The Food and Drug Administration has given the green light to public health and other qualified laboratories to make emergency use of the Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel) for the presumptive diagnosis of the new H1N1 strain.

The panel is authorized for use in “individuals who have been diagnosed with influenza A caused by a virus not subtypeable by currently available FDA-cleared devices.” There is no adequate, approved, and available alternative to emergency use of the panel, the FDA noted.

The Centers for Disease Control and Prevention will distribute the rRT-PCR Swine Flu Panel labeled with the intended use, adequate directions for use, any appropriate limitations on use of the device, and any available information regarding performance of the device. The agency also will provide flu panel fact sheets for health care providers and patients.

The authorized rRT-PCR Swine Flu Panel is a panel of oligonucleotide primers and dual-labeled hydrolysis (Taqman®) probes for use in the real-time RT-PCR assay on the ABI 7500 Fast Dx Real-Time PCR instrument for the in vitro qualitative detection of swine influenza viral RNA in nasopharyngeal and/or nasal swab specimens from patients with signs and symptoms of respiratory infection and viral culture. The universal swine influenza swInfA (NP gene) and swH1 (HA gene) primer and probe sets are designed for detection of swine A/H1N1 influenza viruses.

The assay is to be performed on an Applied Biosystems 7500 Fast Dx Real-time PCR instrument or the RUO marketed Applied Biosystems 7500 Real-time PCR instrument that is validated by Applied Biosystems with regard to the updated software but only partially qualified regarding its lab performance (proficiency testing with the CDC sample panel not performed).

Qualified laboratories must have a process in place for reporting test results to health care providers and federal, state and/or local public health authorities, and the CDC will track adverse events.

The FDA authorization will be effective until the declaration of the public health emergency is terminated.