Group B Streptococcus is the leading cause of severe neonatal infection affect 0.5 – 3 in every 1000 live births. It is associated with high mortality (10%) and morbidity rates. 20 – 30% of pregnant women are colonised with GBS and risk passing the infection to the child. Recent CDC and European Guidelines have recommended that a universal intrapartum GBS screening using a rapid real time test is the best approach to optimise antibiotic prophylaxis and prevent GBS infection.
Unmet Clinical Need:
- Intrapartum testing
- Rapid results – Current culture methods can take up to 72 hrs
- Rapid test for newborns
The Hg Solution:
- Intrapartum Test
- HG GBS gives positive results in < 60 minutes
- Test for symptomatic newborns
The HG GBS test allows for antepartum GBS screening, intrapartum testing and testing for at risk or symptomatic new-borns to provide rapid and effective treatment of GBS.
|Methodology:||Loop Mediated Isothermal Amplification (LAMP)|
|Sample types:||Vaginal and rectal swab
|Hands-on time:||≤ 10 minutes|
|Sample to result:||≤ 60 minutes|
*FDA submission is planned. Product is not available for sale in the US market.
1 Harrison L.H., C.L. Trotter, & M.E. Ramsay. 2009. Global epidemiology of meningococcal disease. Vaccine 27S: B51-B63