Simplexa GBS Direct Kit

Background

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 sites. 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.

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.The 2010 CDC guidelines recommend an 18 to 24 hour broth enrichment of a vaginal-rectal swab prior to detection of GBS. The use of selective enrichment broth such as Lim broth can increase the detection of GBS by 50% compared to non-enriched methods. The conventional means for identifying GBS is through culture on blood agar plates followed by a confirmation test, which can be labor intensive.

Why to choose it

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.

Benefits

Reliability

The Simplexa GBS Direct assay demonstrated excellent clinical agreement against two CE marked NAATs.

SIMPLEXA GBS DIRECT CLINICAL AGREEMENT STUDY

a5/5 discrepant results were negative with a reference culture method.
b2/5 discrepant results were positive with a reference culture method

Fast Turn-Around Time

Our Simplexa GBS Direct assay takes only about an hour to generate high-quality results after Lim broth enrichment without the need for additional confirmation testing.

For use on

LIAISON MDX

Ordering Info

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Simplexa Group B Strep Brochure