A KIT FOR ANALYZING A MATERIAL SAMPLE FOR THE PRESENCE OF ONE OR MORE ANALYTES

FIELD OF INVENTION

The disclosure relates to the means for conducting a rapid analysis of biological samples using chromatographic analysis, in particular thin-layer chromatography, that can be applied in medicine, veterinary medicine, and food quality control.

BACKGROUND OF INVENTION

Chromatography is a physico-chemical method for the substance analysis based on the distribution of the substance components, specifically, the distribution of the substance components between two phases - mobile and stationary ones. The stationary phase is usually a solid (sorbent), while the mobile phase is a liquid or gas that flows through the stationary phase. When the mobile phase is flowing through the stationary phase, the substance components separate and move along the stationary phase at different rates.

According to the technique of the separation of the substance components, there is a type of chromatography, in which the separation is performed in a thin layer of the sorbent. This method is called thin-layer chromatography (TLC).

In TLC method, a stationary solid phase (sorbent) is applied in a thin layer on a base, such as a plate or strip (in the literature it is often referred to a "test plate", "test strip"). Various solvents or mixtures thereof, both organic and inorganic, are used as the mobile phase. The type of the solvent depends on the nature of the sorbent and the properties of the compounds or substances to be analyzed. Aqueous buffer solutions that create a constant pH value are often used as the solvent, which is why, in the literature sources, solvents used in TLC are often referred to as a "buffer fluid". Although such a solvent may not actually be a buffer solution that creates a constant pH value, it may be referred to a "buffer fluid". TLC uses capillary forces that occur when the so-called starting edge of the plate or strip is immersed into the solvent containing the substance to be analyzed. Due to capillary forces, the solvent containing the substance to be analyzed moves from the starting edge of the plate or strip into the volume of the sorbent on the plate or strip and transports the substance components at different rates. That leads to spatial separation and positioning of the substance components in different areas of the plate or strip, and the formation of zones, such as spots or lines.

Target chemicals or substances, whose presence is desirable to be determined in a sample, are referred to "analytes". TLC conditions (such as sorbent, solvent) for detection of the analytes are selected such that the spots or lines formed on the plate or strip acquire a characteristic color and become visible on the plate or strip. In TLC practice, the plate or strip may be positioned inside a closed transparent chamber so that the solvent does not evaporate from the surface of the plate or strip during TLC, and the solvent evaporation does not affect the TLC results.

The TLC method provides many advantages for analysis, such as (1 ) simplicity of the analysis; (2) no demand for expensive equipment; (3) rapidity that is determined by a short period of time (about 5-15 minutes) required to obtain the analysis results; (4) no demand for significant quantities of the sample substance.

Advantages of TLC method, such as versatility, simplicity of the analysis, rapidity, and sensitivity, led to the widespread use of TLC for analytical purposes in biochemistry and medicine, e.g. for identification of the components of the drugs and biochemicals, as well as inorganic compounds and organic compounds of different classes.

One of the subtypes of TLC is immunochromatographic analysis. Immunochromatographic analysis (ICA) also refers to immunochemical analysis. ICA is based on the principle of the thin-layer chromatography, and it uses the reaction between the antigen and the corresponding antibody. The method is often performed using special test strips. In particular, ICA enables detection of antibodies to viruses and virus antigens in samples.

Australian application AU 2021200665 A1 , publ. 18.03.2021 , describes a kit for collecting a material sample (such as saliva) and analyzing this sample for the presence of one analyte, wherein the kit comprises a test device designed to collect the material sample and display the results of the analysis of the material sample, and a container designed to store a buffer fluid required to analyze the material sample.

The test device contains: (1 ) a housing designed in the form of a tube made of transparent material; (2) locking tip connected to the first end of the housing; (3) an assembly for receiving the material sample connected to the second end of the housing; (4) filter located inside the housing near the second end of the housing; (5) test strip designed to analyze the material sample for the presence of one analyte, and indicate the analysis results, wherein one end of the test strip being connected to the locking tip, and the other end of the test strip being leaned against the filter; (6) sealing ring located on the outer portion of the second end of the housing.

The assembly for receiving the material sample comprises a rod and an element for receiving the material sample. The first end of the rod is connected to the second end of the housing so that portion of the rod is located inside the orifice of the second end of the housing. The second end of the rod is designed in a cone shape. The element for receiving the material sample is mounted on the rod.

The container comprises a vessel containing the buffer fluid, a receiving tip designed to receive the end of the test device with the assembly for receiving the material sample connected to it and hold the test device in a certain position, and an impermeable membrane. The vessel containing the buffer fluid is designed such that it has a housing and a neck. The impermeable membrane is designed in the form of a disk made of impermeable material and mounted on the neck of the vessel containing the buffer fluid so that it covers the orifice in the neck and prevents the buffer liquid from being split during transportation and storage. The receiving tip is designed in the form of a tube to be mounted on the housing of the vessel containing the buffer fluid.

The geometric sizes of the second end of the test device housing and the receiving tip of the container are adjusted in such a manner that when the second end of the test device with the assembly for receiving the material sample connected to it is inserted into the receiving tip of the container, the sealing ring located on the outer portion of the second end of the housing comes into close constant contact with the inner surface of the receiving tip, and the resulting friction force leads to fixation of the test device in the container.

The kit is transported and delivered to the user in assembled form, i.e. the test device is inserted into the container and fixed in the container so that the second end of the rod of the assembly for collecting the material sample does not reach the impermeable membrane.

The known kit is used as follows.

The user removes the test device from the container, then inserts the test device into the mouth in such a manner that the element for receiving the material sample is positioned in the oral cavity; holds the element for receiving the material sample in the oral cavity for one to two minutes to allow the element for receiving the material sample to absorb a large amount of saliva; then removes the element for receiving the material sample from the oral cavity. Then, the user inserts the test device into the container so that the second end of the rod of the assembly for receiving the material sample reaches the impermeable membrane and pierces the impermeable membrane; upon that the element for receiving the material sample enters the buffer fluid. Since the sealing ring fits snugly to the outer surface of the second end of the test device housing and to the inner surface of the receiving tip of the container, and prevents the buffer fluid from being spilt out of the container, the buffer fluid passes through the element for receiving the material sample, and, while moving, captures saliva located in the element for receiving the material sample. After that, the buffer fluid passes through the orifice of the second end of the test device housing, reaches the filter, and then passes to the end of the test strip that leans against the filter. The buffer fluid elutes the analyte, if present in saliva, on the test strip. As a result, lines that show the presence or absence of analyte in the saliva sample occur. The lines also show that the analysis of the saliva sample test was correct, and the analysis result can be credible.

The disadvantages of the known kit are as follows: 1 ) the ability to detect the presence or absence of only one analyte in the material sample; if a comprehensive analysis to detect the presence of several analytes in the material sample is desirable, there is a need to purchase and use several such devices; 2) non-zero probability that during transportation, the test device fixed in the container will move inside the receiving tip of the container under the action of any impact and pierce the impermeable membrane resulting in the kit becoming unusable.

SUMMARY OF INVENTION

The objective technical problem of this disclosure is to create an improved kit for analyzing a material sample for the presence of one or more analytes that, due to changes in the design, enables detection of the presence of several analytes in the sample material. Another object is to expand the range of tools for the analysis of the material samples.

The objective technical problem is solved with a kit for analyzing a material sample for the presence of one or more analytes, the kit comprising: a test device (1) designed to receive the material sample and display the result of the analysis of the material sample, and a container (2) designed to store a buffer fluid required for the analysis of the material sample; the test device (1 ) comprising a housing (3) designed in the form of a tube made of the transparent material, the housing (3) having a first end of the housing (8) and a second end of the housing (9), a locking tip (4) connected to the first end of the housing (8), an assembly for receiving the material sample (5) connected to the second end of the housing (9), at least one test strip (6) designed to analyze the material sample for the presence of the analyte and display the result of the analysis; the assembly for receiving the material sample (5) containing a rod (10) and an element for receiving the material sample (11 ), wherein the first end of the rod (12) being connected to the second end of the housing (9) such that a portion of the rod (10) being located inside the orifice of the second end of the housing (9); the element for receiving the material sample (1 1 ) being mounted on the rod (10), wherein the test device (1 ) further comprising a test strip holder (7) designed to fix one or more test strips (6) inside itself and to be positioned inside the housing (3).

According to one of the embodiments, the housing (3) can be designed in the form of a tube such that it preferably has a cylindrical shape.

According to one of the embodiments, the housing (3) can be designed in the form of a tube such that it preferably has a lateral surface formed by three or more lateral faces (22), each of which is a rectangle or parallelogram.

According to one of the embodiments, the lateral surface of the housing (3) can be formed by three, four, five or six lateral faces (22). According to one of the embodiments, the test strip holder (7) can be connected to the locking tip (4).

According to one of the embodiments, the test strip holder (7) can be connected to the housing (3).

According to one of the embodiments, the test strip holder (7) can be designed such that it preferably has a cylindrical shape.

According to one of the embodiments, the test strip holder (7) can be designed such that it preferably has a prism form with a lateral surface formed by three or more side faces (23), each of which is a rectangle or parallelogram.

According to one of the embodiments, the test strip holder (7) can be designed such that it preferably has a prism form with three, four, five or six lateral faces (23).

According to one of the embodiments, the surface of the test strip holder (7) can comprise one or more recesses designed to fix the test strip (6).

According to one of the embodiments, one or more recesses for fixing the test strip (6) can be located on one or more lateral faces (23) of the test strip holder (7).

According to one of the embodiments, the test device (1 ) can comprise one, two, three, four, five or six test strips (6).

According to one of the embodiments, the test device (1 ) further comprises a sealing ring (14) located on the outer portion of the second end of the housing (9), and further comprises a protective cap (15) mounted on the second end of the housing (9) such that the protective cap is in contact with the sealing ring (14) and prevents the element for receiving the material sample (11 ) from contacting with other objects.

According to one of the embodiments, the element for receiving the material sample (1 1 ) can be made of porous material.

According to one of the embodiments, the element for receiving the material sample (1 1 ) can be designed in a cylindrical shape with an axial channel.

According to one of the embodiments, the container (2) can be designed to comprise a vessel containing buffer fluid (16), a receiving tip (17) designed to receive the end of the test device with the assembly for receiving the material sample (5) connected to it and holding the test device (1 ) in a certain position, and an impermeable membrane (18); the container containing the buffer fluid (16) is designed such that it has a housing (19) and a neck (20); the impermeable membrane (18) is designed in the form of a disk made of impermeable material and mounted on the neck (20) such that the impermeable membrane cover the orifice in the neck (20) and prevents the buffer fluid from being split during transportation and storage; the receiving tip (17) is designed in the form of a tube to be mounted on the housing (19) or on the outer portion of the neck (20) of the vessel containing the buffer fluid (16). According to one of the embodiments, the outer portion of the second end of the housing (9) can comprise a sealing collar (21 ).

According to one of the embodiments, the analyte or analytes are preferably selected from the group of substances consisting of, but not limited to, antigens, antibodies, hormones, antibiotics, addictive substances, vitamins, disease markers, markers of allergic reactions, food quality markers.

According to one of the embodiments, the antigens and antibodies are preferably selected from the group of antigens of viruses and antibodies to viruses including, but not limited to, influenza viruses, coronaviruses, adenoviruses, human respiratory syncytial virus, HIV, hepatitis viruses, Epstein-Barr virus, Zika virus, dengue fever viruses, chikungunya fever virus, rubella virus, human cytomegalovirus, herpes viruses.

According to one of the embodiments, the hormones are preferably selected from the group of substances consisting of, but not limited to, chorionic gonadotropin, luteinizing hormone, follicle-stimulating hormone, protein-1 that binds insulin-like growth factor, thyroid-stimulating hormone, thyroxine, triiodothyronine.

According to one of the embodiments, the addictive substances are preferably selected from the group of substances consisting of, but not limited to, cannabinoids, synthetic cannabinoids, morphine, ecstasy, barbiturates, benzodiazepines, cocaine, amphetamine, methamphetamine, mephedrone, tramadol, oxycodone, pregabalin, tricyclic antidepressants, zopiclone.

According to one of the embodiments, the diseases are preferably selected from the group of diseases consisting of, but not limited to, respiratory diseases, infectious diseases, sexually transmitted diseases, hormonal diseases, transmissible diseases, infections of the gastrointestinal tract, cardiovascular diseases, diseases of any organs, kidney diseases, liver diseases.

According to one of the embodiments, the allergic reactions are preferably selected from the group of reactions consisting of, but not limited to, reactions to such factors as drugs, food, milk protein, gluten, egg white, seafood, peanuts, animals, cat hair, dog hair, pollen, ragweed pollen, fungus, mold.

As used herein the term “material sample”, unless otherwise indicated, refers to both an unprocessed sample and processed sample of any material.

Specific cases of the material sample or material samples can be: a) a biological material sample, wherein the biological material sample includes both, but not limited to:

- any unprocessed sample that can be collected in any physical form from the objects including, but not limited to, the body of any creature, any organs and tissues of the body of any creature (in particular, as swabs, scrapings and washes from various organs and tissues of the body of any creature), any substances that both are present in the body of any creature and excreted by the body of any creature, any biological fluids in the body of any creature (e.g., blood, saliva, gastric juice, sperm, vaginal secretions, and the like), any metabolic products of the body of any creature (e.g., urine, feces, and the like), any secretions, any physiological and pathological secretions of the body of any creature (e.g., nasal mucus, sweat, earwax, transudate, exudate, etc.); and that can include, but not limited to, any component of the body of any creature (such as cells and tissues), as well as any substances presented in the body of any creature;

- any processed sample obtained in any method from the unprocessed sample described above that may include, but not limited to, any components of any organ of the body of any creature, any components of any substances that both are present in the body of any creature and excreted by the body of any creature, any components of any biological fluids of the body of any creature (e.g., blood plasma, blood serum, and the like), any components of any metabolic products of the body of any creature, any components of any secretions, any physiological and pathological secretions of the body of any creature; b) a sample of the food material, which means any unprocessed sample that can be collected in any physical form from any food product, as well as any processed sample obtained in any method from an unprocessed sample described above; c) a sample of a chemical substance, which means any unprocessed sample that can be collected in any physical form from any chemical substance, and any processed sample obtained in any method from the unprocessed sample described above.

The term “creature” means any object of the living world, in particular, such as a plant, animal, human, and fungus.

As used herein the term "analyte", unless indicated otherwise, refers to any chemical object, such as: (1 ) any chemical compound, the presence or absence of molecules of which in the material sample can be detected with this disclosure; (2) any substance, the presence or absence of components of which in the material sample can be detected with this disclosure.

As used herein the term "buffer fluid" means any solvent that is used or can be used in thin-layer chromatography.

BRIEF DESCRIPTION OF DRAWINGS

To better understand the essence of the disclosure, the following examples of the claimed disclosure are shown below in connection with the drawings provided in the Drawings.

FIG. 1 represents a general view of the elements of the kit for analyzing the material sample for the presence of one or more analytes. FIG. 2 represents a front view of the test device (1 ).

FIG. 3 represents a section A-A from Figure 2.

FIG. 4 represents a front view of the test device (1 ).

FIG. 5 represents a section B-B from Figure 4.

FIG. 6 represents a front view of the housing (3).

FIG. 7 represents a top view of the housing (3).

FIG. 8 represents a front view of the housing (3).

FIG. 9 represents a top view of the housing (3).

FIG. 10 represents a front view of the housing (3).

FIG. 11 represents a top view of the housing (3).

FIG. 12 represents a front view of the test strip holder (7).

FIG. 13 represents a top view of the test strip holder (7).

FIG. 14 represents a front view of the test strip holder (7).

FIG. 15 represents a top view of the test strip holder (7).

FIG. 16 represents a front view of the test strip holder (7).

FIG. 17 represents a top view of the test strip holder (7).

FIG. 18 represents a section C-C from Figure 2.

FIG. 19 represents a section C-C from Figure 2.

FIG. 20 represents a section C-C from Figure 2.

FIG. 21 represents a section D-D from Figure 4.

FIG. 22 represents a section D-D from Figure 4.

FIG. 23 represents a section D-D from Figure 4.

FIG. 24 represents a section D-D from Figure 4.

FIG. 25 represents a section D-D from Figure 4.

FIG. 26 represents a front view of the rod (12).

FIG. 27 represents a top view of the rod (12).

FIG. 28 represents a front view of the housing (3) with the sealing ring (14). FIG. 29 represents a front view of the housing (3) with the sealing ring (14), the assembly for receiving the material sample (5) connected to it, and the protective cap (15) mounted on it.

FIG. 30 represents a section D-D from Figure 29.

FIG. 31 represents a front view of the housing (3) with the sealing collar (21 ).

FIG. 32 represents a front view of the container (2).

FIG. 33 represents a section E-E from Figure 32.

FIG. 34 represents a cross-sectional view of the container (2) with the test device (1 ) inserted.

DETAILED DESCRIPTION OF INVENTION

The kit for analyzing the material sample for the presence of one or more analytes comprises two separate elements, such as the test device (1 ) and the container (2) (see Figure 1 ).

The test device (1 ) is designed to receive the material sample and display the results of the analysis of the material sample.

The container (2) is designed to store the buffer fluid required for the analysis of the material sample.

The test device (1 ) comprises elements, such as the housing (3), the locking tip (4), the assembly for receiving the material sample (5), the test strip (6), and the test strip holder (7).

The housing (3) is designed in the form of a tube made of the transparent material that has two ends, such as the first end of the housing (8) and the second end of the housing (9) (see Figures 2, 3, 4, and 5). There is an open orifice at each end of the housing (3). The locking tip (4) is connected to the first end of the housing (8). There are two options for the locking tip (4) to be connected to the first end of the housing (8): (1 ) according to the first option, the locking tip (4) is inserted into the orifice at the first end of the housing (8) (shown in Figures 3 and 5), (2) according to the second option, the locking tip (4) is mounted on the outer surface of the first end of the housing (8). The assembly for receiving the material sample (5) is connected to the second end of the housing (9) (shown in Figures 2, 3, 4, and 5).

According to the claimed disclosure, the housing (3) can be designed in the form of a tube of different shapes. According to one of the embodiments, the housing (3) can be designed in the form of a tube of preferably cylindrical shape (this embodiment of the housing (3) is shown in Figures 6 and 7 (front view and top view)). According to another embodiment, the housing (3) can be designed in the form of a tube such that it preferably has a lateral surface formed by three or more lateral faces (22), each of which is a rectangle or parallelogram. An embodiment of the housing (3) with three lateral faces (22) is shown in Figures 8 and 9 (front view and top view). An embodiment of the housing (3) with four lateral faces (22) is shown in Figures 10 and 11 (front view and top view). One skilled in the art will appreciate that the housing (3) can be designed in the form of a tube such that it preferably has a lateral surface formed by more than four lateral faces (22), for example, five, six or seven lateral faces (22).

The test strip (6) is designed to analyze the material sample for the presence of the analyte and display the results of the analysis. The claimed disclosure may comprise one or more test strips (6). One or more test strips (6) are located on the element of the test device (1 ), such as the test strip holder (7) designed to fix one or more test strips (6).

The test strip holder (7) is located inside the housing (3). Both when transporting the kit according to this disclosure and when testing the material sample for the presence of one or more analytes, the test strip holder (7) must be fixed relative to the housing (3). The following options are possible to connect the test strip holder (7) to other elements of the test device (1 ), which ensure its fixation. According to one of the embodiments, the test strip holder (7) can be connected to the locking tip (4), for example, the locking tip (4) comprises the recess of a certain shape, into which one end of the test strip holder (7) is to be inserted (this embodiment is shown in Figures 2 and 3 (dashed line shows the invisible boundaries of the lower portion of the locking tip (4) and invisible boundaries of the test strip holder (7), as well as in Figures 18, 19 and 20). According to another embodiment, the test strip holder (7) can be connected to the housing (3) by landing the test strip holder (7) inside the housing (3) with guaranteed negative allowance. This embodiment is shown in Figures 4 and 5 (dashed line shows the invisible boundaries of the lower portion of the locking tip (4) and invisible boundaries of the test strip holder (7)), as well as in Figures 21 , 22, 23, 24 and 25.

According to the claimed disclosure, the test strip holder (7) can be embodied in two main embodiments. According to one embodiment, the test strip holder (7) can be designed such that it has preferably cylindrical shape. This embodiment is shown in Figures 12 and 13 (front and top view), 18 and 21. According to another embodiment, the test strip holder (7) may be designed such that it has preferably a prism form with a lateral surface formed by three or more lateral faces (23), each of which is a rectangle or parallelogram. An embodiment of the test strip holder (7) with three lateral faces (23) is shown in Figures 14 and 15 (front view and top view), 19, 22 and 24. An embodiment of the test strip holder (7) with four lateral faces (23) is shown in Figures 16 and 17 (front and top view), 20, 23 and 25. It will be apparent to one skilled in the art that the test strip holder (7) can be designed such that it has preferably a prism shape with a lateral surface formed by more than four lateral faces (23), each of which is a rectangle or parallelogram, for example, five, six or seven lateral faces (23).

According to the claimed disclosure, the surface of the test strip holder (7) can comprise one or more recesses designed to fix one or more test strips (6). According to a partial embodiment, one or more recesses designed to fix the test strips (6) can be located on one or more lateral faces (23) of the test strip holder (7). Figure 12 represents an embodiment of the test strip holder (7) with one strip (6); and Figures 14 and 16 represent an embodiment of the test strip holder (7) with two strips (6). It is apparent to one skilled in the art that the test strip holder (7) in Figure 14 can comprise three test strips (6), such as one strip per each lateral face (23); the test strip holder (7) in Figure 16 can comprise both three test strips (6) and four test strips (6), such as one test strip (6) per each lateral face (23). For one skilled in the art it is also apparent that it is possible to design the test strip holder (7) such that more test strips (6) can be fixed in it, for example, five or six. The number of test strips is limited only by the geometric sizes of the test strips (6), as well as by the shape and the geometric sizes of the test strip holder (7).

It will be apparent to one skilled in the art that any test strip (6) can be used as the test strip that enables detection of the analyte in the sample by thin layer chromatography. The analyte or analytes that can be detected with this disclosure are any target chemical compounds or substances that need to be identified in the material sample.

For example, the analyte or analytes may be selected from the group of substances consisting of antigens, antibodies, hormones, antibiotics, addictive substances, vitamins, disease markers, allergic reaction markers, food quality markers, and the like.

For example, antigens and antibodies that can be detected are antigens of the following viruses and antibodies to the following viruses: influenza viruses, coronaviruses, adenoviruses, human respiratory syncytial virus, HIV, hepatitis viruses, Epstein-Barr virus, norovirus, astroviruses, dengue fever viruses, chikungunya fever virus, rubella virus, human cytomegalovirus, herpes viruses, and the like.

For example, hormones that can be detected are substances selected from the group of substances consisting of chorionic gonadotropin, luteinizing hormone, follicle- stimulating hormone, protein-1 that binds insulin-like growth factor, thyroid-stimulating hormone, thyroxine, triiodothyronine, and the like.

For example, addictive substances that can be detected are substances selected from the group of substances consisting of cannabinoids, synthetic cannabinoids, morphine, ecstasy, barbiturates, benzodiazepines, cocaine, amphetamines, methamphetamine, mephedrone, tramadol, oxycodone, pregabalin, tricyclic antidepressants, zopiclone, and the like.

For example, diseases that can be detected by disease markers are respiratory diseases, infectious diseases, sexually transmitted diseases, hormonal diseases, transmissible diseases, gastrointestinal infections, cardiovascular diseases, diseases of any organs, kidney diseases, liver diseases, and the like. In particular, diseases can include:

- respiratory diseases (influenza, coronavirus, adenoviral diseases, diseases caused by human respiratory syncytial virus, pneumonia, streptococcal sore throat, tuberculosis);

- common infectious diseases (HIV, type A, B, C, E hepatitis, syphilis, gonorrhea, chlamydia, TORCH infections (toxoplasmosis, rubella, cytomegalovirus and herpes), brucellosis, diseases caused by Epstein-Barr virus);

- infections of the gastrointestinal tract (diseases caused by adenoviruses, rotaviruses, noroviruses, astroviruses, cryptococci, Giardia, Helicobacter pylori, campylobacteriosis, salmonellosis, cholera);

- transmissible diseases (malaria, dengue fever, chikungunya fever, leishmaniasis, typhus, diseases caused by Zika virus);

- diseases of kidneys and liver;

- diseases of various organs;

- cardiac diseases (detection of the analytes, such as troponin, myoglobin, creatine kinase, d-dimer);

- oncological diseases (detection of the analytes, such as occult blood in feces, prostate-specific antigen, ferritin, transferrin, lactoferrin, alpha fetoprotein, carcinoembryogenic antigen);

- fertility problems (detection of the analytes, such as chorionic gonadotropin, luteinizing hormone, follicle-stimulating hormone, protein-1 , which binds insulin-like growth factor).

For example, allergic reactions that can be detected by markers are reactions to drugs, food, milk protein, gluten, egg white, seafood, cashews, peanuts, animals, cat hair, dog hair, pollen, ragweed pollen, fungus, mold, and the like.

The assembly for receiving the material sample (5) comprises the rod (10) and the element for receiving the material sample (11) (see Figures 3 and 5). The rod (10) comprises the first end of the rod (12) and the second end of the rod (13). The rod (10) must be designed to enable the passage of the buffer fluid that passed through the element for receiving the material sample (11 ) further into the housing (3). One possible embodiment of the rod (10) is shown in Figures 26 and 27. Another embodiment of the rod (10) structure is provided in Australian application AU 2021200665 A1 . The first end of the rod (12) is connected to the second end of the housing (9) such that a portion of the rod (10) is located inside the orifice of the second end of the housing (9). The second end of the rod (13) can be designed in a cone shape. The element for receiving the material sample (11 ) is mounted on the rod (10). According to a preferred embodiment, the element for receiving the material sample (11 ) is made of a porous material. The porous material of the element for receiving the material sample (11 ) enables the element for receiving the sample material (11 ) to receive a significant volume of the material sample, which, accordingly, increases the accuracy of the analysis of the material sample for one or more analytes.

According to one of the embodiments, the element for receiving the material sample (11 ) can be designed in a cylindrical shape with an axial channel. This design of the element for receiving the material sample (11 ) enables the assembly for receiving the material sample (5) to be produced by folding with inserting the rod (10) into the axial channel in the element for receiving the material sample (11 ). In addition, it enables the production of the assembly for receiving the material sample (5) with different geometric sizes (diameter and length) of the element for receiving the material sample (1 1 ).

Reception of the material sample by the element for receiving the material sample (11 ) can be performed in two embodiments. According to the first embodiment, reception of the material sample by the element for receiving the material sample (11 ) is performed in one step, such as by direct collection of the material sample using the element for receiving the material sample (11 ). In this embodiment, the sample material immediately lands on the element for receiving the sample material (1 1 ).

For example, when the assembly for receiving the material sample (5) comprises the element for receiving the material sample (11 ) with small diameter, the test device

(I ) according to the disclosure is embodied for receiving the material sample by collecting the material, such as a nasal swab. Collection of the nasal swab from the nasal cavity is performed by inserting the element for receiving the material sample (11 ) into the nasal cavity and sliding the surface of the element for receiving the material sample (11 ) along the nasal mucosa, for example, by rotating the test device (1 ) several times.

Another embodiment of the test device (1 ) according to this disclosure for receiving the material sample by collecting the material includes saliva collection, which is accomplished by inserting the element for receiving the material sample (11 ) into the mouth and maintaining it in the mouth for 1 to 2 minutes. It is also possible to collect a swab, such as a vaginal swab and/or an anal swab.

According to the second embodiment, reception of the material sample by the element for receiving the material sample (11 ) is performed in two steps. First, the material sample is collected, then some volume of the material sample is applied on the element for receiving the material sample (11 ), or the element for receiving the material sample (11 ) is immersed in the material sample collected. With the second embodiment of reception of the material sample by the element for receiving the material sample

(I I ), it is possible to analyze any unprocessed material samples, as well as any processed material samples to be further analyzed, such as, for example, blood, gastric juice, urine, feces, sweat, earwax, transudates, exudates, swabs, scrapes and washes from various organs and tissues of the body, as well as food. According to one of the embodiments, the test device (1 ) can comprise the sealing ring (14) (see Figures 28, 29, and 30) located on the outer portion of the second end of the housing (9) and can comprise the protective cap (15) mounted on the second end of the housing (9) so that its inner surface is in contact with the sealing ring (14). The protective cap (15) protects the element for receiving the sample material (11 ) from contacting with other objects, thus maintaining the sterility of the element for receiving the material sample (11 ).

According to one of the embodiments, the container (2) comprises the vessel containing the buffer fluid (16), the receiving tip (17), and the impermeable membrane (18) (see Figures 32, 33, and 34). The vessel containing the buffer fluid (16) comprises the housing (19) and the neck (20). The impermeable membrane (18) is designed in the form of a disk made of impermeable material (e.g. foil) and mounted on the neck (20) of the vessel containing the buffer fluid (16) so that it covers the orifice in the neck (20) and prevents the buffer liquid from being split during transportation and storage. The receiving tip (17) is designed to receive the end of the test device (1 ) with the assembly for receiving the material sample (5) connected to it and holding the test device (1 ) in a certain position that can be considered close to the vertical position.

According to one of the embodiments, the geometric sizes of the second end of the housing (9) and the receiving tip (17) are adjusted such that when the second end of the housing (9) with the assembly for receiving the material sample connected to it is inserted into the receiving tip (17), the sealing ring (14) located on the outer portion of the second end of the housing (9) comes into close constant contact with the inner surface of the receiving tip (17), and a friction force, that fixes the test device (1 ) in the container (2), occurs. In this case, when the test device (1 ) is inserted into the container (2) and then the test device (1 ) is pushed along the receiving tip (17), the buffer fluid is displaced from the container containing the buffer fluid (16) to the element for receiving the material sample (11 ). After that the buffer fluid passes through the rod (10) and enters the housing (3) reaching the test strip holder (7). A similar pattern may occur in the presence of the sealing collar (21 ).

According to one of the embodiments, the outer portion of the second end of the housing (9) can comprise the sealing collar (21 ) (see Figure 31 ). In this embodiment, the mutual geometric sizes of the second end of the housing (9) and the receiving tip (17), as well as the geometric sizes of the sealing collar (21 ) are adjusted such that when the second end of the housing (9) with the assembly for receiving the material sample connected (5) to it is inserted into the receiving tip (17), the radial surface of the sealing collar (21 ) is in close constant contact with the inner surface of the receiving tip (17), and a friction force, that fixes the test device (1 ) into the container (2), occurs.

It is apparent and clear to one skilled in the art that the test device (1 ) and the container (2) can be used as similar products, i.e., when using the claimed disclosure, the portion of the test device (1 ) is located inside the container (2) and is held by the container (2) in a vertical position, with no fixation of the test device (1 ) inside the container (2), and the buffer fluid itself passes through the assembly for receiving the material sample (5) and enters the housing (3) reaching the end of the test strip holder (7).

The following are possible examples of the usage of the claimed disclosure.

Example 1 .

In this example, the kit according to the claimed disclosure is used as follows. Remove the test device (1 ) and the container (2), which may be located in one primary package or in two primary packages, from the primary package. Remove the protective cap (15) mounted on the second end of the housing (9) from the test device (1 ) so that its inner surface is in contact with the sealing ring (14). Apply the volume of the sample, such as blood, that has been already collected and prepared for the analysis, on the element for receiving the material sample (11 ).

After receiving the material sample on the element for receiving the material sample (11), insert the test device (1 ) into the receiving tip (17) of the container (2) so that the second end of the rod (13) reaches the impermeable membrane (18), pierces the impermeable membrane (18) and leans against the bottom of the vessel containing the buffer fluid (16). The element for receiving the material sample (1 1 ) is located in the buffer fluid. Due to either the sealing ring (14) or the sealing collar (21 ), the buffer fluid does not spill out of the container (2). The buffer fluid passes through the element for receiving the material sample (11 ) and the rod (10) into the orifice in the second end of the housing (9), and then passes into the housing (3), where it enters the end of the test strip holder (7), which has two test strips (6). The first of the test strips (6) is designed to analyze the material sample for the presence of the analyte, such as antibodies to coronavirus, and the second of the test strips (6) is designed to analyze the material sample for the presence of the analyte, such as antibodies to influenza virus. In this case, antibodies to coronavirus and antibodies to influenza virus are disease markers. After a few minutes, look at the test strips (6) through the transparent housing (3) and observe the display of the results of the analysis of the material sample as colored lines on the test strips (6). By the location of the colored lines on the test strips, detect the presence or absence of antibodies to the coronavirus and influenza virus in the material sample, and make conclusion on the presence or absence of the disease.

Example 2.

In example 2, the kit according to the claimed disclosure is used similarly to the application of the kit according to the disclosure claimed in Example 1. The difference between Example 2 and Example 1 is as follows:

- the test strip holder (7) comprises two test strips (6), first of the test strips (6) is designed to test the material sample for the presence of the analyte, such as coronavirus antigen, and the second of the test strips (6) is designed to test the material sample for the presence of the analyte, such as influenza virus antigen, wherein, in this case, coronavirus antigen and influenza virus antigen are disease markers;

- reception of the material sample by the element for receiving the material sample (11 ) is performed by direct collection of the material, such as a swab from the nasal cavity, which is accomplished by inserting the element for receiving the material sample (11 ) into the nasal cavity and sliding the surface of the element for receiving the material sample (11 ) along the nasal mucosa, for example, by rotating the test device (1 ) several times;

- the user detects the presence or absence of coronavirus antigen and influenza virus antigen in the sample according to the location of the colored lines on the test strips (6) and makes a conclusion on the presence or absence of the disease.

It will be apparent to one skilled in the art that the claimed disclosure may be used similarly to the examples described above to analyze any other possible material samples for the presence of any other analytes.

The disclosure enables achieving the following technical result:

- due to utilization of the test strip holder in the disclosure design and the presence of several test strips, it is possible to rapidly and easily detect the presence of several analytes in the material sample;

- due to the fact that when transporting the test device and the container are located separately and not interconnected, the possibilities of the accidental piercing of the impermeable membrane in the container, further spillage of the buffer fluid from the container and unsuitability of the device for further utilization are eliminated.

The described examples of the embodiments only illustrate the disclosure, but do not limit it.