title: Evaluation of the Septifast MGrade Test on Standard Care Wards--A Cohort Study.
abstract: BACKGROUND
  The immediate need for appropriate antimicrobial therapy in septic patients requires the detection of the causative pathogen in a timely and reliable manner. In this study, the real-time PCR Septifast MGrade test was evaluated in adult patients meeting the systemic inflammatory response syndrome (SIRS) criteria that were treated at standard care wards.
  
  
  METHODS
  Patients with clinical suspected infection, drawn blood cultures (BC), the Septifast M(Grade) test (SF) and sepsis biomarkers were prospectively screened for fulfillment of SIRS criteria and evaluated using the criteria of the European Centre of Disease Control (ECDC) for infection point prevalence studies.
  
  
  RESULTS
  In total, 220 patients with SIRS were prospectively enrolled, including 56 patients with detection of bacteria in the blood (incidence: 25.5%). BC analysis resulted in 75.0% sensitivity (95% confidence interval, CI: 61.6%- 85.6%) with 97.6% specificity (CI: 93.9%- 99.3%) for detecting bacteria in the blood. In comparison to BC, SF presented with 80.4% sensitivity (CI: 67.6%- 89.8%) and with 97.6% specificity (CI: 93.9%- 99.3%). BC and SF analysis yielded comparable ROC-AUCs (0.86, 0.89), which did not differ significantly (p = 0.558). A trend of a shorter time-to-positivity of BC analysis was not seen in bacteremic patients with a positive SF test than those with a negative test result. Sepsis biomarkers, including PCT, IL-6 or CRP, did not help to explain discordant test results for BC and SF.
  
  
  CONCLUSIONS
  Since negative results do not exclude bacteremia, the Septifast M(Grade) test is not suited to replacing BC, but it is a valuable tool with which to complement BC for faster detection of pathogens.
authors.affiliation: Department of Laboratory Medicine, Division of Medical and Chemical Laboratory Diagnostics, Medical University of Vienna, Vienna, Austria.
authors.forename: Franz
authors.initials: F
authors.lastname: Ratzinger
authors.affiliation: Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria.
authors.forename: Irene
authors.initials: I
authors.lastname: Tsirkinidou
authors.affiliation: Department of Laboratory Medicine, Division of Medical and Chemical Laboratory Diagnostics, Medical University of Vienna, Vienna, Austria.
authors.forename: Helmuth
authors.initials: H
authors.lastname: Haslacher
authors.affiliation: Department of Laboratory Medicine, Division of Medical and Chemical Laboratory Diagnostics, Medical University of Vienna, Vienna, Austria.
authors.forename: Thomas
authors.initials: T
authors.lastname: Perkmann
authors.affiliation: Department of Laboratory Medicine, Division of Medical and Chemical Laboratory Diagnostics, Medical University of Vienna, Vienna, Austria.
authors.forename: Klaus G
authors.initials: KG
authors.lastname: Schmetterer
authors.affiliation: Department of Laboratory Medicine, Division of Clinical Microbiology, Medical University of Vienna, Vienna, Austria.
authors.forename: Dieter
authors.initials: D
authors.lastname: Mitteregger
authors.affiliation: Department of Laboratory Medicine, Division of Clinical Microbiology, Medical University of Vienna, Vienna, Austria.
authors.forename: Athanasios
authors.initials: A
authors.lastname: Makristathis
authors.affiliation: Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria.
authors.forename: Heinz
authors.initials: H
authors.lastname: Burgmann
mesh_terms: D000328:Adult; D000368:Aged; D016470:Bacteremia / Q000097:blood / Q000175:diagnosis / Q000382:microbiology; D001419:Bacteria / Q000235:genetics / Q000302:isolation & purification*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D060888:Real-Time Polymerase Chain Reaction; D018746:Systemic Inflammatory Response Syndrome / Q000097:blood* / Q000175:diagnosis / Q000382:microbiology*