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Cepheid
Xpert® GBS

Xpert® GBS

Product catalog summary

Overview: The document discusses the Xpert® GBS, an in vitro diagnostic medical device designed to provide rapid and reliable results for Group B Streptococcus (GBS) testing. It highlights the device's ability to deliver positive results in just over 30 minutes, making it a valuable tool for clinicians during labor and delivery.

Specifications: The Xpert® GBS assay demonstrates a sensitivity of 91.9% and a specificity of 95.6%. The positive predictive value (PPV) is 86.7%, and the negative predictive value (NPV) is 97.4%. The device is designated as CLIA “Moderate Complexity,” allowing it to be used in near-patient settings by non-laboratory personnel.

Impact and Benefits: The Xpert® GBS assay allows for the identification of GBS colonization status at the time of labor and delivery, reducing neonatal Early-Onset GBS infection and preventing early onset GBS disease in newborns. It limits intrapartum antibiotic prophylaxis to only those patients who need it, thereby reducing hospital costs and length of stay.

Reliability: The device was tested with a panel of four simulated specimens across three sites, showing 100% agreement in results. This reliability ensures accurate patient status assessment and the need for intrapartum antibiotic prophylaxis.

The Need for Rapid Testing: GBS is a leading cause of infant mortality and serious neonatal infections. Traditional screening methods at 35-37 weeks of gestation may miss cases, as GBS status can change. Rapid intrapartum testing addresses this issue by providing accurate results at the time of labor and delivery.

Solution: Cepheid’s Xpert GBS meets CDC criteria for rapid and accurate intrapartum GBS testing, offering results in just over 30 minutes. This PCR-based testing improves screening accuracy and helps reduce neonatal GBS disease.

Workflow: The testing process involves two easy steps with a total hands-on time of less than one minute, providing positive results in about 30 minutes.

Ordering Information: The document provides contact details for direct sales offices in the UK, France, and Benelux, along with corporate headquarters information.

Catalog excerpts

GBS result in just over 30 minutes* Immediate GBS results you can trust. They deserve it. * For Positive Results In Vitro Diagnostic Medical Device

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“For term deliveries, GBS screening at the time of labor and delivery, empowers clinicians to accurately assess the patient status and the need for intrapartum antibiotic prophylaxis. Xpert® GBS is easy to use and returns results, if positive, in just over 30 minutes. It helps clinicians to reduce neonatal Early-Onset GBS disease, therefore decreases the hospitalization of newborns.” Sensitive and Specific Comparison of Xpert® GBS assay (intrapartum specimen) against the CDC culture method Culture + Reliable Najoua El Helali Ph.D., Services de Microbiologie and Gyne´cologie-Obste´trique, Groupe...

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Total hands-on time: <1 Minute Insert the swab into the chamber S Insert Cartridge and start assay TOTAL HANDS-ON TIME <1 MINUTE Positive Results in about 30 minutes Ordering Information Xpert® GBS (10 Cartridges with reagents) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Catalog No. GXGBS-100N-10 References: 1. Schrag et al. A population-based comparison of strategies to prevent early-onset group B streptococcal disease in neonates. NEJM. 2002; 247(4): 233-239. 2. Centers for Disease Control and Prevention. Prevention of Perinatal Group B Streptococcal...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.

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