In late 2011, the project of "Vega", which belongs to Alcor Bio — "Development of a diagnostic form of food allergens for skin application tests" — won the competition for the award of the Government of St. Petersburg for the best innovative project implemented in the framework of the cluster . Nominated — "Best innovative project implemented in the framework of the cluster in the field of medicine, biotechnology and pharmaceuticals."
This design is unique to Russia: in our country is nothing like for the diagnosis of allergic diseases is not used. There are few foreign counterparts, but they are in the territory of Russia are not registered and therefore can not be used in medical practice.
This method of diagnosis is aimed at identifying the late allergic reactions, delayed-type: application tests designed just for such patients. In fact, it is — the patch with cells, each cell contains a specific allergen in finished form. This patch is attached, usually on the patient's back.
And after 48 hours, when the patch is removed, the doctor by the presence of cutaneous manifestations can judge what is food allergy is a reaction of the patient. Application tests with food allergens — safe, easy to use and extremely necessary method of diagnosing allergies, especially for pediatricians. It's already in infancy should be determined by what foods to which allergens a child to react. And this is very important because food allergies, if not promptly had an accurate diagnosis can lead to more severe forms of allergic diseases.
Perhaps, today no one immunologist in the world can not give an exhaustive answer to the question, what is an allergy and what mechanisms are involved in the formation of multiple allergic reactions
Every year, hundreds of published scientific papers on the subject, which does not simplify life practicing allergy and immunology. And, nevertheless, currently customary to speak about the four basic types of reactions, although, in fact, they are much more.
But patients suffering from allergic diseases, of course, much more important than knowledge of the subtle mechanisms involved in allergic reactions, and the possibility of an accurate diagnosis, because it is the accuracy of the diagnosis depends largely on the effectiveness of the treatment of allergies.
However, the main types of diagnostics that are currently used by doctors, are aimed at identifying the allergic reactions of immediate hypersensitivity. And for that, there are many test systems, both domestic and imported. Statistics as follows: when a food allergy, atopic dermatitis, approximately 50% of allergy sufferers is impossible to make an accurate diagnosis using the methods that are currently used in practice.
It is impossible, because it — late delayed type allergic reactions as for their test systems not yet been developed. Diagnostics, for example, food allergies related to this type of reaction is generally carried out by the medical history, conduct a food diary, the results of an elimination diet-provocative. That is, in fact, by trial and error.
On the new development and the prospects of its introduction into clinical practice, we talk to the head of the project "Development of a diagnostic form of food allergens for skin application tests", head of the Laboratory of Allergology "Vega" Civil Alcor Bio Lyudmila Tikhonovna Kocsis.
— Lyudmila Tikhonovna, tell us what kind of development and what is it for?
— This design is intended for the diagnosis of allergic diseases. It belongs to the category of in vivo diagnostics (Latin — literally 'in (on) a living "), ie diagnosis of allergic diseases with the participation of the patient. Today there are all kinds of allergodiagnostic in vivo: this skin scarification test, skin prick test (ukolnoe testing), intradermal test, provocative tests. These tests are designed to diagnose IgE-mediated allergy, ie those allergic reactions that are based on mechanisms involving immunoglobulin E.
If we talk about the patch-test, then the diagnosis is aimed primarily at identifying non-IgE-mediated allergic reaction. In our country, these tests do not yet exist. Abroad, there are a few developments of this type, but with a rather limited range of allergens. That is why our laboratory as one of the activities of selected developing test for the diagnosis of allergic diseases which are on non-IgE mechanism.
— Do I understand correctly that today to a patient allergy occurs by this mechanism, it is impossible to make an accurate diagnosis?
— Yes. It would be nice, of course, that the doctor except for the results of clinical tests and allergic history would have been more instrumental and confirmed the criteria on which he could rely for diagnosis, to designate more than adequate treatment. But with allergy flowing through the non-IgE-mediated type of such tools in medical practice yet.
— Why the basis of your design — food allergens?
— This is due to the fact that the food allergy in 50% of cases, the reaction proceeds by non-IgE mechanism. But the reaction to pollen allergens and household — is typically of type I allergic reaction, or immediate hypersensitivity, which are synthesized in the allergen — specific immunoglobulin IgE. So first of all we have taken is the development of a food allergen.
For the record: an allergic reaction — it is a complex immune response of the body to a substance, called an allergen.
Food allergies — one of the most pressing problems of Pediatrics. The frequency of food allergy in children, according to different authors, is 40-80%. One in four children suffering from allergic diseases, identifies symptoms of food hypersensitivity. In a study of children with atopic dermatitis identified the eight most significant products that resulted in the majority of cases, to the development of allergic reactions: cow's milk, egg, wheat, soy, peanuts, tree nuts, fish and seafood.
Due to the diversity of the causes of increased sensitivity to foods is important to establish an accurate diagnosis and distinguish food allergy from food intolerance, as the tactics of their treatment, prevention and prognosis are different. Interest in food allergies has increased significantly in recent years due to the sharp increase of this disease in children and adults.
Diagnosis of food allergy are more challenging due to the lack of common methodological approaches, standardized methods for diagnosing food intolerances, enabling the identification of the variety of mechanisms involved in the implementation of hypersensitivity reactions to foods. Difficulties in diagnosis due to the emergence of a large number of pseudoallergic reactions to foods associated with the content of a variety of dietary supplements in their composition.
— On how many allergens designed your application tests?
— 10 to 20. Of course, not exclude the right direction and 30 allergens. This is valid because, unlike other methods of in vivo — diagnosis of allergies, such as scarification test, skin prick test, in setting patch-test, there is no risk that the patient, this procedure will trigger anaphylactic shock. For example, scarification test is made only in the presence of a doctor and a specially designed cabinet, because the patient may develop a very severe allergic reaction up to anaphylactic shock. The applicator is a test does not cause any adverse reactions. The only condition: a person who is attached to the back of this patch should not take a shower for 48 hours (
taking into account the reaction is carried out in two days).
— At what stage is your development?
— Now we have reached the stage of pre-clinical and clinical trials. This type of diagnosis belongs to the category of drugs, which means that according to Russian law, this development has to go through all the stages of pre-clinical and clinical trials. And it takes a huge investment. So now we're trying to get support from the state. In this we are supported by the country's leading scientific research institute specializing in immunology and allergy. This is quite natural, since the doctors really need a new method of diagnosis of allergic reactions.
— And in the process of development, you done any testing of patch-test?
— Yes, we tested the test animals. Check it out on the toxicity, the absence of any adverse reactions. It was very important to avoid the side effects of main and all auxiliary components that are used in this test. In particular, we have tested on myself, do not have to add irritant patch cells, the components of which are the cells in addition to allergens. And the result was satisfactory. Our application tests do not cause any irritation or discomfort.
— What challenges did you face when developing a new method of diagnosing allergies?
— On plaster are special cells in each cell separate allergen is introduced into the finished shape. The formulation contains the active substance — the actual allergen itself enclosed in a carrier — as determined by gel permitted for use in medicine. At first the development we have taken 30 food allergens, most commonly used in medical practice.
So, the most difficult was the creation of the formulation of allergen, which was applied to the patch on. Because it was necessary to ensure that retained the immunological activity of the allergen to the substance was stable for a long time, both in storage and in use. And so should pick up the carrier to the allergen at a certain speed completely out of it is released and penetrated through the skin. The release rate and the penetration of allergens, storage, and stability — all of this was taken into account when creating the formulation of allergen. Needed to make these conditions — a very difficult task. But we coped with it.