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Biologic variability of C-reactive protein: is the available information reliable?
Federica Braga1, Mauro Panteghini
1Centro Interdipartimentale per la Riferibilità Metrologica in Medicina di Laboratorio (CIRME), Università degli Studi, Milano, Italy. federica.braga@unimi.it
Insights
Robust data on C-reactive protein (CRP) biologic variability is lacking. More studies are needed to establish reliable reference change values for accurate cardiovascular risk assessment using CRP levels.
Area of Science:
- Biochemistry
- Clinical Chemistry
- Cardiovascular Medicine
Background:
- C-reactive protein (CRP) is a key indicator of cardiovascular risk.
- Understanding CRP's biologic variability is essential for accurate individual risk assessment and monitoring changes over time.
Purpose of the Study:
- To systematically review existing literature on the biologic variation of C-reactive protein (CRP).
- To evaluate the consistency and quality of data regarding CRP biologic variability.
Main Methods:
- Systematic literature review of studies on CRP biologic variability.
- Evaluation of studies based on subject demographics, study duration, sample collection frequency, sample handling, analytical methods, assay sensitivity, and statistical analysis.
Main Results:
- Eleven studies on CRP biologic variability were identified.
- Most studies had limitations in methodology, population selection, protocol adherence, and statistical analysis.
- The single study meeting all requirements used logarithmic transformation, hindering clinical application.
Conclusions:
- There is a significant lack of high-quality data on the biologic variability of serum CRP.
- Further well-designed studies are required to determine reliable reference change values.
- More research is needed to establish the optimal number of samples for accurate individual cardiovascular risk estimation using CRP.
Background:
C-reactive protein (CRP) is recognized as a marker of cardiovascular risk. The biologic variability of CRP is crucial to understanding its significance in estimation of individual risk and subsequent changes in serial analyses.
Methods:
We systematically reviewed publications on biologic variation of CRP to evaluate the consistency of available data. Data was evaluated with attention to number and type of enrolled subjects, duration of study, frequency of sample collection, sample type, sample storage, analytical methodology, assay sensitivity and statistical analysis.
Results:
A total of eleven studies on CRP biologic variability were recruited from literature. The majority of studies were limited by choice of analytic methodology, population selection, protocol application, and statistical analysis. Unfortunately, the only study that fulfilled all major pre-analytical, analytical and post-analytical requirements derived biologic variability from logarithmically transformed data, thus making application to clinical practice difficult.
Conclusions:
There is a paucity of robust data on biologic CRP variability in serum. It is obvious that additional well defined studies are needed to define reliable values of reference change values and of number of samples required to estimate the individual's cardiovascular risk by CRP.
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