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Antimicrobial Resistance (AMR)

Test Information
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Xpert® GBS LB XC

On-demand GBS molecular testing for antepartum screening

Xpert<sup>®</sup> GBS LB XC

The Need


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 35–37 weeks along with the use of intrapartum antibiotic prophylaxis (IAP) has resulted in a decrease of early onset disease.1,2

  • Centers for Disease Control and American College of Obstetricians and Gynecologists practice guidelines recommend universal antepartum screening along with intrapartum where indicated based on risk
  • Risk based IAP exposes 65–85% of GBS-negative women with risk factors to antibiotics. This has been linked to emergence of resistant strains3
  • Up to 50% false negatives when testing with agar alone4

1 CDC. Prevention of Perinatal Group B Streptococcal Disease: Revised Guidelines from CDC, 2010. Nov 19, 2010 / 59(RR10);1-32.
2 ACOG Committee Opinion No. 485: Prevention of early-onset group B streptococcal disease in newborns. Obstet Gynecol. 2011 Apr;117(4):1019-27.
3 Alfa MJ, et al. Real-time PCR assay provides reliable assessment of intrapartum carriage of group B Streptococcus. J Clin Microbiol. 2010 Sep;48(9):3095-9.
4 Paolucci M, et al. How can the microbiologist help in diagnosing neonatal sepsis? Int J Pediatr. 2012;2012:120139
US-IVD. For In Vitro Diagnostic Use.

The Solution


The Solution

Cepheid’s GeneXpert® system, with both Xpert® GBS LB XC and Xpert GBS is the only solution able to fully meet CDC criteria for both antenatal and intrapartum testing, with positive results in approximately 40 minutes.

On-demand molecular testing — an ideal solution:

  • System designed with Early Assay Termination (EAT) with positive samples reported STAT

- As soon as positive sample is confirmed, software concludes test and reports immediately

  • Moderately complex testing with minimal hands-on time

- STAT intrapartum specimens can be performed by lab, or by labor and delivery staff

- Reduces lab’s work for antenatal screening

- Random access ensures any test on the menu can be run anytime, without the need to batch run

The Impact


The Impact

The Xpert GBS LB XC test, performed on Cepheid’s GeneXpert systems, delivers an elegant, simple and streamlined solution.

A molecular in vitro diagnostic, Xpert GBS LB XC is designed for use in the clinical lab. It allows users to perform three simple steps and the GeneXpert does the rest.

  • Easy to use screening test
  • Delivers results on positive LIM broth samples in 27* minutes
  • Fast accurate NAAT results
  • Moderate complexity

 

Impact on Patient Pathway

Ordering Info


Xpert® GBS LB XC

Number of Tests: 10

Catalog #: GXGBSLBXC-10

Xpert® GBS LB XC

Number of Tests: 120

Catalog #: GXGBSLBXC-120
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