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Evaluation of Denka-Seiken turbidimetric high-sensitivity C-reactive protein assay
Hyun Ju Sung1, Jeong-Ho Kim, Rojin Park
1Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Korea.
Insights
High-sensitivity C-reactive protein (hsCRP) testing is reliable for assessing inflammation and coronary heart disease (CHD) risk. This study confirms its precision and accuracy on automated analyzers, supporting its clinical utility.
Area of Science:
- Clinical Chemistry
- Cardiovascular Disease Biomarkers
- Inflammation Markers
Background:
- High-sensitivity C-reactive protein (hsCRP) is a key prognostic indicator for acute coronary syndrome.
- Accurate hsCRP measurement is crucial for cardiovascular risk assessment and inflammation monitoring.
Purpose of the Study:
- To evaluate the analytical performance of a specific hsCRP assay (Denka-Seiken CRP II Latex X2).
- To assess hsCRP measurement precision, sensitivity, linearity, and potential interferences on two automated analyzers (Olympus AU 640, Hitachi 747).
Main Methods:
- Turbidimetric method for hsCRP determination.
- Evaluation on Olympus AU 640 and Hitachi 747 chemistry autoanalyzers.
- Assessment of precision (CV), functional sensitivity, linearity, and interference studies (triglycerides, hemoglobin).
Main Results:
- Satisfactory within-run and between-run precision for hsCRP on both analyzers.
- Functional sensitivities: 0.19 mg/l (Hitachi 747) and 0.41 mg/l (Olympus AU 640).
- Assay linearity up to 300 mg/l; no significant interference below triglyceride 34 mmol/l and hemoglobin 4 g/l.
Conclusions:
- The Denka-Seiken hsCRP turbidimetric assay demonstrates satisfactory analytical performance.
- The method is acceptable for coronary heart disease (CHD) risk assessment and as a general inflammation marker.
- hsCRP measurement is reliable for clinical use in cardiovascular risk stratification.
Abstract:
C-reactive protein measured with a high sensitivity method (hsCRP) is an important prognostic indicator in patients with an acute coronary syndrome. We evaluated hsCRP measurement with regard to its precision, functional sensitivity, linearity, and interferences using Denka-Seiken CRP II Latex X2 turbidimetric method on two chemistry autoanalyzers: Olympus AU 640 and Hitachi 747. The coefficients of variation (CV) for within-run and between-run precision of hsCRP were satisfactory on both autoanalyzers. Functional sensitivities, expressed as concentrations associated with 10% total interassay CV, were 0.19 mg/l for the Hitachi 747 analyzer and 0.41 mg/l for the Olympus AU 640. The assay was linear up to 300 mg/l with a wide measuring range, which suggested the possibility of using this hsCRP measurement as an inflammation marker and as a risk marker for coronary heart disease (CHD). No significant interference was observed up to a triglyceride concentration of 34 mmol/l, and up to hemoglobin concentration of 4 g/l. The determination of hsCRP by turbidimetric method was satisfactory and acceptable for CHD risk assessment, as well as for use as a marker of inflammation.
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