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A loop-mediated isothermal amplification (LAMP) system, theillumi gene Mycoplasma DNA amplification assay (Meridian Bioscience, Inc., Cincinnati, OH) was evaluated to determine its analytical sensitivity, specificity, and clinical application in comparison to historic culture in a collection of archived respiratory specimens. Theillumi gene limit of detection was ≤88 CFU/reaction for 10Mycoplasma pneumoniae reference strains. This assay correctly identified 36M. pneumoniae reference strains and clinical isolates from various geographic origins, including both of the main subtypes. No cross-reactions were detected with other mycoplasmas, ureaplasmas, other bacterial species, viruses, yeasts, or human DNA. Among 214 respiratory specimens previously cultured forM. pneumoniae , when real-time PCR with bidirectional sequencing of the PCR products was used to resolve discrepancies, the sensitivity was 22 of 22 (100%) and the specificity was 190 of 192 (99%). This commercial LAMP assay is a useful rapid method for detectingM. pneumoniae in clinical specimens. Additional prospective clinical trials with direct comparison to culture and PCR are warranted.

Comparison of the illumi gene Mycoplasma DNA Amplification Assay and Culture for Detection of Mycoplasma pneumoniae