Biological sample stable preservation system

Abstract

The utility model provides a biological sample stable preservation system which comprises a sample box body, a water-absorbing breathable carrier used for bearing samples is arranged in the sample box body, the inner space of the sample box body is divided into a sample area and a drying area by the water-absorbing breathable carrier, a drying agent filling layer is arranged in the drying area, and the drying agent filling layer is arranged in the sample box body. The drying agent filling layer and the water-absorbing breathable carrier are arranged in a non-contact mode, and the sample box body is provided with a sealing structure. According to the stable storage system for the biological sample, the biological sample can be quickly dehydrated by adopting the water-absorbing breathable carrier, and then is thoroughly dehydrated by adopting the drying agent filling layer through non-contact water absorption, so that the long-term stability of the biological sample is realized; the biological components in the sample preserved by adopting the preservation system disclosed by the utility model cannot be denatured and inactivated because the biological components are in a completely dehydrated state, the stable preservation of subsequent detection is not influenced, and the preservation system has a wide application prospect in the field of medical detection.

Description

TECHNICAL FIELD

[0001] The utility model relates to the field of biology and disease diagnosis technology, especially to a biological sample stable storage system. BACKGROUND

[0002] Human excreta contains a large amount of biological information, including organ pathological bleeding, abnormal proliferation of microorganisms, abnormal increase or decrease of metabolites, etc. These information is closely related to human health. Detecting and monitoring these biomarkers can help understand the personal health status and disease development in time. Currently, the routine and urine routine of hospitals and physical examination centers should be cheap and efficient, and are welcomed by a large number of doctors and patients. However, the patient needs to go to the hospital or physical examination center for sampling due to the need for such detection.

[0003] With the rapid development of express industry, home sampling and sample testing center detection become possible. Currently, the DNA stabilizer for human feces and urine has achieved a technical breakthrough, and a large number of home sampling detection products for intestinal cancer have been put on the market. Compared with DNA stabilizer, the stabilizer for protein is much more difficult. Taking the feces sample as an example, in order to inhibit the activity of DNA enzyme and the proliferation of bacteria, a strong denaturant can solve all the problems, and the denaturant itself will not affect the biological activity of DNA and can be used as a DNA stabilizer. However, the denaturant is fatal to the biological activity of protein, and in addition, the stability of protein itself is far less than that of DNA, so how to ensure the stability of protein components in feces and urine while inhibiting the growth of bacteria and the activity of various proteases is still a technical problem.

[0004] There are many products on the market for human feces sample stabilizer, such as the product "Cologuard" of Precision Science, which contains DNA stabilizer and separate protein stabilizer. The protein stabilizer can ensure the stability of hemoglobin in feces sample at room temperature for 3 days, but it cannot be guaranteed for more than 3 days, so the sample must be mailed to the laboratory within 3 days; OC-sensor of Japan Riken contains a feces sample sampling bottle, and the stabilizer in it can ensure the stability of hemoglobin in feces sample at room temperature for about 2 weeks, but the stability is poor at 37 degrees, and the degradation is serious with time. The above methods are more suitable for community sampling and centralized detection. If the sample is mailed for a long time and the temperature condition is not fixed, these products have hidden dangers. In addition, the temperature difference is large in different regions and different seasons, especially in summer, which is a great test for these products. Therefore, developing a stabilizer with high temperature resistance and good stability is the key to realizing the home sampling service mode.

[0005] A method for processing a fecal sample and its application is disclosed in Chinese patent document CN104931314A, which discloses a simple and effective method for stabilizing a fecal sample. The method is low in cost, convenient to use, and can meet the demand of qualitative detection of hemoglobin. It has been widely used in the market of intestinal cancer screening. However, the method can only meet the demand of qualitative detection, and quantitative FIT requires more stable samples and more reliable data. Therefore, the method needs to be greatly optimized and improved. According to the method recorded in the patent, the stability of the dried fecal sample is good, but the stability is poor during the time period before drying, and the protein is severely degraded. As for how to quickly obtain a dried fecal sample, the patent fails to find a solution. On the other hand, the degree of drying of the sample directly affects its stability. However, the method recorded in the patent can only ensure that the water content of the sample is less than 10%, and the drying is not completely thorough, which is one of the reasons why the stability of the method is not satisfactory. Therefore, how to quickly and completely dry the sample is a problem that needs to be solved at present. In addition, the patent forms a mixture of feces and desiccant by adding a desiccant into a container, which has the technical problem of limited application range and is not suitable for the stable processing of liquid samples. Human body fluids, especially urine, are biological samples with a large amount of information and have important clinical detection significance, but there is still a lack of an effective preservation method. Practical new type content

[0006] In view of the above-mentioned shortcomings of the prior art, the purpose of the present application is to provide a biological sample stable storage system, which solves the problems of poor stability of the existing biological sample storage system under the storage condition of more than 37℃, different regions, different delivery times, different seasons and different transportation conditions, and is not suitable for the storage of liquid samples.

[0007] To achieve the above-mentioned purposes and other related purposes, the present application is realized by the technical scheme comprising the following.

[0008] The present application provides a biological sample stable storage system, which comprises a sample box body, a water-absorbing and air-permeable carrier for carrying a sample is arranged in the sample box body, the water-absorbing and air-permeable carrier divides the internal space of the sample box body into a sample area and a drying area, a desiccant filling layer is arranged in the drying area, the desiccant filling layer is arranged in non-contact with the water-absorbing and air-permeable carrier, and the sample box body has a sealing structure.

[0009] The sample preservation device of the prior art can only preserve solid samples such as solid fecal samples, and the human body fluid and excrement preservation system of the application expands the application range through a separate drying mode, which can preserve both solid samples and liquid samples such as human urine samples. The biological sample stable preservation system of the application can first use a water-absorbing and air-permeable carrier to rapidly dehydrate the biological sample, and then use a desiccant filling layer to completely dehydrate the biological sample in a non-contact water-absorbing mode, thereby realizing long-term stability of the biological sample. The biological components in the sample preserved by the preservation system of the application are in a completely dehydrated state and will not be denatured and inactivated, and will not affect subsequent detection and stable preservation, and the application has a wide application prospect in the medical detection field. The water-absorbing and air-permeable carrier is made of a material with good water-absorbing and air-permeable properties.

[0010] Preferably, a first air-permeable filter screen is arranged below the water-absorbing and air-permeable carrier and fixed to the inner wall of the sample box body. The first air-permeable filter screen can ensure that the first desiccant and the sample are not in contact, but the gas exchange is good.

[0011] Preferably, the inner wall of the sample box body further comprises a carrier support screen arranged above the first air-permeable filter screen, and the water-absorbing and air-permeable carrier is fixed to the center of the carrier support screen, so that the air in the sample box body has good flowability and improves the drying efficiency.

[0012] Preferably, the water-absorbing and air-permeable carrier is arranged in non-contact with the inner wall of the sample box body.

[0013] Preferably, the sample box body is provided with a sealing cover, and the sealing cover and the sample box body are sealingly fixed to form a sealed structure.

[0014] Preferably, the bottom of the sealing cover is provided with a plurality of auxiliary drying tubes with a hollow hole structure, and the auxiliary drying tubes are filled with a drying core material, which can further improve the drying effect of the biological sample, so that the biological components in the sample are in a completely dehydrated state.

[0015] Preferably, the drying core material is arranged in non-contact with the water-absorbing and air-permeable carrier.

[0016] Preferably, at least one of the desiccant filling layer and the drying core material adopts a desiccant that reacts irreversibly with water molecules.

[0017] Preferably, the material of the desiccant filling layer and the drying core material is selected from one or both of a chemical desiccant and a physical desiccant, and at least includes a chemical desiccant.

[0018] More preferably, the chemical desiccant is calcium oxide.

[0019] More preferably, the physical desiccant is active alumina or anhydrous calcium chloride.

[0020] Preferably, a second air-permeable filter screen is arranged between the auxiliary drying tube and the air-permeable water-absorbing carrier, which can ensure that the second drying agent and the sample are not in contact but have good gas exchange.

[0021] Preferably, the air-permeable water-absorbing carrier is an industrial wool felt, which can be used to quickly dehydrate the biological sample before complete dehydration by the drying agent filling layer. The industrial wool felt has the best effect of stable preservation and elution of the biological sample.

[0022] As described above, the biological sample stable preservation system has the following beneficial effects: the biological sample can be first quickly dehydrated by the air-permeable water-absorbing carrier and then completely dehydrated by the non-contact water-absorbing drying agent filling layer, thereby realizing long-term stability of the biological sample. The biological components in the sample preserved by the preservation system are in a completely dehydrated state and will not be denatured and inactivated, which does not affect subsequent detection and stable preservation. The system has a wide application prospect in the field of medical detection. BRIEF DESCRIPTION OF DRAWINGS

[0023] Fig. 1 FIG. 1 shows a structure schematic diagram of a biological sample stable preservation system according to an embodiment of the present application.

[0024] Fig. 2 FIG. 2 shows a structure schematic diagram of a biological sample stable preservation system according to another embodiment of the present application.

[0025] The reference signs are as follows: sample box body 1, sample area 11, drying area 12, drying agent filling layer 121, sealing cover 13, auxiliary drying tube 14, drying core material 141, air-permeable water-absorbing carrier 2, first air-permeable filter screen 3, carrier support net 4. DETAILED DESCRIPTION

[0026] The following specific embodiments illustrate the implementation of the present application, and those skilled in the art can easily understand other advantages and effects of the present application from the disclosed content.

[0027] Please refer to Figs. 1-2It should be understood that the structures, proportions, sizes, etc., illustrated in the accompanying drawings are merely for illustrative purposes to aid those skilled in the art and are not intended to limit the scope of this invention. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in proportions, or adjustments to size, without affecting the effectiveness and purpose of this invention, should still fall within the scope of the disclosed technical content. Furthermore, the terms "upper," "lower," "left," "right," "middle," and "one" used in this specification are merely for clarity and not intended to limit the scope of this invention. Changes or adjustments to their relative relationships, without substantially altering the technical content, should also be considered within the scope of this invention.

[0028] Example 1

[0029] like Fig. 1 As shown, this embodiment of the present invention provides a biological sample stable preservation system, including a sample box body 1. The sample box body contains a water-absorbing and air-permeable carrier 2 for carrying the sample. A first air-permeable filter 3 is located below the water-absorbing and air-permeable carrier and is fixed to the inner wall of the sample box body. The inner wall of the sample box body also includes a carrier support net 4 disposed above the first air-permeable filter, with the water-absorbing and air-permeable carrier fixed at the center of the carrier support net. The water-absorbing and air-permeable carrier divides the internal space of the sample box body into a sample area 11 and a drying area 12. A desiccant filling layer 121 is provided in the drying area. The desiccant filling layer is non-contact with the water-absorbing and air-permeable carrier, and the water-absorbing and air-permeable carrier is non-contact with the inner wall of the sample box body. The sample box body has a sealing cap 13, which forms a sealed structure after being sealed and fixed to the sample box body. The desiccant filling layer uses calcium oxide, which undergoes an irreversible reaction with water molecules, and the water-absorbing and air-permeable carrier is industrial wool felt.

[0030] Taking simulated human urine samples as an example, the working principle of the biological sample stable preservation system in this embodiment is as follows:

[0031] First, the absorbent and breathable carrier is filled with a desiccant layer for gas exchange for 24 hours, so that the residual moisture in the absorbent and breathable carrier can react chemically with the desiccant layer and be completely dehydrated.

[0032] Human urine samples were added to a hemoglobin solution with a concentration of 10 ug / mL and shaken to mix to obtain simulated human urine samples. The simulated human urine samples were then dropped into the middle of a water-absorbing and breathable carrier, and the sealing cap was tightened. The human urine samples were first rapidly dehydrated using the water-absorbing and breathable carrier, and then dried non-contactly using a desiccant filling layer. The samples were then stored statically at room temperature.

[0033] By testing the hemoglobin content in simulated human urine samples stored at 25℃, 37℃, and 65℃ for 13 days, it was found that the samples exhibited good stability during the room-temperature drying period. Excluding errors inherent in immunofluorescence, the hemoglobin in the urine samples stored at 25℃ and 37℃ remained stable over 13 days. At a storage temperature of 65℃, approximately 70% of the hemoglobin remained after the first day of degradation, but it remained stable thereafter. This indicates that even under relatively extreme conditions, trace amounts of residual moisture still affect sample stability; however, complete dehydration afterwards achieves a stable result.

[0034] Example 2

[0035] like Fig. 2 As shown, this embodiment of the present invention provides a biological sample stable preservation system, including a sample box body 1. The sample box body contains a water-absorbing and air-permeable carrier 2 for carrying the sample. A first air-permeable filter 3 is located below the water-absorbing and air-permeable carrier and is fixed to the inner wall of the sample box body. The inner wall of the sample box body also includes a carrier support net 4 disposed above the first air-permeable filter, with the water-absorbing and air-permeable carrier fixed at the center of the carrier support net. The water-absorbing and air-permeable carrier divides the internal space of the sample box body into a sample area 11 and a drying area 12. A desiccant filling layer 121 is provided in the drying area, and the desiccant filling layer is non-contact with the water-absorbing and air-permeable carrier, which is also non-contact with the inner wall of the sample box body. The sample box body is provided with a sealing cap 13, which forms a sealed structure after being sealed and fixed to the sample box body. The bottom of the sealing cap is provided with several auxiliary drying tubes 14 with hollow perforated structures, each filled with a drying core material 141, which is non-contact with the water-absorbing and air-permeable carrier. Both the desiccant filling layer and the desiccant core material are made of calcium oxide, a desiccant that undergoes an irreversible reaction with water molecules, and the water-absorbing and breathable carrier is industrial wool felt.

[0036] Taking simulated human fecal samples as an example, the working principle of the biological sample stable preservation system in this embodiment is as follows:

[0037] First, the absorbent and breathable carrier is subjected to gas exchange for 24 hours using a desiccant filling layer and a drying core material. The residual moisture in the absorbent and breathable carrier undergoes a chemical reaction with the desiccant filling layer and the drying core material to be completely dehydrated.

[0038] A small amount of human fecal sample was added to a hemoglobin solution with a concentration of 10 ug / mL and shaken to mix well to obtain a simulated human fecal sample. The simulated human fecal sample was then dropped into the middle of a water-absorbing and air-permeable carrier, and the sealed cap was tightened. The water-absorbing and air-permeable carrier was first used to rapidly dehydrate the human urine sample, and then a desiccant filling layer and a drying core material were used to non-contactly dry the simulated human fecal sample. The sample was then stored statically at room temperature.

[0039] Excluding the error of immunofluorescence itself, T0 is about 100% of T, which indicates that the sample is stable during the room temperature drying; excluding the error of immunofluorescence itself, the hemoglobin concentration of the samples at 25℃ and 37℃ is close to 100% of T compared with the control day T within 13 days, which indicates that the hemoglobin in the fecal sample is stable according to the method of the application. At 65℃, about 70% of hemoglobin remains after degradation on the first day, but it can remain stable subsequently. It indicates that under relatively extreme conditions, trace amounts of residual moisture still have an impact on sample stability; but after complete dehydration subsequently, the stable effect can be achieved.

[0040] By testing the hemoglobin content in the simulated human fecal sample at 25℃, 37℃ and 65℃ respectively after 13 days, it is found that the sample is stable during the room temperature drying; excluding the error of immunofluorescence itself, the hemoglobin concentration of the samples at 25℃ and 37℃ is close to 100% of T compared with the control day T within 13 days, which indicates that the hemoglobin in the fecal sample is stable according to the method of the application. At 65℃, about 70% of hemoglobin remains after degradation on the first day, but it can remain stable subsequently. It indicates that under relatively extreme conditions, trace amounts of residual moisture still have an impact on sample stability; but after complete dehydration subsequently, the stable effect can be achieved.

[0041] In summary, the biological sample can be quickly dehydrated by the water-absorbing and air-permeable carrier, and then completely dehydrated by the desiccant filling layer, so that the long-term stability of the biological sample is realized. The biological components in the sample saved by the preservation system are in a completely dehydrated state, and will not be denatured and inactivated, so as to not affect the subsequent detection and stable preservation, and have a wide application prospect in the medical detection field. Therefore, the utility model effectively overcomes the shortcomings in the prior art and has high industrial utilization value.

[0042] The above embodiments only exemplarily illustrate the principles and effects of the utility model, and are not used to limit the utility model. Any person skilled in the art can modify or change the above embodiments without departing from the spirit and category of the utility model. Therefore, all equivalent modifications or changes completed by those skilled in the art without departing from the spirit and technical thought disclosed by the utility model should be covered by the claims of the utility model.

Claims

1. A biological sample stable preservation system, characterized in that, The sample box includes a sample box body (1), which contains a water-absorbing and breathable carrier (2) for carrying the sample. The water-absorbing and breathable carrier divides the internal space of the sample box body into a sample area (11) and a drying area (12). The drying area contains a desiccant filling layer (121). The desiccant filling layer is not in contact with the water-absorbing and breathable carrier. The sample box body has a sealed structure. The water-absorbing and breathable carrier is not in contact with the inner wall of the sample box body. The sample box body has a sealing cover (13). The sealing cover is sealed and fixed to the sample box body to form a sealed structure. The bottom of the sealing cover has several auxiliary drying tubes (14) with hollow pore structures. The auxiliary drying tubes are filled with a drying core material (141). At least one of the desiccant filling layer and the drying core material is a desiccant that reacts irreversibly with water molecules.

2. The biological sample stable preservation system according to claim 1, characterized in that: The water-absorbing and air-permeable carrier is provided with a first air-permeable filter (3) below it, and the first air-permeable filter is fixed to the inner wall of the sample box body.

3. The biological sample stable preservation system according to claim 1, characterized in that: The inner wall of the sample box also includes a carrier support net (4) located above the first breathable filter net, and the water-absorbing and breathable carrier is fixed at the center of the carrier support net.

4. The biological sample stable preservation system according to claim 1, characterized in that: The drying core material is disposed in a non-contact manner with the water-absorbing and breathable carrier.

5. The biological sample stable preservation system according to claim 1, characterized in that: A second breathable filter is provided between the auxiliary drying tube and the water-absorbing and breathable carrier.

6. The biological sample stable preservation system according to claim 1, characterized in that: The absorbent and breathable carrier is industrial wool felt.

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