The Great Basin Group B Strep (GBS) Assay is a DNA test that detects pathogens from a pregnant woman’s vaginal/rectal swab. The sample to-result molecular assay provides a definitive result for maternal GBS colonization status by targeting a conserved region within the cfb gene. The assay has a simple workflow with less than one minute of hands-on time.
Need for Testing
GBS or Streptococcus agalactiae is a bacterium that can cause infections in both adults and children. The rates of GBS infections are found to be much higher in infants than adults. GBS disease continues to be the leading cause of early-onset sepsis and meningitis in newborns and is a significant cause of morbidity and mortality in newborns.
According to the Centers of Disease Control (CDC), up to 30% of all pregnant women have GBS in the vagina or rectum. During labor, vertical transmission may infect the newborn. Approximately 50% of children born to a colonized mother are infected with GBS. Because GBS-colonized mothers are often asymptomatic, the CDC and in the American College of Obstetricians and Gynecologists (ACOG) recommend that all pregnant women get screened for GBS at 35 to 37 weeks of gestation. The CDC continues to report that a high proportion of early onset GBS disease cases are occurring among infants born to women with negative prenatal GBS culture screens. Molecular detection has been previously shown to increase detection of GBS by 30% compared to standard culture-based approaches.
Advantage of Great Basin’s GBS Assay over conventional culture methodologies
- Conventional tests have laborious methodology, poor sensitivity and long turnaround times (<96 hours)
- Great Basin’s GBS Assay has easy-to-use molecular methodology, higher sensitivity and a faster turnaround time (105 minutes), after sample enrichment.
The Great Basin System
Great Basin’s diagnostic system employs an integrated disposable cartridge containing all necessary reagents, and a bench-top analyzer that executes the assay, interprets the results and provides electronic output to the clinician.
- True sample-to-result with less than 1 minute of hands-on time
- On-demand testing; no batching of tests that delay results
GBS Sample-to-Result Assay
- Detects Streptococcus agalactiae (group B Streptococcus) from an antepartum women’s vaginal/rectal swabs
- Following enrichment of specimen, the Great Basin GBS Assay provides fast and accurate results in approximately 105 minutes
- Makes a definitive identification of GBS by targeting a highly conserved region of the cfb gene
- Sensitivity: 97.9 % Specificity: 96.0%
- Actionable results: accurately identifies the need for administration of IAP based on a positive test result thereby preventing the transmission of GBS to the child during delivery
For more information on the Great Basin Group B Strep Assay or to purchase our system, please contact Great Basin Sales