Description

The Diagnostic Automation, Inc. Herpes Simplex virus- HSV 2 IgG ELISA kit is intended for use in evaluating a patient\\\'s serologic status to herpes simples virus (HSV) infection, or for evaluating paired sera for the presence of a significant increase in herpes specific IgG.

Purified HSV antigen is coated on the surface of microwells. Diluted patient serum is added to wells, and the HSV 2 IgG specific antibody, if present, binds to the antigen. All unbound materials are washed away. After adding enzyme conjugate, it binds to the antibody-antigen complex. Excess enzyme conjugate is washed off and TMB Chromogenic substrate 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 IgG specific antibody in the sample. The results are read by a microwell reader compared in a parallel manner with calibrator and controls.
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 newly born of premature infants. DIAGNOSTIC AUTOMATION ELISA HSV IgG is an accurate serologic method to detect HSV specific antibody in serum sample.

The precision of the assay was evaluated by testing three different sera of eight replicates over a period of one week. The intra-assay and inter-assay C.V. are summarized below:

Negative Low positive Positive
Intra-assay 10.5% 8.7% 7.6%
Inter-assay 11.5% 9.8% 8.6%

As with other serological assays, the results of these assays should be used in conjunction with information available from clinical evaluation and other diagnostic procedures. Samples obtained too early during primary infection may not contain detectable antibody. A single serum sample should not be used to aid in the diagnosis of recent infection. Paired samples should be collected and tested simultaneously to look for seroconversion.