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.

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.

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.

ImmunoFLOW Mycoplasma, detecting the same complement-fixing IgM antibodies measured using GenBio’s reference ImmunoWELL tests is now available. (Not available within the U.S. yet). ImmunoFLOW is an easy-to-use, visually interpreted, and rapid test. It require no special equipment. ImmunoFLOW is ideal for:

  • Situations where rapid patient results are important
  • Small and medium-sized hospitals
  • Clinics
  • Group practice office laboratories
  • Anywhere that instrumentation may be difficult
  • High humidity environments that may affect lateral flow method results
  • Areas where refrigeration storage is limited
PRODUCT TARGETPRODUCT LINEDESCRIPTIONPACKAGE INSERT (IFU)SALES SHEET
MycoplasmaImmunoWELLMycoplasma Pneumoniae IgGPackage Insert 110-0182
Sales Sheet 700-0452
MycoplasmaImmunoFLOWMycoplasma Pneumoniae IgMPackage Insert 110-0432
MycoplasmaImmunoWELLMycoplasma Pneumoniae IgMPackage Insert 110-0131Sales Sheet 700-0463