Scholarlink

Background <p>In the diagnosis of sexually transmitted infections, there has been a demand for multiple molecular assays to rapidly and simultaneously detect not only pathogens but also drug resistance-associated mutations.</p> Methods <p>In this study, we developed a new rapid simultaneous molecular assay for the detection of <i>Neisseria gonorrhoeae</i>, <i>Chlamydia trachomatis</i>, <i>Trichomonas vaginalis</i>, <i>Mycoplasma genitalium</i>, and <i>M. genitalium</i> macrolide (23S rRNA gene, A2058/A2059) and fluoroquinolone (<i>ParC</i> gene, S83I) drug resistance-associated mutations in approximately 35 minutes. We evaluated the basic and prospective clinical performance of the newly developed assay.</p> Results <p>The newly developed assay showed sufficient sensitivity to detect <i>N. gonorrhoeae</i>, <i>C. trachomatis</i>, <i>T. vaginalis</i>, <i>and M. genitalium</i> relative to the reference method. In a prospective study comparing the reference method across 178 urine samples from men and women, the total concordance rate, sensitivity, and specificity of the two assays for <i>N. gonorrhoeae</i> detection were 98.9% (176/178), 97.9% (46/47), and 99.2% (130/131), respectively; for <i>C. trachomatis</i> detection, they were 98.3% (175/178), 96.4% (81/84), and 100% (94/94); and for <i>M. genitalium</i> detection, they were 100% (178/178), 100% (20/20), and 100% (158/158). All samples were negative for <i>T. vaginalis</i>. Of the 16 <i>M. genitalium</i>-positive samples analyzed for the GENECUBE<sup>TM</sup> assay, 81.3% (13/16) had A2058/A2059 mutations, 31.3% (5/16) had S83I mutations, and 25.0% (4/16) had simultaneous mutations, which was highly correlated with the sequence analysis.</p> Conclusions <p>This study suggests that the recently developed assay performed similarly to existing nucleic acid amplification tests and enables rapid and simultaneous detection, including the detection of drug resistance-associated mutations.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Development of a New Rapid Simultaneous Molecular Assay for the Detection of STI Pathogens and Drug Resistance-Associated Mutations

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年1月17日

查看全文
  • Masashi Michibuchi,
  • Takafumi Yoshikane,
  • Yuma Matsuba,
  • Tomomi Yamazaki,
  • Shinji Hatakeyama,
  • Masaki Takanashi,
  • Takehiro Oikawa,
  • Hiromichi Suzuki

摘要

Background

In the diagnosis of sexually transmitted infections, there has been a demand for multiple molecular assays to rapidly and simultaneously detect not only pathogens but also drug resistance-associated mutations.

Methods

In this study, we developed a new rapid simultaneous molecular assay for the detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, Mycoplasma genitalium, and M. genitalium macrolide (23S rRNA gene, A2058/A2059) and fluoroquinolone (ParC gene, S83I) drug resistance-associated mutations in approximately 35 minutes. We evaluated the basic and prospective clinical performance of the newly developed assay.

Results

The newly developed assay showed sufficient sensitivity to detect N. gonorrhoeae, C. trachomatis, T. vaginalis, and M. genitalium relative to the reference method. In a prospective study comparing the reference method across 178 urine samples from men and women, the total concordance rate, sensitivity, and specificity of the two assays for N. gonorrhoeae detection were 98.9% (176/178), 97.9% (46/47), and 99.2% (130/131), respectively; for C. trachomatis detection, they were 98.3% (175/178), 96.4% (81/84), and 100% (94/94); and for M. genitalium detection, they were 100% (178/178), 100% (20/20), and 100% (158/158). All samples were negative for T. vaginalis. Of the 16 M. genitalium-positive samples analyzed for the GENECUBETM assay, 81.3% (13/16) had A2058/A2059 mutations, 31.3% (5/16) had S83I mutations, and 25.0% (4/16) had simultaneous mutations, which was highly correlated with the sequence analysis.

Conclusions

This study suggests that the recently developed assay performed similarly to existing nucleic acid amplification tests and enables rapid and simultaneous detection, including the detection of drug resistance-associated mutations.