Analytical performance of a platform for point-of-care CRP testing in adults consulting for lower respiratory tract infection in primary care

作者：Matheeussen Veerle^*; Van Hoof Viviane; Loens Katherine; Lammens Christine; Vanderstraeten Anouk; Coenen Samuel; Butler Chris C; Little Paul; Verheij Theo J M; Goossens Herman; Ieven Margareta

来源：European Journal of Clinical Microbiology & Infectious Diseases, 2018, 37(7): 1319-1323.

DOI：10.1007/s10096-018-3253-3

• C-reactive protein
• Point-of-care test
• Rapid test
• Bedside test
• Respiratory infection

C-reactive protein (CRP) is a biomarker widely used for disease severity assessment and treatment of inflammatory conditions. Point-of-care testing (POCT) devices should ideally be rapid and provide similar results to standard tests done in laboratories. Two thousand nine hundred twenty-two serum samples were obtained from adult patients presenting to primary care with symptoms of lower respiratory infection in a European diagnostic study. The analytic performance of the CRP QuikRead POCT device (Orion Diagnostica) was evaluated by comparing results with a central laboratory method (Dimension Vista, Siemens), with both tests performed in a laboratory setting. For a CRP cut-off concentration of ae 30 mg/L, the QuikRead test had a sensitivity of 92.2%, and specificity of 99.4%. The mean difference between the QuikRead and the central lab test was 0.4 mg/L. The slope of the Passing-Bablok regression was 0.94 (95% CI 0.93-0.95) indicating an underestimation of CRP levels of 6% by QuikRead. CRP estimates obtained from the QuikRead test correlate well with a central laboratory assay and the measurement displays low inter-assay variation. Therefore, the QuikRead test is a good candidate for CRP testing in primary care.

• 出版日期2018-7