Mycoplasma pneumoniae is the only known Mycoplasma species that is a primary pathogen in man. Clinical manifestations can range from asymptomatic respiratory infections to severe pneumonia. M. pneumoniae accounts for 15 to 20% of total pneumonia. Other symptoms associated with M. pneumoniae infection include abnormalities of the central nervous system (meningitis, encephalitis), cardiac involvement (myocarditis, pericarditis), hemolytic anemia, arthritis, G.I. inflammations, and mucocutaneous reactions. Mycoplasma pneumoniae is identified as a common infectious cause of Stevens - Johnson syndrome, a well defined systemic disease that can develop into a life-threatening illness in children. The Mycoplasma pneumoniae organism is sensitive to erythromycin and tetracycline; however, it is resistant to drugs more routinely given in the treatment of acute pneumonia. Thus, a rapid and reliable diagnosis of M. pneumoniae infection is essential to proper patient management.

GenBio offers both specific ImmunoWELL Mycoplasma pneumoniae IgM kits and ImmunoWELL Mycoplasma pneumoniae IgG kits. ImmunoWELL Mycoplasma pneumoniae IgM kit is the first commercial IgM enzyme immunoassay (EIA) product providing single specimen acute diseases serodiagnosis. The ImmunoWELL Mycoplasma pneumoniae kits are the worldwide market leading products and the only products detecting specific IgM or IgG antibodies to the 'gold standard' complement fixation antigen. Other products on the market use detergent extracted protein and not the complement fixation glycoprotein as source antigen.

Unlike the case with other infectious diseases, only the IgM test result is required for M. pneumoniae serodiagnosis. Most laboratories still concurrently test both IgG and IgM with the ImmunoWELL test kits, and high IgG reactivity is often used as supplemental evidence for current infection. However, IgG results alone (any method or test kit) do not accurately predict active infection unless paired sera (acute and convalescent specimens) are tested at one time.