Image created by Dr. Michael J. Miller
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.
Sources
1. Hygienemaßnahmen bei Clostridioides difficile-Infektion (CDI), Empfehlung der Kommission für Krankenhaushygiene und Infektionsprävention (KRINKO) beim Robert Koch-Institut Bundesgesundheitsbl 2019, 62: 906-923.
2. RKI Ratgeber C. difficile https://www.rki.de/DE/Content/Infekt/EpidBull/Merkblaetter/Ratgeber_Clostridium.html, retrieved on 07/15/2024
3. RKI Ratgeber Noroviren https://www.rki.de/DE/Content/Infekt/EpidBull/Merkblaetter/Ratgeber_Noroviren.html, retrieved on 07/15/2024
4. RKI Ratgeber Rotaviren https://www.rki.de/DE/Content/Infekt/EpidBull/Merkblaetter/Ratgeber_Rotaviren.html, retrieved on 07/15/2024