Accelerate Diagnostics Expands Antimicrobials in New CE-Marked Accelerate PhenoTest™ BC kit | News

Accelerate Diagnostics Expands Antimicrobials in New CE-Marked Accelerate PhenoTest™ BC kit

Aug 02, 2019

Today we announced the release and CE marking of our latest Accelerate PhenoTest™ BC kit, declaring conformity to the European Directive 98/79/EC on in vitro diagnostic medical devices.

The new CE-IVD Accelerate PhenoTest™ BC kit now includes phenotypic antimicrobial susceptibility test (AST) results for ceftazidime-avibactam and ceftolozane-tazobactam for Enterobacteriaceae and P. aeruginosa bacteria, and trimethoprim-sulfamethoxazole for A. baumannii bacteria.

In addition, the new BC kit contains updates to clinical interpretive breakpoints bringing 144 organism and antimicrobial combinations current to 2019 EUCAST (European Committee on Antimicrobial Susceptibility Testing) guidance. AST results are available in approximately 7 hours, with organism identification results available approximately 5 hours prior.

The new CE-IVD Accelerate PhenoTest™ BC kit (catalog: 10102028) is available to hospitals and health systems within the European Economic Area and other regions that recognize the European Directive.

The US-IVD Accelerate PhenoTest™ BC kit (catalog: 10101018) received clearance for in vitro diagnostic use in February of 2017.

Read the full announcement

See the updated panel on the European site