Description

The Diagnostic Automation, Inc. Varicella-Zoster Virus (VZV) IgM ELISA kit is intended for the detection of IgM antibody to Varicella-Zoster virus in human serum as an aid in the diagnosis of primary infection or reactivation. For in vitro diagnostic use. High complexity test.

Enzyme-Linked Immunosorbent Assays (ELISA) rely on the ability of biological materials (e.g., antigens) to adsorb to plastic surfaces such as polystyrene (solid phase). When antigens bound to the solid phase are brought into contact with a patient\\\'s serum, antigen specific antibody, if present, will bind to the antigen on the solid phase forming antigen-antibody complexes. Excess antibody is removed by washing. This is followed by the addition of goat anti-human IgM globulin conjugated with horseradish peroxidase which will bind to the antibody- antigen complexes. The excess conjugate is removed by washing, followed by the addition of Chromogen/Substrate tetramethylbenzidine (TMB). If specific antibody to the antigen is present in the patient\\\'s serum, a blue color develops. When the enzymatic reaction is stopped with 1N H2SO4, The contents of the wells turn yellow. The color, which is indicative of the concentration of antibody in the serum, can be read on a suitable spectrophotometer or ELISA microwell plate reader.

The various methods of serodiagnostic tests for the detection of VZV antibodies in a patient\\\'s serum include indirect immunofluorescence, neutralization, complement fixation and fluorescent antibody to membrane antigen (FAMA). FAMA is generally considered the most sensitive and specific of the methods, yet requires the use of cell culture which is cumbersome to perform. It has been suggested by clinical and correlation studies performed by Shenab and Brunell that ELISA methodology is as sensitive and perhaps more specific than the FAMA assay.

The sensitivity, specificity, and reproducibility of enzyme-linked immunoassays is comparable to other serological tests for antibody, such as immunofluorescence, complement fixation, hemagglutination and radioimmunoassays.