A diagnosis should not be made on the basis of antimycoplasma results alone. Test results should be interpreted in conjunction with the clinical evaluation and the results of other diagnostic procedures.
The use of hemolytic, lipemic, bacterially contaminated, or heat-inactivated specimens should be avoided as erroneous results may occur.
Assay performance characteristics have not been established for matrices other than serum.
The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.
Testing should not be performed as a screening procedure for the general population. Testing should only be done when clinical evidence suggests the diagnosis of Mycoplasma pneumoniae-associated disease.
The performance of this test has not been established on neonates and immunocompromised patients.
Performance of the IgM assay has not been tested with specimens known to be positive for antibodies to organisms that are known to be associated with lower respiratory illness (ie, influenza A and B, cytomegalovirus, Chlamydia-pneumoniae, parainfluenza), and closely related serovars known to cross-react with Mycoplasma pneumoniae, such as Mycoplasma geitalium and Mycoplasma hominis, as well as various Ureaplasma species. Cross-reactivity studies with such organisms have not been performed with this assay.
The IgG removal system included with the IgM test system has been shown to functionally remove the IgG from specimens containing total IgG levels ranging from 300 to 600 mg/mL. The effectiveness of this removal system at IgG levels exceeding 600 mg/mL has not been established.
The prevalence of mycoplasma IgM antibody is relatively low, which affects the assay's predictive value.