title: Evaluation of a polymerase chain reaction assay for pathogen detection in septic patients under routine condition: an observational study.
abstract: BACKGROUND
  Treatment of septic shock relies on appropriate antimicrobial therapy. Current culture based methods deliver final results after days, which may delay potentially lifesaving adjustments in antimicrobial therapy. This study was undertaken to compare PCR with blood culture results under routine conditions regarding 1. impact on antimicrobial therapy, and 2. time to result, in patients with presumed sepsis.
  
  
  RESULTS
  This was an observational study in a 50 beds ICU of a university hospital. In 245 patients with suspected sepsis, 311 concomitant blood cultures and blood for multiplex PCR (VYOO(®)) were obtained. 45 of 311 blood cultures (14.5%) and 94 of 311 PCRs (30.1%) were positive. However, blood culture or microbiological sampling from the presumed site of infection rarely confirmed PCR results and vice versa. Median time to positivity and interquartile range were 24.2 (18.0, 27.5) hours for the PCR and 68 (52.2, 88.5) hours for BC (p<0.01). PCR median time to result was dependent on technician availability (53.5 hours on Saturdays, 7.2 hours under optimal logistic conditions). PCR results showed good correlation with procalcitonin (p<0.001). In 34% of patients with positive PCRs antimicrobial therapy was considered inadequate according to assessment of clinical arbitrators including 5 patients with vancomycin-resistant enterococci (VRE), 3 cases with multiresistant staphylococci, and 4 patients with fungi.
  
  
  CONCLUSIONS
  The results of this observational study support the hypothesis that PCR results are available faster, are more frequently positive, and may result in earlier adjustment of antimicrobial therapy. However, shorter time to result can only be fully exploited when the laboratory is adequately staffed for a 24 hour/7 day service, or when point of care/automated assay systems become available.
authors.affiliation: Deptartment of Anesthesiology and Intensive Care Therapy, Jena University Hospital, Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Bloos
authors.forename: Svea
authors.initials: S
authors.lastname: Sachse
authors.forename: Andreas
authors.initials: A
authors.lastname: Kortgen
authors.forename: Mathias W
authors.initials: MW
authors.lastname: Pletz
authors.forename: Marc
authors.initials: M
authors.lastname: Lehmann
authors.forename: Eberhard
authors.initials: E
authors.lastname: Straube
authors.forename: Niels C
authors.initials: NC
authors.lastname: Riedemann
authors.forename: Konrad
authors.initials: K
authors.lastname: Reinhart
authors.forename: Michael
authors.initials: M
authors.lastname: Bauer
mesh_terms: D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001419:Bacteria / Q000235:genetics / Q000302:isolation & purification*; D004269:DNA, Bacterial / Q000235:genetics / Q000302:isolation & purification; D004271:DNA, Fungal / Q000235:genetics / Q000302:isolation & purification; D005260:Female; D005658:Fungi / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods*; D018805:Sepsis / Q000097:blood / Q000175:diagnosis* / Q000188:drug therapy*
chemical_list: D000900:Anti-Bacterial Agents; D004269:DNA, Bacterial; D004271:DNA, Fungal