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The Diagnostic Hybrids, Inc. device, D3 Duet DFA RSV/Respiratory Virus Screening Kit, is intended for the qualitative detection and identification of respiratory syncytial virus, while screening for influenza A virus, influenza B virus, adenovirus, and parainfluenza virus types 1, 2 and 3 viral antigens, in nasal and nasopharyngeal swabs and aspirates or in cell culture. The assay detects viral antigens by immunofluorescence using monoclonal antibodies (MAbs), from patients with signs and symptoms of respiratory infection. It is recommended that specimens found to be negative after examination of the direct specimen result be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Performance characteristics for influenza A virus detection and identification were established when influenza A (H3N2) and influenza A (H1N1) were the predominant influenza A strains circulating in the United States. Performance characteristics for influenza A virus detection and identification were established when influenza A H3N2 and influenza A H1N1 were the predominant influenza A strains circulating in the United States. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to a state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The Diagnostic Hybrids, Inc. device, D3 Duet DFA RSV/Respiratory Virus Screening Kit, uses a blend of viral antigen-specific murine MAbs. MAbs for RSV are directly labeled with R-phycoerythrin (R-PE) for the rapid detection and identification of RSV. MAbs for influenza A virus, influenza B virus, adenovirus, and parainfluenza virus types 1, 2, and 3 are directly labeled with fluorescein isothiocyanate (FITC), for rapid detection of these agents. Kit components: - D3 Duet DFA RSV/Respiratory Virus Screening Reagent - Normal Mouse Gamma Globulin DFA Reagent - Respiratory Virus Antigen Control Slides - Wash Solution Concentrate - Mounting Fluid The cells to be tested, derived from a clinical specimen or cell culture, are placed onto a glass slide and allowed to air dry. The cells are fixed in acetone. The D3 Duet DFA RSV/Respiratory Virus Screening Reagent is added to the cells which are then incubated for 15 to 30 minutes at 35° to 37°C in a humidified chamber or humidified incubator. The stained cells are then washed with the diluted wash solution, a drop of the supplied Mounting Fluid is added and a coverslip is placed on the prepared cells. The cells are examined using a fluorescence microscope. The respiratory syncytial virus infected cells will fluoresce golden-yellow, while cells infected with any of the other six viruses will fluoresce apple-green. Uninfected cells will contain no fluorescence but will be stained red by the Evans Blue counter-stain. If only golden-yellow fluorescent cells are present the specimen can be reported as positive for respiratory syncytial virus antigen. If only apple-green fluorescent cells are present, the particular virus is identified using the individual reagents from the D3 Ultra DFA Respiratory Virus Screening & ID Kit (D3 Ultra) on new, separate cell preparations. If both golden-yellow and apple-green are present, the additional virus may be identified using the individual reagents from the D3 Ultra on new, separate cell preparations.

The PathoDx Respiratory Virus Panel (RVP) kit is a direct immunofluorescence test for the qualitative detection of 7 common respiratory viruses (respiratory syncytial virus, influenza A, influenza B, parainfluenza viruses 1,2, and 3, and adenovirus) in prepared direct patient specimens and following growth in cell culture. The materials supplied are intended for in vitro use only.

Direct immunofluorescence test for the qualitative detection of seven common respiratory viruses. The PathoDx Respiratory Virus Panel kit consists of one screening reagent containing monoclonal antibodies to each respiratory virus and seven virus-specific monoclonal antibody reagents. All reagents contain monoclonal antibody labeled with fluorescein. Acetone-fixed cells from either patient specimens or cell culture are stained with the Screening Reagent and the Negative Control Reagent. The Screening Reagent contains fluorescein-labeled monoclonal antibodies to RSV, influenza A. influenza B. parainfluenza viruses 1, 2, and 3, and adenovirus. They will react specifically to any of the above viral antigens, if present in the cell. The Negative Control Reagent contains fluorescein-labeled murine antibodies which do not react with the viral agents. Unbound antibody and Evans blue counterstain are washed off with buffered saline, and the slide is mounted with buffered glycerol. Under fluorescence microscopy, the viral antigens recognized by the monoclonal antibodies present will show a characteristic apple-green fluorescence, while uninfected cells will counterstain red with Evans blue. To identify which of the seven respiratory viruses is reactive with the Screening Reagent, acetonefixed cell preparations are stained with each of the seven virus-specific reagents, washed free of unbound antibody, mounted with buffered glycerol, and observed under fluorescence microscopy. The responsible virus(es) will show characteristic apple-green fluorescence with uninfected cells counterstaining red.