Comparative analysis of femoflor and microscopic examination in vaginal flora assessment
DOI:
https://doi.org/10.58676/sjmas.v3i7.139Keywords:
Molecular Diagnostics, Microscopic Examination, Femoflor-16 PCR, Bacterial Vaginosis, Vaginal MicrobiomeAbstract
Background: Vaginal health is intricately tied to the composition and balance of the vaginal microbiome, which is predominantly dominated by Lactobacillus species. Disruptions in this balance can lead to bacterial vaginosis (BV), aerobic vaginitis, and other complications. Traditional diagnostic methods such as Nugent scoring and Amsel’s criteria have been widely used to assess vaginal flora but are limited by subjectivity, low sensitivity, and inability to detect polymicrobial infections. Molecular techniques, such as Femoflor multiplex real-time PCR, offer a more sensitive, rapid, and comprehensive approach to diagnosing vaginal dysbiosis and identifying co-infections.
Methods and Materials: This cross-sectional retrospective study included symptomatic women aged 18 to 45 undergoing both microscopic and Femoflor-16 testing. Vaginal swabs were analyzed by Gram-stained microscopy using Nugent and Amsel criteria, and by Femoflor-16 PCR, which quantifies 16 microbial groups and assesses total bacterial biomass. Diagnostic outcomes were compared based on sensitivity, specificity, and Cohen’s kappa to determine concordance. Turnaround time, microbial load, and species-level detection rates were also analyzed to evaluate diagnostic efficiency and clinical applicability.
Results: Femoflor-16 demonstrated significantly higher diagnostic accuracy, with 99% sensitivity and 93% specificity for BV, compared to 75% and 82% respectively for microscopy. Femoflor detected polymicrobial infections, including Gardnerella vaginalis, Atopobium vaginae, and Mycoplasma spp., which microscopy often missed. It also identified intermediate dysbiosis and quantified microbial loads, aiding in stratifying the severity of infection. Additionally, Femoflor provided results within 2 hours, compared to the 48-hour average for microscopy. In samples with normocenosis, Femoflor detected asymptomatic low-abundance pathogens, highlighting its diagnostic precision.
Conclusion: Femoflor multiplex PCR offers superior sensitivity, specificity, and turnaround time compared to traditional microscopy in vaginal flora assessment. Its ability to quantify bacterial loads, detect polymicrobial infections, and differentiate Lactobacillus species provides enhanced clinical insights for personalized treatment strategies. These findings support the integration of molecular diagnostics into routine gynecological practice to improve early detection, reduce misdiagnosis, and optimize patient outcomes.
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