Abstract
OBJECTIVES: The use of point-of-care (POC) methods and the measurements of C-reactive protein (CRP) as a diagnostic marker have both increased over the past years. This has led to an increase in POC-methods analysing CRP. High CRP levels are often seen as an indication for the subscription of antibiotics. The quality of POC-systems compared to routine diagnostic measurements for the analysis of CRP is thereby of main importance, since many small practises will use POC-methods. This study compared high-level CRP concentrations (above 100 mg/L) using an i-CHROMA(TM) with 2 routinely used laboratory-based systems (Architect and ABX). DESIGN: and Methods: A total of 199 patient samples with a CRP concentration above 100 mg/L were analysed with the i-CHROMA(TM) POC system and the turbidimetric routine methods using the Architect and ABX equipment. RESULTS: The results of the i-CHROMA(TM) device showed a significant decrease in the CRP levels compared to those obtained with the Architect and the ABX (i-CHROMA(TM) vs. Architect: y = 0.6792x + 94.701; R(2) = 0.4980, i-CHROMA(TM) vs. ABX: y = 0.3674x + 118.05; R(2) = 0.3964, Architect vs. ABX: y = 0.7657x + 36.337; R(2) = 0.9311). Furthermore, data analysis showed a partition of the i-CHROMA(TM) measurements in two defined clouds, which could not be explained with any of the available sample information. CONCLUSIONS: This analysis showed the limitations of the i-CHROMA(TM) CRP analyser. In addition, it illustrates the need for strict regulations on the information and output provided by companies regarding the boundaries of novel and existing diagnostic methods.