Abstract

Objective To evaluate the performance and clinical utility of Verigene gram-negative blood culture (BC-GN) assay for a rapid identification of gram-negative bacteria and resistance genes. Methods Non-repetitive blood culture samples containing gram-negative bacteria were collected from inpatients in the Second Affiliated Hospital of Zhejiang University School of Medicine from June to October, 2013. BC-GN assay was performed to identify the species and genetic resistance determinants of gram-negative bacteria directly from the positive blood culture bottles. VITEK MS and the VITEK 2 Compact were used for species identification and antimicrobial susceptibility test, the results of which were considered as gold standards. The resistance genes were further validated by PCR amplification and sequencing analysis. A comparison of the results and time between the BC-GN assay and routine methods was conducted. Results The detection range of BC-GN assay almost covered all of the common gram-negative bacteria. BC-GN assay showed an advantage of high accuracy in the identification of Escherichia coli (13/13), Klebsiella pneumoniae (19/24), Klebsiella oxytoca (9/9), Pseudomonas aeruginosa (39/39), Serratia marcescens (4/5), Enterobacter spp. (6/8), Citrobacter spp. (11/11), Proteus spp. (6/6) and Acinetobacter spp. (24/24) with an overall accuracy of 94.24% for the identification of mono-microbial blood culture samples. Moreover, BC-GN assay accurately identified all of the bacteria and resistance genes from the two multi-microbial samples. Species identification and resistance profiles could be 42 hours earlier available by using BC-GN assay than those by using routine methods. Conclusion BC-GN assay could simultaneously and accurately identify bacteria and resistance determinants from blood cultures within 2 hours. More time for clinically effective therapy could be achieved by using BC-GN assay for the reduction of mortality associated with bloodstream infection. Key words: Bloodstream infection; Gram-negative; Antimicrobial resistance; Rapid identification

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