title: Performance of a Novel Molecular Method in the Diagnosis of Late-Onset Sepsis in Very Low Birth Weight Infants.
abstract: OBJECTIVE
  To compare the use of a generic molecular assay to 'standard' investigations used to assist the diagnosis of late onset bacterial sepsis in very low birth weight infants (VLBW, <1500 g).
  
  
  METHODS
  VLBW infants, greater than 48 hours of age, who were clinically suspected to have sepsis were investigated using standard tests (full blood count, C-reactive protein (at presentation) and blood culture), in addition, blood was taken for a universal molecular assay (16S rRNA reverse transcriptase PCR) for comparison. Clinical data were recorded during the suspected infection episode. A validated sepsis score (NEO-KISS) was used to retrospectively determine the presence of sepsis (independent of blood culture). The performance of each of the tests were compared by sensitivity, specificity, positive/negative likihood ratios (+/-LR) and postive/negative predictive values (PPV/NPV).
  
  
  RESULTS
  Sixty-five babies with suspected clinical sepsis were prospectively included. The performance indicators are presented with 95% confidence limits. For the detection of bacteria, blood culture had sensitivity of 0.57 (0.34-0.78), specificity of 0.45 (0.30-0.61); +LR of 1.05 (0.66-1.66) and-LR of 0.94 (0.52-1.7); PPV of 33.3 (18.56-50.97) and NPV of 68.97 (49.17-87.72). Serum CRP had sensitivity of 0.92 (0.64-1) and specificity of 0.36 (0.17-0.59); +LR of 1.45 (1-2.1) and-LR of 0.21 (0.03-1.5); PPV of 44.46 (26.6-66.6) and NPV of 88.9 (51.8-99.7). The universal molecular assay had sensitivity of 0.76 (0.53-0.92), specificity of 0.95 (0.85-0.99); +LR of 16.8 (4.2-66.3) and-LR of 0.25 (0.1-0.5); PPV of 88.9 (65.3-98.6) and NPV of 89.4 (76.9-96.5).
  
  
  CONCLUSIONS
  In VLBW infants this universal molecular assay performed better in the diagnosis of late onset sepsis (LOS) than blood culture and CRP. Further development is required to explore and improve the performance of the assay in real-time diagnosis.
authors: St Michael's Hospital, University Hospitals Bristol, Foundation Trust, Bristol, United Kingdom.
authors: Jonathan
authors: J
authors: Davis
authors: Belfast Health & Social Care Trust, Belfast, United Kingdom.
authors: Sharon
authors: S
authors: Christie
authors: Belfast Health & Social Care Trust, Belfast, United Kingdom.
authors: Derek
authors: D
authors: Fairley
authors: Belfast Health & Social Care Trust, Belfast, United Kingdom.
authors: Peter
authors: P
authors: Coyle
authors: Belfast Health & Social Care Trust, Belfast, United Kingdom.
authors: Richard
authors: R
authors: Tubman
authors: Belfast Health & Social Care Trust, Belfast, United Kingdom; The Queen's University of Belfast, Belfast, United Kingdom.
authors: Michael D
authors: MD
authors: Shields
mesh_terms: D017668:Age of Onset; D002097:C-Reactive Protein / Q000378:metabolism; D005260:Female; D006403:Hematologic Tests / Q000379:methods*; D006801:Humans; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight / Q000097:blood*; D008297:Male; D012336:RNA, Ribosomal, 16S / Q000235:genetics; D012372:ROC Curve; D018805:Sepsis / Q000097:blood* / Q000175:diagnosis*
chemical_list: D012336:RNA, Ribosomal, 16S; D002097:C-Reactive Protein