title: Utility of qualitative C- reactive protein assay and white blood cells counts in the diagnosis of neonatal septicaemia at Bugando Medical Centre, Tanzania.
abstract: BACKGROUND
  Neonatal septicaemia diagnosis based on clinical features alone is non-specific leading to the initiation of unnecessary antibiotic treatment posing a danger of increased antibiotic resistance. In the present study the utility of serial qualitative C-reactive protein (CRP) assay and white blood cells count (WBC) in the diagnosis of neonatal septicaemia was investigated using blood culture as gold standard.
  
  
  METHODS
  A total of 305 neonates admitted at Bugando Medical Centre (BMC) neonatal units between September 2013 and April 2014 were enrolled. Demographic and clinical data were collected using standardized data collection tool. Blood specimens were collected for blood culture, WBC count and qualitative CRP assay.
  
  
  RESULTS
  Of 305 neonates; 224 (73.4%) were ≤ 72 hrs of age and 91(29.8%) had low birth weight. The positive CRP assay was observed in 67 (22.0%), 80 (26.2%) and 88 (28.9%) of neonates on day 1, 2 and 3 respectively; with any CRP positive occurred in 104 (34.1%) of neonates. The sensitivities of CRP assay in the diagnosis of septicaemia using culture as gold standard on day 1, 2, 3 and any positive were 40.4%, 53.2%, 54.8% and 62.9% respectively. While specificities were 82.7%, 80.7%, 77.8% and 73.3% respectively. Higher sensitivity of 75% was observed when CRP was used to diagnose gram negative septicaemia compared to 50% that was observed in the diagnosis of gram positive septicaemia. WBC count of ≥13 × 109 /L had sensitivity and specificity of 64.5% and 66.7% respectively with area under the curve of 0.694. When the any positive CRP and WBC of ≥13 × 109 /L were used the sensitivity increased to 90.3% with specificity of 50%. Neonates with septicaemia due to gram negative bacteria were significantly found to have higher rates of positive CRP than neonates with gram positive septicaemia and with negative culture (p < 0.001, OR 8.2, 95 CI; 2.9-26).
  
  
  CONCLUSIONS
  In place where blood culture is limited neonates having clinical features of neonatal sepsis with positive qualitative CRP assay and increased WBC should urgently be initiated on appropriate sepsis management in order to reduce morbidity and mortality associated with neonatal sepsis.
authors.forename: Flora
authors.initials: F
authors.lastname: Chacha
authors.forename: Mariam M
authors.initials: MM
authors.lastname: Mirambo
authors.forename: Martha F
authors.initials: MF
authors.lastname: Mushi
authors.forename: Neema
authors.initials: N
authors.lastname: Kayange
authors.forename: Antke
authors.initials: A
authors.lastname: Zuechner
authors.forename: Benson R
authors.initials: BR
authors.lastname: Kidenya
authors.affiliation: Department of Microbiology/Immunology Weill Bugando School of Medicine, Catholic University of Health and Allied Sciences (CUHAS), P,O, BOX 1464, Mwanza, Tanzania. mshana72@yahoo.com.
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Mshana
mesh_terms: D002097:C-Reactive Protein / Q000032:analysis*; D003430:Cross-Sectional Studies; D005260:Female; D005334:Fever / Q000453:epidemiology; D006090:Gram-Negative Bacteria / Q000302:isolation & purification; D006094:Gram-Positive Bacteria / Q000302:isolation & purification; D006700:Home Childbirth; D006801:Humans; D007231:Infant, Newborn; D007567:Jaundice, Neonatal / Q000453:epidemiology; D007958:Leukocyte Count; D008297:Male; D008471:Meconium Aspiration Syndrome / Q000453:epidemiology; D010100:Oxygen / Q000097:blood; D011237:Predictive Value of Tests; D012640:Seizures / Q000453:epidemiology; D012680:Sensitivity and Specificity; D018805:Sepsis / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology / Q000382:microbiology; D013636:Tanzania / Q000453:epidemiology
chemical_list: D002097:C-Reactive Protein; D010100:Oxygen