Clinical validation of a new molecular test (Seegene® Allplex<sup>TM</sup> Vaginitis) for the diagnosis of vaginitis: a cross sectional study

BJOG. 2021 Feb 4. doi: 10.1111/1471-0528.16661. Online ahead of print.

ABSTRACT

OBJECTIVE: To validate the use of Seegene® AllplexTM Vaginitis assay in the diagnosis of candidiasis, bacterial vaginosis (BV) and trichomoniasis DESIGN: Cross-sectional, prospective study conducted in a single center SETTING: Outpatient clinic of a gynaecology department POPULATION: Consecutive symptomatic and asymptomatic women (18-60 years) METHODS: Comparison of the assay test to the gold standards for the diagnosis of vaginitis (cultures for yeasts, Nugent for BV, and nucleic acid amplification test for trichomoniasis).

MAIN OUTCOME MEASURES: Performance of the investigational assay, in comparison to the gold standards for the diagnosis of the presence of Candida spp., T. vaginalis, and BV. Secondary objectives are the evaluation of the performance of the test in postmenopausal and in symptomatic women.

RESULTS: A diagnosis of vaginitis was established in 14.0%. The global prevalences of BV, Candida spp. and T. vaginalis were of 22.3%, 13.2%, and 2.4%, respectively. The sensitivity and specificity of the assay test for those 3 causes of vaginitis was: BV 91.7% and 86.6%; any Candida spp. 91.1% and 95.6%; C. albicans 88.1% and 98.2%, Candida non-albicans 100% and 97.5%, T. vaginalis 94.4 and 99.9%. The performance of test was identical in the subgroup of women that reported vulvovaginal symptoms. Presence of multiple infections did not interfere with the performance of the test.

CONCLUSIONS: The Seegene® AllplexTM Vaginitis assay has an excellent performance in the diagnosis of the BV and presence of Candida; while the results were good for trichomoniasis, the study was underpowered for this outcome.

PMID:33540484 | DOI:10.1111/1471-0528.16661