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Xpert® Xpress GBS
Qualitative real-time PCR test providing accurate intrapartum detection of Group B Streptococcus in labor/delivery
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XPRSGBS-10
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Collection Device (Pack of 50)
900-0370
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The Need
In the U.S., Group B Streptococcus (GBS) remains a leading cause of early-onset neonatal sepsis. Rates of maternal colonization have not changed, but universal antenatal screening at 36–37 weeks along with the use of intrapartum antibiotic prophylaxis (IAP) has resulted in a decrease of early onset disease.1,2
Challenges remain, including:
Challenges remain, including:
- The latest ACOG practice guidelines recommend universal antepartum screening along with intrapartum where indicated based on risk.
- GBS colonization can be transient 2 and identifying women colonized at the time of delivery can be challenging.
- Some women present at the delivery room with unknown GBS status.
1 ASM, March 2020, Guidelines for the Detection and Identification of Group B Streptococcus - Revised Guidelines from CDC, 2020.
2 ACOG Committee Opinion No. 797: Prevention of Group B Streptococcal Early-Onset Disease in Newborns. Obstet Gynecol. 2020 Feb;135(2):e51-e72.
2 ACOG Committee Opinion No. 797: Prevention of Group B Streptococcal Early-Onset Disease in Newborns. Obstet Gynecol. 2020 Feb;135(2):e51-e72.
The Solution
The Xpert® Xpress GBS test is intended to aid in the diagnosis of GBS colonization intrapartum to identify candidates for antibiotic prophylaxis. With results in less than an hour, the Xpert® Xpress GBS test delivers 93.5% sensitivity and 95.5% specificity.
Not just a solution, a complete solution - The Xpert® GBS LB XC test and the Xpert Xpress GBS test are aligned with ACOG criteria for antenatal and intrapartum testing, respectively.
On-demand molecular testing — an ideal solution:
Not just a solution, a complete solution - The Xpert® GBS LB XC test and the Xpert Xpress GBS test are aligned with ACOG criteria for antenatal and intrapartum testing, respectively.
On-demand molecular testing — an ideal solution:
- System designed with Early Assay Termination (EAT) which can reduce the test time for positive results to approximately 30 minutes*
- As soon as positive sample is confirmed, software concludes test and reports immediately
- Random access ensures any test on the menu can be run anytime, without the need to batch
* Otherwise, the full test runtime is approximately 42 minutes.
The Impact
- Identify GBS colonization status at the time of labor (intrapartum) of low-risk women at term with unknown GBS status.
- Xpert Xpress GBS test is designed to run in the clinical lab 24 hours a day, 365 days a year.
- Fast and easy-to-interpret results enable adequate Intrapartum Antibiotic Prophylaxis (IAP) delivered to mothers with unknown status.
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Product Resources
Product Information
Package Inserts & MSDS
Technical Documentation
ADF Files
Frequently Asked Questions
Group B Streptococcus (GBS) bacterial infection is associated with rare but serious illness in infants born to women who are colonized with Streptococcus agalactiae. Illness can occur in the first 7 days after birth (early-onset disease) or between a week and a few months after birth (late-onset disease). Infants with GBS infection can present with sepsis, pneumonia, or meningitis.1
Xpert® Xpress GBS is a next-generation, dual-target test to replace the single-target Xpert GBS test. The new dual targets are in highly conserved regions of the GBS genome, thereby improving the sensitivity of the test.
The Xpert® Xpress GBS test, performed on the GeneXpert® Instrument Systems, is an automated, real-time PCR test for the qualitative detection of Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens collected from pregnant patients for intrapartum testing at term (e.g., >37 weeks) who have unknown or unavailable antepartum GBS screening test results and no additional risk factors that would warrant empiric antibiotic prophylaxis. The Xpert Xpress GBS test performed during intrapartum is intended to aid in the detection of GBS colonization in patients presenting in labor who may be candidates for antibiotic prophylaxis.
The Xpert® Xpress GBS test does not provide antimicrobial susceptibility test results. Culture is necessary to obtain isolates to perform susceptibility testing as recommended for penicillin-allergic women.
References
1 Cepheid. Xpert GBS LB XC Package Insert. Accessed April 3, 2024. https://www.cepheid.com/en-USntent/dam/www-cepheid-com/documents/package-insert-files/Xpert%20GBS%20LB%20XC%20ENGLISH%20Package%20Insert%20302-4580%20Rev%20B.pdf