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FDA Clears CDC Panel for Human Influenza Virus

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has given 510(k) clearance to the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel.

The test, which was modified to use an alternative enzyme, the Quanta BioSciences qScript One-Step qRT-PCR Low ROX, is intended for use on Life Technologies' Applied Biosystems' ABI 7500 Fast Dx Real-Time PCR instrument. It comprises oligonucleotide primers and TaqMan probes for use in rRT-PCR for the in vitro qualitative detection and characterization of human influenza viruses from viral RNA respiratory specimens from patients with illnesses resembling influenza.

Specifically, the test is for the qualitative detection of influenza virus type A or B from viral RNA in patients with signs and symptoms of respiratory infection and/or from viral culture, FDA said. It also is for determining the subtype of seasonal human influenza A viruses as seasonal A/H1, A/H3, and/or A/H1pdm09 from viral RNA in patients; the presumptive identification of virus in patients who may have influenza A subtype A/H5; and to provide epidemiological information for surveillance of circulating influenza viruses.

For subtype A/H5 testing, FDA said that "[t]esting with the influenza H5a and H5b primer and probe sets should not be performed unless the patient meets the most current US Department of Health and Human Services clinical and epidemiological criteria for testing suspect A/H5 specimens."