Assay Detects Streptococcus in Women Giving Birth

The infection can be passed from mother to child during birth, causing neonatal disease including neonatal sepsis, meningitis and pneumonia, mental retardation, and death. The disease needs to be detected as early as possible so that GBS-colonized women are properly treated and to reduce unnecessary antibiotic use in those not colonized by the bacteria.

Developed by Cepheid (Sunnyvale, CA; USA), the Xpert GBS test was released for clinical diagnostic use on the GeneXpert System, expanding the menu of in vitro diagnostics (IVD) available in Europe with the CE Mark. The assay produces results in just over an hour and is designed for diagnosis of GBS by physicians at the time of delivery or 35-37 weeks. The test can be available 24 hours a day, seven days a week.

According to John Bishop, CEO of Cepheid, the Xpert GBS is the second IVD product with the CE mark released for use on the GeneXpert system in 2006. The system will be particularly useful in the clinical market, for use in hospital and reference labs, satellite labs, and physician's office labs.



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