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Intended Use
For the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human sera by indirect enzyme immunoassay (EIA). This test can aid in the assessment of the patient's immunological status, or may aid in the diagnosis of M. pneumoniae-associated disease. The test can be performed either manually or in conjunction with Mago® Plus automated systems.
For In Vitro Diagnostic Use.
Summary
Mycoplasmas are members of the Mollicutes class of bacteria and are the smallest self-replicating organisms. These bacteria lack a cell wall making them resistant to many antibiotics. The primary human pathogen is Mycoplasma pneumoniae, which is known to cause a wide range of clinical symptoms, ranging from mild respiratory infections ("walking pneumonia"), to tracheobronchitis and severe atypical pneumonia. Unlike other respiratory infections, M. pneumoniae infections tend not to be seasonal. In large populations, disease is endemic year-round with periodic increases in incidence, whereas in smaller populations, outbreaks appear as epidemics. The elderly and children are at elevated risk of infection.
Diagnostic tests for M. pneumoniae infections include cold agglutinins, complement fixation, EIA and culturing. The use of enzyme immunoassays offers several advantages over the other assay methods. Increased specificity is obtained by using purified detergent-treated M. pneumoniae extracts as antigens, which minimize cross-reacivity. Isotype-specific enzyme conjugates provide antibody information and the assay can be optimized for high sensitivity.
Principle of the Procedure
Purified Mycoplasma antigen is bound to microwells. Diluted patient sera, Cut-Off Calibrator and controls are placed in the microwells and incubated. Anti-M. pneumoniae IgG antibodies, if present, will bind to the antigen forming antigen-antibody complexes. Residual sample is eliminated by aspirating and washing. Conjugate (horseradish peroxidase-labeled anti-human IgG) is added and will bind to these complexes. Unbound conjugate is removed by aspiration and washing. Substrate is then 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 600-630 nm) and is directly proportional to the concentration of IgG antibodies to M. pneumoniae present in the sample.
Please refer to complete Package Insert for greater detail about the test.
Features & Benefits
Formatted Procedures
