title: Diagnosis of neonatal sepsis using universal primer polymerase chain reaction before and after starting antibiotic drug therapy.
abstract: OBJECTIVE
  To study universal primer 16S rRNA gene polymerase chain reaction (PCR) for diagnosis of blood culture-positive neonatal sepsis before and after starting antibiotic drug therapy.
  
  
  METHODS
  Prospective study of diagnostic tests.
  
  
  METHODS
  Level III neonatal intensive care unit. Patients Neonates with a fresh episode of clinically suspected sepsis were enrolled; those with major malformations, life expectancy less than 12 hours, or contaminated blood cultures were excluded.
  
  
  METHODS
  Before starting antibiotic drug therapy, PCR (0 hour), blood culture, and sepsis screening (complete blood cell counts, micro-erythrocyte sedimentation rate, and C-reactive protein level) were performed. The PCR was repeated 12, 24, and 48 hours after starting antibiotic drug therapy.
  
  
  METHODS
  The primary outcomes were the sensitivity and specificity of 0-hour PCR for diagnosing blood culture-positive sepsis, and the secondary outcome was the proportion of 0-hour PCR-positive patients who remained positive after antibiotic drug therapy.
  
  
  RESULTS
  Of 306 patients evaluated, 242 were included (mean [SD] gestation, 32.2 [3.1] weeks; and mean [SD] birth weight, 1529.2 [597.2] g). Blood culture was positive in 52 patients and 0-hour PCR in 57. The sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios of PCR were 96.2%, 96.3%, 87.7%, 98.8%, 26.1, and 0.04, respectively. Two patients were blood culture positive but 0-hour PCR negative, whereas 7 were 0-hour PCR positive but blood culture negative. Of the 0-hour PCR-positive patients, 7 remained positive at 12 hours and none at 24 and 48 hours after starting antibiotic drug therapy. In 0-hour PCR-positive patients, no predictors of positive 12-hour PCR were identified.
  
  
  CONCLUSIONS
  Universal primer PCR can accurately diagnose neonatal sepsis before but not after antibiotic drugs are given.
authors.affiliation: Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh 160012, India. sourabhdutta@yahoo.co.in
authors.forename: Sourabh
authors.initials: S
authors.lastname: Dutta
authors.forename: Anil
authors.initials: A
authors.lastname: Narang
authors.forename: Anuradha
authors.initials: A
authors.lastname: Chakraborty
authors.forename: Pallab
authors.initials: P
authors.lastname: Ray
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001769:Blood / Q000382:microbiology*; D002097:C-Reactive Protein / Q000032:analysis; D015331:Cohort Studies; D017931:DNA Primers; D004269:DNA, Bacterial / Q000032:analysis; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy; D007363:Intensive Care Units, Neonatal; D008297:Male; D016133:Polymerase Chain Reaction / Q000379:methods*; D011446:Prospective Studies; D012336:RNA, Ribosomal, 16S; D012680:Sensitivity and Specificity; D018805:Sepsis / Q000097:blood / Q000175:diagnosis* / Q000188:drug therapy*
chemical_list: D000900:Anti-Bacterial Agents; D017931:DNA Primers; D004269:DNA, Bacterial; D012336:RNA, Ribosomal, 16S; D002097:C-Reactive Protein