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

Eur J Clin Microbiol Infect Dis. 2018 Jul;37(7):1319-1323. doi: 10.1007/s10096-018-3253-3. Epub 2018 May 10.

Abstract

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 ≥ 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.

Keywords: Bedside test; C-reactive protein; Point-of-care test; Rapid test; Respiratory infection.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Biomarkers / analysis
  • C-Reactive Protein / analysis*
  • Diagnostic Tests, Routine / standards
  • Female
  • Humans
  • Male
  • Middle Aged
  • Point-of-Care Testing* / standards
  • Respiratory Tract Infections / diagnosis*
  • Sensitivity and Specificity
  • Young Adult

Substances

  • Biomarkers
  • C-Reactive Protein