AI Article Synopsis

  • The illumigene Mycoplasma DNA amplification assay was evaluated for its ability to detect Mycoplasma pneumoniae in archived respiratory samples, demonstrating a limit of detection of ≤88 CFU/reaction.
  • The assay identified all 36 tested reference strains and showed no cross-reactivity with other pathogens, indicating high analytical specificity.
  • In a comparison with traditional culture methods, the assay achieved 100% sensitivity and 99% specificity, suggesting it is a reliable rapid detection method for clinical use, though further clinical trials are recommended.

Article Abstract

A loop-mediated isothermal amplification (LAMP) system, the illumigene 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. The illumigene limit of detection was ≤88 CFU/reaction for 10 Mycoplasma pneumoniae reference strains. This assay correctly identified 36 M. 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 for M. 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 detecting M. pneumoniae in clinical specimens. Additional prospective clinical trials with direct comparison to culture and PCR are warranted.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3993520PMC
http://dx.doi.org/10.1128/JCM.02913-13DOI Listing

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ABSTRACT.

Acta Clin Belg

November 2018

a Belgian Reference Centre for Respiratory Pathogens , University Hospital Antwerp, Belgium.

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is a common cause of community-acquired pneumonia. The Mycoplasma Direct (iMD) DNA amplification assay is a qualitative test utilizing loop-mediated isothermal amplification (LAMP) technology for the direct detection of DNA in respiratory specimens. The iMD assay does not require the preextraction of nucleic acids from specimens, which is a prerequisite step for the previously approved Mycoplasma (iM) assay.

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Article Synopsis
  • The illumigene Mycoplasma DNA amplification assay was evaluated for its ability to detect Mycoplasma pneumoniae in archived respiratory samples, demonstrating a limit of detection of ≤88 CFU/reaction.
  • The assay identified all 36 tested reference strains and showed no cross-reactivity with other pathogens, indicating high analytical specificity.
  • In a comparison with traditional culture methods, the assay achieved 100% sensitivity and 99% specificity, suggesting it is a reliable rapid detection method for clinical use, though further clinical trials are recommended.
View Article and Find Full Text PDF

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