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) DNA in pregnant women at the time of delivery or at any other stage of their pregnancy. BD GeneOhm™ StrepB test results may be available in less than one hour, enabling 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 effectively aids in the prevention and control of GBS infections in newborns.

Group B Strep (GBS)

One of every 20 babies infected with GBS die.¹ 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 GBS infected babies do not have any risk factors at the time of delivery.^{2, 3}

As the traditional diagnostic tool, culture has two major shortcomings: 2 to 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.²

• 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;⁴
• 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;⁵
• About 5% of women do not receive adequate prenatal care and are not tested for GBS.⁶

Offering significantly greater sensitivity and specificity than culture, the BD GeneOhm™ StrepB test can identify GBS DNA 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.”⁶

The BD GeneOhm™ StrepB test represents 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.