Intended Use SeroMP™ Recombinant IgM kit is a qualitative Enzyme Linked Immunosorbent assay (ELISA) for the detection of IgM antibodies specific to Mycoplasma pneumoniae in human serum. The test enables early diagnosis of current or acute infection in a single serum specimen by determination of IgM antibodies. For In Vitro Diagnostic Use
Introduction M. pneumoniae is a common cause of community-acquired pneumonia, often characterized by gradual onset of headache, fever, malaise and, most typically, dry cough. M. pneumoniae is common in all age groups, however, it is most common in the first two decades of life and is rare in children under the age of four. It has been reported as the cause of up to 30% of all pneumonia cases (2). M. pneumoniae has also been associated with non respiratory diseases as meningitis, encephalitis, pancreatitis, sensorineural hearing loss, and acute brainstem syndrome (5). Due to its common occurrence, one should consider M. pneumoniae in all cases of pneumonia, but being the same symptoms for different agents, additional diagnostic tools, such as serological tests, are required (3). The ELISA technique is sensitive, specific and enables a differential determination of specific IgG, IgA and IgMantibodies (6).