NEW YORK – Bosch Healthcare Solutions has obtained CE-IVDR marking for its Vivalytic Bacterial Meningitis PCR test running on the company's fully automated Vivalytic analysis platform.
The single-cartridge test can detect six important bacterial meningitis pathogens — Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae, Streptococcus agalactiae, Escherichia coli, and Listeria monocytogenes — in less than an hour from a cerebrospinal fluid (CSF) sample.
Bosch noted that according to antibiotic testing susceptibility guidelines, positive PCR tests should be supplemented by a CSF culture, but antibiotic treatment should be started immediately after collecting the CSF sample.
"Bacterial meningitis is an absolute medical emergency," Stefan Zimmermann, senior physician at the Center for Infectious Diseases at Heidelberg University Hospital, said in a statement. "To prevent death and permanent damage following meningitis, prompt and targeted antibiotic treatment in the hospital is crucial."
Bosch said that the assay is now available from its distribution partners including Randox Laboratories and R-Biopharm.