Review of Two Recently FDA-cleared Assays for Nucleic Acid Extraction, Amplification and Detection of Respiratory Viruses

The Door Opens Wider for Molecular Infectious Disease Testing

July 17, 2008 at 1pm and 4pm EDT

Until recently, laboratories wanting to offer nucleic acid-based testing for respiratory viruses were faced with development of their own assays which required rigorous clinical and analytical validation. With the FDA’s clearance of Prodesse’s ProFlu+ and Luminex’s xTAG RVP assays, testing once thought of as esoteric can now be adopted as routine testing by a wider range of clinical labs. In addition, a state-of-the-art automated nucleic acid extraction solution is validated for use with both tests, further enhancing the accessibility of molecular testing for these important infectious disease agents.

Topics covered will include:

• Improved patient care and other benefits of molecular testing for respiratory viruses
• Efficient automation of viral nucleic acid extraction using NucliSENS easyMAG
• Implementation and performance of the Prodesse Pro-Flu+ assay Implementation and performance of the Luminex xTAG Respiratory Viral Panel

Following the presentation all attendees will have the opportunity to participate in an interactive question and answer session with the speakers.

Presenters:

Belinda Yen-Lieberman, Ph.D.
Professor of Pathology, Lerner College of Medicine
Director of Clinical Virology, Serology and Cellular Immunology
The Cleveland Clinic

Christine C. Ginocchio, Ph.D.
Director Microbiology, Virology and Molecular Diagnostics
North Shore-LIJ Health System Laboratories

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