Xpert GBS

Now rapid intrapartum or antepartum GBS results can be available in as quickly as 30+ minutes (for positive samples) versus 2 days. This revolutionary in vitro diagnostic test is the first and only molecular test designed to be run in the clinical lab and near-patient by non-laboratory professionals such as labor and delivery nurses — 24 hours a day, 365 days a year. Xpert^® GBS is the only in vitro diagnostic test to fully meet the CDC criteria for rapid intrapartum GBS testing. Cepheid’s Xpert GBS assay empowers clinicians to make appropriate patient management decisions at the time of delivery.

Runs On: GeneXpert^® System

Problem

In Europe and the United States, Group B streptococcus (GBS) is a leading cause of infant mortality and serious neonatal infections such as sepsis, pneumonia and meningitis. Transmission of GBS occurs from GBS colonized women to their babies during childbirth.

The current standard of care for preventing neonatal GBS disease calls for the use of culture in screening expectant mothers at 35-37 weeks of gestation. Although adequate for obtaining antepartum GBS results, this is an unacceptable solution for providing timely results for intrapartum patients who’s GBS status is unknown when they present in the hospital to deliver. Current rapid GBS testing methods provide an underwhelming sensitivity level of less than 65%.

Solution

To better guide proper patient management, intrapartum GBS status must be determined quickly. Introducing Cepheid’s Xpert GBS, the only in vitro diagnostic test to fully meet CDC criteria for rapid intrapartum GBS testing. With results in 30+ minutes for positive and 52 minutes for negative, Xpert GBS delivers 91.9% sensitivity and 95.6% specificity for intrapartum testing.

Comparison of Xpert GBS assay and the CDC culture technique for intrapartum testing:

		Culture
		Positive	Negative	Total
Xpert® GBS	Positive	91	14	105
	Negative	8	302	310
	Total	99	316	415

Simple

The Xpert GBS test, performed on Cepheid’s GeneXpert System®, delivers unprecedented ease-of-use. It is the only molecular in vitro diagnostic GBS test designed for use in the clinical lab and by non-laboratory professionals such as labor and delivery nurses — a first for a molecular test. Now Xpert GBS tests can be run as needed — 24 hours a day, 365 days a year. Users simply perform four easy steps and the GeneXpert System does the rest.

Fully-Controlled

Xpert GBS can lower healthcare costs and reduce patient hospital stays. By identifying mothers colonized with GBS, the test enables more targeted and effective antibiotic prophylaxis. This can prevent illness in a greater number of infants and reduce unnecessary antibiotic use in uncolonized women and the emergence of antibiotic-resistant GBS strains.