Bacterial Vaginosis and Candidiasis

Bacterial vaginosisBacterial vaginosis (BV) is a common vaginal disorder, characterised by an imbalance of the normal bacterial flora. A reduction in lactobacillus species occurs together with an increase in the diversity and load of commensal anaerobic bacteria. Remarkably, while the number of BV associated species is quitehigh the detection of just a few bacterial species is enough for accurate diagnossiss. Gardnerellavaginalis or/and Atopobium vaginae were shown to be in a high concentration in almost all BV cases. Hence these bacteria are considered as BV markers.

CandidiasisCandidiasis is a fugal infection caused by Candida albicans and more rarely by other Candida species. Candidas can be commensal and therefore not needing treatment if asymptomatic. However under some conditions Candida can increase spontaneously or in response to disturbance of vaginal flora (for instance in case of antibiotic therapy). The symptoms are quite non-specific and hardly discriminative from other genital infections: genital itching, burning, and sometimes a vaginal discharge.

Bacterial Vaginosis and Candidiasis

Diagnostics of BV with classical method• Microscopy with bacteria scoring using Nugent scale is considered as a gold standard laboratory test for BV. The presence of clue cells is a second important marker of BV• Nugent scoring system is based on proportion of normal (Lactobacillus) flora and different kinds of anaerobic bacteria

Diagnostics of BV with molecular method• Molecular assays allow accurate and

specific measurement of marker bacteria species. Comparative quantitation of these bacteria allow the calculation of a ratio, similar to the Nugent score

• Additional calculation of the human cell number and estimation of the ratio between human cells and anaerobic bacteria serves as a molecular surrogate for clue cell detection

HIGH-PLEX SYSTEM Vaginitis and vaginosis(8-well), REF.27117

Gardnerella vaginalis

Atopobium vaginae

Lactobacillus spp.

Candida albicans and krusei

Candida glabrata and parapsilosis

Trichomonas vaginalis

Human DNA control

Artificial sequence for assay control

ULTRA-PLEX SYSTEM Candida and BV (8-well), REF. 87117

Gardnerella vaginalis

Atopobium vaginae

Lactobacillus spp.

Candida albicans and tropicalis

Candida glabrata and krusei

Candida parapsilosis

Human DNA control

Artificial sequence for assay control

Panels Design

Candida diagnosis, typing and drug resistance• Candida can be commensal and therefore does not need treatment. However under some

conditions Candida can increase spontaneously• The symptoms are non-specific and hard to discriminate from other genital infections.

So reliable diagnosis is essential for proper treatment, especially for discrimination from BV and trichomoniasis

• Classical methods of diagnostics are microscopy and yeast culture. Microscopy is rapid, but does not allow Candida typing. On the other hand yeast culture causes a delay in diagnosis

• Molecular diagnostics methods benefit from quantitative assessment of the yeast level, relatively fast results, high accuracy and capability of Candida species typing

• Different Candida species might have different sensitivity to anti-fungal treatment brining rationale for typing assays

BACTERIAL VAGINOSIS AND CANDIDIASIS

TARGET BV OR INTERMEDIATE CANDIDA

Sensitivity %(95% CI)

95.3(82.9-99.2)

95.1(82.2-99.2)

Specificity %(95% CI)

94.0(85.9-97.8)

95.3(87.7-98.5)

Kit validation studyThe validation of the algorithm was performed by comparison with the subjective call of an expert microbiologist examining a Gram stain of the swab by high power light microscopy considering the Nugent or Ison/Hay score and other factors.A study carried out in Melbourne, Australia showed the following clinical performance:

Kit performance

BACTERIAL VAGINOSIS AND CANDIDIASIS

Normal floraMicroscopy:

Molecular:

Bacterial vaginosisMicroscopy:

Molecular:

Candidiasis

Microscopy:

Molecular:

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B9 rev.2 March 2018