Abstract
An improved turbidimetric assay for the measurement of C-reactive protein (CRP) has been evaluated in six laboratories on various analytical systems (Boehringer Mannheim Hitachi systems 704, 717, 747, 911, 917 and on Keysys® analyzer). Compared to the previous test version this assay has better transferability of results from instrument to instrument, less lipemia and gammopathy interference, a better linearity in the lower concentration range, the applicability of EDTA plasma or heparin plasma and a satisfactory recovery of target values according to CRM 470 standardization. The detection limit of the Tina-quant® CRP assay is 1.9 mg/l CRP. Median values of CVs within run of lower than 2.5% and between day of lower than 3.3% were obtained. A survey with 50 human pool sera revealed a good transferability of results obtained in different laboratories and on different analytical systems. Method comparison studies between the Tina-quant® CRP assay and fixed-time nephelometry, rate nephelometry and turbidimetry were in reasonable agreement (± 10%) throughout the entire measuring range. No drift effect was noticed with the tubing system on Boehringer Mannheim/Hitachi 747 analyzers. The reagent and calibration stability was extended to 12 weeks. The Tina-quant® CRP assay enables the precise, accurate, rapid and convenient determination of CRP used for routine clinical chemistry and STAT purposes.
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