This test employs immunofluorescence to detect IgM, IgG, and IgA antibodies to Chlamydia pneumoniae in human serum. C pneumoniae has been implicated as one of the agents of atypical pneumonia and may be responsible for as many as 10% of all hospitalized and outpatient cases of pneumonia. Additionally, it may also be responsible for sinusitis and otitis.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. Results of this test are for investigational purposes only. The result should not be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure.