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Light Diagnostics™ Human Metapneumovirus DFA Kit is intended for the detection and identification of human metapneumovirus (hMPV) in direct respiratory specimen cell preparations from nasopharyngeal swabs from patients with febrile respiratory illness. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV. Negative results do not preclude hMPV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. It is recommended that specimens found to be negative after examination of the direct specimen results be confirmed by FDA cleared hMPV molecular assay. For In Vitro Diagnostic Use.

Light Diagnostics Human Metapneumovirus DFA Kit utilizes a single reagent for the detection and identification of human metapneumovirus. The fluorescein labeled monoclonal antibodies, specific for human metapneumovirus will bind to viral antigen in human metapneumovirus infected cells. Unbound reagent is removed by rinsing with phosphate-buffered saline (PBS/Tween 20). Illumination allows visualization of the antigenantibody complex by fluorescence microscopy. When a FITC filter set is used, the human metapneumovirus antibody complex will exhibit an apple-green fluorescence. Uninfected cells stain a dull red due to the presence of Evans blue in the reagent.

The Light Diagnostics™ HSV 1/2 Typing DFA Kit is an in vitro diagnostic test for the qualitative detection and identification of herpes simplex virus type 1 and/or type 2 in direct specimens from patients with vesicular lesions and symptoms consistent with herpes infection and for culture confirmation by immunofluorescence. Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Specimens found negative on direct specimen detection should be confirmed by culture. For In Vitro Diagnostic Use.

Light Diagnostics™ HSV 1/2 Typing DFA Kit is a qualitative test that uses specific typing reagents and FITC filter fluorescence microscope to detect and differentiate herpes simplex viruses 1 and 2 in direct specimens from symptomatic patients with lesions and in specimens amplified by cell culture. The kit consists of HSV-1 Typing Reagent vial, HSV-2 Typing Reagent vial, two HSV Control Slides, Phosphate-Buffered Saline packet; Tween 20/Sodium Azide Solution (100X) vial, and Mounting Fluid vial. The kit utilizes specific reagents for the detection and identification of HSV-1 and HSV-2, therefore two cell spots on slides of specimens are required to identify the type of HSV. The HSV-1 Typing Reagent consists of two fluorescein-labeled monoclonal antibodies specific for HSV-1 glycoprotein C and ICP35 respectively. The HSV-2 Typing Reagent consists of two fluorescein-labeled monoclonal antibodies that specifically bind HSV-2 polypeptides. In Western blots these appear as two major bands with molecular weights of between 110-120 kD and between 78-82 kD and are consistent with the monoclonal antibodies recognizing epitopes within glycoprotein G of HSV-2. The typing reagents will bind to HSV-1 or HSV-2 infected cells fixed on microscope slides specifically. Separate cell spots on slides should be prepared for use with each reagent. Unbound reagent is removed by rinsing with phosphate-buffered saline (PBS). Illumination with ultraviolet light allows visualization of the antigen-antibody complexes by fluorescence microscopy. HSV-infected cells will exhibit apple-green fluorescence with the specific reagent while cells stain a dull red due to the presence of Evans blue in the typing reagents. The controls contained in this kit are acetone fixed slides with one well containing HSV-1 infected cells, one well containing HSV-2 infected cells, and one well containing uninfected cells to verify functioning of reagents, culture methodology and functioning of the microscope.