Molecular Flu/RSV Test Provides Accurate Results in 30 Minutes

The new assay rapidly tests for influenza and respiratory syncytial virus (RSV) infections on the GeneXpert System and is now available in the EU and all countries recognizing the CE Mark.

Early symptoms for a wide variety of viral and bacterial respiratory infections are often clinically indistinguishable, yet treatment is different depending on cause of infection, highlighting the importance of accurate diagnostic tests. With Xpert Xpress Flu/RSV from Cepheid (Sunnyvale, CA, USA), healthcare providers can now use a single test to provide fast reference-quality results for patients suspected of influenza or RSV infection. It provides reliable diagnosis of influenza and RSV infection within 30 minutes, twice as fast as its predecessor, Xpert Flu/RSV XC, but with comparable performance characteristics (when run in Flu-only or RSV-only reporting mode, positive results can be reported in soon as 20 minutes).

The new assay features a novel design that employs multiple targets for each virus. The built-in redundancy provides very high test sensitivity, avoiding the impact of seasonal drift that has historically been a problem with molecular tests, while maintaining high specificity.

"For too long, clinicians have been asked to treat suspected cases of influenza empirically, since gold-standard RT-PCR based tests took too long to process in the critical first 24 hours of symptom onset," said David H. Persing, MD, PhD, chief medical & technology officer, Cepheid, "With the arrival of fast molecular tests like Xpert Xpress Flu/RSV, patients and their healthcare providers can now expect an accurate diagnosis and access to targeted therapies substantially more quickly. Unnecessary treatment with antimicrobial agents can also be avoided. This supports clinical efforts to improve the patient experience, and further streamlines workflow in the laboratory, which can be particularly challenging in the midst of a busy respiratory virus season."

The GeneXpert System uses proprietary Xpert test cartridges. It provides the ability to perform from 1 to 80 Xpert tests simultaneously, and so can meet the throughput requirements from lower volume point-of-care settings to higher volume reference laboratories.

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