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19th August 2019  Product update: Paul Carton

EU Accelerates Approval of Bloodstream Infection Assay Kit


A time of only 12 hours is now all it  takes for a clinician in the EU to diagnose patients with bloodstream infections with the recent CE-IVD marking of the Accelerate Phenotest™ BC kit that provides antibiotic susceptibility test (AST) results from positive blood samples in just 7 hours.

The Phenotest™ Blood culture assay kit received US FDA clearing back in 2017 however upon Accelerate’s move into the EU market, the Phenotest™ BC Kit has been updated with new additions to its AST capabilities. This phenotypic antimicrobial susceptibility test kit now gives results for the following bacteria pathogens and antimicrobials: ceftazidime-avibactam and ceftolozane-tazobactam for Eneterobacteriaceae and P. aeruginosa bacteria, and trimethoprim-sulfamethoxazole for A. baumannii bacteria.

The Accelerate PhenoTest™ BC kit, which has a 48-channel cassette, is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) methods and is intended for use with the Accelerate Pheno™ system. The Accelerate PhenoTest™ BC kit is capable of simultaneous detection and identification of multiple microbial targets followed by susceptibility testing of the appropriate detected bacterial organisms. The Accelerate PhenoTest BC kit is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results.

Design of automated instruments for rapid identification and rapid AST results regarding bloodstream infections is welcomed by all in this area of medicine. In order to prevent bacteraemia progressing onto septicaemia the workflow in the laboratory needs to move at a quick pace and the Accelerate PhenoTest™ BC kit states this automated machine is 48 hours faster than traditional methods.

Sepsis is a blood infection by a virulent organism that enters the blood from a point of infection, multiplies and moves to tissues and organs in the body by use of the blood pathways. Many of the Enterobactericiae the PhenoTest™ BC kit can identify and interrogate have peritrichous flagella enabling quick movement and invasion of tissue.

Sepsis is extremely serious with up to 40% of sepsis cases being fatal. Once the infection moves through the bloodstream and lymph nodes it can result in massive inflammation, septic shock and rapid death.

Chad Brueck, who is head of global marketing for Accelerate Diagnostics says this product is needed for clinicians as the feedback from them is that there is very few treatment options available for patients with bloodstream infections. 

Christopher D Doern, Associate Director of Microbiology at the Virginia Commonwealth University welcomed the approval of the Phenotest™ BC Kit  “Approval of the Accelerate PhenoTest represents an important advance in the pursuit of more-rapid, phenotypic AST. The success or failure of such a product, as measured by improved patient outcomes, will depend largely on the local prevalence of resistance and the manner in which the system is integrated into an institution's practice. Clinical medical laboratories that pair the implementation of the Accelerate PhenoTest with their antimicrobial stewardship programs will undoubtedly have a significant impact on patient care. The literature is now replete with studies describing promising new technologies that can offer similar gains in AST performance. Hopefully, the success of the Accelerate PhenoTest system will spur the development of these technologies into commercially viable products”.

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.


    

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Date Published: 19th August 2019

Source article link: Paul Carton

Note: This content has been edited by a rapidmicrobiology staff writer for style and content.


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