title: Evaluation of the Broad-Range PCR/ESI-MS Technology in Blood Specimens for the Molecular Diagnosis of Bloodstream Infections.
abstract: BACKGROUND
  Rapid identification of the etiological agent in bloodstream infections is of vital importance for the early administration of the most appropriate antibiotic therapy. Molecular methods may offer an advantage to current culture-based microbiological diagnosis. The goal of this study was to evaluate the performance of IRIDICA, a platform based on universal genetic amplification followed by mass spectrometry (PCR/ESI-MS) for the molecular diagnosis of sepsis-related pathogens directly from the patient's blood.
  
  
  METHODS
  A total of 410 whole blood specimens from patients admitted to Emergency Room (ER) and Intensive Care Unit (ICU) with clinical suspicion of sepsis were tested with the IRIDICA BAC BSI Assay (broad identification of bacteria and Candida spp.). Microorganisms grown in culture and detected by IRIDICA were compared considering blood culture as gold standard. When discrepancies were found, clinical records and results from other cultures were taken into consideration (clinical infection criterion).
  
  
  RESULTS
  The overall positive and negative agreement of IRIDICA with blood culture in the analysis by specimen was 74.8% and 78.6%, respectively, rising to 76.9% and 87.2% respectively, when compared with the clinical infection criterion. Interestingly, IRIDICA detected 41 clinically significant microorganisms missed by culture, most of them from patients under antimicrobial treatment. Of special interest were the detections of one Mycoplasma hominis and two Mycobacterium simiae in immunocompromised patients. When ICU patients were analyzed separately, sensitivity, specificity, positive and negative predictive values compared with blood culture were 83.3%, 78.6%, 33.9% and 97.3% respectively, and 90.5%, 87.2%, 64.4% and 97.3% respectively, in comparison with the clinical infection criterion.
  
  
  CONCLUSIONS
  IRIDICA is a promising technology that offers an early and reliable identification of a wide variety of pathogens directly from the patient's blood within 6h, which brings the opportunity to improve management of septic patients, especially for those critically ill admitted to the ICU.
authors.affiliation: Microbiology Service, Germans Trias i Pujol University Hospital, Department of Genetics and Microbiology, Autonomous University of Barcelona, Badalona, Spain; CIBER in Respiratory Diseases (CIBERES), Madrid, Spain; Health Sciences Research Institute (IGTP), Badalona, Spain.
authors.forename: Elena
authors.initials: E
authors.lastname: Jordana-Lluch
authors.affiliation: Microbiology Service, Germans Trias i Pujol University Hospital, Department of Genetics and Microbiology, Autonomous University of Barcelona, Badalona, Spain; CIBER in Respiratory Diseases (CIBERES), Madrid, Spain.
authors.forename: Montserrat
authors.initials: M
authors.lastname: Giménez
authors.affiliation: Microbiology Service, Germans Trias i Pujol University Hospital, Department of Genetics and Microbiology, Autonomous University of Barcelona, Badalona, Spain.
authors.forename: M Dolores
authors.initials: MD
authors.lastname: Quesada
authors.affiliation: Microbiology Service, Germans Trias i Pujol University Hospital, Department of Genetics and Microbiology, Autonomous University of Barcelona, Badalona, Spain.
authors.forename: Belén
authors.initials: B
authors.lastname: Rivaya
authors.affiliation: Microbiology Service, Germans Trias i Pujol University Hospital, Department of Genetics and Microbiology, Autonomous University of Barcelona, Badalona, Spain.
authors.forename: Clara
authors.initials: C
authors.lastname: Marcó
authors.affiliation: Emergency Room, Germans Trias i Pujol University Hospital, Badalona, Spain.
authors.forename: M Jesús
authors.initials: MJ
authors.lastname: Domínguez
authors.affiliation: Intensive Care Unit, Germans Trias i Pujol University Hospital, Badalona, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Arméstar
authors.affiliation: Microbiology Service, Germans Trias i Pujol University Hospital, Department of Genetics and Microbiology, Autonomous University of Barcelona, Badalona, Spain; Health Sciences Research Institute (IGTP), Badalona, Spain; CIBER in Epidemiology and Public Health (CIBERESP), Madrid, Spain.
authors.forename: Elisa
authors.initials: E
authors.lastname: Martró
authors.affiliation: Microbiology Service, Germans Trias i Pujol University Hospital, Department of Genetics and Microbiology, Autonomous University of Barcelona, Badalona, Spain; CIBER in Respiratory Diseases (CIBERES), Madrid, Spain; Health Sciences Research Institute (IGTP), Badalona, Spain.
authors.forename: Vicente
authors.initials: V
authors.lastname: Ausina
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000494:pharmacology; D001769:Blood / Q000382:microbiology*; D024881:Drug Resistance, Bacterial / Q000235:genetics; D004636:Emergency Service, Hospital; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D016133:Polymerase Chain Reaction / Q000379:methods*; D018805:Sepsis / Q000097:blood* / Q000175:diagnosis* / Q000382:microbiology; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents