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news.Cepheid, a molecular diagnostics company, has released the Xpert MRSA/SA Nasal test as a European CE IVD Mark product under the European directive on in vitro diagnostic medical devices.
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According to Cepheid, the test is designed for the simultaneous detection of nasal carriage of both Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-sensitive Staphylococcus aureus in less than one hour. Xpert MRSA/SA Nasal is believed to be Cepheid’s 10th CE in vitro diagnostic (IVD)test for use on the GeneXpert System, a healthcare associated infection (HAI) molecular testing platform.
Cepheid has said that its on-demand Xpert MRSA/SA Nasal test provides rapid determination of pre-operative carrier status by detecting MRSA and S aureus, enabling clinicians to determine the best course of treatment for colonized patients.
John Bishop, Cepheid’s CEO, said: “With the addition of Xpert MRSA/SA Nasal, Cepheid now offers European clinicians the most comprehensive suite of on-demand molecular tests currently available to aid in the overall management of HAIs. This includes a broad line of diagnostic, surveillance, and pre-surgical screening tests for MRSA, SA, C difficile, and vanA/vanB.”