Description:

Species: HumanSample Type: SerumFor the quantitative determination of IGM Antibodies to Herpes Simplex Virus Type 1 (HSV-1) in serum. DNA Virus Infections, Infection, Blood, Skin Diseases Viral, Pathologic Processes Product Name: IGM Antibodies to Herpes Simplex Virus Type 1 (HSV-1)Sample Type: Serum# of Samples: 1X96 AssaysIntended Use: The GenWay Biotech HSV-1 IgM ELISA is intended for the detection of IgM antibodies to herpes simplex virus HSV-1.Introduction: Herpes Simplex Virus is a common pathogen and its primary infection is usually asymptomatic. There are two immunologically distinct types of HSV: Type 1 and Type 2. HSV-1 is generally associated with oral infection and lesions above the waist, and HSV-2 is associated with genital infections and lesions below the waist. Clinical cases primarily are (1) eczema herpeticum with eczematous skin changes with numerous lesions, (2) gingivo-stomatitis, and (3) herpes sepsis, almost only found in premature newborn infants. The GenWay Biotech HSV-1 IgM ELISA is an accurate serologic method to detect HSV-1 IgM specific-antibody in serum samples.Principle of the test: Purified HSV-1 antigen is coated on the surface of microwells. Diluted serum is added to the wells, and the HSV-1 IgM- specific antibody, if present, binds to the antigen. All unbound materials are washed away. HRP-conjugate is added, which binds to the antibody-antigen complex. Excess HRP-conjugate is washed off and a solution of TMB Reagent is added. The enzyme conjugate catalytic reaction is stopped at a specific time. The intensity of the color generated is proportional to the amount of HSV-1 IgM-specific antibody in the sample. The results are read by a microwell reader compared in a parallel manner with calibrator and controls.Storage and Stability: 1. Store the kit at 2-8C.2. Keep microwells sealed in a dry bag with desiccants.3. The reagents are stable until expiration of the kit.4. Do not expose test reagents to heat, sun or strong light during storage or usage.Limitation of the Test: 1. Reliable and reproducible results will be obtained when the assay procedure is carried out with a complete understanding of the package insert instructions and with adherence to good laboratory practice.2. The wash procedure is critical. Insufficient washing will result in poor precision and falsely elevated absorbance readings.3. Serum samples demonstrating gross lipemia, gross hemolysis, or turbidity should not be used with this test.Precision: A study was performed to document typical assay precision with the GenWay Biotech HSV-1 IgM EIA product. The mean, SD, and %CV were calculated for Intra- and Inter-Assay in O.D. value (A450).Product Name: IGM Antibodies to Herpes Simplex Virus Type 1 (HSV-1) Subcellular Location: Isoform 1: Secreted. Note=During differentiation, B-lymphocytes switch from expression of membrane-bound IgM to secretion of IgM.Subcellular Location: Isoform 2: Cell membrane; Single-pass type I membrane protein.Polymorphism: All 4 combinations of the S/G and V/G polymorphisms at positions 191 and 216 have been observed in human mu chains.

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