Vaginal panel assay aids in accurate clinical diagnosis of vaginitis, study finds

USA: Molly Broache and colleagues in a recent trial discovered that the vaginal panel assay might increase diagnosis accuracy for vaginitis and promote appropriate and early treatment. This study's findings were reported in the journal Obstetrics & Gynecology.

Historically, diagnosing vaginitis has been difficult. For all three forms of vaginitis, wet mount microscopy has extremely low sensitivity. To do microscopy in the clinic environment and reliably identify the causes of vaginitis, a microscope, suitable training, and certification (e.gClinical Laboratory Improvement Amendments) are necessary.

The purpose of this study was to evaluate the efficacy of clinical vaginitis diagnosis to molecular detection of organisms associated with vulvovaginal candidiasis, bacterial vaginosis, and Trichomonas vaginalis using a vaginal panel test.

This cross-sectional diagnostic accuracy research involved 489 participants from five collection locations, where those with vaginitis symptoms had a vaginal test swab obtained and a clinical diagnosis established during their visit. The sample was then transferred to a different lab for the vaginal panel assay. Positive, negative, and overall percent agreement (with 95 percent CIs) of clinical evaluation with the vaginal panel test are among the outcome measures. Using the McNemar test, P.05 was employed to differentiate significant differences in paired proportions between the vaginal panel assay and clinical diagnosis. Cohen's kappa coefficient was used to assess inter-rater agreement between the two diagnostic approaches.

The key findings of this work are:

1. Clinical diagnosis demonstrated a positive percent agreement with the vaginal panel test of 57.9% for bacterial vaginosis, 53.5% for vulvovaginal candidiasis, and 28.0% for T vaginalis, respectively.

2. For clinical diagnosis, the negative percent agreement was 80.2%, 77.0%, and 99.8%, respectively.

3. Sixty-five percent (67/103), 44% (26/59), and 56% (10/18) of patients with bacterial vaginosis, vulvovaginal candidiasis, and T vaginalis were not treated for vaginitis based on a negative clinical diagnosis.

4. Clinical diagnosis exhibited false-positive rates of 19.8%, 23.0%, and 0.2% for bacterial vaginosis, vulvovaginal candidiasis, and T vaginalis, respectively, when compared to the test.

5. For the detection of bacterial vaginosis and T vaginalis, there were significant differences in paired proportions between the vaginal panel assay and clinical diagnosis.

In conclusion, it is impossible to establish with confidence how a clinical diagnosis of vaginitis acquired in this environment compares to a vaginitis diagnosis received in regular care settings. Recent recommendations for handling symptomatic women in emergency departments show that using a speculum has minimal benefit. More real-world or health economics outcomes research studies should be conducted to delve deeper into this topic.

Reference:

Broache, M., Cammarata, C. L., Stonebraker, E., Eckert, K., Van Der Pol, B., & Taylor, S. N. (2021). Performance of a Vaginal Panel Assay Compared With the Clinical Diagnosis of Vaginitis. In Obstetrics & Gynecology (Vol. 138, Issue 6, pp. 853–859). Ovid Technologies (Wolters Kluwer Health). https://doi.org/10.1097/aog.0000000000004592