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Integrated Solutions®
Intended Use
For the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human sera. The test may aid in the determination of the patient's serological status, or in the diagnosis of disease associated with Mycoplasma pneumoniae . Potential cross-reactivity with M. genitalium has not been assessed, nor were studies performed on very young and/or elderly patients. The test can be performed manually or in conjunction with Mago® Plus automated systems.
For In Vitro Diagnostic Use.
Summary
Mycoplasma pneumoniae is the most common cause of pneumonia and febrile upper-respiratory tract infections in the general population (except for influenza A).
Mycoplasma pneumoniae , a prokaryote, is the smallest (10 x 200nm), and simplest self-replicating microorganism known. Because it lacks a cell-wall, a resistance to cell-wall-active antibiotics is obvious ( i.e., penicillin, cephalosporins 1 ). 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.
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.
Principle of the Procedure
Partially purified Mycoplasma antigen is bound to microwells. Diluted patient sera, Calibrator and controls are placed in the microwells and incubated. Anti-Mycoplasma IgG antibodies, if present, will bind to the antigen in the microwells. After washing the microwells to remove unbound antibodies, a second incubation with anti-human IgG conjugated to horseradish peroxidase is carried out. The conjugate will bind to human anti-Mycoplasma IgG antibodies, if present, forming an immunocomplex. The microwells are then washed again to remove unbound components and the enzyme substrate is added and incubated. In the presence of bound enzyme, the substrate is converted to an end product. The absorbance of this end product can be read spectrophotometrically at 450 nm (reference 630 nm) and is directly proportional to the concentration of IgG antibodies to Mycoplasma antigen present in the sample.
Please refer to complete Package Insert for greater detail about the test.
Features & Benefits
Formatted Procedures
