Smart GBS

The Cepheid Smart GBS test, performed on the SmartCycler® System, is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA in vaginal/rectal specimens using proven real-time PCR technology. When run directly from LIM broth cultures, Smart GBS delivers the most accurate GBS test results available today. Smart GBS – better Group B Streptococcus answers.

Runs On: SmartCycler System

Problem

According to the CDC, Group B Streptococcus (GBS) bacterium is the most common cause of life-threatening infections in newborns and is the leading cause of neonatal morbidity and mortality. Untreated, GBS can lead to the development of sepsis, pneumonia and meningitis. GBS sepsis and meningitis occur in newborns annually resulting in an approximately 4% fatality rate of those infected and roughly $300 million in healthcare costs1 annually.

Currently, the standard of care for preventing neonatal GBS disease is screening pregnant women at 35 – 37 weeks of gestation to determine their GBS colonization status1. Transmission of GBS occurs from GBS colonized women to their babies during childbirth. Most GBS testing is performed by culture and typically takes up to 4 days to finalize results. This process can be both laborious and error prone — due to the numerous steps involved and possible limitations in identifying lightly colonized GBS specimens.

Solution

Smart GBS is the first FDA cleared product that can be run from LIM broth cultures or directly from vaginal/rectal specimens, providing your laboratory with the greatest flexibility to meet your physician needs. Through real-time PCR technology, lightly colonized specimens are easily identified. In addition, antepartum testing utilizing Smart GBS with LIM broth provides the highest level of sensitivity available for a GBS test.

Impact

With Smart GBS, time to result and labor costs are significantly decreased when compared to culture. More importantly, Smart GBS can better help guide physicians in the appropriate treatment of GBS colonization, therefore significantly decreasing the risk of perinatal GBS disease.