Lab Medicine Significance 5/10

ETEST Eravacycline Validated for Susceptibility Testing of Enterobacteriaceae and Enterococci

A multicenter study validated the gradient diffusion ETEST for eravacycline against Enterobacteriaceae and Enterococcus species, demonstrating 99.4% and 100% essential agreement for clinical isolates respectively, compared to reference broth microdilution. The method provides a practical and accurate alternative for susceptibility testing of this newer tetracycline-class antibiotic approved for complicated intra-abdominal infections.

The original study

Multicenter Clinical Evaluation of ETEST Eravacycline for Susceptibility Testing of

Authors
Blanchard LS, Armstrong TP, Kresken M, Emery CL, Ying YX, Sauvonnet V, et al.
Journal
Journal of clinical microbiology
Type
Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't
PMID
36877080
Read the original study →

Original abstract

Eravacycline (ERV) (brand name Xerava [Tetraphase]) is a new tetracycline-class antibacterial that has been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for treatment of complicated intra-abdominal infections (cIAIs). ETEST is a gradient diffusion method that represents a simple alternative to the broth microdilution (BMD) method for performing antimicrobial susceptibility testing (AST). A multicenter evaluation of the performance of the new ETEST ERV (bioMérieux) in comparison with BMD was conducted following FDA and International Standards Organization (ISO) recommendations, using FDA- and EUCAST-defined breakpoints. Clinical isolates of Enterobacteriaceae (n = 542) and Enterococcus spp. (n = 137) were included. Based on the BMD reference method, 92 Enterobacteriaceae isolates and 9 enterococcal isolates were nonsusceptible to ERV according to the FDA breakpoints, while 7 Escherichia coli isolates and 3 Enterococcus sp. isolates were classified as ERV resistant according the EUCAST breakpoints. Referring to FDA performance criteria, the ETEST ERV demonstrated 99.4% and 100.0% essential agreement (EA), 98.0% and 94.9% categorical agreement (CA), very major error (VME) rates of 5.4% and 33.33%, and major error (ME) rates of 1.3% and 3.1% with clinical and challenge isolates, respectively, of Enterobacteriaceae and Enterococcus spp. According to EUCAST breakpoints, E. coli and Enterococcus sp. isolate results also met ISO acceptance criteria for EA and CA (EA of 99.0% and 100.0%, respectively, and CA of 100.0% for both), without any VMEs or MEs. In conclusion, we report that ETEST ERV represents an accurate tool for performing ERV AST of Enterobacteriaceae and Enterococcus sp. isolates.