title: Development of a new microparticle-enhanced turbidimetric assay for C-reactive protein with superior features in analytical sensitivity and dynamic range.
abstract: 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.
authors.affiliation: F. Hoffmann-La Roche Ltd. Diagnostics Division, Basel, Switzerland. shinichi.eda@roche.com
authors.forename: S
authors.initials: S
authors.lastname: Eda
authors.forename: J
authors.initials: J
authors.lastname: Kaufmann
authors.forename: W
authors.initials: W
authors.lastname: Roos
authors.forename: S
authors.initials: S
authors.lastname: Pohl
mesh_terms: D000787:Angina Pectoris / Q000175:diagnosis; D000911:Antibodies, Monoclonal / Q000378:metabolism; D002097:C-Reactive Protein / Q000032:analysis*; D018604:Epitope Mapping; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007700:Kinetics; D008863:Microspheres; D009391:Nephelometry and Turbidimetry / Q000295:instrumentation / Q000379:methods*; D010316:Particle Size; D012044:Regression Analysis; D012680:Sensitivity and Specificity
chemical_list: D000911:Antibodies, Monoclonal; D002097:C-Reactive Protein