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Vivalytic Bacterial Meningitis by Bosch: PCR rapid test for medical emergencies

09.01.2025

Press release

Healthcare

Vivalytic Bacterial Meningitis by Bosch: PCR rapid test for medical emergencies

Waiblingen – Bosch Healthcare Solutions (BHCS) has developed a new PCR test Vivalytic Bacterial Meningitis for its Vivalytic analysis platform. The test can detect six important bacterial meningitis pathogens in less than an hour using highly sensitive PCR technology. BHCS is thus expanding its test portfolio to cover an additional critical medical indication. “Bacterial meningitis is an absolute medical emergency,” says Dr. Stefan Zimmermann, Senior Physician at the Center for Infectious Diseases at Heidelberg University Hospital. “To prevent death and permanent damage following meningitis, prompt and targeted antibiotic treatment in the hospital is crucial.” According to the current guideline for adults, antibiotic treatment should commence within one to three hours of arrival at the emergency room 1 . A cerebrospinal fluid (CSF) test with Vivalytic Bacterial Meningitis delivers reliable results within the required timeframe. Bacterial meningitis is an absolute medical emergency. To prevent death and permanent damage following meningitis, prompt and targeted antibiotic treatment in the hospital is crucial. ...Dr. Stefan Zimmermann, Senior Physician at the Center for Infectious Diseases at Heidelberg University Hospital Multiplex PCR test for in-depth and rapid diagnostics The current guideline recommends the use of multiplex PCR tests for suspected bacterial meningitis due to their short analysis time and high sensitivity 1 . With Vivalytic Bacterial Meningitis, test results are available in less than an hour. The test is suitable for all patients with suspected bacterial meningitis. The following pathogens are detected: Neisseria meningitidis Streptococcus pneumoniae Haemophilus influenzae Streptococcus agalactiae Escherichia coli Listeria monocytogenes The Bosch test thus covers the most important bacterial pathogens in all age groups on a single cartridge. Newborns and young infants are particularly at risk from Streptococcus agalactiae, but also from Escherichia coli and Listeria monocytogenes. Older infants, toddlers, and young adults can become infected with Neisseria meningitidis and Streptococcus pneumoniae. Elderly individuals are often affected by Streptococcus pneumoniae 2 . According to the guideline for testing antibiotic susceptibility, PCR tests should be supplemented by a CSF culture. After collecting the CSF, it is recommended to start antibiotic treatment immediately, possibly in combination with dexamethasone 1 . An underestimated danger for millions of people Meningitis is an inflammation of the membranes that surround the brain and the spinal cord. The pathogens often enter the body through the respiratory tract and then spread via the bloodstream 1 . The infection can also be transmitted from neighboring structures, such as in the case of inflammation of the middle ear or paranasal sinuses. Worldwide, 2.5 million people are affected every year, mainly in poorer regions. More than half of the cases affect children under five years of age 3 . The main symptoms include headaches, attention deficits, fever, and a stiff neck. The pathogens can be bacteria, viruses, fungi, or parasites 1 . However, bacterial meningitis is particularly worrying, with one in five cases leading to permanent complications such as hearing loss, brain damage, and seizures 4 . Without immediate treatment, about half of those afflicted will die 5 . Rapid diagnosis and immunization as key elements of WHO 2030 strategy Thanks to the introduction of conjugate vaccines and improved medical care, the global mortality rate from bacterial meningitis has fallen from 32 percent before 1961 to 15 percent after 2010 6 . Pneumococcal vaccines against various serotypes provide good protection against pneumococcal infection 7 . In addition to antibiotics, doctors are increasingly prescribing anti-inflammatory therapies such as dexamethasone, which reduce mortality rates, hearing loss, and neurological complications 8 . The WHO has set itself the goal of eliminating bacterial meningitis worldwide by 2030 9 , among other things by eliminating meningitis epidemics. “Rapid diagnosis using multiplex PCR tests could play a crucial role in this,” says Marc Meier, president of Bosch Healthcare Solutions. While PCR takes a day in the laboratory and culture confirmation requires two days, Vivalytic Bacterial Meningitis delivers results in less than an hour. Vivalytic for simple and intuitive testing The Vivalytic system is intuitive to use 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 in under an hour. The fully automated workflow of the all-in-one platform minimizes the risk of infection for the user. Vivalytic Bacterial Meningitis enables reliable and easy-to-establish diagnostics, even at off-peak times at weekends and in the evenings. BHCS recently obtained CE certification for the Vivalytic Bacterial Meningitis-test. It is now available for order from distribution partners such as Randox Laboratories and R-Biopharm.Sources 1) Pfister H.-W., Klein M. et al., Ambulant erworbene bakterielle Meningoenzephalitis im Erwachsenenalter, S2k-Leitlinie, 2023, in: Deutsche Gesellschaft für Neurologie (Ed.), Leitlinien für Diagnostik und Therapie in der Neurologie. https://dgn.org/leitlinie/ambulant-erworbene-bakterielle-meningoenzephalitis-im-erwachsenenalter (retrieved on 12/17/2024) 2) https://www.msdmanuals.com/de/profi/neurologische-krankheiten/meningitis/akute-bakterielle-meningitis#%C3%84tiologie_v8339873_de (retrieved on 12/17/2024) 3) GBD 2019 Meningitis Antimicrobial Resistance Collaborators. Global, regional, and national burden of meningitis and its aetiologies, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2023 Aug;22(8):685-711 https://pubmed.ncbi.nlm.nih.gov/37479374/ (retrieved on 12/17/2024) 4) GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9. Erratum in: Lancet. 2020 Nov 14;396(10262):1562. https://pubmed.ncbi.nlm.nih.gov/33069326/ (retrieved on 12/17/2024) 5) https://www.who.int/news-room/fact-sheets/detail/meningitis (retrieved on 12/17/2024) 6) van Ettekoven CN, Liechti FD, Brouwer MC, Bijlsma MW, van de Beek D. Global Case Fatality of Bacterial Meningitis During an 80-Year Period: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2024 Aug 1;7(8):e2424802. https://pubmed.ncbi.nlm.nih.gov/39093565/ (retrieved on 12/17/2024) 7) https://www.rki.de/DE/Content/Infekt/Impfen/Materialien/Faktenblaetter/Pneumokokken.pdf?__blob=publicationFile (abgerufen am 17.12.2024) 8) Brouwer MC, McIntyre P, Prasad K, van de Beek D. Corticosteroids for acute bacterial meningitis. Cochrane Database of Systematic Reviews 2015, Issue 9. Art. No.: CD004405. https://pubmed.ncbi.nlm.nih.gov/26362566/ (retrieved on 12/17/2024) 9) https://www.who.int/initiatives/defeating-meningitis-by-2030 (retrieved on 12/17/2024) 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/

Near-patient PCR rapid test for whooping cough for Vivalytic by Bosch now available

03.09.2024

Press release

Healthcare

Near-patient PCR rapid test for whooping cough for Vivalytic by Bosch now available

Waiblingen – Bosch Healthcare Solutions (BHCS) has introduced a new PCR test Vivalytic Bordetella, expanding the Vivalytic analysis platform’s capabilities to include whooping cough. This test can specifically detect the three major whooping cough pathogens Bordetella pertussis, B. parapertussis , and B. holmesii in under an hour. BHCS is expanding its test portfolio for “respiratory diseases” to include “pertussis” diagnosis, just in time for the upcoming cold and flu season. The triple test, unique in its composition of pathogens, allows for rapid diagnosis in local healthcare facilities. Previously, such pathogens were only detectable in larger test panels. “Vivalytic Bordetella is our response to the rising number of pertussis cases in Germany. Pertussis poses a significant risk, particularly to infants, the elderly, and individuals with pre-existing health conditions, necessitating rapid diagnosis,” says Marc Meier, president of Bosch Healthcare Solutions. Whereas PCR testing in a central laboratory requires one day and culture detection takes three to seven days 1 , Vivalytic Bordetella provides results in under an hour. The new test is available for immediate order through distribution partners such as Randox Laboratories and R-Biopharm. Vivalytic Bordetella is our response to the rising number of pertussis cases in Germany. Pertussis poses a significant risk, particularly to infants, the elderly, and individuals with pre-existing health conditions, necessitating rapid diagnosis...Marc Meier, president of Bosch Healthcare Solutions Rapid diagnosis is crucial for prompt treatment Pertussis typically starts with mild cold-like symptoms, including a slight cough, sneezing, a runny nose, and possibly a moderate fever. 2 The characteristic staccato cough then develops, sometimes accompanied by wheezing, thick mucus, and vomiting. 2 Over 90% of patients under three months old and about 10% of those over 65 years old require hospitalization. Pertussis is especially hazardous for infants, for whom it can be life-threatening. 3 “Prompt treatment is crucial for Bordetella infections, as the course and severity of the cough can only be mitigated if antibiotic therapy begins early. Moreover, initiating antibiotic treatment promptly and specifically can halt the disease’s transmission by breaking the infection chain,” says Dr. Stefan Zimmermann of Heidelberg University Hospital. Moreover, two-thirds of pertussis cases occur in adolescents and adults. In these individuals, the infection may not present with the characteristic coughing fits. 2 These factors underscore the importance of rapid near-patient testing. The Vivalytic Bordetella test is an excellent option for this. Prompt treatment is crucial for Bordetella infections, as the course and severity of the cough can only be mitigated if antibiotic therapy begins early. Moreover, initiating antibiotic treatment promptly and specifically can halt the disease’s transmission by breaking the infection chain...Dr. Stefan Zimmermann, Heidelberg University Hospital Rising case numbers make the case for rapid testing In Germany, pertussis case numbers have increased for the second consecutive year in 2024. By the end of July, the Robert Koch Institute (RKI) had been notified of over 11,000 cases. 4 Germany, along with Poland and Austria, reports some of the highest case numbers. 5 The surge is attributed to diminished immunity from coronavirus protection measures and a reduced vaccination rate against pertussis. The trend is therefore expected to persist. Whooping cough is extremely contagious. Triggers such as cold air, exertion, or cigarette smoke can induce a dry, tickly cough even months after the coughing fits have subsided. Prompt antibiotic treatment can reduce the duration of the illness. 2 Comprehensive testing for all pertussis pathogens Typically, B. pertussis triggers the infection, releasing a toxin that harms the respiratory tract’s mucous membrane. In recent years, B. parapertussis has been responsible for around ten percent of all infections, which tend to be milder as this pathogen does not produce a toxin. 2 Since late 2022, the RKI has noted a surge in B. parapertussis infections, now accounting for over 50 percent of cases, with increased virulence. 6 This rise may be attributable to a catch-up effect post-COVID-19 pandemic, more frequent testing, and the absence of an effective vaccine. 7 B. holmesii , the third pathogen tested, is less virulent than B. pertuss is 2 and typically causes milder, shorter-lasting pertussis-like symptoms. Vivalytic Analyser enables rapid diagnosis in a remote testing environment The Vivalytic Analyser allows for quick and easy testing for B. pertussis , B. parapertussis and B. holmesii directly in the medical practice. 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 and the use of a deactivating sample medium significantly lower 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 the new Vivalytic Bordatella test.Sources 1) https://www.ecdc.europa.eu/en/publications-data/bordetella-pertussis-laboratory-diagnosis-and-molecular-surveillance , retrieved on 07/24/2024 2) https://www.rki.de/DE/Content/Infekt/EpidBull/Merkblaetter/Ratgeber_Pertussis.html#doc2374534bodyText7 , retrieved on 07/24/2024 3) https://www.impfen.de/impfungen/keuchhusten/#gefahr , retrieved on 07/24/2024 4) https://www.nali-impfen.de/monitoring-daten/krankheitsfaelle-in-deutschland/keuchhusten-pertussis/ , retrieved on 07/24/2024 5) https://www.ecdc.europa.eu/en/publications-data/pertussis-annual-epidemiological-report-2021 , https://www.ecdc.europa.eu/en/publications-data/pertussis-annual-epidemiological-report-2022 , retrieved on 07/24/2024 6) https://www.rki.de/DE/Content/Infekt/EpidBull/Archiv/2023/33/Art_01.html retrieved on 07/24/2024 7) https://www.aerzteblatt.de/archiv/234049/Robert-Koch-Institut-Zunahme-von-Keuchhusten-durch-B-parapertussis , retrieved on 07/24/2024Bosch 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/

PCR rapid test for 3 important gastroenteritis pathogens for Vivalytic by Bosch  ...

18.07.2024

Press release

Healthcare

PCR rapid test for 3 important gastroenteritis pathogens for Vivalytic by Bosch ...

Waiblingen, Germany – 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. 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....Marc Meier, president of Bosch Healthcare Solutions 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. 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 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. 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.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 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/en/distribution/