Developing new test for rapid detection of influenza
Dated: 10/1/2008
The Association of Public Health Laboratories (APHL) collaborated with the Centers for Disease Control and Prevention (CDC) in the development of a new test for influenza, which received 510(k) clearance today by the Food and Drug Administration (FDA).
The test can accurately detect and identify all commonly circulating human influenza viruses as well as avian influenza A (H5N1) viruses.
It operates using polymerase chain reaction (PCR), a highly sensitive laboratory method, and can produce results within four hours.
The test will help standardize influenza virus testing and sub-typing in the US.
FDA clearance of the test will now allow CDC's PCR reagents to be distributed to qualified laboratories for diagnosing influenza using an Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument that was concurrently cleared by FDA.
This should help to ensure the accuracy of influenza test results among the different laboratories that conduct sophisticated influenza testing.
