Description:

1. Intended UseThe GenWay Herpes 1 IgM Antibody ELISA Test Kit has been designed for the the detection andthe quantitative determination of specific IgM antibodies against Herpes 1 in serum and plasma.Further applications in other body fluids are possible and can be requested from the TechnicalService of GenWay.This assay is intended for research use only.

2. General InformationThe Herpes simplex virus type 1 is an ubiquitous pathogen of humans that usually causes either asymptomatic infection or mild skin and mucosal diseases. Antibodies to HSV 1 occur in about 90%of adults. Normally HSV 1 is transmitted by oral secretions or open wounds prior to the age of five.Recently in adults primary infections were observed, too. After the primary infection some virusesestablish a latent state in their host cells (mostly ganglial cells). The virus DNA is integrated intothe genome of the host cell, where it remains until the infected person dies. After stimulation of thehost cell, recurrent infection occurs, which is called an exacerbation, when clinical symtoms appear.The recurrence may be caused by different kinds of traumas, as fever or physiological changes anddiseases. Immunosuppressed persons may show a severe clinical course. HSV 1 causes differentclinical symptoms in about 10% of the primary infections. HSV 1 causes 85% and HSV 2 15% oforal primary infections. The major clinical manifestations associated with HSV 1 infections aregingivostomatitis, keratitis, conjunctivitis, vesicular eruptions of the skin, encephalitis, eczema andsome lethal infections of newborns. In some cases HSV 1 infection leads to a meningitis withdifferent neurological symptoms. Persons at an increased risk for serious or prolonged HSVinfections are those with eczema, severe burns or a defect in their cell-mediated immunity. The drugAcyclovir is the treatment of choice for most serious HSV infections. The common manifestationsof HSV infections are so typical that the infection may be easily diagnosed on clinical recognitionalone. The \"gold standard\" for diagnosis of HSV infection remains isolation of the virus in tissueculture. For typing HSV 1/HSV 2 Western blots or indirect immunofluorescence may be performed.Diagnosis of the primary infection by HSV 1/HSV 2 can be confirmed by a significant rise of theIgG titer within 6 to 10 days. A finished infection can be monitored by the IgG ELISA. In case of asuspicion of HSV encephalopathy it is recommended to perform a parallel determination of bothHSV-specific antibodies (IgG and IgM) in serum and liquor.

3. Principle of the TestThe GenWay Herpes 1 IgM antibody test kit is based on the principle of the enzyme immunoassay(EIA). Herpes 1 antigen is bound on the surface of the microtiter strips. Diluted sample serum orready-to-use standards are pipetted into the wells of the microtiter plate. A binding between theIgM antibodies of the serum and the immobilized Herpes 1 antigen takes place. After a one hourincubation at room temperature, the plate is rinsed with diluted wash solution, in order to removeunbound material. Then ready-to-use anti-human-IgM peroxidase conjugate is added and incubatedfor 30 minutes. After a further washing step, the substrate (TMB) solution is pipetted and incubatedfor 20 minutes, inducing the development of a blue dye in the wells. The color development isterminated by the addition of a stop solution, which changes the color from blue to yellow. Theresulting dye is measured spectrophotometrically at the wavelength of 450 nm. The concentrationof the IgM antibodies is directly proportional to the intensity of the color.

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