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PCR rapid test for Candida auris for Vivalytic by Bosch now available

Healthcare

World’s first fully automated PCR test for detection of the multidrug-resistant fungus at the point of care.

  • Vivalytic test detects Candida auris in under an hour at the point of care, making it the world’s first test suitable for screenings.
  • Candida auris infection rates are on the rise in Germany and can cause severe infections, for example of the bloodstream (sepsis).
  • Hospitals can use the new screening test to detect colonization, allowing them to implement measures to contain outbreaks.
Thomas Berroth

Thomas Berroth

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Waiblingen – Bosch Healthcare Solutions has developed a PCR test for detecting Candida auris (C. auris) on the Vivalytic platform. The test is a global innovation now available for order from distribution partners including Randox Laboratories Ltd. and R-Biopharm. This test enables the fully automated detection of the frequently multi-resistant fungus in less than an hour at the point of care. The rapid testing capability also makes it suitable for carrying out screenings when necessary. In contrast, traditional culture tests in centralized laboratories require one to three days1, delaying diagnosis and the initiation of targeted treatment. “Considering the heightened risk of severe progression in individuals with pre-existing conditions, we have developed a new test that enables clinics to respond more swiftly,” 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, face a heightened risk of active infection with C. auris. The mortality rate for C. auris infections ranges from 30 to 72 percent².

Considering the heightened risk of severe progression in individuals with pre-existing conditions, we have developed a new test that enables clinics to respond more swiftly.

Marc Meier, managing director of Bosch Healthcare Solutions

“Candida auris can be transmitted from person to person through contact and contaminated surfaces. When this fungus presents, rapid detection is therefore paramount to enable implementation of effective control and prevention strategies,” says Dr. med. Alexander Maximilian Aldejohann, deputy head of the Würzburg Laboratory at the National Reference Center for Invasive Fungal Infections (NRZMyk.) Since July 2023, Germany has implemented a limited statutory reporting requirement under the Infection Protection Act. Aldejohann is in favor of extending this reporting obligation: “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.”

Candida auris can be transmitted from person to person through contact and contaminated surfaces. When this fungus presents, rapid detection is therefore paramount to enable implementation of effective control and prevention strategies.

Dr. med. Alexander Maximilian Aldejohann, deputy head of the Würzburg Laboratory at the National Reference Center for Invasive Fungal Infections (NRZMyk)

Increasing spread of Candida auris

C. auris is spreading globally. In some states in the U.S., the annual incidence rate has been shown to increase by a factor of 2 to 3.³ The Robert Koch Institute (RKI) also drew attention to a rise in cases within Germany during the past year in the Epidemiological Bulletin4 at the beginning of May. The RKI points out that in specific areas screening could be beneficial. In the U.S., the annual case count has in the meantime 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.5 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.

Easy handling, rapid detection

The Vivalytic Analyser enables effortless testing directly at the point of care: The sample is 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.

This is a press release for journalists. Under no circumstances does it replace a consultation or recommendation by a medical practitioner.

Sources

1) Leonhard, S. E., Chong, G. M., Foudraine, D. E., Schaftenaar, E., Klaassen, C. H. W., & Severin, J. A. (2024). Proposal for a screening protocol for Candida auris colonization. The Journal of Hospital Infection. https://doi.org/10.1016/j.jhin.2023.12.019 (retrieved on 05/10/2024).
2) Sikora A, Hashmi MF, Zahra F. Candida auris. [Updated 2023 Aug 28]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK563297/ (retrieved on 05/10/2024).
3) Centers for Disease Control and Prevention (CDC): Tracking Candida auris. https://www.cdc.gov/fungal/candida-auris/tracking-c-auris.html (retrieved on 05/10/2024).
4) Aldejohann AM, Hecht J, Martin R, Walther G, Kurzai O: Zunahme von Candida Auris in Deutschland im Jahr 2023. Epid Bull 2024;18:3-7 | DOI 10.25646/12004 https://www.rki.de/DE/Content/Infekt/EpidBull/Archiv/2024/Ausgaben/18_24.pdf?__blob=publicationFile (retrieved on 05/10/2024).
5) Centers for Disease Control and Prevention (CDC): Screening for Candida auris colonization in healthcare settings. https://www.cdc.gov/fungal/candida-auris/c-auris-screening.html (retrieved on 05/10/2024).

Bosch Healthcare Solutions on social media
YouTube: https://www.youtube.com/@boschhealthcaresolutions
LinkedIn: https://www.linkedin.com/company/bosch-healthcare-solutions/

Distribution partners for Vivalytic: https://www.bosch-vivalytic.com/vertrieb/

Contact person/s for press inquiries:
Thomas Berroth
Marketing & Communication
Thomas.berroth2@de.bosch.com
+49 (0) 160 90437856

Bosch Healthcare Solutions GmbH is a wholly owned subsidiary of Robert Bosch GmbH. The subsidiary was established in 2015 with the aim of developing products and services that improve people’s health and quality of life. Nearly 300 associates (state 2024) are employed at the company’s headquarters in Waiblingen, Germany. The subsidiary’s solutions draw on the Bosch Group’s core competencies: sensors to collect data, software to evaluate that data, and services based on this data analysis.

Additional information is available online at www.bosch-healthcare.com, www.vivatmo.com, www.bosch-vivalytic.com.

The Bosch Group is a leading global supplier of technology and services. It employs roughly 429,000 associates worldwide (as of December 31, 2023). The company generated sales of 91.6 billion euros in 2023. Its operations are divided into four business sectors: Mobility, Industrial Technology, Consumer Goods, and Energy and Building Technology. With its business activities, the company aims to use technology to help shape universal trends such as automation, electrification, digitalization, connectivity, and an orientation to sustainability. In this context, Bosch’s broad diversification across regions and industries strengthens its innovativeness and robustness. Bosch uses its proven expertise in sensor technology, software, and services to offer customers cross-domain solutions from a single source. It also applies its expertise in connectivity and artificial intelligence in order to develop and manufacture user-friendly, sustainable products. With technology that is “Invented for life,” Bosch wants to help improve quality of life and conserve natural resources. The Bosch Group comprises Robert Bosch GmbH and its roughly 470 subsidiary and regional companies in over 60 countries. Including sales and service partners, Bosch’s global manufacturing, engineering, and sales network covers nearly every country in the world. Bosch’s innovative strength is key to the company’s further development. At 136 locations across the globe, Bosch employs some 90,000 associates in research and development, of which nearly 48,000 are software engineers.

Additional information is available online at www.bosch.com, www.iot.bosch.com, www.bosch-press.com.

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