On our test for bacterial vaginosis and Candida (fungal infections)

With the help of our test for troubles with bacteria and fungal infections in the vagina, women with symptoms can be quickly informed about whether their itching/discharge may be due to vaginal microflora associated with bacterial vaginosis or Candida.

Currently bacterial vaginosis and candida infections are diagnosed by a clinical examination of the vaginal area and in some cases microscopy. Often this examination does not determine which bacterial and fungal species are present or quantify the included species.

Dynamic Code has developed both a DNA method to detect and quantify six bacteria associated with bacterial vaginosis in relation to lactobacilli, as well as a method to detect and quantify the Candida fungus. Since bacterial vaginosis and vaginal fungus can cause similar symptoms, but bacterial vaginosis should be treated with antibiotics, it is important to know which type of infection you suffer from.

If you have trouble with vaginal discharge but your results indicate that you have vaginal microflora that are not associated with bacterial vaginosis or Candida, this may be due to other causes such as chlamydia or a mycoplasma infection. For symptoms that cannot be clarified by this test you should seek medical care.

We offer cooperative opportunities in which we tailor solutions for each customer. Our concept covers the entire chain from sampling kits and method of analysis to performing analysis and distribution of analytical results.

Simple sampling and secure results

Our test for bacterial and fungal disorders of the vagina is simple to perform. The CE-marked sampling kit contains sampling material, instructions and return packaging. A vaginal sample is taken by the patient at home and then sent to our quality-assured laboratory for DNA analysis. The result of the analysis, which has a methodological certainty of 99.5%, is obtained via our website with a personal code within 3 days after the sample is received at our laboratory.

Background of our test

Many women are bothered by vaginal itching and discharge caused by bacterial vaginosis or Candida (fungal infection).

Bacterial vaginosis is a common occurrence, prevalence rates between 5 and 50% have been reported in studies from different parts of the world (Morris 2001). A Swedish study found that 26% of women who visited an STI clinic had bacterial vaginosis (Moi 1990).

Bacterial vaginosis may occur with an imbalance in vaginal bacterial flora. Vaginal microflora is normally dominated by lactobacilli. If other bacteria take over at the expense of lactobacilli, vaginal problems may occur (Srinivasan 2008, Falagas 2007, Nugent 1991). Symptoms that may occur include smelly vaginal discharge as well as itching and burning. You may also have bacteria associated with bacterial vaginosis without showing any symptoms (Srinivasan 2008, Morris 2001). In most cases this is not dangerous and does not need treatment. Bacterial vaginosis can cause complications. For example it increases the risk of preterm labour (Romero 2004, McGregor 1995) as well as the risk of infection after abortion, cesarean section or hysterectomy (removal of uterus). The risk of contracting chlamydia increases with bacterial vaginosis (Gallo 2012).

Candida

Moreover yeast infections are very common, 70-75% of all women are affected at some point in life. Approximately 5% of these women suffer from recurrent infections (Sobel 2007, Eckert 1998 Mårdh 2002). Yeast infections primarily affect women of childbearing age and are relatively rare before menarche and after menopause (Mårdh 2002).

Vaginal fungal infections are usually caused by the fungus Candida and are due to excessive growth. Symptoms that may occur include vaginal itching and burning but you may also have a grainy discharge. The infection can be treated with prescription antifungal medications. For repeated infections you should seek medical care. One can also be a carrier of Candida without having any symptoms and this is not dangerous.

Unique and safe method of analysis

Dynamic Code’s DNA test method is based on PCR and detects and quantifies six of the most common bacteria in bacterial vaginosis (Gardnerella vaginalis, Atophobium vaginae, Leptotrichia / Sneathia sp., Megasphaera sp., Mobiluncus sp., and BVAB2) in relation to Lactobacillus sp. It also detects the fungus Candida sp..

The test was developed and validated according to accredited procedures. The DNA test is specific to the intended bacterial and fungal species and does not detect more or less closely related bacteria and fungi.

The reproducibility of the DNA test was examined and experiments showed complete agreement in the results when samples were analysed on several separate occasions.

Furthermore a study was conducted in conjunction with one of the largest clinics. The study included women who were diagnosed with bacterial vaginosis and/or Candida and healthy women with respect to bacterial vaginosis and Candida. Vaginal samples from these women were analysed with our test. The levels of respective bacteria and yeast in the different groups were determined and based on these results a model was developed for calculating the probability of bacterial vaginosis and Candida based on calculation of so-called "likelihood ratios" for each bacterium.

In our test the detection of specific bacteria and fungi and their quantities in relation to lactobacilli as well as the likelihood calculation are the basis for detection of bacterial vaginosis and Candida.

Information and price quotes

Contact us for more information about our test for bacteria and yeast infections and for potential collaboration.

Phone: +46(0)13 465 53 20

E-mail: info@dynamiccode.se

Quality and security

• Specificity and reproducibility of the studies (see above) show that the Dynamic Code test has a methodological certainty of >99.5%.

• The analyses are carried out in Dynamic Code’s quality assured laboratory.

• Sampling kits are CE marked according to IVD Directive 98/79/EC and the MDD directive 93/42/EEC and in addition to future legislative changes.

• The test is registered with the Swedish Food and Drug Administration.

References

Eckert LO, Hawes SE, Stevens CE, Koutsky LA, Eschenbach DA and Holmes KK. Vulvovaginal candidiasis: clinical manifestations, risk factors, management algorithm. Obstet Gynecol. 1998;92:757-65

Falagas ME, Betsi GI and Athanasiou S. Probiotics for the treatment of women with bacterial vaginosis. Clin Microbiol Infect. 2007;13:657-64.

Gallo MF, Macaluso M, Warner L, Fleenor ME, Hook EW 3rd, Brill I, Weaver MA. Bacterial vaginosis, gonorrhea, and chlamydial infection among women attending a sexually transmitted disease clinic: a longitudinal analysis of possible causal links. Ann Epidemiol. 2012; 22: 213-220

McGregor JA, French JI, Parker R, Draper D, Patterson E et al. Prevention of premature birth by screening and treatment for common genital tract infections: results of a prospective controlled evaluation. Am J Obstet Gynecol. 1995;173:157-67.

Moi H. Prevalence of bacterial vaginosis and its association with genital infections, inflammation, and contraceptive methods in women attending sexually transmitted disease and primary health clinics. Int J STD AIDS. 1990;1:86-94.

Morris M, Nicoll A, Simms I, Wilson J and Catchpole M. Bacterial vaginosis: a public health review. BJOG. 2001;108(5):439-50.

Mårdh PA, Rodrigues AG, Genç M, Novikova N, Martinez-de-Oliveira J and Guaschino S. Facts and myths on recurrent vulvovaginal candidosis--a review on epidemiology, clinical manifestations, diagnosis, pathogenesis and therapy. Int J STD AIDS. 2002;13:522-39.

Nugent RP, Krohn MA and Hillier SL. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J Clin Microbiol. 1991;29:297-301.

Romero R, Chaiworapongsa T, Kuivaniemi H and Tromp G. Bacterial vaginosis, the inflammatory response and the risk of preterm birth: a role for genetic epidemiology in the prevention of preterm birth. Am J Obstet Gynecol. 2004;190:1509-19.

Sobel JD. Vulvovaginal candidosis. Lancet. 2007 Jun 9;369:1961-71.

Srinivasan S, Fredricks DN. The human vaginal bacterial biota and bacterial vaginosis. Interdiscip Perspect Infect Dis. 2008;2008:750479.

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