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."
Application of the test to detect an emergent influenza virus would be especially important in the early stages of a pandemic when quick detection of a pandemic virus could help government officials determine when to begin containment strategies as well as life-saving mitigation strategies, such as closing schools, cancelling social gatherings and informing businesses to begin work-at-home policies.
"Public health laboratories must be able to detect a broad range of influenza viruses -- not just those commonly circulating," said Frances Downes, DrPH, president of APHL and director of Michigan's public health laboratory. "Influenza viruses mutate and migrate, rendering some tests ineffective as the virus evolves. This test gives the speed and precision we need to detect and respond effectively to novel influenza viruses."
The Association of Public Health Laboratories is a national non-profit dedicated to working with its members to strengthen laboratories with a public health mandate. By promoting effective programs and public policy, APHL strives to provide laboratories in public health with the resources and infrastructure needed to protect the health of US residents and to prevent and control disease globally.