Integrated Human Practices

A gold medal criteria for iGEM is not only engaging with the community, but integrating their feedback to change our project for the better. New perspectives and expert feedback helped us think outside the box, and reconsider our previous decisions and approaches.

Motivation from experts

We talked with Physicians, Pharmacists, and consulted with Literature

“It is estimated that worldwide around 75 % of women acquire a Candida albicans (C. albicans) infection at least once, and 40-45 % experience two or more episodes.”
(Sobel, J.D., Vulvovaginal candidosis. The Lancet, 2007. 369(9577): p. 1961-1971.
Hurley, R. and J. de Louvois, Candida vaginitis. Postgraduate Medical Journal, 1979. 55(647): p. 645)

Dr. med. Franke, gynecologist, Germany
“During a normal work day, I diagnose at least two C. albicans infections.”

After interviewing experts and consulting with literature, we were assured that vulvovaginal candidiasis is a widespread problem.

Möhringer, general practitioner, Germany
“I’m diagnosing C. albicans infections solely through the symptoms of the patient like itching, burning, potentially discharge.”

PD Dr., Dr. med. Grunewald, dermatologist, Germany
“After examination of the patient I perform a pap test and grow the sample on Sabouraud Agar.”

Sex og Samfunn, Norway
“At Sex og Samfunn (Sex and Society, free clinic in Oslo), we would in most cases diagnose C. albicans by looking at the discharge under a microscope and look for fungal hyphae. If we do not observe any fungal hyphae, but the patient experience typical fungal infection symptoms, we recommend her to try an antifungal product to see if it helps. If the symptoms are chronic and she has earlier tried an antifungal product that did not relieve the symptoms, it happens that we take a sample from the patient and grow it for further inspection.”

After interviewing several physicians with different backgrounds, ranging from gynecologists to dermatologists to general practitioners, we observed that doctors have different approaches on how to diagnose a vulvovaginal C. albicans infection. A test-kit could provide diagnostic support, allowing for easy detection of C. albicans overgrowth.

"Women suffering from a vaginal C. albicans infection must either go to the doctor for diagnosis or self-treat by purchasing antimycotics over the counter without a prescription. Only 30 % of all women who self-treat in Norway had an actual C. albicans infection”
(http://www.antibiotikaiallmennpraksis.no/index.php?action=showtopic&topic=DrmsfZGV 22.08.2018)

Margrethe K. Kristiansen, Pharmacist, Norway
“I would estimate that about 9/10 times I sell antimycotics against C. albicans infections to women that were not at physician before going to the pharmacy store.”

Antimicrobial resistance is a global problem that is constantly increasing. Unspecific treatment, like buying over-the-counter antimycotics for treating a non-existing C. albicans infection is further reinforcing this issue. Our team agreed on tackling the high number of vulvovaginal candidiasis misdiagnoses.

Aina Kristin Pham, Pharmacist, Norway
“I don’t know any test for detecting vaginal C. albicans infections. I don’t think pharmacy stores are selling them.”

Anita Binder, Pharmacist, Germany
“I know Canetest. It is a pH dependent test to distinguish between bacterial vaginosis and thrush. But I have never sold one. I think this is due to missing education and advertisement.”

Alexandra Möhringer, general practitioner, Germany
“I really like the idea of an easy-to-use test for detecting C. albicans since this would lead to a more targeted and therefore better therapy. But I would like the test to be done at a practitioner, so that in case of a C. albicans infection the physician could prescribe the right antimycotics.”

Dr. med. Bastian Czogalla, gynecologist, Germany
“In my opinion a test would be very meaningful. My personal idea would be that if a person is treated with antibiotics (for example for treating a bladder infection) the test could be sold together with the antibiotics, since the risk is very high that the women will get a fungal infection due to overgrowth of potentially pathogenic organisms.”

The idea of a kit which can be performed by a physician or a pharmacist sounded promising. This could not only reduce the amount of misdiagnosed cases, but also aid in reducing the unnecessary use of antimycotics.

Conclusion

After careful consideration of the experts feedback, we decided against our initial plan to have our test-kit for use at home. Rather, we found a consensus in providing physicians and pharmacies with the kit, in order to provide diagnostic support. The condition can then be properly evaluated, and proper treatment may be administered if applicable.

This will assure proper storage and handling protocols, as the guide RNAs included in the kit, requires specific storage conditions. Last, but not least, the contents of this kit will be properly disposed off in this setting. This is especially important considering our kit contains nitrocefin which has antibiotic activity, and must be handled according to national guidelines. All of these factors combined made us certain that a fast detection-kit handled by health professionals would be more beneficial than a home-detection-kit handled by the consumer. More information can be found on our Design page.

Further considerations

In order to assess the acceptance of the test, we conducted a questionnaire, which we wrote about in Human Practices. The participants were new master students at the Institute for Biosciences at the University of Oslo.

Out of 66 participants, 71 % (n=47) were female, while 29 % (n=19) were male.
The age of the participants ranged from 21 to 43 years, with a mean age of 24 years.

Question: If you have the suspicion of suffering from a vaginal C. albicans infection, would you use a “home-testing kit” in order to obtain a more targeted treatment (1 being not likely and 5 being very likely)?

Female participants n = 41 , Male participants n = 15

The answers were as expected very widespread. The reason for that could be, that people are not well informed about vaginal infections, especially with the fungus C. albicans. That is why we added some general questions about vaginal C. albicans infections to the questionnaire:

Question: Did you know what C. albicans is before the presentation?

Female participants n = 47 , Male participants n = 19

The evaluation shows that more than half of the participants did not have prior knowledge of C. albicans, with a higher percentage of men not knowing about C. albicans.

Question: Did you know that C. albicans is a frequent cause of vaginal infections?

Female participants n = 47 , Male participants n = 19

The evaluation of the questionnaire showed that the participants were not well informed about C. albicans. Thereupon we were wondering if women are educated about the normal vaginal flora and thereby the right hygiene of the genital area.

Dr. med. Franke, gynecologist, Germany
“I experienced that women are in general poorly educated about commensal microorganisms in the vaginal flora and the knowledge about good hygiene of the genital area is even worse. I could observe that people living in the city are commonly poorly informed whereupon women living on the countryside are even worse educated. In my opinion there is a big need of a campaign that should brief women about these topics.”

PD Dr. Dr. med. Susanne Grunewald, dermatologist, Germany
“No, I don’t think that women are well informed about these topics. Very often, we as physicians have to educate women about intimate care. In my opinion it would be a good idea to start a campaign for informing women about health of the genital area.”

Conclusion

The outcome of the questionnaire and the interview with different physicians was the crucial factor for us to start an educational campaign. We established a flyer where women can get informed about the normal vaginal flora, the best hygiene of the genital area and the different symptoms and treatments between bacterial vaginitis and fungal vaginitis.