Fast PCR test for medical emergencies

With the PCR test Vivalytic Bacterial Meningitis, Bosch Healthcare Solutions (BHCS) has developed another test for its Vivalytic analysis platform. The test detects six important bacterial meningitis pathogens in less than an hour using highly sensitive PCR technology. BHCS is thus expanding its test portfolio to include an important indication: “Bacterial meningitis is an absolute medical emergency,” says Dr. med. Stefan Zimmermann, senior physician at the Center for Infectious Diseases at Heidelberg University Hospital. “In order to avoid death and permanent damage after meningitis, rapid and targeted antibiotic treatment in the clinic is essential.” According to the current guidelines for adults, antibiotic therapy should be started no later than one to three hours after arrival in the emergency room1. A CSF test with Vivalytic Bacterial Meningitis provides a reliable result within the required time.

Vivalytic test is a rapid PCR test that specifically detects the six most common pathogens that cause bacterial meningitis in less than an hour
Reliable, rapid pathogen detection is essential for reducing high morbidity and mortality through immediate, targeted antibiotic therapy

Multiplex PCR test for comprehensive and rapid diagnostics

The current guideline recommends the use of multiplex PCR tests when bacterial meningitis is suspected due to the short analysis time and high sensitivity1. For Vivalytic Bacterial Meningitis, the test result is available in less than an hour. The test is suitable for all patients with suspected bacterial meningitis.

The following pathogens have been detected:

Neisseria meningitis
Streptococcus pneumoniae
Haemophilus influenzae
Streptococcus agalactiae
Escherichia coli
Listeria monocytogenes

The Bosch test therefore covers the most important bacterial pathogens in all age groups on one cartridge: newborns and young infants are particularly affected Streptococcus agalactiaebut also through Escherichia coli and Listeria monocytogenes endangered. Older infants, toddlers and young adults become infected Neisseria meningitis and Streptococcus pneumoniae. Older people are particularly common Streptococcus pneumoniae affected2.

PCR tests should be supplemented by CSF culture according to the guidelines for antibiotic susceptibility testing. After the CSF has been removed, it is recommended to start immediately with antibiotic therapy – if necessary in combination with dexamethasone1.

Underestimated danger for millions of people

Meningitis is an inflammation of the membranes of the brain and spinal cord. The pathogens often enter the body via the respiratory tract. It then spreads via the bloodstream1. The infection can also be transmitted from neighboring structures, for example in the case of a middle ear or sinus infection. 2.5 million people worldwide become ill every year, especially in poorer regions. More than half of the diseases affect children under the age of five3. The main symptoms include headache, difficulty paying attention, fever and a stiff neck. Possible pathogens include bacteria, viruses, fungi and parasites1. Of particular concern, however, is bacterial meningitis. One in five cases leads to permanent complications such as hearing loss, brain damage and seizures4. Without immediate treatment, around half of those affected die5.

Rapid diagnosis and vaccination as key to the WHO Strategy 2030

Thanks to the introduction of conjugate vaccines and improved medical care, the global mortality rate for bacterial meningitis has fallen from 32 percent before 1961 to 15 percent after 20106. Pneumococcal vaccines against different serotypes offer good protection against pneumococcal infection7. In addition to antibiotics, doctors are increasingly prescribing anti-inflammatory concomitant therapies such as dexamethasone, which reduce mortality rates, hearing damage and neurological complications8.

The WHO has set itself the goal of containing bacterial meningitis worldwide by 20309, including by eliminating meningitis epidemics. “Rapid diagnosis using multiplex PCR tests could play a crucial role,” says Marc Meier, Managing Director of Bosch Healthcare Solutions. While PCR in the laboratory takes one day and culture detection takes two days, Vivalytic Bacterial Meningitis delivers the result in less than an hour.

Vivalytic for simple and intuitive testing

The operation of the Vivalytic system is intuitive; a short briefing by the medical staff is sufficient: the sample taken is placed into the test cartridge. This contains all the reagents necessary for the test. The cartridge is then inserted into the Vivalytic analyzer for automated evaluation. The test result appears on the display in less than an hour. The automated workflow of the “All in One” platform minimizes the risk of infection for the people using it. Even during off-peak times on weekends and evenings, Vivalytic Bacterial Meningitis enables reliable and easy-to-establish diagnostics. BHCS recently received CE Mark for the Vivalytic Bacterial Meningitis test. It can now be ordered through sales partners such as Randox Laboratories and R-Biopharm.

Sources

Pfister H.-W., Klein M. et al., Community-acquired bacterial meningoencephalitis in adults, S2k guidelines, 2023, in: German Society for Neurology (ed.), Guidelines for diagnostics and therapy in neurology. https://dgn.org/leitlinie/ambulant-erworbene-bakterielle-meningoenzephalitis-im-erwachsenenalter (accessed on December 17, 2024)
https://www.msdmanuals.com/de/profi/neurologische-krankheiten/meningitis/akute-bakterielle-meningitis#%C3%84tiologie_v8339873_de (accessed on December 17, 2024)
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/ (accessed on December 17, 2024)
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/ (accessed on December 17, 2024)
https://www.who.int/news-room/fact-sheets/detail/meningitis (accessed on December 17, 2024)
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/ (accessed on December 17, 2024)
https://www.rki.de/DE/Content/Infekt/Impfen/Materialien/Faktenblaetter/Pneumokokken.pdf?__blob=publicationFile (accessed on December 17, 2024)
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/ (accessed on December 17, 2024)
https://www.who.int/initiatives/defeating-meningitis-by-2030 (accessed on December 17, 2024)