Evidence map›Paper›PMID 41029704›Full record

ArticleAnnals of clinical microbiology and antimicrobials2025

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

Loukaiyi Lu, Yisheng Chen, Qiang Wang, Chunmei Ying, Mingjie Xiang

Abstract readEvaluation Study
In one paragraph

Article in Annals of clinical microbiology and antimicrobials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

5 authors.

Loukaiyi Lu *Department of Laboratory Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Yisheng Chen *Department of Laboratory Medicine, Obstetrics and Gynecology Hospital of Fudan University, No 419 Fangxie Road, Shanghai, 200011, China.
Qiang WangDepartment of Laboratory Medicine, Obstetrics and Gynecology Hospital of Fudan University, No 419 Fangxie Road, Shanghai, 200011, China.
Chunmei YingDepartment of Laboratory Medicine, Obstetrics and Gynecology Hospital of Fudan University, No 419 Fangxie Road, Shanghai, 200011, China. ycmzh2012@163.com.
Mingjie XiangDepartment of Laboratory Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. mjxiang123456@126.com.

Funding

National Natural Science Foundation of China 81873970
6 · The paper itself

Abstract

backgroundThis 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.

methodsSpeimens 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.

resultsIn 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.

conclusionsThis 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.

Indexed as

CandidaCandidiasis, VulvovaginalMolecular Diagnostic TechniquesNucleic Acid Amplification TechniquesVaginaAdolescentAdultAgedFemaleHumansMiddle AgedPredictive Value of TestsReal-Time Polymerase Chain ReactionSensitivity and SpecificityYoung AdultCandida cultureDiagnostic performanceSimultaneous amplification and testing (SAT)VVC

Identifiers

PMID41029704
PMCPMC12482817

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