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Updated: Jun 21, 2025
Author Spotlight: Biological Standardization to Ensure Reproducibility and Harmonization in Research
Published on: August 4, 2023
C-Reactive Protein and Brain Natriuretic Peptides Harmonization
Sara Pasqualetti1, Michele Mussap2, Elena Monteverde3
1Laboratory Chimical Chemistry, ASST Ovest Milanese, Hospital of Legnano, Milan, Italy.
Insights
Harmonizing laboratory biomarkers like C-Reactive Protein (CRP) and NT-proBNP is crucial for accurate cardiovascular disease diagnosis. This review found significant measurement variability, highlighting the need for universal standardization to improve patient outcomes.
Area of Science:
- Clinical Chemistry
- Biomarker Standardization
- Cardiovascular Diagnostics
Background:
- Laboratory biomarker harmonization ensures consistent diagnostic outcomes across clinical settings.
- C-Reactive Protein (CRP) and N-Terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) are key biomarkers for cardiovascular disease (CVD) diagnosis and management.
- Variability in biomarker measurements can impact clinical decision-making and patient care.
Purpose of the Study:
- To systematically review the harmonization of C-Reactive Protein (CRP) and N-Terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) measurements.
- To identify the extent of variability in CRP and NT-proBNP assays.
- To emphasize the need for standardized practices in biomarker measurement for improved healthcare delivery.
Main Methods:
- A systematic literature search was conducted on the PubMed database.
- Keywords included C-Reactive Protein, CRP, hs-CRP, N-terminal pro B-type natriuretic peptide, and NT-proBNP.
- Studies published in English involving human subjects between June 1 and September 26, 2021, were included, resulting in 97 articles for analysis.
Main Results:
- Significant variability persists in the measurement of CRP and NT-proBNP.
- This variability stems from a lack of standardized pre-analytical, analytical, and post-analytical practices.
- The identified inconsistencies can negatively affect clinical decisions and patient outcomes.
Conclusions:
- There is a critical need for international standards and guidelines to achieve better harmonization of CRP and NT-proBNP measurements.
- Establishing universal protocols is essential to enhance the reliability of these vital biomarker measurements.
- Improved harmonization will lead to more reliable diagnostic outcomes and better healthcare delivery for cardiovascular diseases.
Abstract:
The harmonization of laboratory biomarkers is pivotal in ensuring consistent and reliable diagnostic outcomes across different clinical settings. This systematic review examines the harmonization of C-Reactive Protein (CRP) and N-Terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) measurements, both of which are jointly utilized in the diagnosis and management of cardiovascular diseases. To identify relevant studies, we searched the PubMed electronic database using specific medical subject headings and keywords such as C-Reactive Protein, CRP, high sensitivity C-Reactive Protein (hs-CRP), N-terminal pro B-type natriuretic peptide, and NT-proBNP, focusing on publications from June 1 to September 26, 2021. The query filtered studies to include only those in English involving human subjects. From our search, 97 articles met the inclusion criteria and were included for in-depth analysis. Despite their widespread use, significant variability remains in the measurements of CRP and NT-proBNP due to a lack of standardized pre-analytical, analytical, and post-analytical practices. This review highlights the consequences of this variability on clinical decision-making and patient outcomes and emphasizes the need for international standards and guidelines to achieve better harmonization. Our findings advocate for the establishment of universal protocols to enhance the reliability of these biomarker measurements across different clinical environments, ensuring improved healthcare delivery.
