[Development and validation of Russian olfactory test].

Unlabelled: Olfactory disorders is one of the first symptoms of diseases from various departments of medicine (otorhinolaryngology, psychology, neurology, etc.). Based on international clinical recommendations, olfactory tests are the gold standard for the diagnosis of olfactory disorders. There are many different psychophysical tests: UPSIT (USA, Pennsylvania), Sniffin' Sticks test (Germany), BAST-24 (Spain), etc. Currently, there is an acute shortage of olfactory tests available for clinical practice In Russia. This problem is related to the fact that there are no olfactory tests registered as medical devices on the territory of the Russian Federation. Also, a significant limitation is the unrecognizability of odors by the population of our country, which include foreign analogues (licorice, anise, turpentine, etc.).

Objective: To develop and validate the national olfactory test on healthy volunteers.

Material And Methods: The development and validation of the olfactory test included several stages. First, the development of an olfactory test was carried out, the selection of aromas to assess the threshold and identification ability of olfaction. 25 dilutions of -butanol were used for the assessment of the threshold olfactory ability. For the stage of assessing the identification ability of the sense of smell, in our previous study, an assessment of the recognition of odor names in the territory of the Russian Federation was carried out. A total of 3.000 people from 8 federal districts of the Russian Federation were interviewed. During the development of the test, 20 names of flavors with the highest rating were used. By the 8, the selection of monocomponent substances was carried out. Commercially available certified food and perfume flavorings have been used for fragrances whose equivalent in the test cannot be a monocomponent substance. A group of 25 healthy volunteers selected a flavor or a monocomponent for each of the 20 positions. To carry out the identification stage of testing, a booklet was developed with answer options for each fragrance, including 80 images associated with the smell. A methodology for conducting diagnostics has been created. Next, the validation of the developed olfactory test was carried out on 150 healthy volunteers. The study included an assessment of the threshold and identification ability of the sense of smell using the developed test and conducting a comparative analysis with a set of flavors and descriptors corresponding to the Sniffin' Sticks test.

Results: The developed test includes: 2 panels - panel 1 to assess the threshold ability of smell, panel 2 to assess the identification ability of smell, a booklet with 80 images and captions to them. The norms of threshold and identification olfactory abilities were also determined in the developed test. The domestic test was validated against the relative foreign Sniffin' Sticks test. Spearman's correlation between the accuracy values of the domestic test (17-20; 85.00-100.00%) and the values of the foreign test (11-16; 68.75-100.00%) did not reveal statistically significant differences (=0.065, =0.432), which confirms the equally effective assessment of olfactory ability by the domestic olfactory test in comparison with its foreign counterpart.

Conclusion: In this work, a methodology for the use of Russian olfactory test was developed and validated on healthy volunteers. The features of the developed test are an assessment of the threshold and identification ability of smell, an adapted set of odors for the Russian population, the use of paper blotters when applying flavor and visual images of descriptors. Despite the wide variety of psychophysical tests, this problem requires further study and comparative analysis of olfactory tests available In Russia and foreign analogues in order to obtain a universal and effective diagnostic method for the populations of our country.

Unlabelled: This work was supported by the Russian Foundation for Basic Research (Project No. 24-25-00415).