Test That Detects 12 Respiratory Viruses Simultaneously Approved By FDA

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Main Category: Flu / Cold / SARS
Also Included In: Respiratory / Asthma;  Medical Devices / Diagnostics;  Infectious Diseases / Bacteria / Viruses
Article Date: 05 Jan 2008 - 9:00 PDT

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A test that can detect and identify 12 respiratory viruses at the same time - the xTAG Respiratory Viral Panel - has been approved for marketing by the FDA (Food and Drug Administration), USA. It is the first test that can detect and differentiate influenza A subtypes H1 and H3.

Influenza A has been the main cause of several major epidemics, it is also the most severe form of human influenza. The xTAG Respiratory Viral Panel is also the first test for hMPV (human metapneumovirus), which was first identified in 2001.

The xTAG Respiratory Viral Panel augments genetic material of viruses that are found in secretions taken from the back of the throat in patients who have suspected infection of the respiratory tract. Specific beads (microspheres) bind to the amplified viral genetic material in the test. The beads are then sorted so that the precise virus can be identified.

It is the first FDA-approved test that is able to test for several viruses at the same time from a single sample.

Daniel G. Schultz, M.D., Director, Center for Devices and Radiological Health, FDA, said "Nucleic acid tests such as the xTAG Respiratory Viral Panel utilize small amounts of genetic material, and then replicate it many times. This speeds up the usual process of detecting and identifying respiratory viruses, which can take up to a week. And, because this multiplex viral panel tests for 12 viruses at once, it uses less of a patient's test specimen."

The xTAG Respiratory Viral Panel also identifies:

-- Influenza B
Less severe than influenza A. It is one of three types of human influenza.

-- Respiratory syncytial virus subtype A and B
The main causes of infant pneumonia and bronchiolitis.

-- Parainfluenza1, 2 and 3
Main causes of croup and the common cold.

-- Rhinovirus
A very common viral infective agents in humans. Also a cause of the common cold.

-- Adenovirus
Commonly causes respiratory tract infections.

The test, which returns results in a few hours, is much faster than conventional ones which can take days. It should be utilized with other diagnostics, such as the available information on the patient, bacterial/viral cultures, and X-rays.

Patrick Balthrop, President and CEO of Luminex, the makers of the xTAG Respiratory Viral Panel, said "The approval of the Luminex xTAG RVP is a critical milestone in the diagnosis, treatment and control of the respiratory viruses that impact millions of individuals every year. In addition to helping improve the surveillance of viruses - both in hospitals and community wide - this test can significantly improve patient care. In a matter of hours, rather than days, xTAG RVP can determine whether a patient has a cold, the flu or another virus, allowing a doctor to prescribe an effective treatment much more quickly."

-- http://www.luminexcorp.com
-- http://www.fda.gov

Written by - Christian Nordqvist
Copyright: Medical News Today
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