title: Prospective intervention study with a microarray-based, multiplexed, automated molecular diagnosis instrument (Verigene system) for the rapid diagnosis of bloodstream infections, and its impact on the clinical outcomes.
abstract: The Verigene Gram-positive blood culture test (BC-GP) and the Verigene Gram-negative blood culture test (BC-GN) identify representative Gram-positive bacteria, Gram-negative bacteria and their antimicrobial resistance by detecting resistance genes within 3 h. Significant benefits are anticipated due to their rapidity and accuracy, however, their clinical utility is unproven in clinical studies. We performed a clinical trial between July 2014 and December 2014 for hospitalized bacteremia patients. During the intervention period (N = 88), Verigene BC-GP and BC-GN was used along with conventional microbiological diagnostic methods, while comparing the clinical data and outcomes with those during the control period (N = 147) (UMIN registration ID: UMIN000014399). The median duration between the initiation of blood culture incubation and the reporting time of the Verigene system results was 21.7 h (IQR 18.2-26.8) and the results were found in 88% of the cases by the next day after blood cultures were obtained without discordance. The hospital-onset infection rate was higher in the control period (24% vs. 44%, p = 0.002), however, no differences were seen in co-morbidities and severity between the control and intervention periods. During the intervention period, the time of appropriate antimicrobial agents' initiation was significantly earlier than that in the control period (p = 0.001) and most cases (90%; 79/88) were treated with antimicrobial agents with in-vitro susceptibility for causative bacteria the day after the blood culture was obtained. The costs for antimicrobial agents were lower in the intervention period (3618 yen vs. 8505 yen, p = 0.001). The 30-day mortality was lower in the intervention period (3% vs. 13%, p = 0.019).
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, Tsukuba, Japan; Department of Clinical Laboratory Medicine, Tsukuba Medical Center Hospital, Tsukuba, Japan. Electronic address: hsuzuki@tmch.or.jp.
authors.forename: Hiromichi
authors.initials: H
authors.lastname: Suzuki
authors.affiliation: Department of Infectious Disease, University of Tsukuba Hospital, Tsukuba, Japan.
authors.forename: Shigemi
authors.initials: S
authors.lastname: Hitomi
authors.affiliation: Miroku Medical Laboratory Inc., Saku, Japan.
authors.forename: Yuji
authors.initials: Y
authors.lastname: Yaguchi
authors.affiliation: Miroku Medical Laboratory Inc., Saku, Japan.
authors.forename: Kiyoko
authors.initials: K
authors.lastname: Tamai
authors.affiliation: Department of Clinical Laboratory, Tsukuba Medical Center Hospital, Tsukuba, Japan.
authors.forename: Atsuo
authors.initials: A
authors.lastname: Ueda
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, Tsukuba, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Kamata
authors.affiliation: Japan Community Healthcare Organization, Tokyo, Japan.
authors.forename: Yasuharu
authors.initials: Y
authors.lastname: Tokuda
authors.affiliation: Department of Infectious Disease, University of Tsukuba Hospital, Tsukuba, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Koganemaru
authors.affiliation: Department of Infectious Disease, University of Tsukuba Hospital, Tsukuba, Japan.
authors.forename: Yoko
authors.initials: Y
authors.lastname: Kurihara
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Tsukuba Medical Center Hospital, Tsukuba, Japan.
authors.forename: Hiroichi
authors.initials: H
authors.lastname: Ishikawa
authors.affiliation: Miroku Medical Laboratory Inc., Saku, Japan.
authors.forename: Hideji
authors.initials: H
authors.lastname: Yanagisawa
authors.affiliation: Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
authors.forename: Katsunori
authors.initials: K
authors.lastname: Yanagihara
mesh_terms: D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D016470:Bacteremia / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology*; D003141:Communicable Diseases / Q000175:diagnosis / Q000188:drug therapy / Q000382:microbiology; D003428:Cross Infection / Q000175:diagnosis / Q000188:drug therapy / Q000382:microbiology; D005260:Female; D006090:Gram-Negative Bacteria / Q000187:drug effects / Q000235:genetics; D006094:Gram-Positive Bacteria / Q000187:drug effects / Q000235:genetics; D006801:Humans; D008297:Male; D046228:Microarray Analysis / Q000379:methods; D025202:Molecular Diagnostic Techniques / Q000295:instrumentation*; D011446:Prospective Studies
chemical_list: D000900:Anti-Bacterial Agents
keywords: Antimicrobial stewardship; Bacteremia; Gram-negative bacteria; Gram-positive bacteria; Verigene system