Diagnostic Hybrids gains FDA clearance for influenza A and B virus identification kit

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 format.

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.