistently follow the proposed recommendations.
  • • All package inserts for B-type natriuretic peptide immunoassays should include uniform information on assay design, preanalytical performance characteristics, analytical performance characteristics, and clinical performance characteristics.
  • • Quality specifications for each assay should be published in peer-reviewed journals.
  • • Regulatory agencies should adopt a minimal and uniform set of criteria for manufacturers to provide when seeking clearance for new and/or improved assays.
 
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