Simplexa™
GBS Direct Kit

Group B Streptococcus (GBS) infection is a leading cause of sepsis and meningitis among newborns. Approximately 25% of pregnant women are asymptomatically colonized with GBS in the genital and rectal mucous membrane sites¹. Vertical transmission of GBS to the newborn can result in an invasive infection known as early onset disease (EOD). Infants with EOD will present with fever, lethargy, sepsis, pneumonia and more rarely, meningitis within the first 24 to 48 hours of life. The World Health Organization estimates that GBS causes an estimated 150,000 preventable stillbirths and infant deaths every year.¹

The screening of pregnant women for GBS colonization at 35 to 37 weeks gestation and intrapartum antibiotic prophylaxis for colonized women have substantially decreased the risk of GBS transmission to the newborn thus reducing the occurrence of EOD.² The 2010 CDC guidelines recommend an 18 to 24 hour broth enrichment of a vaginal-rectal swab prior to detection of GBS.³ The use of selective enrichment broth such as Lim broth can increase the detection of GBS by 50% compared to non-enriched methods.^3,4 The conventional means for identifying GBS is through culture on blood agar plates followed by a confirmation test, which can be labor intensive.³

1. World Health Organization. http://www.who.int/immunization/newsroom/press/news_group_b_strep_stillbirths_infant_deaths_2017/en/.
2. Sarah Teatero, Patricia Ferrieri, Irene Martin, Walter Demczuk, Allison McGeer, and Nahuel Fittipaldi. Serotype Distribution, Population Structure, and Antimicrobial Resistance of Group B Streptococcus Strains Recovered from Colonized Pregnant Women;J. Clin. Microbiol. February 2017 55:2 412 to 422.
3. Centers for Disease Control and Prevention; Prevention of Perinatal Group B Streptococcal Disease Revised Guidelines from CDC, 2010; MMWR 2010;59;No. RR-10.
4. Philipson EH, Palermino DA, Robinson A. Enhanced antenatal detection of group B Streptococcus colonization. Obstet Gynecol 1995;85:437–9.144.

A CLIA moderate complexity assay for the direct detection of Group B Strep bacterial DNA from Lim broth enrichment. The assay is high performing with a greater than 97% Positive Percent Agreement and 99% Negative Percent Agreement.