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The ELVIS®HSV ID and D3 Typing Test System provides Cells, Replacement Medium and Test Reagents for the culture, qualitative identification and typing of Herpes simplex virus (HSV) from cutaneous or mucocutaneous specimens collected from patients with clinical suspicion of HSV infection. The performance characteristics of this assay have not been established for antiviral therapy, prenatal monitoring or CSF specimens.

The ELVIS®HSV ID and D3 Typing Test System provides Cells, Replacement Medium and Test Reagents for the culture, qualitative identification and typing of herpes simplex virus (HSV) from cutaneous or mucocutaneous specimens as an aid in the diagnosis of HSV type 1 (HSV-1) and HSV type 2 (HSV-2) infections. The performance characteristics of this assay have not been established for antiviral therapy, prenatal monitoring or use with cerebral spinal fluid specimens. ELVIS HSV Cells are genetically engineered Baby Hamster Kidney (BHK) cells, which, when infected with either HSV-1 or HSV-2, are induced to generate and accumulate an endogenous, intracellular bacterial enzyme, ßgalactosidase. Other related viruses (e.g., Varicella zoster) are not capable of inducing the formation of this enzyme. HSV infection of the ELVIS®HSV Cells also results in the formation of HSV-type-specific proteins. The presence of these proteins can be detected microscopically when fluorescent labeled HSV-type-specific antibodies are used. The two Type 1 monoclonal antibodies used in ELVIS® are directed against specific to epitopes on the HSV-1 protein. The three Type 2 monoclonal antibodies are directed against the HSV-2 glycoproteins C, G and a recombinant glycoprotein G that occur in the cytoplasm of infected cells. The ELVIS®HSV ID and D2 Typing Test System consists of: 1. ELVIS®HSV Cells: The ELVIS®HSV Cells have a routine use period of 7 days from customer receipt while all other components have a shelflife of months (see expiration date on label of each component). ELVIS® HSV Cells are provided as 75% to 95% confluent monolavers in shell-vials with or without coverslips, or in multi-well plates with or without coverslips, and up to 24 monolayers per plate. Each monolayer is covered by at least 0.75-mL of Eagle's Minimum Essential Medium (EMEM) with fetal bovine serum (FBS), penicillin, and streptomycin. Cells are characterized by isoenzyme analysis and have been tested and found free of Mycoplasma spp. and other adventitious organisms. 2. ELVIS HSV Replacement Medium: Sterile EMEM containing FBS, Penicillin, Streptomycin and Amphotericin B. ELVIS®HSV Replacement Medium is for use with ELVIS®HSV Shell-Vials and Multi-well Plates. 3. ELVIS® HSV Solution 1 (Cell Fixative): an aqueous acetone solution. 4. ELVIS® HSV Solution 2T (Staining Buffer): A diluted solution of X-Gal (5-Bromo-4-Chloro-3-Indolyl-B-D-Galactopyranoside), N.N-Dimethylformamide, iron, sodium and magnesium salts, fluorescein-labeled HSV-2-specific murine MAbs (directed against HSV-2 glycoproteins C, G, and a recombinant glycoprotein G) and nonlabeled HSV-1-specific murine MAbs (specific to epitopes on the HSV-1 protein UL42), penicillin, streptomycin, bovine serum albumin and Evans Blue in an aqueous, buffered solution. 5. ELVIS®HSV Solution 3: An aqueous, stabilized, buffered solution containing fluorescein-labeled, affinity purified goat-anti-mouse IgG antibody and Evans Blue with sodium azide as preservative. 6. ELVIS®HSV Mounting Fluid (Buffered Glycerol): Aqueous, stabilized, buffered glycerol (pH 7.3 +/- 0.5), containing sodium azide as preservative. 7. 40X PBS Concentrate. 25-mL: One bottle of a 40X PBS concentrate consisting of 0.4% sodium azide (0.1% sodium azide after dilution to 1X using de-mineralized water).

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.

This test system is designed for the manual or automated, qualitative detection of IgG antibodies to HSV-2 in human serum. The test system is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross reactivity of shared antigens, the HSV-1 IgG ELISA test should be performed in conjunction with this test system to fully evaluate the patient serum. The test is for in vitro diagnostic use.

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This test system is designed for the manual or automated, qualitative detection of IgG antibodies to HSV-1 in human serum. The test system is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross reactivity of shared antigens, the HSV-2 IgG ELISA test should be performed in conjunction with this test system to fully evaluate the patient serum. The test is for in vitro diagnostic use.

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