Labeling for RVP Diagnostic Test Updated

Labeling updates for a respiratory viral panel (RVP) diagnostic test will include data about the performance of the test in humans infected with the pandemic strain of influenza A virus, the 2009 influenza A(H1N1).

The xTAG RVP labeling has been updated to include information from two new studies demonstrating that xTAG RVP can be an effective aid in the detection of 2009 Influenza A(HIN1) virus, but cannot identify the hemagglutinin gene of the 2009 Influenza A(H1N1) virus in clinical specimens.

xTAG RVP can simultaneously detect 12 respiratory viruses and subtypes, including influenza A with subtyping at the DNA/RNA level. The viral panel was designed to detect the matrix gene that is shared across several influenza A strains, including 2009 influenza A(H1N1) virus. In contrast, it does not detect the hemagglutinin gene of the 2009 Influenza A(H1N1) virus strain whereas it does detect the hemagglutinin gene of seasonal strains of H1N1 and H3N2. This design enables xTAG RVP to provide 3 types of results for patients infected with influenza A: 1) influenza A-H1; 2) influenza A-H3; 3) influenza A-unsubtypeable.

Luminex Corporation (Austin, TX, USA), announced that the U.S. Food and Drug Administration (FDA; Silver Spring, MD, USA) has cleared labeling updates for the company's xTAG RVP to include data about the performance of the xTAG RVP test in humans as demonstrated by the two separate studies.

"The studies now referenced in the xTAG RVP package insert demonstrate that the test can help determine if a patient is carrying a typical, seasonal respiratory virus or an unsubtypeable flu A virus," said Patrick J. Balthrop, president CEO of Luminex. "The xTAG RVP test can be a critical first line of defense in virus surveillance and in separating patients with more common respiratory infections from novel cases."

The xTAG RVP package insert has been updated to reference two recent publications of studies led by Dr. Christine Ginocchio at North Shore-LIJ Health System Laboratories (New York, NY, USA). One study demonstrated that all 1,108 influenza flu A unsubtypeable samples tested by the x TAG RVP were confirmed to be the 2009 Influenza A(H1N1) virus. The confirmation was carried out with the U.S. Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA) rRT-PCR assay for the 2009 Influenza A(H1N1) virus. This study is slated to appear in the Journal of Clinical Virology, (July 2009, in press).

The validation of the x TAG RVP test was carried out during the 2009 Influenza A/H1N1 outbreak in New York (NY, USA). Ninety-nine of the 101 unsubtypeable specimens tested with the CDC assay were identified as positive for the 2009 influenza A(H1N1) virus. This study appeared ahead of print in the July 2009 edition of the Journal of Clinical Microbiology.

Luminex Corporation develops, manufactures, and markets biological testing technologies with applications throughout the diagnostic and life sciences.

Related Links:
Luminex Corporation
U.S. Food and Drug Administration
North Shore-LIJ Health System Laboratories
U.S. Centers for Disease Control and Prevention