Cuur Diagnostics

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Vaginal Microbiota Panel

VAGINAL MICROBIOTA PANEL

CUUR DiagnosticsTM is dedicated to maintaining the largest data set of infectious disease targets available in the world.

The implications of diagnosing women’s health infections extend far beyond that of each patient – it can affect their partners and even their children. Particularly when it comes to infectious disease, it’s essential to get fast, reliable and actionable results.

The newly discovered female urinary microbiota has the potential to deepen our understanding of urinary tract health and disease, including common lower urinary tract conditions such as urinary incontinence and urinary tract infection. The female urinary microbiota possesses characteristics that differ between women affected by urgency urinary incontinence and matched, unaffected controls.

Traditional culture-based or microscopy-based methods for analysis of the vaginal microbiota can be time-consuming, overly subjective and inaccurate due to lack of sensitivity and specificity. CUUR Diagnostics’ molecular technology solution can detect microbes that are slow growing, difficult to grow or that fail to grow under traditional methods providing clear, precise and actionable categorization of microorganisms involved.

A Healthy Vaginal Microbiome

A healthy vaginal microbiome is crucial for a woman’s health. An imbalance in the vaginal microbiome has been associated with an increased risk of several diseases, varying from fungal infections to sexually transmitted infections and preterm births. The analysis of the vaginal microbiome is complicated since its composition not only varies with general factors like age, genomic background and lifestyle, but also varies temporally related to the menstrual cycle and sexual activity. Moreover, menopause, pregnancy and birth probably have a large impact on the composition of a woman’s vaginal microbiome.

The vaginal microbiome mainly consists of Lactobacillus species, more specifically L. crispatus, L. iners, L. jensenii and L. gasseri. These contribute to the maintenance of the vaginal homeostasis and prevent colonization and growth of other unwanted microorganisms, by producing lactic acid. In case of infections or dysbiosis however, other microbes are involved like Gardnerella vaginalis, Mycoplasma hominis and Prevotella species.

Recurrent or chronic vaginitis is one of the most common reasons that women seek medical attention. Although vaginitis may be caused by a foreign organism, such as gonorrhea, far more cases stem from alterations in the vaginal environment which in turn can trigger inflammation and discomfort.

Factors influencing the vaginal environment include:

• Acid/base balance (pH)

• Level of protective Lactobacilli

• Glycogen and glucose

• Diabetes mellitus

• Sex hormones

• Sexual contact

• Immune health

• Oral contraceptives

• Natural flushing action of vaginal secretions

Identifying these factors is essential in preventing re-occurrence of infection. Just as important is the identification of the causative organisms so that the most effective treatment can be used.

qPCR vs Culture for Assessment

It comes down to qPCR’s enhanced sensitivity and specificity, as well as reduced TAT and cost. While Gram staining plus Nugent scoring is considered the gold-standard, it is a technique fraught with problems:

• Nugent requires expertise at staining and scoring morphotypes;

• Several clinically significant microbes, either of variable morphology or lacking a cell wall, are regularly misidentified or overlooked;

• Some 20% of symptomatic subjects score between 4 and 6, rendering their status “intermediate” – an ambiguous diagnosis that is not helpful for the healthcare provider and may lead to inappropriate clinical intervention, or, conversely, to no intervention when it is actually needed.

Given the complexity of microbiome alterations now known to be associated with disease, the second of these shortcomings may account for Nugent’s reportedly poor sensitivity and specificity. Finally, Nugent scoring has also been shown to occasionally miss differential diagnoses such as Trichomonas vaginalis infections with potentially problematic effects on patient well-being due to inappropriate therapy.       

An older and more commonly used diagnostic tool is the application of Amsel’s criteria. This test, first described in 1983, requires the satisfaction of at least three of four criteria to qualify for a BV diagnosis: elevated pH (>4.5), characteristic discharge, fishy odor upon the addition of 10% KOH to a slide prep, and the microscopic visualization of “clue cells”  (smaller bacteria adhering to epithelial cells) in a wet mount. However, while easy to implement in theory, Amsel’s criteria are reportedly underutilized in clinical settings and are technically limited by the lack of consideration of the abundance of healthy Lactobacillus species.

Vaginal Microbiota
Helix DNA
TARGETS

BACTERIA VAGINOSIS 
Bacteria VaginosisAtopobium vaginae
Bacteria VaginosisBacteroides fragilis
Bacteria VaginosisBVAB2
Bacteria VaginosisGardnerella vaginalis
Bacteria VaginosisPrevotella bivia
Bacteria VaginosisMegasphaera 1*
Bacteria VaginosisMegasphaera 2*
Bacteria VaginosisMobiluncus curtisii
Bacteria VaginosisMobiluncus mulieris
Bacteria VaginosisMycoplasma hominis
Bacteria VaginosisUreaplasma urealyticum**

NORMAL FLORA (NON-PATHOGENIC) 
Normal Flora (Non-Pathogenic)Lactobacillus crispatus
Normal Flora (Non-Pathogenic)Lactobacillus gasseri
Normal Flora (Non-Pathogenic)Lactobacillus iners
Normal Flora (Non-Pathogenic)Lactobacillus jensenii

Vaginal Microbiota Aerpboc Vaginitis 
Aerpboc VaginitisStaphylococcus aureus
Aerpboc VaginitisStreptococcus agalactiae (group B)
Aerpboc VaginitisEnterococcus faecalis
Aerpboc VaginitisEscherichia coli

Vaginal Candidiasis 
Vaginal CandidiasisCandida albicans
Vaginal CandidiasisCandida dubliniensis
Vaginal CandidiasisCandida glabrata
Vaginal CandidiasisCandida krusei
Vaginal CandidiasisCandida lusitaniae
Vaginal CandidiasisCandida parapsilosis
Vaginal CandidiasisCandida tropicalis

Vaginal Group-B Strep 
Vaginal Group-B StrepStreptococcus agalactiae

Sexually Transmitted Infectious (STI) Pathogens 
Sexually Transmitted Infectious (STI) PathogensChlamydia trachomatis
Sexually Transmitted Infectious (STI) PathogensHaemophilus ducreyi
Sexually Transmitted Infectious (STI) PathogensHerpes simplex 1
Sexually Transmitted Infectious (STI) PathogensHerpes simplex 2
Sexually Transmitted Infectious (STI) PathogensMycoplasma genitalium
Sexually Transmitted Infectious (STI) PathogensNeisseria gonorrhoeae
Sexually Transmitted Infectious (STI) PathogensTreponema pallidum
Sexually Transmitted Infectious (STI) PathogensTrichomonas vaginalis

ICD-10 CODES

ICD-10 CodesDescription
N71.0Acute inflammatory disease of uterus
N71.1Chronic inflammatory disease of uterus
N71.9Inflammatory disease of uterus, unspecified
N72Inflammatory disease of cervix uteri
N73.9Female pelvic inflammatory disease, unspecified
N74Female pelvic inflammatory disorders in diseases classified elsewhere
N76.0Acute vaginitis
N76.1Subacute and chronic vaginitis
N76.2Acute vulvitis
N76.3Subacute and chronic vulvitis
N76.4Abscess of vulva
N76.8Other specified inflammation of vagina and vulva

Infectious Disease Care

D I A G N O S T I C S

STATISTICALLY SPEAKING
  • Vulvovaginal candidiasis (VVC) affects about 75% of reproductive-aged women at least once during their lives, with about 5% of them suffering of recurrences.
  • Chlamydia trachomatis (CT) represents the most common bacterial STI worldwide, and new infections probably exceed 131 million per year