New Info for xTAG RVP Package Insert
Luminex Corp., leader in multiplexed solutions, announced the FDA has cleared labeling updates for the company's xTAG Respiratory Viral Panel (RVP) to include data about the performance of the test in humans infected with H1N1 or swine flu.
The package inserts now include information from two studies and explain that the test can determine if a patient is carrying a typical respiratory virus or H1N1. The xTAG RVP provides three types of results for patients with influenza A: influenza A-H1, influenza A-H3, and influenza A-unsubtypeable.
First cleared by the FDA in January 2008, xTAG RVP is the only commercially available test that can detect 12 respiratory viruses, according to a Luminex press release. It was designed to detect the matrix gene that is shared across several influenza A strains, including H1N1. It does not detect the hemagglutinin gene of the 2009 H1N1 but does detect the same gene of seasonal trains of H1N1 and H3N2.
For more information on xTAG RVP visit, www.luminexcorp.com/rvp.