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Published on: October 23, 2011
Performance of Allplex™ MG & AziR Assay for Detecting Macrolide-Resistant Mycoplasma genitalium
Gilho Lee1, Yumi Seo2, Donghoon Lim3
1Department of Urology, Dankook University College of Medicine, Cheonan, Korea. multiorigins@yahoo.com.
Background:
Mycoplasma genitalium is a sexually transmitted pathogen for which azithromycin is recommended as the first-line therapy. However, the prevalence of macrolide resistance has increased globally, reaching peak levels in Asia-Pacific countries. Macrolide resistance-guided therapy (MRT) is cost-effective, with minimal collateral damage and a high cure rate. We aimed to validate the performance of the Allplex™ MG & AziR Assay (AziR), which was designed to detect genetic variations in MRT.
Methods:
Using 279 M. genitalium-positive genitourinary samples, the performance of the AziR assay was compared with that of Sanger sequencing of the 23S rRNA gene of M. genitalium.
Results:
The AziR assay targeting positions 2058 and 2059 in the 23S rRNA gene revealed that 133 and 146 cases, respectively, carried the wild and mutant types of adenosine, while sequencing detected the wild and mutant types in 134 and 145 cases, respectively. The AziR assay demonstrated a sensitivity of 100% (95% confidence interval [CI], 0.968-1) and specificity of 99.254% (95% CI, 0.953-1) in distinguishing wild type from mutant variants. Of the 279 samples, only six showed genetic discrepancies between the two tests: one wild type by sequencing was found to have A2059G by the AziR assay, two A2059Gs were discordant as A2058Ts, one A2059G was discordant as A2058G, and two A2058Gs by sequencing were reported as A2059Gs by the AziR assay.
Conclusion:
Our results show that the AziR assay can identify specific mutants in a single reaction and demonstrates high sensitivity and specificity for detecting macrolide resistant M. genitalium. Therefore, the AziR assay can be reliably used for MRT.
Insights
The Allplex™ MG & AziR Assay (AziR) accurately detects macrolide resistance in Mycoplasma genitalium, supporting macrolide resistance-guided therapy (MRT). This assay shows high sensitivity and specificity for identifying specific mutations, enabling effective treatment strategies for this sexually transmitted infection.
Area of Science:
- Molecular diagnostics
- Antimicrobial resistance
- Sexually transmitted infections
Background:
- Mycoplasma genitalium is a significant sexually transmitted pathogen.
- Increasing azithromycin resistance necessitates alternative treatment strategies.
- Macrolide resistance-guided therapy (MRT) offers a cost-effective solution with high cure rates.
Purpose of the Study:
- To validate the performance of the Allplex™ MG & AziR Assay (AziR) for detecting macrolide resistance-guided therapy (MRT).
- To assess the AziR assay's ability to identify specific genetic variations associated with macrolide resistance in Mycoplasma genitalium.
Main Methods:
- The AziR assay was evaluated using 279 Mycoplasma genitalium-positive genitourinary samples.
- Assay performance was compared against Sanger sequencing of the 23S rRNA gene.
- Detection of mutations at positions 2058 and 2059 in the 23S rRNA gene was analyzed.
Main Results:
- The AziR assay demonstrated high sensitivity (100%) and specificity (99.25%) in distinguishing wild-type from mutant variants.
- The assay accurately identified mutations at positions 2058 and 2059, with minor discrepancies in six samples.
- A single reaction capability for identifying specific macrolide resistance mutants was confirmed.
Conclusions:
- The AziR assay reliably identifies specific macrolide resistance mutations in Mycoplasma genitalium.
- The assay exhibits high sensitivity and specificity, making it suitable for macrolide resistance-guided therapy (MRT).
- The AziR assay is a valuable tool for guiding treatment decisions in Mycoplasma genitalium infections.
