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.
Introduction
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.
Principle of the Method
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.