Description

The Diagnostic Automation, Inc. Mycoplasma IgM ELISA kit intended for the qualitative determination of IgM antibodies in human serum to Mycoplasma pneumoniae antigen. The DAI anti-Mycoplasma IgM assay may be used as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population. High complexity test.

Mycoplasma pneumoniae is among the smallest of free-living organisms. In humans, it is usually found in the throat and lungs and is susceptible to antimicrobial agents that inhibit protein synthesis (1). The
spread of mycoplasmal infections depends on close and prolonged contact between people, as it is transmitted by means of droplet nuclei from the respiratory tract (2). Mycoplasmal infection may be asymptomatic or may produce upper respiratory tract disease or atypical pneumonia. The pneumonia is difficult to differentiate from viral diseases by clinical means alone (1,2). Laboratory tests such as isolation, Complement Fixation serology, and ELISA serology are helpful as an aid in the diagnosis (1, 2, 3, 4).

Enzyme-linked immunosorbent assays (ELISA) rely on the ability of biological materials, (i.e. 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 then binds to the antibody-antigen complexes. The excess conjugate is removed by washing, followed by the addition of substrate and chromogen, 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 proportional to the concentration of antibody in the serum, can be read on a suitable spectrophotometer or ELISA microwell plate reader (5, 6, 7, 8). The sensitivity, specificity, and reproducibility of enzyme-linked immnuoassays can be comparable to other serological tests for antibody, such as immunofluorescence, complement fixation, hemagglutination and radioimmunoassays (9, 10, 11).