HiberGene Diagnostics recently validated the direct testing of rectovaginal swabs with its HG Group B Streptococcus (GBS) test. The company has also secured a European Community (CE) mark for this new application.
GBS is a type of bacteria that is the most common cause of neonatal meningitis and can be transmitted to a child during gestation and labor, with potentially fatal consequences in up to 10 percent of cases. GBS can also lead to septicemia and pneumonia. Up to 30 percent of children infected with GBS can develop permanent disabilities such as cerebral palsy, blindness, deafness, and learning difficulties.
The Centers for Disease Control and Prevention (CDC) and European Guidelines have recommended a universal intrapartum GBS screening using a rapid real-time test, since this was found to be the best approach for antibiotic treatment and GBS infection prevention.
The HG GBS test was developed to be used in clinical and near-patient settings. The test allows for antepartum GBS screening, intrapartum testing, and testing for at-risk or symptomatic newborns to provide rapid and effective treatment of GBS. The direct swab application was designed to be used rapidly and accurately to diagnose GBS infections in pregnant women.
“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 healthcare professionals to tailor a care plan to ensure correct treatment during labor,” Brendan Farrell, CEO of HiberGene Diagnostics, said in a press release.
HiberGene Diagnostics previously launched an HG Meningococcus Direct Swab Test to detect the bacteria Neisseria meningitidis, which is responsible for meningococcal disease, a condition that’s estimated to cause 50,000 deaths and is most prevalent in young children and the elderly. The HG Meningococcus test is performed on blood or cerebrospinal fluid (CSF) for neonates and Enriched Broth for pregnant women. The new HG GBS test should be applied in addition to the HG Meningococcus test.
HiberGene is a company that specializes in the development of molecular tests for infectious diseases. HiberGene’s GBS test takes about one hour and can be performed outside the laboratory. For reference, current screening tests for GBS can take up to 48 hours.
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