BD GeneOhm™ Line of Products

BD GeneOhm™ StrepB Assay

• Package Insert
• BD GeneOhm™ StrepB Product Information
• BD GeneOhm™ StrepB Collection Protocol
• BD GeneOhm™ StrepB Test Procedure
  
• BD GeneOhm™ StrepB CLSI Procedure
  
• BD GeneOhm™ StrepB MSDS Document
  

The BD GeneOhm™ StrepB Assay is a qualitative in vitro diagnostic test for the rapid detection of Group B Streptococcus (GBS) in pregnant women at the time of delivery or at any other stage of their pregnancy. The BD GeneOhm™ StrepB test results can be available in less than one hour, enabling new capabilities for earlier and more definitive treatment of mother and newborn.

With greater sensitivity than culture, and ~1 hour protocol, the BD GeneOhm™ StrepB test represents a breakthrough for the identification of GBS colonization, which can effectively result in the prevention and control of GBS infections in newborns.

Group B Strep (GBS)

GBS remains one of the leading causes of morbidity and mortality among newborns. In some populations, up to 40% of pregnant women are colonized in the vaginal-rectal area.² One of every 20 babies infected with GBS die.² Complications that arise during a neonatal GBS infection are serious and can involve septicemia, pneumonia, meningitis, as well as visual and auditory problems.

In order to evaluate the colonization of pregnant women, physicians often rely on the risk factor method. However, between 18% and 46% of women delivering infected babies do not have any risk factors at the time of delivery.^3,4

As the traditional diagnostic tool, culture has two major shortcomings: 2–3 days are required to provide a result and the culture must be performed during weeks 35 to 37 of the pregnancy. Up to 45% of women may receive unsuitable care when a culture is the only diagnostic tool used.³

• Up to 20% of women tested during weeks 35 to 37 of their pregnancy do not or may not have the result available at the time of delivery;⁵
• The 10% of women who deliver prematurely often cannot benefit from proper treatment since either they did not have the opportunity to be tested or the culture test results were not ready when needed;⁶
• About 5% of women do not receive adequate prenatal care and are not tested for GBS.⁷

Offering significantly greater sensitivity and specificity than culture, the BD GeneOhm™ StrepB test can identify GBS in pregnant women in less than one hour of test procedure time. The test can be used just prior to delivery or at any other stage of pregnancy.

With performance that exceeds the CDC guidelines, the test is performed directly from a vaginal-rectal swab specimen.

The BD GeneOhm™ StrepB test offers numerous advantages:

• Better sensitivity and specificity than culture;
• Suitable for premature or rush deliveries;
• Integrates easily into lab workflow;
• Minimal hands-on time;
• Definitive result interpretation;
• Random access testing.

A study evaluating intrapartum testing for GBS in pregnant women with a rapid molecular test demonstrated that:

    “…a rapid molecular based test performed in less than one hour at the time of delivery is more cost effective than either a culture or the risk factor approach.”⁸

The BD GeneOhm™ StrepB test enables a significant new capability in neonatal healthcare by improving the identification of GBS colonization, which can effectively result in the prevention and control of GBS infections in newborns.

CDC Guidelines (2002)

Revised in Aug. 2002, the CDC guidelines recommend the screening of all pregnant women for Group B Streptococcus (GBS) at 35-37 weeks of pregnancy.⁹

Points related to rapid testing include:

• “If appropriate techniques for rapid detection of GBS become commercially available, they may be integrated into the currently recommended screening strategy.”
• “Rapid tests for detection of GBS colonization at the time of onset of labor or rupture of amniotic membranes might obviate the need for prenatal culture-based screening if their sensitivity and specificity are comparable to culture in selective broth media and they yield results rapidly enough to permit administration of adequate intrapartum antibiotic prophylaxis to women detected as carriers.”

The BD GeneOhm™ StrepB Assay from BD meets and surpasses all criteria recommended by the CDC.

References

1. FDA Talk Paper, November 18, 2002, http://www.fda.gov/opacom/hpnews.html.

2. Bergeron, M.G., Picard, F. J. Laboratory detection of group B Streptococcus for prevention of perinatal disease.  Eur J Clin Microbiol  2004; 23: 665-671.

3. Davies, Dele H. Preventing Group B streptococcal infections: New recommendations. Canadian Journal of Infectious Diseases July/Aug 2002;13(4):232-35.

4. Rosenstein, N.E. and Schuchat, A. Opportunities for prevention of perinatal group B streptococcal disease: a multistate surveillance analysis. The Neonatal Group B Streptococcal Disease Study Group. Obstetrics and Gynecology Dec 1997;90(6):901-6

5. Centers for Disease Control and Prevention. Early-Onset Group B Streptococcal Disease – United States, 1998-1999. Atlanta, GA: Centers for Disease Control and Prevention; MMWR Sept 08, 2000;49(35):793-6.

6. Rush, W and Spinnato, J. Prevention of Perinatal Group B Streptococcal Disease: A Cost-Effective Analysis. University of Cincinnati, Ohio, Sept 2002:1-14 .

7. Centers for Disease Control and Prevention. Births: Final Data for 2000. National Vital Statistics Reports. Atlanta, GA: Centers for Disease Control and Prevention; Feb 2002;12.

8. Haberland et al., Perinatal Screening for Group B Streptococci: Cost-Benefit Analysis of Rapid Polymerase Chain Reaction. Pediatrics. 2002; 110 (3): 471-480

9. Centers for Disease Control and Prevention. Prevention of Perinatal Group B Streptococcal Disease; Revised Guidelines from CDC.  Atlanta, GA: Centers for Disease Control and Prevention; August 16, 2002 / 51(RR11);1-22.