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The Trinity Biotech Captia™ Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to determine serologic status in females of child bearing age, and to evaluate paired sera for the presence of a seroconversion of IgG as an aid in the diagnosis of Herpes simplex virus infection. It is not intended for determining the type of Herpes simplex virus.

The Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions of IgG as an aid in the diagnosis of Herpes simplex virus infection. The Herpes Group IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Herpes simplex virus. Purified Herpes Group antigen is attached to a solid phase microtiter well. Diluted test sera are added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing and indirect measurement of specific antibody in the patient specimen.

This test system is designed for the manual or automated, qualitative detection of IgM antibodies to Herpes Simplex Virus (HSV) type 1 and type 2 in human serum. The test system is designed to detect IgM antibody to HSV-1 and/or HSV-2. but can not distinquish between the two IgM antibodies. The test system is intended to evaluate serologic evidence of primary or reactivated infection with HSV-1 and/or HSV-2.

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The POCkit™ HSV-2 Rapid Test is a single unit, membrane-based immunoassay for the qualitative determination, either in heparinized capillary whole blood taken by fingerstick or in serum, of circulating IgG antibodies specific for herpes simplex virus type 2 (HSV-2), which arise as a result of infection with HSV-2. It is intended for in-vitro diagnostic use by health professionals in Point of Care testing. The presence of antibodies to HSV-2 may be indicative of a previous infection with HSV-2 and may be of value in determination of previous immunological experience and to aid in the diagnosis of HSV associated disease. This assay will not differentiate whether infection is currently in a latent or active state.

The POCkit™ HSV-2 Rapid Test is a qualitative membrane immunoassay for the detection of IgG antibodies to herpes simplex virus type 2 (HSV-2) in human capillary whole blood and serum. The POCkit™ HSV-2 Rapid Test consists of a lest device that has a solid phase membrane housed in a plastic envelope containing wicking material. The membrane is visible to the user through a test window on the front of the device. The method employs a unique combination of a specific antibody binding protein conjugated to colloidal gold particles and a semi-purified HSV-2 specific antigen (glycoprotein G2, derived from HSV-2 virus). This protein has been bound to the membrane as a TEST spot on the right side of the test window. Human IgG has been bound to the membrane as a CONTROL spot on the left side of the test window. When a pro-diluted (fingerprick) capillary whole blood sample is allowed to pass through the membrane any anti-HSV-2 antibodies present become bound to the HSV-2 antigen in the TEST spot. Upon addition of the developing reagent, which reacts with human IGG antibodies, a pink/red color develops. The developing reagent also reveals the human IgG immobilized in the CONTROL spot, which demonstrates that the test is functioning property. The test device is designed to absorb the pro-calibrated volume of reagents that are provided in each test kit.

The PREMIER™ TYPE SPECIFIC HSV-2 IgG ELISA TEST is to be used in the testing of human serum specimens from individuals for whom the qualitative presence of detectable IgG antibody to herpes simplex virus type 2 is warranted; specifically, when used in conjunction with the Premier™ Type Specific HSV-1 IgG ELISA in the screening of sexually active adults. This test is indicated for individuals at risk for a sexually transmitted HSV infection or disease (STD), For example, this test is to be used to screen samples from patients with or without clinical history of herpes and can clarify when an individual with symptoms suggestive of genital herpes has genital HSV-2 infection. The PREMIER™ TYPE SPECIFIC HSV-2 IgG ELISA TEST is not recommended for use in a pediatric population. The performance characteristics of this device have not been established for prenatal and neonatal screening, the testing of patients with other HSV associated diseases and immunosuppressed patients, or the detection of early stages of HSV seroconversion.

The Premier™ Type Specific HSV-2 IgG ELISA Test is an in vitro diagnostic medical device is intended for the qualitative detection of IgG antibody to the herpes simplex virus type 2 in human serum by the enzyme-linked immunosorbent assay (ELISA) method. The Premier™ Type Specific HSV-2 IgG ELISA Test is comprised of the following items: 1. Antigen-Coated ELISA Plate: One 96-well plate comprised of twelve 8-well strips with breakaway wells, each well coated with affinity purified HSV-2 glycoprotein G (gG-2). 2. IgG Specimen Diluent: One bottle containing 30 ml of a lavender colored dilution buffer with sodium azide. 3. Conjugate: One bottle containing 15 ml of a pink colored solution of alkaline phosphatase-labeled antihuman IgG (Caprine) with sodium azide. 4. Substrate Buffer: One bottle containing 30 ml of a blue colored buffer solution with sodium azide. 5. p-NPP Tablets: One foil pack containing 6 tablets of p-nitrophenyl phosphate (p-NPP). 6. Stopping Reagent: One bottle containing 30 ml of a colorless solution of 1.5 N sodium hydroxide (NaOH). 7. Positive Control and Negative Control: One vial of each containing 200 ul of serum (human) with sodium azide. 8. Reference Serum: One vial containing 400 ul of serum (human) with sodium azide. 9. 20X Wash Solution: One bottle containing 60 ml of a green colored solution with detergent and sodium azide. 10. ELISA Plate Sealer: One acetate sheet with contact adhesive. 11. Resealable Storage Bag: One plastic sealable bag. 12. ELISA Worksheet: One worksheet for recording data. When the Premier™ Type Specific HSV-2 IgG ELISA Test is employed, diluted patient serum is incubated with purified herpes simplex virus type 2 glycoprotein (gG2) bound to the ELISA plate wells. If antibodies to the herpes simplex virus type 2 are present, they bind to the antigen and do not rinse off. Subsequently when enzyme-labeled antihuman IgG is added to the reaction site it binds to the immobilized IgG antibodies. After washing and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to the herpes simplex virus type 2 produce a color endpoint reaction which can be read with a standard ELISA plate reader.

The Zeus Scientific, Inc. Herpes Simples Virus (HSV) -1 and/or HSV-2 IgM ELISA Test System is intended for the qualitative detection of IgM antibodies to Herpes Simplex Virus type 1 and 2 in human serum. The test system is designed to detect IgM antibody to HSV-1 or HSV-2, but can not disginguish between the two IgM antibodies. The test system is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV-1 and/or HSV-2.

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The HSV 1+2 IgG ELISA TEST is to be used manually or in conjunction with the Duet™ instrument in the testing of human serum specimens from individuals in whom the qualitative presence or absence of detectable IgG antibody to herpes simplex virus type 1 and type 2 is warranted in the determination of immunological experience pertaining to infection with herpes simplex virus type 1 and type 2 and as an aid in the diagnosis of herpes simplex virus associated disease.

The HSV 1+2 IgG ELISA Test is an in vitro diagnostic medical device intended for the qualitative detection of IgG antibody to the herpes simplex virus (HSV) in human serum by the enzyme-linked immunosorbent assay (ELISA) method. The HSV 1+2 IgG ELISA Test is comprised of the following items: Antigen-Coated ELISA Plate, IgG Specimen Diluent, Conjugate, Substrate Buffer, p-NPP Tablets, Stopping Reagent, Positive Control and Negative Control, Reference Serum, 20X Wash Solution, ELISA Plate Sealer, Resealable Storage Bag, and ELISA Worksheet. When the HSV 1+2 IgG ELISA Test is employed, diluted patient serum is incubated with partially purified HSV antigen bound to the ELISA plate wells. If antibodies to herpes simplex virus are present, they bind to the antigen and do not rinse off. Subsequently when enzyme-labeled antihuman IgG is added to the reaction site it binds to the immobilized IgG antibodies. After washing and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to herpes simplex virus produce a color endpoint reaction which can be read with a standard ELISA plate reader.

The Diamedix Is-HSV 1 & 2 IgG is an indirect Enzyme Immunoassay (EIA) for the qualitative and semi-quantitative determination of IgG antibodies to herpes simplex virus (HSV) type 1 and/ or type 2 in human serum. This test is useful for indicating a past infection with HSV in a single specimen, including females of child-bearing age. The evaluation of acute and convalescent specimens, by demonstrating seroconversion or a significant increase in antibody level, can aid in the diagnosis of primary infection with HSV. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

The Is-HSV 1 & 2 IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to HSV 1 and/or HSV 2 antigens in human serum