MicroELISA

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Enzyme ImmunoAssay   (ELISA) for   the   determination of   IgM antibodies to Herpes Simplex Virus types 1&2 in human plasma and sera with the "capture" system. The devise is intended for the follow-up of HSV infected patients and for the monitoring of risk of neonatal defects due to HSV infection during pregnancy. For “in vitro” diagnostic use only.

Herpes Simplex Virus type 1 (HSV1) and type 2 (HSV2) are large complex DNA-containing viruses which have been shown to induce the synthesis of several proteins during infection, possessing an high number of cross-reactive determinants and just a few of type-specific sequences.

The majority of primary and recurrent genital herpetic infections are caused by HSV2; while non genital infections, such as common cold sores, are caused primarily by HSV1.

The detection of virus specific IgG and IgM antibodies are important in the diagnosis of acute/primary virus infections or reactivations of a latent one, in the absence of evident clinical symptoms.

A-symptomatic infections may happen for HSV in apparently healthy individuals and during pregnancy. Severe herpetic infections may happen in immuno-compromised and suppressed patients in which the disease may evolve toward critical pathologies. The determination of HSV specific antibodies has then become important in the monitoring of “risk” patients and in the follow up of acute and severe infections.

The assay is based on the principle of "IgM capture" where IgM class antibodies in the sample are first captured by the solid phase coated with anti hIgM antibody.

After washing out all the other components of the sample and in particular IgG antibodies, the specific IgM captured on the solid phase are detected by the addition of a purified preparation of inactivated HSV1&2, labeled with a specific antibody conjugated with peroxidase (HRP).

After incubation, microwells are washed to remove unbound conjugate and then the substrate is added. In the presence of bound conjugate the colorless substrate is hydrolyzed to a colored end-product, whose optical density may be detected and is proportional to the amount of IgM antibodies to HSV1&2 present in the sample.

The kit contains sufficient reagents to perform 96 tests (code 091008).