11th February 2019 Content supplied by: bioMérieux (Clinical Diagnostics)
New FDA Clearance for VITEK® MS: Expanded ID for Challenging Pathogens
bioMérieux’s latest VITEK® MS V3.2.0 database received clearance by the US Food and Drug Administration (FDA) on Dec 21st 2018. The first IVD database to include the highly pathogenic Brucella species, it also enables identification of Candida auris, Elizabethkingia anophelis, as well as differentiation within the Acinetobacter complex, amongst other new benefits.
This FDA clearance offers microbiology laboratories an important solution to keep pace with new and emerging pathogens such as C. auris which has recently been in the spotlight.
“Candida auris is an emerging pathogen that is responsible for very severe bloodstream infections in patients,” says Dr. François Lacoste, Executive Vice President, bioMérieux Clinical Unit. “Previously, it could be misidentified, and it requires specific treatment – so being able to precisely identify it brings high medical value compared with existing solutions.”
The CDC warns: “Its severity, communicability, and drug resistance make correctly identifying C. auris crucial to treating patients and preventing infections.”1 VITEK® MS V3.2.0 shows excellent results in identification of C. auris. VITEK® MS V3.2.0 also follows an RUO version (SARAMIS® version 4.15) that was shown in 2017 to correctly identify all C. auris isolates using direct extraction, which is not the case for all MALDI-TOF MS systems that can require full-tube extraction.2
The VITEK® MS V3.2.0 database, which previously received IVD and CE-marking in June 2018, also enables more exact identifications. Dr. Lacoste points to the Acinetobacter complex as an example: “Different treatments are required for different species of Acinetobacter, so it is an instrumental benefit for the patient to be able to identify the microorganism at the species level more than at the genus level.”
- Centers for Disease Control, National Center for Emerging and Zoonotic Infectious Diseases, “Algorithm to identify Candida aurisbased on phenotypic laboratory method and initial species identification”. 16 Aug. 2018.
- Mizusawa, M. et. al. “Can a multi-drug resistant Candida auris be reliably identified in clinical microbiology laboratories?” J Clin Microbiol. 2017 Feb; 55(2): 638–640.
Date Published: 11th February 2019
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