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Evaluation of four automated high-sensitivity C-reactive protein methods: implications for clinical and
W L Roberts1, R Sedrick, L Moulton
1Department of Pathology, University of Utah Health Sciences Center, Salt Lake City, UT 84132, USA. william.roberts@arup-lab.com
Insights
High-sensitivity C-reactive protein (hs-CRP) assays show method-dependent variations in apparently healthy individuals. Standardization is needed for accurate prognostic risk assessment of atherosclerotic complications.
Area of Science:
- Clinical Chemistry
- Cardiovascular Disease Biomarkers
- Immunodiagnostics
Background:
- C-reactive protein (CRP) offers prognostic value for atherosclerotic risk in healthy individuals.
- Quantifying lower CRP concentrations is crucial for this new clinical application.
Purpose of the Study:
- To evaluate the precision, linearity, and comparability of four automated high-sensitivity CRP (hs-CRP) assays.
- Assess the performance of BN II, Abbott IMx, DPC IMMULITE, and Beckman Coulter IMMAGE methods.
Main Methods:
- Assessed precision (CV) and linearity down to low concentrations.
- Compared results from 322 apparently healthy blood donors across four hs-CRP methods.
- Analyzed method-dependent differences in CRP quartiles.
Main Results:
- All four hs-CRP methods demonstrated acceptable precision and linearity.
- Method-dependent variations were observed in CRP concentrations within a healthy population.
- The IMx and IMMULITE methods showed comparability with the BN II assay, while IMMAGE had more scatter.
Conclusions:
- Significant differences exist among the four evaluated hs-CRP methods for healthy populations.
- Further standardization is essential for correlating hs-CRP results with large-scale epidemiologic studies.
Background:
C-reactive protein (CRP) can provide prognostic information about the risk of developing atherosclerotic complications in apparently healthy patients. This new clinical application requires quantification of CRP concentrations below those traditionally measured in the clinical laboratory.
Methods:
The Dade Behring BN II, the Abbott IMx, the Diagnostic Products Corporation IMMULITE, and the Beckman Coulter IMMAGE are four automated analyzers with high-sensitivity CRP (hs-CRP) methods. We evaluated these assays for precision, linearity, and comparability with samples from 322 apparently healthy blood donors.
Results:
The imprecision (CV) of the BN II, IMx, IMMULITE, and IMMAGE methods was < or = 7.6%, < or = 12%, < or = 9.8%, and < or = 9.7% at 3.5 mg/L, respectively. The BN II, IMx, IMMULITE, and IMMAGE methods were linear down to < or = 0.30, < or = 0.32, < or = 0.85, and 2.26 mg/L, respectively. CRP concentrations demarcating each quartile in a healthy population were method dependent. The IMx method gave results comparable to the BN II method for values in the reference interval. The IMMULITE method had a positive intercept compared with the BN II method. The IMMAGE method demonstrated more scatter and a positive intercept compared with the BN II method, which may reflect the fact that it is a less sensitive assay.
Conclusions:
The four hs-CRP methods exhibited differences in results for a healthy population. Additional standardization efforts are required to ensure that hs-CRP results can be related to large-scale epidemiologic studies.