PCR rapid test for 3 important gastroenteritis pathogens for Vivalytic by Bosch now available / World’s first fully automated PCR test for detection of C. difficile, norovirus, and rotavirus at the sampling point

Thursday 18 July, 2024
The Vivalytic test is the first test to specifically detect 3 of the
most important gastroenteristis pathogens: Clostridioides difficile,
norovirus, and rotavirus.

Clostridioides difficile infection rates are on the rise in
Germany, with cases becoming more severe and increasingly affecting
younger patients.

Pathogen differentiation is crucial to initiate the appropriate
treatment, avoid complications, and control the spread of the
infection.Bosch Healthcare Solutions has introduced a new PCR test for C.
difficile, norovirus, and rotavirus, expanding the Vivalytic
analysis platform’s capabilities to include gastroenteritis. This
innovative test can simultaneously and automatically detect these 3
major diarrhea pathogens in under an hour right on site. Unlike previous
tests that either included these pathogens in a larger panel or tested
for each individually, this triple test is the first of its kind. The
new Vivalytic test is available through distribution partners such as
Randox Laboratories and R-Biopharm. “We developed this test so that
medical practices and clinics can identify the cause of gastroenteritis
more quickly and respond appropriately: with the right treatment and
measures to prevent further spread and infection," explains Marc Meier,
president of Bosch Healthcare Solutions. Due to transportation and
limited test availability, the complete detection of C. difficile
can take up to several days.
Rapid diagnosis is crucial for correct treatment
Gastroenteritis is one of the most common reasons for visiting a
doctor’s practice or clinic, especially among children and older adults.
“Rapid and accurate diagnosis of the pathogen is crucial to initiate the
right treatment, prevent potential complications, and bring the
infection under control,” says Dr. Stefan Zimmermann, Senior Physician
at the Center for Infectious Diseases at Heidelberg University Hospital.
The bacterium Clostridioides (formerly Clostridium) difficile is
the main cause of nosocomial diarrheal diseases, which are associated
with a relatively high mortality rate. To prevent life-threatening
outcomes, an infection must be diagnosed quickly and treated
effectively, emphasizes Zimmermann. According to the Robert Koch
Institute (RKI), however, C. difficile is still under-tested.1
In addition, other pathogens can also cause diarrhea, making a more
comprehensive diagnosis, such as the Vivalytic test for norovirus,
rotavirus, and C. diff. sensible. The Vivalytic Analyser from
Bosch Healthcare Solutions supports rapid sample processing, which is
particularly important for C. difficile, as the toxin may no
longer be detectable at room temperature within two hours. Rapid sample
processing is therefore recommended by the RKI.2
Risk factors and effects of Clostridioides difficile
infections
Clostridioides difficile (C. difficile) infections cause
gastrointestinal complications, especially during and after antibiotic
therapy, and are particularly prevalent in older, multimorbid
individuals. Risk factors include advanced age, underlying
gastrointestinal diseases, prolonged hospital stays, and
immunosuppression. The incidence of C. difficile infections has
risen in recent decades due to demographic aging, increased comorbidity,
and multimedication. In addition, more virulent C. difficile
strains lead to more severe courses of disease. Recently, an increase in
community-acquired C. difficile infections has been observed in
young, healthy patients without recognizable risk factors. Mortality
averages one to two percent, but it is significantly higher in older
patients with comorbidities and in intensive care units. This makes
meaningful, rapid testing for C. difficile all the more
important, and with the new Vivalytic PCR test from Bosch Healthcare
Solutions now quickly possible.
Rotavirus and norovirus, especially in children and the elderly
Preventing outbreaks of viral gastroenteritis, such as those caused by
rotavirus and norovirus, in hospitals is crucial. Differentiating these
viruses from other pathogens such as C. difficile is essential
for effective management. Noroviruses are responsible for the majority
of non-bacterial gastroenteritis cases, affecting approximately 30
percent of children and up to 50 percent of adults.³ Children under five
and adults over 70 are particularly vulnerable. Rotaviruses are highly
infectious, with as few as 10 to 100 virus particles capable of causing
an infection. They are the most common cause of viral intestinal
infections in children aged six months to two years.4 Just 10 virus
particles can be enough to infect a child. The incidence of rotavirus
infections increases again in people over 60 years of age. According to
RKI reporting data, 35 percent of reported rotavirus infections in this
age group require hospital treatment.
Vivalytic Analyser enables rapid diagnosis at the point of care
The Vivalytic Analyser allows for quick and easy testing for C.
difficile, norovirus, and rotavirus directly at the point of care.
The system is user-friendly and requires only a brief training session
for medical staff. The collected sample is placed into a test cartridge,
which already contains all necessary reagents. The cartridge is then
inserted into the Vivalytic Analyser for automatic processing. The test
result is shown on the display. The fully automated process
significantly lowers the risk of infection for the user. The Vivalytic
Analyser thus facilitates rapid and precise diagnostics in PCR quality,
bypassing the frequently lengthy process through a central laboratory.
Bosch Healthcare Solutions recently obtained CE certification for 3
versions of its new gastroenteritis test: Vivalytic C. difficile,
Vivalytic norovirus and the triple test Vivalytic norovirus, rotavirus,
C. diff.
This is a press release for journalists. Under no circumstances does it
replace a consultation or recommendation by a medical practitioner.
SourcesHygienemaßnahmen bei Clostridioides difficile-Infektion
(CDI), Empfehlung der Kommission für Krankenhaushygiene und
Infektionsprävention (KRINKO) beim Robert Koch-Institut
Bundesgesundheitsbl 2019, 62: 906-923.RKI Ratgeber C. difficile https://www.rki.de/DE/Content/Infekt/EpidBull/Merkblaetter/Ratgeber_Clostridium.html,
retrieved on 07/15/2024RKI Ratgeber Noroviren https://www.rki.de/DE/Content/Infekt/EpidBull/Merkblaetter/Ratgeber_Noroviren.html,
retrieved on 07/15/2024RKI Ratgeber Rotaviren https://www.rki.de/DE/Content/Infekt/EpidBull/Merkblaetter/Ratgeber_Rotaviren.html,
retrieved on 07/15/2024Bosch 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/en/distribution/
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.
The company was set up in Stuttgart in 1886 by Robert Bosch
(1861–1942) as “Workshop for Precision Mechanics and Electrical
Engineering.” The special ownership structure of Robert Bosch GmbH
guarantees the entrepreneurial freedom of the Bosch Group, making it
possible for the company to plan over the long term and to undertake
significant upfront investments in the safeguarding of its future.
Ninety-four percent of the share capital of Robert Bosch GmbH is held by
Robert Bosch Stiftung GmbH, a charitable foundation. The remaining
shares are held by Robert Bosch GmbH and by a corporation owned by the
Bosch family. The majority of voting rights are held by Robert Bosch
Industrietreuhand KG. It is entrusted with the task of safeguarding the
company’s long-term existence and in particular its financial
independence – in line with the mission handed down in the will of the
company’s founder, Robert Bosch.
Additional information is available online at www.bosch.com,
www.iot.bosch.com, www.bosch-press.com.

Contact person for press inquiries:

Thomas BerrothMarketing & CommunicationThomas.berroth2@de.bosch.com+49 (0) 160 90437856

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