Diagnostic Assay Standardizes Influenza Virus Testing and Subtyping

A new diagnostic assay was developed to standardize influenza virus testing and subtyping, and provide accuracy, specificity, and dependability of influenza test results.

The test can accurately detect and identify commonly circulating human influenza viruses as well as avian influenza A (H5N1, Asian lineage) viruses within four hours and in multiple samples at one time. The test enables clinical researchers to discriminate between both the common seasonal subtypes of flu as well as the avian influenza A subtype, in order to aid public health officials in making a rapid and accurate diagnosis.

Performed on the Applied Biosystems, Inc. (Foster City, CA, USA) 7500 fast Dx real-time polymerase chain reaction (PCR) instrument, the assay has received 510(k) clearance from the U.S. Food and Drug Administration (FDA, Rockville, MD, USA) for use with the new U.S. Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA) human influenza virus (RT-PCR) detection and characterization panel (rRT-PCR Flu Panel). Although both products received independent FDA 510(k) clearances, they are required to be used together as a system for the detection of influenza.

The 510(k) clearance for the 7500 fast Dx instrument is Applied Biosystems' first clearance of a real-time PCR instrument for the clinical diagnostics market. Real-time PCR is a common laboratory method that measures PCR amplification as it occurs, cycle-by-cycle, allowing quantitative measurements to be made in the highly reproducible exponential phase of PCR. This enables extremely accurate and precise quantification over a large dynamic range compared to traditional techniques.

Mark Stevenson, president and COO for Applied Biosystems said, "[We have] been able to apply our real-time PCR technology to support laboratories on the front line of influenza testing in the United States. This is an important diagnostic tool that will enhance monitoring of influenza infections each year and improve early detection of influenza viruses with pandemic potential in the United States and abroad.”

Related Links:
Applied Biosystems
U.S. Food and Drug Administration
U.S. Centers for Disease Control and Prevention