IntelligentMDx (IMDx) has obtained CE-marking for a new automated, high-throughput, qualitative in vitro diagnostic test for the rapid detection of group B streptococci (GBS) for use in screening pregnant women and those in labour who may be infected with the pathogen. Group B streptococci are responsible for life-threatening bacterial infections, including sepsis, meningitis and pneumonia, in newborns.
The IMDx GBS utilises a real-time polymerase chain reaction (PCR0 method, operates on the Abbott m2000 system and addresses the need to screen large numbers of patients rapidly, and make quick, informed decisions about antibiotic treatment.
The IMDx GBS test offers robust and accurate detection of GBS both from direct swabs and enriched culture broth samples. With this test, results for up to 48 patient samples can be obtained simultaneously in approximately five hours. When compared to traditional culture methods, the IMDx GBS test exhibits 95.5% sensitivity and 98.3% specificity with direct swabs, and 100% sensitivity and 100% specificity with enriched culture broth samples.