The world’s first fully automated PCR test for the detection of the multidrug-resistant fungus Candida auris at the point of care is now available for Vivalytic by Bosch.

Bosch Healthcare Solutions Announces World’s First Point-of-Care Test for Candida Auris

On Thursday 16 May, 2024, Bosch Healthcare Solutions made a groundbreaking announcement – the development of a PCR test for detecting Candida auris (C. auris) on the Vivalytic platform. This test is a global innovation that is now available for order from distribution partners including Randox Laboratories Ltd. and R-Biopharm. It is the first test of its kind that enables the fully automated detection of the frequently multi-resistant fungus in less than an hour at the point of care.

Candida auris is a type of fungus that is on the rise in Germany and can cause severe infections, particularly in hospitals. This test allows for the rapid detection of colonization, which can help hospitals implement measures to contain outbreaks. Traditional culture tests, which are typically done in centralized laboratories, can take one to three days for results, delaying diagnosis and treatment.

“We have developed a new test that enables clinics to respond more swiftly, considering the heightened risk of severe progression in individuals with pre-existing conditions,” states Marc Meier, managing director of Bosch Healthcare Solutions. Patients with compromised immune systems, such as those in intensive care, individuals with serious underlying conditions such as diabetes, or those who are immunosuppressed due to cancer or HIV, as well as patients about to undergo invasive surgery, are at a heightened risk of active infection with C. auris. The mortality rate for C. auris infections can range from 30 to 72 percent.

According to Dr. med. Alexander Maximilian Aldejohann, deputy head of the Würzburg Laboratory at the National Reference Center for Invasive Fungal Infections (NRZMyk), “Candida auris can be transmitted from person to person through contact and contaminated surfaces. When this fungus presents, rapid detection is paramount to enable implementation of effective control and prevention strategies.” Aldejohann is in favor of extending the limited statutory reporting requirement that Germany implemented under the Infection Protection Act in July 2023. “The fungus has the capacity to rapidly develop resistance to many common antifungal agents coupled with the ability to survive for a relatively long time on surfaces. This high so-called tenacity also increases the risk of outbreaks that are difficult to contain.”

C. auris is not only a concern in Germany, but it is also spreading globally. In some states in the U.S., the annual incidence rate has been shown to increase by a factor of 2 to 3. The Robert Koch Institute (RKI) has also drawn attention to a rise in cases within Germany during the past year in the Epidemiological Bulletin at the beginning of May. The RKI suggests that in specific areas, screening could be beneficial. In the U.S., the annual case count has reached the thousands. The Centers for Disease Control and Prevention (CDC) already consider the screening of patients, visitors, and staff for C. auris as a crucial strategy to curb its spread in healthcare settings. While the fungus is harmless for healthy individuals, it can lead to severe nosocomial infections, i.e. infections acquired in hospitals or other healthcare environments, in patients at high risk and, if the fungus enters the bloodstream, can trigger sepsis.

The Vivalytic Analyser is the key to the success of this new test. It enables effortless testing directly at the point of care, with the sample being placed into the test cartridge, which already contains all necessary reagents. The cartridge is then inserted into the Vivalytic Analyser for automated processing. Healthcare professionals require only minimal training to use the system, and the fully automated process significantly lowers the risk of infection. The Vivalytic Analyser thus facilitates rapid and precise diagnostics in PCR quality, bypassing the frequently lengthy process through a central laboratory. Bosch Healthcare Solutions is expecting CE certification for the Vivalytic C. auris test soon.

For press inquiries, please contact:

Thomas Berroth

Marketing & Communication

Thomas.berroth2@de.bosch.com

+49 (0) 160 90437856

Derick is an experienced reporter having held multiple senior roles for large publishers across Europe. Specialist subjects include small business and financial emerging markets.

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