Herpes Simplex 2 IgM (HSV-2 IgM) ELISA kit description:

The DIAGNOSTIC AUTOMATION ELISA, HSV 2 IgM is intended for the detection of IgM antibodies to herpes simplex virus 2.

Purified HSV antigen is coated on the surface of microwells. Diluted patient serum is added to wells, and the HSV 2 IgM 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 IgM 2 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 2 IgM is an accurate serologic method to detect HSV 2 specific antibody IgM 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 10.2% 8.5% 7.5%
Inter-assay 12.1% 9.7% 8.4%

To prevent false negative and false positive IgM test results caused by the presence of specific IgG and rheumatoid factor (RF) in some specimens, reagents provided in this kit has been formulated to resolve these interferences. However, specimens with extremely high RF and high autoimmune antibodies, the possibility of these interferences cannot be ruled out entirely. 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.

A negative serological test does not exclude the possibility of past infection. Following primary HSV infection, antibody may fall to undetectable levels and then be boosted by later clinical infection with the same or heterologous type. Such a phenomenon may lead to incorrect interpretations of seroconversion and primary infection, or negative antibody status. In addition, samples obtained too early during primary infection may not contain detectable antibody. Some persons may fail to develop detectable antibody after Herpes infection.