Document Detail

Development of a new microparticle-enhanced turbidimetric assay for C-reactive protein with superior features in analytical sensitivity and dynamic range.
MedLine Citation:
PMID:  9591699     Owner:  NLM     Status:  MEDLINE    
Novel assay techniques were applied to a newly developed microparticle-based assay for C-reactive protein (CRP). By using two different sized microparticles covalently coated with two monoclonal antibodies of different reactivity, high analytical sensitivity and a high upper measuring limit could be simultaneously attained, resulting in a remarkably wide dynamic range. This range was further increased by calculating the signal (reaction rate) optimally with a new software capability of COBAS INTEGRA, a clinical chemistry analyzer. The assay showed high precision between 2 mg/l and 160 mg/l with use of only 2.5 microl specimen. The detection limit was estimated as 0.3 mg/l CRP. The assay was four to eight times more sensitive and precise than existing turbidimetric or nephelometric assays with comparable upper measuring limits. The assay also showed good linearity and correlated well with commercial assays. This new microparticle-based CRP assay provides the accuracy and precision that are required to determine CRP at low concentrations where new clinical implications such as prognosis of cardiovascular diseases are envisaged. The assay's wide dynamic range will additionally lead to a reduction in the number of repeated analyses, thus improving the efficiency of CRP determinations in clinical laboratories.
S Eda; J Kaufmann; W Roos; S Pohl
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of clinical laboratory analysis     Volume:  12     ISSN:  0887-8013     ISO Abbreviation:  J. Clin. Lab. Anal.     Publication Date:  1998  
Date Detail:
Created Date:  1998-06-26     Completed Date:  1998-06-26     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  8801384     Medline TA:  J Clin Lab Anal     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  137-44     Citation Subset:  IM    
F. Hoffmann-La Roche Ltd. Diagnostics Division, Basel, Switzerland.
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MeSH Terms
Angina Pectoris / diagnosis
Antibodies, Monoclonal / metabolism
C-Reactive Protein / analysis*
Epitope Mapping
Immunoassay / methods
Nephelometry and Turbidimetry / instrumentation,  methods*
Particle Size
Regression Analysis
Sensitivity and Specificity
Reg. No./Substance:
0/Antibodies, Monoclonal; 9007-41-4/C-Reactive Protein

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