Performance characteristics of an automated high-sensitivity C-reactive protein assay on the Dimension RXL analyzer

Background: C-reactive protein (CRP) is a nonspecific marker of inflammation that can be used as a marker for atherosclerotic risk. This application requires increased precision at low CRP concentrations compared to traditional assays. Methods: The Dimension RXL is an automated chemistry analyzer fo...

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Bibliographic Details
Published in:Clinica chimica acta 2002-09, Vol.323 (1), p.151-155
Main Authors: De, Barun K, Smith, Linda G, Owen, William E, Roberts, William L
Format: Article
Language:English
Subjects:
Adult
Aged
Arteriosclerosis - blood
Atherosclerosis
Autoanalysis - instrumentation
Autoanalysis - methods
Automation - instrumentation
Automation - methods
Biological and medical sciences
C-reactive protein
C-Reactive Protein - analysis
Disease Susceptibility
Humans
Immunoassay
Investigative techniques, diagnostic techniques (general aspects)
Medical sciences
Middle Aged
Miscellaneous. Technology
Pathology. Cytology. Biochemistry. Spectrometry. Miscellaneous investigative techniques
Reference Values
Sensitivity and Specificity
Software
Turbidimetry
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Summary:Background: C-reactive protein (CRP) is a nonspecific marker of inflammation that can be used as a marker for atherosclerotic risk. This application requires increased precision at low CRP concentrations compared to traditional assays. Methods: The Dimension RXL is an automated chemistry analyzer for central laboratory use. The limit of detection, limit of quantification, linearity and imprecision of a high-sensitivity CRP assay developed for it were assessed. Method comparison studies were performed using samples both inside and outside the reference interval. The presence of a prozone effect was also evaluated. Results: The limit of detection was 0.7 mg/l. The method was linear from 2 to 60 mg/l and from 1 to 60 mg/l using systematic error limits of 10% and 20%, respectively. The total imprecision was
ISSN:0009-8981
1873-3492
DOI:10.1016/S0009-8981(02)00185-7