title: Evaluating the QuikRead® C-reactive protein test as a point-of-care test.
abstract: BACKGROUND
  Available tests to diagnose infection in neonates often provide results after 12-24 hours. A bedside test that is reliable will facilitate earlier exclusion or diagnosis of infection.
  
  
  OBJECTIVE
  To validate a bedside C-reactive protein (CRP) test against the currently available laboratory CRP test in neonates with suspected sepsis.
  
  
  METHODS
  This was a prospective observational study where a bedside CRP was done concurrently with and validated against a laboratory CRP in neonates with suspected sepsis. The sensitivities, specificities and predictive values for the bedside CRP tests were calculated using the laboratory CRPs as the reference test.
  
  
  RESULTS
  There were 209 measured CRP-sample pairs. Seventy per cent of these had suspected early-onset neonatal sepsis and 30% had suspected late-onset neonatal sepsis. Twelve per cent had culture-proven sepsis. At the recommended cut-off of 8.0 mg/L for the bedside CRP test, the sensitivity, specificity, positive and negative predictive values were 84%, 80%, 30% and 97%, respectively. Adjusting the cut-off value from 8.0 to 15.0 mg/L improved the specificity to 88%. The sensitivity, specificity and positive and negative predictive values were not different between early-onset and late-onset sepsis. The receiver operating characteristic curve had an area below the curve of 0.84 for the cut-off at 16.2 mg/L on the beside CRP test.
  
  
  CONCLUSIONS
  The bedside CRP test may be used as a screening test to aid decisions to either commence or discontinue antibiotics in circumstances where the clinical diagnosis of sepsis is in doubt. By using a cut-off of 16.0 mg/L for the bedside CRP test, the possibility of a false negative result is minimised.
authors.affiliation: Division of Neonatology, Department of Paediatrics, Chris Hani Baragwanath Academic Hospital, and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. hitesh.diar@wits.ac.za
authors.forename: H A
authors.initials: HA
authors.lastname: Diar
authors.forename: F L
authors.initials: FL
authors.lastname: Nakwa
authors.forename: R
authors.initials: R
authors.lastname: Thomas
authors.forename: E N
authors.initials: EN
authors.lastname: Libhaber
authors.forename: S
authors.initials: S
authors.lastname: Velaphi
mesh_terms: D002097:C-Reactive Protein / Q000032:analysis*; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000097:blood / Q000175:diagnosis*; D008297:Male; D019095:Point-of-Care Systems; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012372:ROC Curve; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D018805:Sepsis / Q000097:blood / Q000175:diagnosis*
chemical_list: D011933:Reagent Kits, Diagnostic; D002097:C-Reactive Protein