Enhancing Rapid Tests for perinatal GBS

Group B streptococcus (GBS) is a major cause of perinatal infections affecting both pregnant mothers (causing chorioamnionitis) and specially their offspring causing an intolerably high burden of disease and death in newborns, particularly in low-income settings. Carriage of GBS, which occurs in 18 % of pregnant women (with regional variation ranging from 11% to 35%) is a necessary condition for vertical transmission of this pathogen. A positive detection triggers the proactive administration of preventive antibiotics to the mother during delivery, to ensure that GBS is not vertically transmitted during childbirth, thus minimizing risks to the baby.

Unfortunately, the detection of the pathogens involves microbiological culturing methods, which require a minimum volume of blood and/or CSF and long turnaround times (a few days) for results and laboratory infrastructure.

AmpliSens proposal addresses the development of a rapid and portable molecular test for the screen-out of neonatal sepsis due to GBS in the blood or CSF of the suspected newborn and for the screening of pregnant women. Such a test can be used both in low resource settings where microbiological cultures are not available, and in high income countries to dramatically improve turnaround times for results and reduce costs.

The product (AmpliFast) can generate billions of tagged DNA copies from a single target molecule, increasing the sensitivity of the approach, which can be rapidly detected with the RDT platform to provide the results of GBS infection within half an hour and in low resource settings.