Document Type

Article

Publication Date

7-2025

Publisher

American Society for Microbiology

Source Publication

Microbiology Spectrum

Source ISSN

2165-0497

Original Item ID

DOI: 10.1128/spectrum.00738-25

Abstract

Recent work has optimized parameters of a real-time reverse transcriptase PCR-based laboratory-developed test on the Panther Fusion system which detects Mycoplasma genitalium-specific macrolide resistance-associated mutations LDT (MRM-LDT) from primary swab and urine specimens. In this study, MRM-LDT was applied to a large multi-demographic study set to further characterize M. genitalium resistance in the United States. A total of 2,145 primary clinical specimens testing positive for M. genitalium 16S rRNA by transcription-mediated amplification (TMA) were initially titered by the same assay using serial 10-fold dilutions to determine relative target nucleic acid burden. Specimens were then processed for MRM-LDT. Findings were stratified by men who have sex with men (MSM; n = 3 settings), community care (n = 2), and university student (n = 3) populations. The mean log10 target nucleic acid titer of a TMA-positive specimen was 3.46 (median 3; range 0–10). A 43.2% MRM-LDT detection rate was found in specimens derived from community care settings. Analogous assessments of university student and MSM demographics revealed 60.8% and 62.0% detection, respectively (P ≤ 0.0004 versus community care). Within the university student demographic, differences existed in target nucleic acid titer for two settings (P = 0.01); similar differences were encountered between a local MSM cohort and two that were nationally based (P ≤ 0.01). Within the university cohort, MRM-LDT detection rate was increased in symptomatic patients (P = 0.005). M. genitalium macrolide resistance rates among multiple demographics, as determined by MRM-LDT, are high in the United States and are consistent with target nucleic acid burden within the primary specimen. However, caveats experienced within subgroupings of these demographics support reflex MRM-LDT on M. genitalium-positive specimens.

Comments

Published version. Microbiology Spectrum, Vol. 13, No. 7 (July 2025): e0073825. DOI. © 2025 Moore et al. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license. Used with permission.

Erik Munson was affiliated with Wisconsin Clinical Laboratory Network Laboratory Technical Advisory Group, Madison, WI at the time of publication.

Creative Commons License

Creative Commons Attribution 4.0 International License
This work is licensed under a Creative Commons Attribution 4.0 International License.

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