Abstract
BACKGROUND: Infections due to carbapenem-resistant Gram-negative bacteria are emerging as an important challenge in health-care settings and a growing concern worldwide. Lateral flow immunoassay NG-Test(®) CARBA 5 can detect the five most reported carbapenemases (KPC, OXA-48-like, VIM, IMP, and NDM). Direct testing of positive blood cultures could reduce time to detection. This study aims to validate and report on the diagnostic yield of a novel method for carbapenemase detection in positive blood culture vials using NG-Test(®) CARBA 5. METHODS: We implemented an investigator-developed method for the direct testing of positive blood cultures using NG-Test(®) CARBA 5. We compared results between genotypic, phenotypic, and direct NG-Test(®) CARBA 5 in blood. RESULTS: A total of 32 isolates were tested (21 Enterobacterales and 11 Pseudomonas aeruginosa). Genotypic testing detected 23 carbapenemases. When comparing the results of NG-Test(®) CARBA 5 in blood with genotypic testing, agreement was observed in 31/32 (97%) tests. The sensitivity, specificity, positive predictive value, and negative predictive value of the NG-Test(®) CARBA 5 in blood were 93%, 100%, 100%, and 94%, respectively. CONCLUSIONS: Our method using NG-Test(®) CARBA 5 directly in blood culture samples presented an excellent diagnostic yield when compared to genotypic profiling and permits an accurate detection of carbapenemases.