25th October 2016 Content supplied by: HiberGene Diagnostics Limited
CE Mark for HiberGene Group B Strep Direct Swab Test
HiberGene Diagnostics has validated the direct testing of rectovaginal swabs with its HG Group B Streptococcus (GBS) Test, having previously launched its HG Meningococcus Direct Swab Test. HiberGene has also secured a CE mark for this new application.
The HG GBS Test was developed for use in clinical and near patient settings, and the new direct swab application can be used to rapidly and accurately diagnose the presence of Group B Streptococcus in pregnant women. This application is in addition to the use of CSF and whole blood for neonates, and Enriched Broth for pregnant women, in the GBS test previously launched by HiberGene.
Using Loop Mediated Isothermal Amplification (LAMP), HiberGene’s GBS test takes approximately an hour and can be performed outside the laboratory setting.
Date Published: 25th October 2016
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