Test Panel Checks for 12 Viruses

In January 2008 the FDA approved a new lab test for a panel of viruses.

In early November, the Wall Street Journal reported on the test as

" A new cold and flu test can precisely diagnose a dozen winter ailments and reduce unneeded use of antibiotics, says the company that sells it. Physicians say the test is accurate and the most comprehensive available, but some say its long processing time limits usefulness in emergency rooms. "

Health News Review today ranks this article with 5 Stars and says

"This story does a good job of presenting accurate, comprehensive information - a balanced approach in presenting the evidence supporting the pros and cons of the test."

More on the evaluation of the story can be found on their web site.

FDA Clears Test to Identify 12 Respiratory VirusesFDA Clears First Test Designed to Detect and Identify 12 Respiratory Viruses from Single Sample The U.S. Food and Drug Administration today cleared for marketing a test that simultaneously detects and identifies 12 specific respiratory viruses.

The test, called the xTAG Respiratory Viral Panel, is the first test for the detection and differentiation of influenza A subtypes H1 and H3. Influenza A is the most severe form of influenza for humans, and has been the cause of major epidemics. The new panel is also the first test for human metapneumovirus (hMPV), newly identified in 2001.

The xTAG Respiratory Viral Panel amplifies viral genetic material found in secretions taken from the back of the throat in patients with possible respiratory tract infections. In the test, specific beads, or microspheres, bind to the amplified viral genetic material. The beads are then sorted so that the specific virus can be identified.

The xTAG panel is the first FDA-cleared test for infectious respiratory disease viruses that uses a multiplex platform, allowing several tests to be processed using the same sample.

"Nucleic acid tests such as the xTAG Respiratory Viral Panel utilize small amounts of genetic material, and then replicate it many times," said Daniel G. Schultz, M.D., director of FDA's Center for Devices and Radiological Health.

"This speeds up the usual process of detecting and identifying respiratory viruses, which can take up to a week," said Schultz. "And, because this multiplex viral panel tests for 12 viruses at once, it uses less of a patient's test specimen."

Other viruses identified by the xTAG Respiratory Viral Panel:

influenza B - one of three types of human influenza, less severe than influenza A respiratory syncytial virus subtype A and B - both are leading causes of infant pneumonia and bronchiolitis (an infection of the airways leading to the lungs) and often contribute to the development of long-term pulmonary disease

parainfluenza 1, 2 and 3 - all are leading factors in the croup and the common cold

rhinovirus - the most common viral infective agent in humans and a cause of the common cold

adenovirus - a cause of respiratory tract infections often similar to strep throat or tonsillitis

While the test is faster than conventional tests, it is specific to the dozen viruses listed and should be used with other diagnostics such as patient data, bacterial or viral cultures and X-rays. Positive results do not rule out other infection or co-infection and the virus detected may not be the specific cause of the disease or patient symptoms.

The xTAG Respiratory Viral Panel is manufactured by Toronto-based Luminex Molecular Diagnostics.

SOURCE: FDA Press Release, January 3, 2008

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