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  • 专利说明
  • 权利要求
  • 类似技术
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  • 引用文献
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  • 优先权
    • 专利摘要:
    The invention relates to a method of identification with respect to the norm of certain indices the urine by the moistening of a urine strip. This problem was solved by the invention of a method of impregnating indicator reagents into urine strips by wetting with the use of diapers for the selection of biological samples and urine dipstick placement devices. The study of the validity of the results obtained under the conditions of a clinical laboratory showed a validity of 100% relative to the glucose, ketone and Ph indices. The proposed invention can also be used to find the leucocyte Eritrocytes and albumin in the urine. The invention can be used both in medical institutions and by non-professionals in domestic conditions.
    公开号:CH713752A2
    申请号:CH00685/17
    申请日:2017-05-24
    公开日:2018-11-30
    发明作者:Porvan Pavlo
    申请人:Palma Group S A；
    IPC主号:
    专利说明:

    Description
    Technical Field [0001] The invention relates to the qualitative visual identification in vitro in human urine of compounds absent in normal urine (glucose, ketones, albumin, leukocytes, eritrocytes), as well as to the identification deviations from the norm of certain urine indices such as, for example, Ph.
    The invention can be used for carrying out research in the field of medicine, as well as for diagnosing the state of health of human beings on the basis of an analysis of deviations from the standard of the indices of l 'urine.
    The invention can be used both in medical establishments and by non-professionals in domestic conditions.
    Description of the invention
    State of the art Despite the existence of a large amount of means and methods of urine analysis, until now remains unclaimed the search for a simple and affordable method that can be used as well in medical establishments only by non-professionals in domestic conditions.
    This is especially necessary for children aged 0-18 months who are still carrying diapers and cannot pass urine by traditional means, as well as other humans of any age with limited physical ability.
    The diagnostic screening (qualitative) of deviations from the norm used in the analyzes of urine of children during their first year of life makes it possible to identify disturbances in the state of health, to timely start prophylaxis and treatment of disturbances in metabolism, obesity, diabetes mellitus, rotavirus infection, genetic diseases, disturbances in the functions of the thyroid gland. The governments of many countries are concerned about the constantly rising level of childhood illnesses and morbidity. A child's first year of life is a milestone in their health. In Canada, for example, a government program for screening urine and blood of newborn babies exists and operates successfully. Any pathology identified at its initial stage is much more capable of being treated for a neglected disease. This rule applies to both adults and children, as diseases often develop faster in children than in adults.
    Existing methods of urinalysis are performed with the use of urine test strips. Urine indicator strips are intended for in vitro research of the properties of urine and for the measurement of urine indices under domestic conditions, with the aim of identifying deviations from the norm. The existing urinary indicator strips are plastic strips on which reagents are worn. They are packaged in tubes with 50-100 strips in each of them. Each of these contains a moisture absorber. The evaluation of the results of urinalysis is based on the change in the color of the indicator reagent due to the action of the urine compounds. Each of these compounds has its individual indicator reagent. The analysis method is based on the action principle of an IMMERSION / ABSORPTION system. According to the latter, to receive the result of an analysis and compare this result with a color scale, you must immerse the strip in the container containing the urine, remove it from there quickly and wait for the result.
    The principle of analyzing the urine of a child wearing a diaper, according to the IMMERSION / ABSORPTION system, is illustrated in fig. 1.
    The present invention makes it possible to carry out the qualitative analysis of urine and to identify any deviations from the standard of some of its compounds through the use of the principle of action of a F HUMECTATION system / ACCUMULATION.
    In the invention, to carry out the analysis, a layer useful for the selection of biological samples having a urine accumulator and a device for placing urine strips is used. The layer for the selection of biological samples is described in detail in the patent application No. 00429/17 Date of filing 30.03.2017. This layer collects 2-3 ml of urine in a special accumulator (ACCUMULATION), this being sufficient to carry out a qualitative analysis by moistening (HUMECTATION).
    In FIG. 2 is shown the general view of the layer for the selection of biological samples.
    The device for placing the indicator urine strips is in an individual hermetic package. This device is made of laminated paper with relief extrusions on the edges preventing overflow of urine. This device has the following several zones: 1. Indicator reagent disposal zone (test zone) 2. Colorimetric scale zone 3. Urine accumulator disposal zone 4. moisture absorber 5. Extrusion zone in relief [0008] In FIG. 3 shows the composition of the device for placing the urinary indicator strips.
    To perform an analysis in accordance with the method according to the HUMECTATION / ACCUMULATION system, it is necessary to remove the accumulation element from the diagnostic layer. Then place the accumulator on the test area of the dipstick placement device. Then wait 30-60 seconds after which remove the accumulator. The time indicated is necessary to obtain valid results. Next, pay attention to the color of the indicator reagents and compare these colors with the color scale. In case of deviation from the "Standard" part of this scale, it is recommended to repeat the analysis again two hours after and at least one hour before or after a meal.
    In FIG. 4 shows the diagram for carrying out a urinalysis according to the method according to the HUMECTATION / ACCUMULATION system.
    Disadvantages Existing methods of urinalysis require that the urine is in a container into which an indicator strip can be inserted. It is difficult to collect urine in children carrying diapers or bedridden adults with limited physical possibilities, this is often painful and, consequently, regular daily screening cannot be performed.
    This is why these groups of the population are deprived of the possibility of identifying possible initial disturbances in their state of health and of receiving medical aid.
    The indicator strips are packed in tubes at a rate of 50-100 units, this being convenient only for medical establishments or laboratories or for the chronically ill and not convenient for screening under the domestic conditions of other groups. Population.
    In these latter conditions, the existing means and methods of analysis require great time wasters to obtain a result because it is then necessary to bring the samples to a hospital and wait a certain time for the results of the analysis.
    Technical problem The present invention arose before it the aim of developing a screening method for urine compounds for children aged up to 18 months and for adults with limited physical possibilities . This method had to be painless, effective and give the possibility of receiving a result immediately.
    Solution The problem was solved by invention of a method of impregnating indicator reagents by wetting, using a layer for selecting biological samples and a device for placing urine indicator strips.
    The invention was carried out in such a way that the amount of urine accumulating in the urine accumulator of the diaper was sufficient for the indicator reagents to be able to react with the urine. For example, if ketones have been identified in the urine, acetylacetic acid reacts with sodium nitroprusside in the corresponding reagent.
    A special area for placing the urine accumulator is provided on the indicator reagent placement device.
    The invention has been made in such a way that, to carry out the analysis, the same standard indicator reagents are used as for the urinary strips existing on the market and, to put the strips in place, an area has been provided. test.
    The invention was carried out in such a way that, to visually evaluate the result of an analysis, a standard colorimetric scale was used.
    To prevent overflow of urine, on the device (board) for placing the strips are provided extrusions in relief (congresses).
    To make the work of users more convenient, the device for placing the urine strips was packed in an airtight individual package. The moisture absorber is attached to the device, which avoids its direct influence on the reagents.
    The urine strip placement device is provided for at least 3 indicators (glucose, ketones, Ph).
    The results of the screening received by us by the wetting method have shown that this method allows, in a certain way, to determine the appearance in the urine of glucose, ketones, leukocytes, eritrocytes and albumin. This method also gives the possibility of identifying the deviation from the standard of Ph.
    Advantages The essence of the invention consists in that the proposed method makes it possible, thanks to the screening of urine, the identification, at their initial stages, of disturbances in the state of health and the call timely to specialists for consultation and treatment.
    To collect urine is used a special painless layer providing no discomfort or discomfort to users. To perform the analysis, 2-3 ml of urine is sufficient. The result of the analysis can be obtained after one minute.
    The method is easy to use and does not require special knowledge and experience. This is why it can be used in domestic conditions and at any time by parents of children up to 18 months old and by people caring for children and adults with possibilities. limited physical condition suffering from chronic diseases.
    The color scales used are identical to those which exist on the market, which does not require special training of health personnel.
    The drawings [0029] fig. 1 the image which shows the existing traditional method of collecting urine and its analysis in a child aged up to 18 months fig. 2 the image which shows the layer for the selection of biological samples with the urine accumulator, an element which provides a selection of biological sample fig. 3 the image which shows the device for placing the urinary indicator strips and its zones:
    Indicator reagent disposal area (test area)
    Color scale area
    Urine accumulator disposal area Moisture absorber disposal area Relief extrusion area fig. 4 the image which shows the diagram for carrying out a urinalysis according to the HUMECTATION / AC- CUMULATION method.
    To perform an analysis in accordance with the HUMECTATION / ACCUMULATION method, it is necessary to remove 2-3 the accumulation element 4 from the diagnostic layer 1. Next, place the urine accumulator 4 on the area test of the strip placement device 5. Then wait 30-60 seconds after which remove the accumulation element. Next, pay attention to the color of the indicator reagents and compare these colors with the color scale 6. fig. 5 in the image is shown in fig. proposed to illustrate the abstract on the title page of the application and of the patent specification Realizations of the invention The study of the invention was carried out under the conditions of a clinical laboratory. The purpose of this study was to determine the validity of the urine test results obtained by the reagent wetting method and to compare these results with those obtained using the traditional means of of test strips in a container containing urine. The study method provided for the analysis of urine from the same person by both means of moistening and immersion.
    To carry out the study were used 50 layers with integrated urine accumulator and 50 devices with integrated urine strips manufactured by the company DiaSys Group for Palma Group SA In these devices were integrated test strips with indicator reagents for glucose, ketones and Ph. To carry out the analysis by traditional means, similar urinary strips were used, produced by the company DiaSys Group for Palma Group SA
    The operating principle and the studies concerning the layer for the selection of biological samples are described in detail in the documents accompanying patent application N ° 00429/17.
    The study was carried out as follows. Under the conditions of a clinical laboratory, the urine coming from the same person was divided into two equal parts studied then simultaneously relative to three compounds: glucose, ketones and Ph. The comparative analysis showed the validity of 100% of the results obtained by both methods of wetting and immersing the test strips in a container containing urine, which confirms the validity of the proposed method.
    In the case of moistening, the indicator reagents changed their color after the scheduled time, equal to one minute.
    Under the conditions of the same laboratory, the study of the validity of the data relating to the identification of leukocytes and of the protein was carried out by the moistening method.
    For this study were used urine accumulator layers and urine strips from the company AIITest Biotech.
    This study was carried out as follows. Under the conditions of a clinical laboratory, urine from the same person was analyzed by moistening and immersion methods. The validity of the results was confirmed by the microscopic study of the deposit.
    The data obtained confirmed the validity of the results obtained by the moistening method in 80% of cases in comparison with the results obtained by the traditional method and by the microscopization of the deposit. The determination of the causes of error of the results showed that they were related to the structure of the tissue of the accumulator element of the layer which retained the indissoluble elements in the urine, which demonstrates the effectiveness of the screening analysis of urine by the moistening method for the identification of leukocytes and protein in the urine. The error in the results obtained will be eliminated by changing the compactness of the fibers in the urine accumulator.
    权利要求:
    Claims (7)
    [1]
    Claims 1. The identification of deviations from the norm of the indices of human urine by the method of impregnation of urine indicator strips by moistening is carried out with the use of a urine accumulator integrated in a sample selection layer. biological and a device / placement of reagents indicators of urinary strips.
    [2]
    2. The method differs in that we use the HUMECTATION / ACCUMULATION principle
    [3]
    3. The method differs in that to obtain valid results, 2-3 ml of urine collected in a urine accumulator or brought to the test area by drip is sufficient.
    [4]
    4. The method differs in that it can be used at any time of the day or night with the result after one minute.
    [5]
    5. The method differs from the fact that a device is provided to ensure the validity of the result by virtue of the presence of various zones (test zone, accumulator placement zone) to place the urine strips with the indicator reagents. , relief extrusion area, moisture absorber area, color scale area) and the presence of relief extrusions preventing overflow of urine.
    [6]
    6. The method differs in that wetness can occur within a minute without affecting the chemical properties of the reagents and without giving incorrect results.
    [7]
    7. The method differs in that the moisture absorber is attached to the tape placement device.
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    同族专利:
    公开号 | 公开日
    US20200200739A1|2020-06-25|
    WO2018215822A1|2018-11-29|
    CH713752B1|2019-06-14|
    EP3629939B1|2020-09-23|
    SI3629939T1|2021-01-29|
    EP3629939A1|2020-04-08|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
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    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    CH00685/17A|CH713752B1|2017-05-24|2017-05-24|Method for identifying deviations from the norm of urine indices.|CH00685/17A| CH713752B1|2017-05-24|2017-05-24|Method for identifying deviations from the norm of urine indices.|
    US16/614,775| US20200200739A1|2017-05-24|2017-11-01|Urine sampling kit and method|
    EP17822010.9A| EP3629939B1|2017-05-24|2017-11-01|Kit and method for the collection of urine|
    PCT/IB2017/056789| WO2018215822A1|2017-05-24|2017-11-01|Urine samlping kit and method|
    SI201730482T| SI3629939T1|2017-05-24|2017-11-01|Kit and method for the collection of urine|
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