Products

BD MAX™ GBS*
Streamlining Group B Streptococcus Testing

BD MAX™ GBS Package Insert BD MAX™ GBS Product Information BD MAX™ GBS CLSI Procedure BD MAX™ GBS MSDS Document

The BD MAX GBS assay is an automated in vitro diagnostic test for the detection of Group B Streptococcus DNA in Lim Broth cultures obtained from vaginal/rectal swab specimens from antepartum pregnant women. It is performed on the BD MAX System, which fully automates cell lysis, nucleic acid extraction, PCR set-up, amplification and detection. It is the only automated IVD method for PCR detection of GBS from Lim Broth cleared by the FDA. Results from the BD MAX GBS Assay can be used as an aid to establish the GBS colonization status in pregnant women as recommended by current CDC guidelines.

GBS Infection is a Leading Cause of Neonatal Morbidity and Mortality

GBS infection is the leading cause of morbidity and mortality among newborns. Maternal colonization with GBS is a major risk factor for early-onset GBS disease in infants. GBS colonized women are >25 times more likely to deliver infants with early-onset GBS disease. GBS causes severe, invasive disease in young infants, including sepsis, meningitis and pneumonia. One of every 20 babies that become infected with GBS will die.¹

CDC Guidelines Recommend Universal Screening

Screening of vaginal/rectal swabs late in gestation can detect women who are likely to be colonized with GBS at the time of delivery. Clinical data support prevention of early onset GBS disease with antibiotics administered during labor and delivery to mothers who are colonized with GBS. In 2002, the Centers for Disease Control and Prevention recommended universal screening for GBS colonization at 35 to 37 weeks gestation to identify candidates for intrapartum chemoprophylaxis for the prevention of early onset GBS disease.¹

A recent study reported good compliance towards the CDC goal of achieving universal screening. Eighty five percent of pregnant women were screened before delivery.²

Studies have shown that preventable cases may contribute substantially to the remaining burden of disease.²

The majority of cases of GBS disease occurred in term infants. Surprisingly, missed screening contributed to only a small portion of these cases. Despite receiving appropriate prenatal care, >60% of cases of GBS disease occurred in infants whose mothers were tested by culture and reported as negative for GBS colonization and were not given antibiotics during labor. This rate was higher than expected and underscores the importance of avoiding false negative culture results.²

Concerns with Culture Results

Although culture has been the traditional method for GBS detection, it is limited by turn around time and labor requirements. The process can take up to 3 to 4 days to complete and requires numerous manual, subjective and labor-intensive steps that must be performed by qualified, trained laboratory personnel.³

Sensitivity of culture has been reported to be as low as 42%. GBS colonies may be missed due to non-hemolytic strains or may be difficult to visualize in the presence of overgrowth of other bacterial species.³

Lim Broth enrichment followed by PCR greatly simplifies detection and provides the highest level of sensitivity for detection of GBS.^{4, 5} Updated CDC guidelines released in 2010 include an option for molecular testing from overnight enrichment broth.¹

Benefits of the BD MAX GBS Assay

• Simplifies detection of GBS colonization in antepartum pregnant women
• Addresses concerns about subjective visual interpretation of culture by providing rapid, objective results
• Faster than culture methods: Identifies Group B streptococcal DNA in just over one hour from enrichment broth
• Less than 1.5 minutes hands-on time per sample
• Built-in process control for each sample