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

ABSTRACT:

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, positiv

SUBMITTER: Lu L 

PROVIDER: S-EPMC12482817 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature