CanDia5®

Is the world’s first and only blood based Professional Point of Care test for Vulvovaginal Candidiasis. This CE-marked test utilizes just 2.5 microlitres of whole blood taken from a fingerstick to provide accurate diagnosis within 6 minutes.

The test is indicated as a screening test during pregnancy. This is because women are at high risk of developing VVC during the pregnancy and it is known that VVC during pregnancy is significantly associated with Intrauterine Growth Retardation. Recent evidence has also shown that screening and treatment of VVC during pregnancy may significantly reduce the prevalence of preterm labour.

Between 5% and 10% of healthy women of reproductive age may suffer from recurrent VVC. This is defined in the medical literature as 4 -5 infections per year. Since symptoms of VVC are usually non specific, it is important to ensure that accurate differential diagnosis is performed before embarking on a course of treatment.

CanDia5® is a lateral flow assay which requires five simple steps in order to perform accurate diagnosis. All of the accessories required to perform the test are included within the box.

A comprehensive series of instructions accompanies the test. A video illustrating the test is also available and can be observed following the links below


Vulvovaginal Candidiasis

Vulvovaginal Candidiasis (VVC) also known as Thrush, Monilial or yeast infection is a common cause of vaginal irritation. The condition affects up to 75% of all women during their reproductive years (age 15 – 45) and is characterized by symptoms of burning, itching, redness and soreness of the vulva or vagina.

In severe cases the infection may also be associated with abnormal discharge which is typically described as cottage cheese like in nature although may vary from watery to thick in consistency.

The condition is caused by an overgrowth of yeast cells, most commonly Candida albicans although several other clinically important sub species are known to be involved.

The overgrowth usually occurs as a result of a change in the vaginal pH and as a consequence many infections occur around the time of the menses, when the pH changes are most discernable.

Other factors which can influence pH and hence are pre disposing factors to VVC are uncontrolled diabetes, frequent use of oral contraceptives or antibiotics, increased frequency of sexual intercourse, use of douche and hygiene sprays.

One of the most significant pre disposing factors is pregnancy, since significant changes to vaginal pH can occur during this time.

Recent studies have highlighted the importance of screening for VVC during pregnancy (see below)

Since VVC is relatively difficult to distinguish from other common vaginal infections such as Trichomonas and Bacterial Vaginosis, it is important to have a convenient and reliable diagnostic tool to aid with differential diagnosis.

Link to clinical references for VVC



CanDia5® Video

Instruction For Use (IFU) 2137 kb

Link to clinical references for CanDia5

 

Diagnostic Strategies
As vaginal infections may be caused by organisms other than Candida, such as trichomonas and bacteria, it is not possible to make a diagnosis based solely on a patient's history and genital examination. A patient will further need to have a pelvic examination and have a vaginal swab taken and examined under a microscope. In some cases, the vaginal swab may need to be cultured by a laboratory for diagnosis. The diagnosis of Thrush usually involves finding the normal vaginal pH (which is pH4 to pH4.5) and obtaining positive results on microscopy. However, due to the poor sensitivity of these tests and the lack of specificity of clinical signs, accurate diagnosis of Thrush is difficult, and a vaginal culture should be obtained. The above procedure may take up to a week for proper diagnosis of Thrush to be established.


1. Kiss, H., et al (2004), Prospective randomised controlled trial of an infection screening programme to reduce the rate of preterm delivery:BMJ 329 371-374.

2.

Vazquez, J. A., and J. D. Sobel. Fungal infections in diabetes. Infectious Diseases Clinics of North America, March 1995; Volume 9: 97?116.


3. Duerr, A., M. F. Sierra, J. Feldman, L. M. Clarke, I. Ehrlich, and J. DeHovitz. Immune compromise and prevalence of Candida vulvovaginitis in human immunodeficiency virus-infected women. Obstetrics & Gynecology, 1997; Volume 90: 252?256. .

4. Otero, L., V. Palacio, F. Carreño, F. J. Méndez, and F. Vázquez. Vulvovaginal candidiasis in female sex workers. International Journal of STD & AIDS, 1998; Volume 9: 526?530.

5. Sobel, J. D., S. Faro, R. W. Force, B. Foxman, W. J. Ledger, P. R. Nyirjesy, B. D. Reed, and P. R. Summers. Vulvovaginal candidiasis: Epidemiological, diagnostic, and therapeutic considerations. American Journal of Obstetrics and Gynecology, February 1998; Volume 178, Number 2: 203?211.

6. Ferrer, J.. Vaginal candidiasis: epidemiological and etiological factors. International Journal of Gynecology & Obstetrics, 2000; Volume 71: S21?S27.
Paavonen J, Stamm WE. Sexually transmitted diseases: lower genital tract infections in women. Infect Dis Clin North Am 1987;1(1):179-98

7. Paavonen J, Stamm WE. Sexually transmitted diseases: lower genital tract infections in women. Infect Dis Clin North Am 1987;1(1):179-98

8. Foxman, B et al. Candida Vaginitis. Self-Reported Incidence and Associated Cost. Sexually Transmitted Disease, April 2000;Volume 27, No 4:230-235.

9. Bergman, J. J, A. O. Berg, R. Schneeweiss, and F. E. Heidrich. Clinical comparison of microscopic and culture techniques in the diagnosis of Candida vaginitis. The Journal of Family Practice, 1984; Volume 18: 549?552.

10. DoctorFungus Corporation. Candidiasis: Overview and full index. Retrieved 11 June 2002, from http://www.doctorfungus.org/mycoses/human/candida/Vulvovaginal.htm.