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 PCR (polymerase chain reaction), a highly sensitive laboratory method, and can produce results within four hours.
This new PCR test will help standardize influenza virus testing and sub-typing in the country. 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.
APHL member laboratories in Virginia, Iowa, California, Massachusetts, Wisconsin and Washington State conducted clinical trials of the new PCR test. The results from the clinical trials confirmed the high sensitivity and specificity of the test, paving the way for FDA clearance.
"The partnership between CDC, APHL and participating state laboratories has strengthened our national capability to monitor and detect influenza viruses," said Rosemary Humes, senior advisor for scientific affairs, Association of Public Health Laboratories. "This is a positive development for public health laboratories, which provide the backbone for influenza surveillance in the US, and for the American public."