Mycoplasma IgG Test System provides a means for the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human sera. When performed according to these instructions, the results of this test may aid in the diagnosis of M. pneumoniae infections in the adult population, or the determination of the patient’s serological status. Potential cross-reactivity has not been assessed, nor were studies performed on very young and/or elderly patients.
Mycoplasma pneumoniae is the most common cause of pneumonia and febrile upper- respiratory tract infections in the general population (except for influenza A). Other nonrespiratory complications may also develop with the disease in virtually any organ system, with insult ranging from mild to life-threatening Mycoplasma pneumoniae, a prokaryote, is the smallest (10 x 200nm), and simplest self- replicating microorganism know, and more closely resembles a bacterium rather than a virus. However, because it lacks a cell-well, a resistance to cell-well-active antibiotics is obvious (i.e., penicillin, cephalosporins). This concern for diagnostic, or at least therapeutic accuracy in the early management of community-acquired infections is particularly critical in very young or elderly patients where very little temporal margin of error exists. Until recently, the routine laboratory diagnosis of this infection has been limited to insensitive and/or non-specific assays (i.e., cold agglutinins, complement-fixation, and culture isolation). Species-specific antibodies to surface antigens are now known to exist. They are protective, and are readily detected by ELISA, even in the early stages of the disease. The diagnosis therefore, is best achieved serologically.