Simplexa
Group B Strep Direct Kit

Sensitive and simple detection of Group B Strep directly from Lim broth enrichment

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KIT for Infectious Diseases

Overview

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 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.

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

Reliable performance that you can count on

greater than 97% clinical agreement

The Simplexa Group B Strep Direct assay demonstrated excellent clinical agreement against two CE marked NAATs.

SimplexaTM Group B Strep Direct Clinical Agreement Study
Sample TypeSample Type Positive % Agreement Negative % Agreement
Sample TypeLim broth enriched vaginal/rectal swabs Positive % Agreement97.1% (169/174)a
95% CI: 93.5% to 98.8%
Negative % Agreement99.0% (504/509)b
95% CI: 97.7% to 99.6%
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

Fast Turn-Around Time

about 1 h for results

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


Ordering info

Product Code Reactions
Product

Simplexa™ Group B Strep Direct Kit

Code MOL3550 Reactions 24
Product

Simplexa™ Group B Strep Positive Control Pack

Code MOL3560 Reactions 10

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Our repository

All the answers you need.
Access our database to find:
instructions for use, safety data sheets,
assay protocols and more.

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