Diagnostic Hybrids gains FDA clearance for influenza A and B virus
13 November 2009
Diagnostic Hybrids, a developer of in vitro diagnostic
fluorescent staining kits and cell culture products, has announced FDA
(510k) clearance of its D3 FastPoint L-DFATM Influenza A/ Influenza B
Virus Identification Kit. The Kit identifies influenza A virus and
influenza B virus from a patient’s specimen in under 30 minutes.
The kit represents the second product in the company’s D3 FastPoint
L-DFA product line.
D3 FastPoint incorporates the same proprietary and proven monoclonal
antibodies present in Diagnostic Hybrids’ other respiratory virus
products. The kit uses the fluorescent labeling technologies of the
company’s D3 Ultra and D3 Duet product lines in combination with newly
developed L-DFA processing technology to create a unique rapid testing
The new patent-pending L-DFA technology also allows for the
simultaneous identification of two respiratory viruses in a single slide
well. The kit will allow laboratories to identify influenza A virus and
influenza B virus infections in the same timeframe as currently
available point-of-care rapid antigen tests.
“The D3 FastPoint Flu A/B kit allows laboratories to report DFA
quality results within the critical care window, while confirming the
specimen adequacy to avoid false negatives due to poor specimen
collection, which is not possible when using rapid antigen tests,” said
Brooke McCutchan, MT (ASCP), Assistant Director of the Rapid Diagnostic
Testing Systems Program at Diagnostic Hybrids.
“This next product in the D3 FastPoint line is the logical
progression for advancing our premier L-DFA products towards a more
useful alternative to rapid antigen cartridge tests,” said David R.
Scholl, Ph.D., President & CEO of Diagnostic Hybrids. “With the D3
FastPoint Flu A/B kit, we are able to provide improved rapid respiratory
testing solutions to laboratories focused on influenza A virus and
influenza B virus diagnosis,” Scholl added.