The Rabies Virus immunofluorescence reagents primarily refer to lab materials used in diagnosing rabies, specifically the Rabies Detection Reagent from Merck Millipore (RU5500). This reagent blends two rabies virus monoclonal antibodies, clones 103.7 and 502.2.

The diagnostic method used with these reagents is the Direct Fluorescent Antibody Technique (DFA). The process involves fixing brain samples, incubating them with fluorescein isothiocyanate (FITC)-labeled antibodies to rabies virus, and then viewing the sample under a fluorescence microscope. If rabies viral antigens are present, they will bind to the labeled antibodies and can be visualized as fluorescent stains.

Rabies virus immunofluorescent reagents are devices that consist of rabies virus antisera conjugated with a fluorescent dye used to identify rabies virus in specimens taken from suspected rabid animals. The identification aids in the diagnosis of rabies in patients exposed to animal bites and provides epidemiological information on rabies. Rabies is an acute infectious disease of the central nervous system which, if undiagnosed, may be fatal. The disease is commonly transmitted to humans by a bite from a rabid animal.

Intended Use: Rabiesvirus immunofluorescent reagents are devices that consist of Rabiesvirus antisera conjugated with a fluorescent dye used to identify rabiesvirus in specimens taken from suspected rabid animals. The identification aids in the diagnosis of rabies in patients exposed to animal bites and provides epidemiological information on rabies. Rabies is an acute infectious disease of the central nervous system which, if undiagnosed, may be fatal. The disease is commonly transmitted to humans by a bite from a rabid animal.

Device Description: Rabies DFA Reagent uses fluorescein-labelled monoclonal antibodies directed against the rabies nucleocapsid protein to detect the virus in infected tissue. The direct immunofluorescence assay requires incubation of a user-determined dilution of the reagent with suspected rabies-infected tissue such as the brain (medulla, cerebellum, and hippocampus) and submaxillary salivary glands. If a virus is present, the FITC-labeled monoclonal antibodies will bind to the nucleocapsid protein. Unbound antibody is removed by washing. The antigen-antibody complex is visualized using fluorescence microscopy. Positive reactions in infected tissue will appear as bright apple-green cytoplasmic inclusions or “dusting”.

A blend of monoclonal antibodies is used in the Light Diagnostics Rabies DFA reagent. These monoclonal antibodies are specific for the rabies virus nucleocapsid protein. The use of monoclonal antibodies ensures increased specificity of the reagent and reduces the risk of non-specific background or interference.

• Stability Studies
• Precision/Reproducibility
• Detection studies
• Detection limit
• Analytical specificity
• Traceability (controls, calibrators, or method)
• Retrospective Study
• Analytical Sensitivity
• Assay cut-off.
• Analytical Specificity (Cross-Reactivity)
• Interfering Substances
• Precision – Intra and Inter-assay
• Prozone effect study

The same is applicable for CE Marking under IVDR also.

No Guidance available  for 510k submission and IVDR CE Marking