Bruker Daltonik’s test for Candida auris gets US clearance

23 April 2018 (Last Updated April 23rd, 2018 11:29)

Medical equipment maker Bruker Daltonik has received clearance from the US Food and Drug Administration (FDA) to market its test to detect the Candida auris (C. auris) pathogen.

Medical equipment maker Bruker Daltonik has received clearance from the US Food and Drug Administration (FDA) to market its test to detect the Candida auris (C. auris) pathogen.

The test is set to be run on the company’s Bruker Maldi Biotyper CA system, currently approved to identify 333 species or species groups across 424 clinically relevant bacteria and yeast.

C. auris is a yeast known to result in serious infections in hospitalised patients and is mostly resistant to various antifungal drugs.

“The test will be run on the company’s Bruker Maldi Biotyper CA system, currently approved to identify 333 species or species groups across 424 clinically relevant bacteria and yeast.”

Bruker’s device employs a matrix-assisted laser desorption/ionisation (MALDI-TOF) mass spectrometry to generate an organism spectrum based on the microbes found in patient samples.

The spectrum is then cross-checked with a reference organism database to ensure correct identification.

FDA Office of In Vitro Diagnostics and Radiological Health acting director Donald St Pierre said: “The FDA has confidence in this technology and recognises the need to rapidly address outbreaks both for C. auris and for other pathogenic microorganisms to help protect Americans through the recognition and identification of emerging infectious pathogens.”

Meanwhile, a research carried out by the University of Oxford in the UK revealed that multi-use of thermometers led to a previous C. auris outbreak at the university hospitals’ neurosciences intensive care unit (NICU).

The researchers reached the conclusion based on the analysis of 70 C. auris patients. It was observed that the same thermometers were used in 57 of the 66 patients infected after admission into the NICU.

University of Oxford Nuffield Department of Medicine researcher Dr David Eyre said: “Despite a bundle of infection control interventions, the outbreak was only controlled following removal of the temperature probes.

“This reinforces the need to carefully investigate the environment, and in particular multi-use patient equipment, in any unexplained healthcare-associated outbreak.”