ATHENS, Ohio--(BUSINESS WIRE)--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.
About Diagnostic HYBRIDS
Diagnostic HYBRIDS invents, develops, manufactures, and sells innovative diagnostic and analytical products for a wide range of viral respiratory diseases, herpes virus infections, and other specific viral and thyroid diseases. The company also develops and commercializes innovative and genetically engineered cell-based detection products for the pharmaceutical and biotechnology industry, with an initial focus on pharmacology assays and products that measure drug clearance and anti-viral interventions with drugs and vaccines. The company is certified to ISO 13485 standards and manufactures live continuous and primary cell cultures for clinical diagnostics and pharmacology assays from its headquarters in Athens, OH. Diagnostic HYBRIDS was named one of the 500 Fastest Growing Companies in America in 2004 and 2005 by Inc. Magazine. The company is a pillar member of BioOhio, a statewide organization of bioscience companies accelerating the bioscience and healthcare economy in Ohio. For more information, please visit www.dhiusa.com.
Contact:
Diagnostic HYBRIDS Christina Dierkes, 740-589-3300 Coordinator, Marketing Communications & Public Relations christina_dierkes@dhiusa.com
