Diagnostic HYBRIDS Gets FDA Clearance For The Detection Of Influenza A (H1N1)v Virus

Main Category: Swine Flu
Also Included In: Flu / Cold / SARS;  Public Health;  Regulatory Affairs / Drug Approvals
Article Date: 01 Sep 2009 - 7:00 PDT

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Diagnostic HYBRIDS announced that the US Food and Drug Administration has cleared an additional claim for the company's D3 UltraTM DFA Respiratory Virus Identification Kit, which confirms that the assay can detect the 2009 influenza A (H1N1)v virus.

"The D3 Ultra kit is the only commercially available monoclonal antibody screening kit cleared for the detection and identification of influenza A virus as well as influenza B virus, RSV, adenovirus, and parainfluenza virus types 1, 2, and 3. The kit can be used to test all types of respiratory specimen types (i.e. nasopharyngeal swabs and aspirates), by either direct detection or cell culture isolate identification. Confirmation of the D3 Ultra kit's reactivity to the influenza A (H1N1)v virus was critical since the kit serves as an important tool for health care professionals in the diagnoses of their patients, particularly during influenza A outbreak," said Steve Ewers, Senior Product Manager for respiratory products at Diagnostic HYBRIDS.

Although the D3 Ultra kit has been shown to detect the 2009 influenza A (H1N1)v virus in two culture isolates, the performance characteristics of this device with clinical specimens that are positive for the 2009 influenza A (H1N1)v virus have not been established. The D3 Ultra kit can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes.

The D3 Ultra DFA kit was initially cleared by the FDA in January 2006 for the detection and identification of influenza A virus, influenza B virus, respiratory syncytial virus, adenovirus, and parainfluenzavirus 1, 2, and 3.

Source
Diagnostic HYBRIDS

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