Scholarlink

Background <p>This study evaluated the performance of the simultaneous amplification and testing (SAT) assay for detecting common <i>Candida</i> species in vaginal specimens compared with culture (gold standard) at the Obstetrics and Gynecology Hospital of Fudan University from December, 2024 to January, 2025.</p> Methods <p>Speimens were analyzed by both <i>Candida</i> culture (with MALDI-TOF MS identification) and the SAT-<i>Candida</i> assay. Discordant results were further confirmed by real-time polymerase chain reaction (RT-PCR) and bidirectional sequencing. A comparative analysis (kappa coefficient) was conducted as well. We assessed the limit of detection, technical specificity, repeatability and the clinical diagnostic effectiveness, including sensitivity, specificity, diagnostic accuracy, positive predictive value (PPV), and negative predictive value (NPV) of SAT-<i>Candida</i> assay.</p> Results <p>In our study, among the 472 initially collected specimens, 5 were excluded because the presence of the <i>Candida</i> species were outside the detection spectrum of the SAT-<i>Candida</i> assay. The ages of the rest 467 cases ranged from 13 to 77 years old, and by comparison with SAT-<i>Candida</i> assay and <i>Candida</i> culture, 444 concordant results and 23 discordant results were discovered. After the reconfirmation, the SAT-<i>Candida</i> assay presented a overall sensitivity of 98.7%, specificity of 97.8%, PPV of 97.9%, NPV of 98.7%, and diagnostic accuracy of 98.3% in detecting <i>Candida</i> species. The kappa value between <i>Candida</i> culture and SAT-<i>Candida</i> assay in detecting <i>Candida</i> species was 0.91.</p> Conclusions <p>This SAT-<i>Candida</i> assay is acute, highly sensitive, and specific, which can be applied as an optimal diagnostic tool for detecting and identifying common <i>Candida</i> species from vaginal samples of vulvovaginal candidiasis (VVC) suspected patients.</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

Evaluation of SAT-Candida: a rapid RNA-based isothermal amplification assay for detection and identification of Candida spp. in vaginal specimens

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年9月30日

查看全文
  • Loukaiyi Lu,
  • Yisheng Chen,
  • Qiang Wang,
  • Chunmei Ying,
  • Mingjie Xiang

摘要

Background

This study evaluated the performance of the simultaneous amplification and testing (SAT) assay for detecting common Candida species in vaginal specimens compared with culture (gold standard) at the Obstetrics and Gynecology Hospital of Fudan University from December, 2024 to January, 2025.

Methods

Speimens were analyzed by both Candida culture (with MALDI-TOF MS identification) and the SAT-Candida assay. Discordant results were further confirmed by real-time polymerase chain reaction (RT-PCR) and bidirectional sequencing. A comparative analysis (kappa coefficient) was conducted as well. We assessed the limit of detection, technical specificity, repeatability and the clinical diagnostic effectiveness, including sensitivity, specificity, diagnostic accuracy, positive predictive value (PPV), and negative predictive value (NPV) of SAT-Candida assay.

Results

In our study, among the 472 initially collected specimens, 5 were excluded because the presence of the Candida species were outside the detection spectrum of the SAT-Candida assay. The ages of the rest 467 cases ranged from 13 to 77 years old, and by comparison with SAT-Candida assay and Candida culture, 444 concordant results and 23 discordant results were discovered. After the reconfirmation, the SAT-Candida assay presented a overall sensitivity of 98.7%, specificity of 97.8%, PPV of 97.9%, NPV of 98.7%, and diagnostic accuracy of 98.3% in detecting Candida species. The kappa value between Candida culture and SAT-Candida assay in detecting Candida species was 0.91.

Conclusions

This SAT-Candida assay is acute, highly sensitive, and specific, which can be applied as an optimal diagnostic tool for detecting and identifying common Candida species from vaginal samples of vulvovaginal candidiasis (VVC) suspected patients.