8th November 2016 Content supplied by: Cepheid
CE Marked 30 Minute Or Less Molecular Flu/RSV Test
Why Choose Between Fast or Accurate When You Can Have Both?
With the flu season fast approaching, healthcare providers no longer need to choose between a fast test result or an accurate test result for patients suspected of influenza infection. Now, they can have both, with Xpert® Xpress Flu/RSV from Cepheid, a new test that delivers reference-quality molecular test results in as little as twenty minutes.1
"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, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer.
"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."
Upper respiratory infections are among the most common reasons for outpatient visits in the United States and worldwide.2,3 Early symptoms for a wide variety of viral and bacterial respiratory infections are often clinically indistinguishable, yet treatment is different depending on the cause of infection, highlighting the importance of accurate diagnostic tests like Xpert Xpress Flu/RSV. With this development, hospitals and clinics can reliably diagnose influenza and respiratory syncytial virus (RSV) infection in 30 minutes or less.
Xpert Xpress Flu/RSV is twice as fast as its predecessor, Xpert Flu/RSV XC, but has comparable performance characteristics. The new assay features a novel design, which employs multiple targets for each virus. The built-in redundancy provides very high test sensitivity, avoiding the impact of seasonal drift that has been a problem historically with molecular tests, while maintaining high specificity. This assay is the first in a series of tests from Cepheid that will deliver results in 30 minutes or less.1
The new test is available immediately in the EU and all countries recognizing the CE-Mark.
References: 1 Results from negative specimens are reported in approximately 30 minutes. When running in a Flu only or an RSV only reporting mode, positive results can be reported in soon as 20 minutes. 2 "Upper Respiratory Tract Infection" Medscape. Menegetti et al; June 2016 (http://emedicine.medscape.com/article/302460-overview) 3 http://www.cdc.gov/rsv/research/us-surveillance.html
Date Published: 8th November 2016
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