xTAG™ Respiratory Viral Panel (RVP) - K063765
This is a brief overview of information related to FDA’s approval to market this product.
Product Name: xTAG™ Respiratory Viral Panel (RVP)
Manufacturer: Luminex Molecular Diagnostics Inc.
Address: 439 University Ave., Toronto, ON, Canada M5G 1Y8
Approval Date: January 3, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/k063765.pdf
What is it? The xTAG™ Respiratory Viral Panel (RVP) assay is a new device that can simultaneously detect and identify nucleic acids of multiple respiratory viruses in nasopharyngeal swab specimens from individuals suspected of respiratory tract infections.
Acute respiratory diseases are the most common illnesses worldwide, and are usually caused by respiratory viruses. Respiratory tract infections can range in severity and include common cold, influenza, bronchitis, croup, and pneumonia. This new assay uses the latest in molecular biology techniques to provide early detection and differentiation between potential causative viruses responsible for the signs and symptoms of a respiratory infection.
The following 12 viruses are tested by xTAG™ RVP: Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza B, Respiratory Syncytial Virus subtype A, Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus.
This is the first product cleared by FDA for multiplex detection of viral nucleic acids. It is also the first FDA cleared product for detection of Human Metapneumovirus (hMPV), as well as the first FDA cleared product for detection and differentiation of Influenza A subtype H1 and Influenza A subtype H3.
How does it work?
- A nasopharyngeal swab (NPS) specimen is obtained from patients and taken to the lab.
- The lab separates nucleic acids (DNA and RNA) from the cells in the sample.
- The lab prepares nucleic acids and mixes them with the assay reagents.
- The DNA and RNA are processed and products bound to specific beads.
- Beads are sorted and analyzed by Luminex® xMAP instrument which reads the test result.
- The doctor uses the test results together with clinical presentation and other laboratory findings to help determine whether patient has a respiratory viral infection caused by a specific virus.
When is it used? The test should be used on NPS specimens from individuals exhibiting signs and symptoms of respiratory infection. Positive results do not rule out bacterial infection, or co-infection with other viruses. The agent detected may not be the definite cause of disease. The assay should be used in conjunction with the clinical presentation and other laboratory tests such as:
- Bacterial culture.
- Viral culture.
- Immunofluorescence antibody testing.
- Bronchoalveolar lavage (BAL) testing.
The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection if used together with other clinical and laboratory findings.
If this assay detects Influenza A virus, but is negative for both H1 and H3 subtype, the notification of appropriate local, state or federal public health authorities is required to determine necessary measures for verification of results in accordance with the MMWR notice, since such result raises a possibility that the patient is infected with a novel strain of Influenza A.
What will it accomplish? The use of the test together with other laboratory results and clinical presentation will help the doctor to determine whether there is a respiratory infection and whether a specific respiratory virus is causing it. If patient’s signs and symptoms are caused by a viral infection, this information may help determine appropriate patient management and potentially curb the overuse of antibiotics.
When should it not be used? The xTAG™ RVP assay should not be used:
- As the only test to determine the cause of respiratory illness. Other laboratory test results, clinical information and patient history should also be considered.
- The negative RVP results should not be used as the sole basis for diagnosis, treatment or other management decisions.
- If infections with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to a state or local health department for testing.
- In immunocompromised patients.
- 510(k) Summary and Approval order will be available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/k063765.pdf.