Evaluation of a rapid enzyme immunoassay system for serologic diagnosis of Mycoplasma pneumoniae infection.

A 5-min qualitative membrane enzyme-linked immunoassay (EIA) from Remel (Mycoplasma pneumoniae immunoglobulin G (IgG)/IgM Antibody Test System) was evaluated for its ability to detect IgM and IgG at levels indicating active or recent infection. Specimens from 131 patients were evaluated using an immunofluorescent antibody assay (IFA) to determine IgG and IgM titers and the membrane EIA. An enzyme-linked immunosorbent assay (ELISA) performed by a reference laboratory was used for discrepancy resolution. There were 34 IgM positive specimens (titer > or = 1:16), 19 IgG positive specimens (titer > or = 1:64), and 78 negative specimens. Compared with IFA and/or ELISA, the membrane EIA was 97% sensitive for the detection of IgM and 79% sensitive for the detection of IgG. Of the 78 specimens called negative, 17 specimens had IgG titers< or = 1:32) or an ELISA result indicating prior exposure, and the membrane EIA called seven of 17 (41%) positive. For the detection of both IgG and IgM, the membrane EIA had a sensitivity of 91%, specificity of 91%, and positive and negative predictive values of 87 and 93%, respectively. The Remel membrane EIA is a rapid and reliable assay for the diagnosis of active or recent M. pneumoniae respiratory tract infections.