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

Maria Franzini¹, Silvia Masotti, Concetta Prontera

¹Scuola Superiore Sant'Anna, Pisa, Italy; Department of Laboratory Medicine, Fondazione Toscana G. Monasterio, Pisa, Italy.

Clinica Chimica Acta; International Journal of Clinical Chemistry

|July 16, 2013

Summary

Different B-type natriuretic peptide (BNP) immunoassays show significant variations. This study compared the new ST-AIA-PACK (TOSOH) method with others, finding notable differences in BNP measurements and heart failure patient classification.

Keywords:

BNP Heart failure Immunoassay Method comparison Quality control

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Area of Science:

Clinical Chemistry
Biomarker Assay Validation
Cardiovascular Diagnostics

Background:

Commercial immunoassays for B-type natriuretic peptide (BNP) exhibit significant systematic differences.
Variability in BNP assay results can impact clinical decision-making.

Purpose of the Study:

To compare the performance of the new ST-AIA-PACK (TOSOH Corporation) BNP immunoassay with existing methods.
To evaluate the clinical utility of the TOSOH method in classifying heart failure patients.

Main Methods:

BNP levels were measured in healthy subjects and heart failure patients using the ST-AIA-PACK and Triage Biosite methods.
External quality assessment samples were analyzed using TOSOH and other common Italian BNP immunoassays.

Main Results:

The TOSOH method demonstrated good correlation but significant underestimation compared to the Triage Biosite method (-46.9%).
The TOSOH method showed agreement with ADVIA Centaur but underestimated BNP compared to Triage (-52.5%) and ARCHITECT (-39.4%).
Classification of heart failure patients using a 100 ng/L BNP cutoff showed 65% positive agreement and 73% overall agreement between ST-AIA-PACK and Triage Biosite.

Conclusions:

Marked differences exist among commercial BNP assay methods.
Assay variability necessitates careful consideration when interpreting BNP results and classifying heart failure.