Multicenter evaluation of the Xpert Carba-R assay for detection and identification of carbapenemase genes in sputum specimens Journal Article


Authors: Cai, Z.; Tao, J.; Jia, T.; Fu, H.; Zhang, X.; Zhao, M.; Du, H.; Yu, H.; Shan, B.; Huang, B.; Chen, L.; Tang, Y. W.; Jia, W.; Qu, F.
Article Title: Multicenter evaluation of the Xpert Carba-R assay for detection and identification of carbapenemase genes in sputum specimens
Abstract: Rapid diagnosis of infections caused by carbapenem-resistant Enterobacteriaceae (CRE) is crucial for proper treatment and infection control. The Xpert Carba-R assay is a qualitative multiplex real-time PCR method that qualitatively detects and differentiates five common carbapenemase genes (blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP) directly from rectal swabs or purified colonies within approximately 1 h. We performed a multicenter evaluation of the investigational use of the Carba-R assay for detection and differentiation of carbapenemase genes from sputum specimens in patients with a clinical diagnosis of pneumonia. The intra- and interassay coefficients of variation values for the Carba-R assay were 0.2% to 2.0% and 1.4% to 2.3%, respectively. A total of 301 sputum specimens were collected and tested. Compared to bacterial culture followed by PCR identification of resistance genes from colonies, the Carba-R assay reduced turnaround time from 56 to 84 h to less than 2 h. Carbapenemase genes were detected by the Carba-R assay in Klebsiella pneumoniae (n=236), Escherichia coli (n=22), Enterobacter cloacae (n=23), Klebsiella oxytoca (n=8), Serratia marcescens (n=6), Citrobacter freundii (n=4), and Klebsiella aerogenes (n=2). The Carba-R assay detected 112 blaKPC (33.5%), 70 blaNDM (21.0%), 8 blaIMP (2.4%), and 2 blaVIM (0.6%) genes, with positive percent agreement, negative percent agreement, and concordance rates of 92.9%, 86.7%, and 88.3%, respectively, for the dominant blaKPC and 85.0%, 87.8%, and 87.4%, respectively, for the blaNDM genes. Neither method detected the blaOXA-48 carbapenemase gene. The convenient, rapid, and simple characteristics of the Xpert Carba-R assay make it a potential tool for CRE detection and identification directly in sputum specimens. © 2020 American Society for Microbiology.
Keywords: sputum; carbapenem-resistant enterobacteriaceae; blakpc; blandm; carba-r assay
Journal Title: Journal of Clinical Microbiology
Volume: 58
Issue: 9
ISSN: 0095-1137
Publisher: American Society for Microbiology  
Date Published: 2020-09-01
Start Page: e00644-20
Language: English
DOI: 10.1128/jcm.00644-20
PUBMED: 32522829
PROVIDER: scopus
PMCID: PMC7448655
DOI/URL:
Notes: Article -- Source: Scopus
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  1. Yi-Wei Tang
    188 Tang
  2. Xin Zhang
    6 Zhang