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

Hiromichi Suzuki, Shigemi Hitomi, Yuji Yaguchi, Kiyoko Tamai, Atsuo Ueda, Kazuhiro Kamata, Yasuharu Tokuda, Hiroshi Koganemaru, Yoko Kurihara, Hiroichi Ishikawa, Hideji Yanagisawa, Katsunori Yanagihara
2015 Journal of Infection and Chemotherapy  
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
more » ... . During the intervention period (N ¼ 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 ¼ 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 18.2e26.8) 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 ¼ 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 ¼ 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 ¼ 0.001). The 30-day mortality was lower in the intervention period (3% vs. 13%, p ¼ 0.019).
doi:10.1016/j.jiac.2015.08.019 pmid:26433422 fatcat:emlupi32qjhsrnzatnz76z63g4