TECHNICAL FIELD The present invention relates to a urine test kit used in the detection of viral diseases, especially SARS-CoV-2 virus and its mutants, where the clinical picture of disease can be determined through the detection of the protein and amino acid structures of the virus and their metabolites in urine and to the method of use thereof.

More specifically, the invention relates to a urine test kit applied to determine protein and amino acid structures of the virus and their metabolites in urine using a reactant, foaming the urine and evaluating the foamed urine through a marker in order to detect viral diseases and to the method of use thereof.

BACKGROUND ART

The increasing global population of living creatures causes epidemic diseases to be more effective and threaten human life. The sudden outbreaks and high transmission rate of epidemics have led to the development of new technologies for early detection of virus causing the epidemic and for taking precautions.

Viruses are infectious agents that contain their genetic structures, protein structures and amino acid structures, which are the sub-sequences of these protein structures and can only be examined under microscope. For example, the virus causing COVID-19 (SARS-CoV-2) is also an RNA virus with its own genetic structure, protein and amino acid structures. SARS- CoV-2 reproduces rapidly once it enters the body. Prior to the onset of clinical symptoms and lung findings, some metabolic and chemical changes start to occur in the body. Some of these changes may be monitored by blood, urine and similar tests. As the virus load in the body increases, viral structures, the metabolites of viral structures and some substances forming due to the problems indirectly caused by the virus start to be excreted in the urine. The excretion rate is directly related to the infection ability of the virus, the count of the virus transmitted to an individual, the immune system strength as well as metabolism and other diseases of such individual.

Several kits are known in existing applications; however, the urine-related tests are: standard complete urinalysis, urine culture, examination of urine with strips and urine electrophoresis. These examinations help to detect substances that are excreted in urine and should not be present in normal conditions. However, if the microorganism load that increases especially in viral, bacterial, fungal or parasitic diseases is detected in urine, not all the available urine tests can detect this load. The underlying reason is that urine test devices cannot identify the structures of microorganisms and their metabolites and are not calibrated for this process.

Since test periods in the current art are long and this period leads to disadvantage in the risk of transmission and tests must always be performed in the hospital, these tests are not practical enough.

In conclusion, due to the drawbacks described above and insufficiency of existing solutions, there is need for development in the technical field.

OBJECT OF THE INVENTION

An object of the invention is to provide a fast and practical urine test kit that can be used for detecting within seconds the virus load of any patient suffering from a contagious disease that requires instant diagnosis since preliminary diagnosis, final diagnosis and clinical follow up are vital, to separate healthy and sick individuals and to regulate and monitor the diagnosis and treatment processes. This test offers an extremely important advantage to the countries that face challenges in this regard, doctors working on this area and people who want to self-test easily without going to any health institution.

This test kit plays a major role in the early detection of the virus in the body and thus, the treatment of the patient and preventing any contact with other living creatures since it is practical and gives fast results.

Another object of the invention is to enable patients with or without symptoms to self-test on the spot without going to any health institution and increasing the risk of transmission, and to acquire information within seconds about the presence of virus and the count of viruses being exposed to.

Another object of the invention is to enable the infected patients to be alerted immediately to take precautions since the viral density is also detected in a short time.

Yet another object of the invention is to make sure that the test kit notifies individuals about viral density rather than simply giving positive or negative results and thus, to enable to refer patients with high viral density, i.e., risk of having a more severe course of disease, to health institutions.

Another object of the invention is to eliminate the test load on the health institutions, to prevent the risk of transmission during this process and to reduce the cost of consumables related to analysis devices and the equipment used.

Another object of the invention is to provide a result that is easily understandable for everyone by means of the level indicators on the test. For example, when coloring scales are used, the test gives an entirely visual result and even an illiterate person can get an idea about the result.

Yet another object of the invention is to prevent the kit used in the invention from requiring any specific space and specific physical conditions. Thus, tests can be performed in any environment.

The structural and characteristic properties and advantages of the invention will be more clearly understood by the accompanying figures and the detailed description made with references to these figures. Thus, the evaluation should be made in consideration of these figures and the detailed description.

BRIEF DESCRIPTION OF FIGURES TO HELP UNDERSTAND THE INVENTION FIGURE 1 is a drawing of urine test according to the invention and its method of use. REFERENCE NUMBERS

10. Urine Test Kit

20.Tube

30. Reactant

40. Marker

50. Urine Container

DETAILED DESCRIPTION OF THE INVENTION

Under normal conditions, urine has a pH of 6 and a density of 1010-1020. It is a light yellow bodily fluid with its unique odor. Normally, urine does not foam or slightly foams, and the resulting foam disappears immediately.

The invention will be explained, by way of example, by evaluating the protein structures of the SARS-CoV-2 virus, especially the Serine and Arginine amino acids. The protein structures of the SARS-CoV-2 virus, especially the structure of the Serine and Arginine amino acids, serve as an identification for the virus. Such that this structure is composed of Lysine and Glutamine amino acids in Influenza virus.

Therefore, each virus has a unique amino acid structure and a protein structure consisting of these amino acids. This plays an important role in distinguishing viruses from each other. SARS-CoV-2 reproduces rapidly once it enters the body. In the meantime, its proteins and amino acid structures, which are the building blocks of these proteins, are excreted from the body either directly or in the form of metabolites via stool, urine and other body fluids. Live and dead viruses can also be excreted in the same manner. Developed countries, therefore, try to detect viruses in samples taken from sewers in the fight against SARS-CoV-2 and take advanced health measures in that particular region, accordingly. In the urine test kit (10) according to the invention application, there is provided a tube (20) containing a reactant (30) specially developed against the protein and amino acid structures of SARS-CoV-2. The tube (20) is selected in terms of shape and size in compliance with the chemical and physical structure of the reactant (30) contained therein.

The amount of reactant (30) in the tube (20) and the amount of urine to be placed into the tube (20) are determined according to the chemical and physical phases of the expected reaction. In line with the data obtained after the studies, a marker (40) showing the viral load in the body was placed on the tube (20). This marker (40) may be in the form of color scale, number, line, etc. In the urine test kit (10) according to the invention, a color scale is used as the marker (40) for sampling. This color scale was placed on the tube (20).

In the invention, it is possible to fill the urine that needs to be placed into the tube (20) manually or to add vacuum feature to the tube (20) for ease of use.

The physical structure, cap and the ergonomics of the tube (20) during the testing phase are determined in the method.

A urine container (50) that can be used both directly and in a vacuum tube (20) is added to the urine test kit (10) so that the urine can be collected easily.

In the method of using the urine test kit (10), the urine sample taken from an individual to be tested is placed into the urine container (50). Urine is filled up to the level line on the tube (20) and the cap of the tube (20) is closed. This step is not needed in a vacuum tube (20). The vacuum automatically draws sufficient urine amount to the level line. The vacuum tube (20) is produced with its cap closed.

The reactant (30) of particulate form in the tube (20) is agitated vigorously for 15 seconds in order to mix it homogeneously in the urine. After fifteen seconds, the tube (20) is placed on a flat surface and approximately ten seconds are allowed to eliminate the foam arising from agitation. After this period, the foam appearing in the tube (20) is the foam occurring due to the chemical reaction caused by the reactant (30). The foam level in the tube (20) is interpreted according to the explanations in the user manual, corresponding to the level on the marker (40), i.e., the color scale, on the tube (20).

The invention, in summary, relates to a urine test kit (10) used in the detection of viral diseases, especially SARS-CoV-2 virus and its mutants, where the clinical picture of disease can be determined through the detection of the protein and amino acid structures of the virus and their metabolites in urine, and to the using method of it. In the urine test kit (10), there are provided the urine container (50) in which the urine sample taken from an individual to be tested is placed and a tube (20) containing the reactant (30) that reacts with the protein and amino acid structures of the virus.

A vacuum tube (20) may be used as a tube (20) in the urine test kit (10) so that it can automatically draw urine into its body. This tube (20) may also be filled manually. There is a marker (40) on the tube (20) in the urine test kit (10) to show the viral load in the body. This marker (40) can be in the form of a color scale for easy interpretation or in the form of a line scale created during the production of the tube (20). Another area on the tube (20) used in the invention is the urine borderline that can be formed at the bottom during the production of the tube (20) and used to determine the level of urine to be filled.

The method of using the urine test kit (10) in Figure 1, comprises of placing the urine sample taken from an individual to be tested into the urine container (50), filling the urine up to the urine borderline on the tube (20), mixing the reactant (30) in the particulate form in the tube (20) homogeneously in the urine, reacting the reactant (30) with the urine as a result of mixing, placing the tube (20) on a flat surface after mixing, waiting for the resulting foam due to the effect of reaction to disappear, the foam forming in the tube (20) after the waiting being the foam of the chemical reaction caused by the reactant (30), determining the level of foam in the tube (20) based on the marker (40) on the tube (20) and interpreting the health condition of the individual based on the foam level. Similarly, in this method, if vacuum tube (20) is used, urine will be automatically filled up to the urine borderline on the tube (20) by means of vacuum. Similarly, in this method, mixing the reactant (SO) of particulate form in the tube (20) homogeneously in the urine is realized with vigorous agitation. The viral density of individual is determined based on the foam density of the chemical reaction caused by the reactant (30) in the tube (20) after agitation and resting.