Open AccessDevelopment of a new microparticle‐enhanced turbidimetric assay for C‐reactive protein with superior features in analytical sensitivity and dynamic range
Author(s) -
Eda Shinichi,
Kaufmann Jörg,
Roos Werner,
Pohl Stefan
Publication year - 1998
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/(sici)1098-2825(1998)12:3<137::aid-jcla2>3.0.co;2-6
Subject(s) - microparticle , sensitivity (control systems) , range (aeronautics) , chemistry , materials science , physics , engineering , optics , composite material , electronic engineering
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 μl 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. J. Clin. Lab. Anal. 12:137–144, 1998. © 1998 Wiley‐Liss, Inc.