HiberGene Diagnostics has validated the direct testing of rectovaginal swabs with its HG Group B Streptococcus (GBS) Test, having previously launched its HG Meningococcus Direct Swab Test.
HiberGene has also secured a CE mark for this new application.
The HG GBS Test was developed for use in clinical and near patient settings, and the new direct swab application can be used to rapidly and accurately diagnose the presence of Group B Streptococcus in pregnant women.
This application is in addition to the use of CSF and whole blood for neonates, and Enriched Broth for pregnant women, in the GBS test previously launched by HiberGene.
GBS is the most common cause of neonatal meningitis, and can also cause septicaemia and pneumonia. The infection can be transmitted to a child during gestation and labour, causing fatal consequences in up to 10% of cases.
In addition, up to 30% of those infected can suffer permanent disabilities such as cerebral palsy, blindness, deafness and learning difficulties.
Current screening methods for GBS use cell culture with an enrichment step, and can take up to 48 hours. HiberGene’s GBS test takes approximately an hour and can be performed outside the laboratory setting.
Brendan Farrell, CEO of HiberGene, said: “The ability to test for GBS in pregnant women with a simple swab will significantly improve patient care by returning a rapid test result. This will mean that intrapartum testing can be a reality and will enable health care professionals to tailor a care plan to ensure correct treatment during labour.”