Respiratory Test Systems Cleared
The xTAG Respiratory Viral Panel, manufactured by Luminex, was cleared by the Food and Drug Administration. The new test simultaneously assesses specimens for the presence of 12 different respiratory viruses.
This is also the first test to receive FDA approval that detects and differentiates between influenza A subtypes H1 and H3. Influenza A is the most severe from of the flu experienced by humans. Previous major epidemics have been attributed to this virus. Additional viruses detected with the test include influenza B, parainfluenza 1, 2, and 3, adenovirus, rhinovirus, and respiratory synctial virus subtype A and B.
Specimens collected for laboratory assessment include swabs from the back of the patient’s throat. The test method amplifies genetic material found in those secretions. Amplified viral genetic material binds to microspheres. The test then sorts the microsphere beads to identify the specific virus that a patient afflicted with.
The new test uses a multiplex platform for specimen assessment. This is the first FDA-approved test for infectious respiratory viruses that uses such an evaluation approach. This type of assessment platform enables multiple tests to be completed with the same specimen. This reduces the quantity of specimen required for complete analysis.
The process used for evaluation further accelerates the detection and identification of respiratory viruses. Tests that are currently available usually require a week before results become available.
Importantly, the test is designed to be used in conjunction with other available data and findings from clinical exam. Positive findings from the xTAG Respiratory Viral Panel do not rule out other possible diagnoses or the possibility that clinical symptoms are the result of another disease state.
January 9, 2008 Related topics: Laboratory, Infectious Diseases, Product Approval & Certification