Clinical validation of a new molecular test (Seegene Allplex™ Vaginitis) for the diagnosis of vaginitis: a cross‐sectional study

Abstract

Objective To validate the use of Seegene Allplex™ Vaginitis assay in the diagnosis of candidiasis, bacterial vaginosis (BV) and trichomoniasis. Design Cross‐sectional, prospective study conducted in a single centre. Setting Outpatient clinic of a gynaecology department. Population Consecutive symptomatic and asymptomatic women (18–60 years of age). Methods Comparison of the assay test with the reference 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 with the reference standards for the diagnosis of the presence of Candida spp., Trichomonas vaginalis and BV. Secondary objectives are the evaluation of the performance of the test in postmenopausal women 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 22.3%, 13.2% and 2.4%, respectively. The sensitivity and specificity of the assay test for those three causes of vaginitis were as follows: BV 91.7% and 86.6%; any Candida spp. 91.1% and 95.6%; Candida albicans 88.1% and 98.2%, non‐albicans Candida 100% and 97.5%, and T. vaginalis 94.4 and 99.9%. The performance of the test was identical in the subgroup of women that reported vulvovaginal symptoms. The presence of multiple infections did not interfere with the performance of the test. Conclusions The Seegene Allplex™ Vaginitis assay has an excellent performance in the diagnosis of the BV and presence of Candida; the results were good for trichomoniasis, but the study was underpowered for this outcome. Tweetable abstract Seegene Allplex™ Vaginitis is an excellent option for screening and diagnosis of vaginitis.

Recent Advances in Presentation, Diagnosis and Treatment for Mixed Vaginitis

“…A mixed vaginitis diagnosis is made according to the presence of symptoms, clinical findings and laboratory tests (Gram-staining, wet-mount smears, PCR tests and combination of point-of-care tests) ( Tempera et al., 2004 ). Some studies confirm that the presence of multiple vaginitis did not interfere with the assay performance ( Vieira-Baptista et al., 2021 ). The key points in diagnosing mixed vaginitis are as follows ( Sobel et al., 2013 ): an abnormal vaginal milieu and the simultaneous presence of at least two types of vaginitis.…”

“…The skill level of technicians is an influencing factor ( Nyirjesy et al., 2020 ). Recent research has shown that some new molecular assays (Affirm VPIII, Aptima, BD Max, Seegene Allplex) for the diagnosis of mixed vaginitis have performed well, identifying proportions ranging from 7.58% to 27.23% ( Schwebke et al., 2020 ; Vieira-Baptista et al., 2021 ).…”

Prevalence of Pathogens and Other Microorganisms in Premenopausal and Postmenopausal Women with Vulvovaginal Symptoms: A Retrospective Study in a Single Institute in South Korea

“…These tests have also shown higher sensitivity than the original Amsel's test (92.7% vs. 75.6%; p < 0.0001) [9]. The recent results of a real-time multiplex PCR assay for bacterial vaginosis have a sensitivity of 91.7% and a specificity of 86.6%, compared to Nugent score and/or Amsel's criteria [10]. A previous study reported that sexually active women had a higher prevalence of bacterial vaginosis than the menopausal group, which is different from the results of this study [11].…”

Diagnosis of bacterial vaginosis: Clinical or microscopic? A cross‐sectional study

“…25 Multiplex PCR tests, such as the Allplex Vaginitis, allow the concomitant diagnosis of other causes of vaginitis. 14 The sensitivity In the future, reports may include which bacteria are involved and even antibiotic resistance, as already happens in other clinical situations. 28 A combination with sexually transmitted infections (including HPV) may be a cost-effective option, allowing a full evaluation of the cervicovaginal milieu.…”

“…One sample was collected using a flocked swab for culture. 14 Measurement of the vaginal pH was performed using Macherey-Nagel pH strips (3.6-6.1) (Macherey-Nagel GmbH & Co. KG), applied directly to the vaginal wall. Whiff test was performed, adding a drop of 10% KOH to a sample of discharge.…”