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The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit is intended for the qualitative identification of adenovirus and to screen for the presence of parainfluenza virus types 1, 2, and 3 in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection by direct detection of immunofluorescence using monoclonal antibodies (MAbs). It is recommended that specimens found to be negative for parainfluenza virus and adenovirus after examination of the direct specimen result be confirmed by cell culture. Negative results do not preclude parainfluenza virus and adenovirus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.

The D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit (D3 FastPoint PIV/ADV Kit) uses a blend (called an "L-DFA Reagent") of viral antigen-specific murine monoclonal antibodies that are directly labeled with either R-phycoerythin (PE) (parainfluenza virus types 1, 2 and 3) or fluorescein isothiocyanate (FITC) (adenovirus) for the qualitative identification of adenovirus and to screen for the presence of parainfluenza virus types 1, 2, and 3. The cells to be tested are derived from respiratory specimens from patients with signs and symptoms of respiratory infection. The cells are permeabilized and stained concurrently in a liquid suspension format with the L-DFA Reagent. After incubating at 35℃ to 37℃ for 5-minutes, the stained cell suspensions are rinsed with 1X PBS. The rinsed cells are pelleted by centrifugation and then re-suspended with the Resuspension Buffer and loaded onto a specimen slide well. The cells are examined using a fluorescence microscope. Cells infected with parainfluenza virus types 1, 2 and 3 will exhibit golden-yellow fluorescence. Cells infected with adenovirus will exhibit apple green fluorescence due to the FITC. Non-infected cells will exhibit red fluorescence due to the Evans Blue counter-stain. Nuclei of intact cells will exhibit orange-red fluorescence due to the propidium iodide.