Description
Intended Use: The Mycoplasma IgM ELISA Kit is intended for the detection of IgM antibody to Mycoplasma in human serum plasma.
Summary and Explaination: Mycoplasma pneumoniae is a pathogen with spectrum of clinical presentations ranging from asymptomatic to pronounced pneumonia. Symptoms start from 6 to 32 days after exposure with headache, malaise, cough, sore throat and fever. The illness can last from a few days to a month or more. Detection by ELISA of M. pneumoniae IgM antibodies or demonstration of a significant increase of specific IgG antibodies is strong evidence for recent infection in the appropriate clinical setting.Specific IgM antibodies typically increase significantly 1 week after clinical onset and specific IgG levels rise in the second week.M. pneumoniae IgM can, however, persist for more than two years after infection, and therefore, detection of specific IgM does not accurately indicate the time of infection. Primary infection and reinfection may be distinguished by the presence of elevated specific IgA and of specific IgM in primary infections and by the presence of elevated specific IgA in the absence of specific IgM in reinfections.In general, the absence of specific IgM in serum collected 10-20 days after onset is strong evidence against primary pneumonia due to M. pneumoniae.
Principle of the test: Diluted patient serum (serum diluent contains sorbent to remove Rheumatoid Factor and human IgG interference) is added to wells coated with purified antigen. IgM specific antibody, if present, binds to the antigen. All unbound materials are washed away and the enzyme conjugate is added to bind to the antibody-antigen complex, if present. Excess enzyme conjugate is washed off and substrate is added. The plate is incubated to allow the hydrolysis of the substrate by the enzyme. The intensity of the color generated is proportional to the amount of IgM specific antibody in the sample