Diagnostic HYBRIDS, a leading developer of IVD fluorescent staining kits and cell culture products, today announced the U.S. Food and Drug Administration (FDA) (510k) clearance of its D3 FastPoint L-DFA Respiratory Virus Identification Kit, which allows the individual detection of influenza A, influenza B, respiratory syncytial virus (RSV), human metapneumovirus (hMPV), adenovirus and parainfluenza viruses from a patient’s specimen in under 30 minutes.
D3 FastPoint incorporates the same proprietary and proven monoclonal antibodies present in Diagnostic HYBRIDS’ other respiratory virus IVD products. The kit uses the fluorescent labeling technologies of the company’s D3 UltraTM and D3 DuetTM product lines in combination with newly developed L-DFA processing technology to create a unique rapid testing format. The new patent-pending technology also allows for the simultaneous identification of two respiratory viruses in a single slide well. The 3-well format of the D3 FastPoint L-DFA Respiratory Virus Identification Kit will allow laboratories to simultaneously detect 6 respiratory viruses on a single slide.
The D3 FastPoint L-DFA Respiratory Virus Identification Kit underwent a multi-site trial of nearly 1500 specimens in early 2009. Scientific posters on trial results were presented at the 2009 Clinical Virology Symposium in Daytona Beach, Fla. Abstracts are available at www.virology.org.