HSV 1 IgG Chemiluminescence ELISA 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. For investigational use only.

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. HSV IgG Chemiluminescence ELISA is an accurate serologic method to detect HSV
specific antibody in serum sample.

Purified HSV antigen is coated on the surface of microwells. Diluted patient serum is added to wells, and
the HSV 1 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 substrate A & substrate B mixture is added. The light generated (RLU) is
proportional to the amount of IgG specific antibody in the sample. The results are read by a microwell
luminometer compared in a parallel manner with calibrator and controls.