An artificial urine buffer matrix, its preparation method and application

Abstract

The application discloses an artificial urine buffer matrix and a preparation method and application thereof. The artificial urine buffer matrix comprises urea, uric acid, alpha-hydroxy acid, amino acid, ions and sugar. The artificial urine buffer matrix can eliminate background interference, guarantee the immune reaction detection of small molecules, proteins and other biomarkers in urine, and has small matrix effect.

Description

Technical Field

[0001] This invention belongs to the field of in vitro diagnostic reagent detection technology, and relates to an artificial urine buffer matrix, its preparation method and application. Background Technology

[0002] Artificial urine has various applications in medical research, drug testing, and urine analysis calibration. The main purpose of developing artificial urine is to create a substance with chemical and physical properties similar to real urine, including replicating the main components of urine, such as pH, specific gravity, and the presence of various metabolites and waste products.

[0003] While artificial urine has been used in some research contexts, its application has limitations. Existing artificial urine is typically formulated with a single ingredient and cannot accurately reproduce all the biochemical components found in real urine. Furthermore, due to the complexity of the urinary system and human metabolic processes, developing an artificial urine that can consistently replicate the chemical and physical properties of human urine is a challenging task.

[0004] In a 2010 paper, Hutipongtanate et al. mentioned an artificial urine matrix suitable for in vitro cell research; in a 2019 paper, Sarigul et al. mentioned a new artificial urine formula and compared it with two other artificial urine formulas. Through FTIR component analysis, they showed that this is a formula that is closest in composition to real human urine and can be widely used in various fields.

[0005] Patent CN202310017611 discloses a quality control matrix for urine biochemical analysis, comprising a human urine matrix, a buffer matrix, quality control additives, stabilizers, and lyophilized additives. This matrix requires filtered human urine as part of the matrix, placing high demands on sample biosafety and making it unsuitable for routine laboratory preparation. Patent CN202211622890 discloses a reagent combination that can eliminate non-specific interference in MALB reagent detection. This combination includes components such as phosphate, chloride ions, preservatives, PEG6000, and goat anti-human Malb antiserum. It is primarily used to reduce non-specific interference and improve detection accuracy in the immunoturbidimetric test for MALB. However, this reagent combination is only suitable for the immunoturbidimetric detection of urinary microalbumin and not for the detection of other items in urine, nor for immunochromatography.

[0006] In summary, current quality control matrices for urine biochemical analysis suffer from limitations such as inability to detect specific proteins or multiple biomarkers in urine, and interference from background detection by existing matrix formulations. Therefore, providing an artificial urine buffer matrix that ensures the detection of small molecules, proteins, or other biomarkers in urine via immune reactions remains unaffected has become a pressing issue in the field of in vitro diagnostic reagents. Summary of the Invention

[0007] To address the shortcomings of existing technologies and practical needs, this invention provides an artificial urine buffer matrix, its preparation method, and its application. It solves the problems of existing quality control matrices used for urine biochemical analysis, such as their inability to detect specific proteins or multiple items in urine, and the interference of existing matrix formulations with background detection. This invention can target specific proteins or small molecules in urine, eliminate background interference, ensure that the detection of small molecules, proteins, and other biomarkers in urine is not affected, and has a small matrix effect.

[0008] To achieve this objective, the present invention employs the following technical solution:

[0009] In a first aspect, the present invention provides an artificial urine buffer matrix, the artificial urine buffer matrix comprising: urea, uric acid, α-hydroxy acid, amino acids, ions and sugars.

[0010] The artificial urine buffer matrix of the present invention can target specific proteins or small molecules in urine, eliminate background interference, and ensure that the detection of immune responses to small molecules, proteins, and other biomarkers in urine is not affected, with minimal matrix effect.

[0011] Preferably, the volume percentage of uric acid in the artificial urine buffer matrix is ​​0.1-0.5%.

[0012] The specific point values ​​in the above 0.1-0.5% range can be 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, etc.

[0013] Preferably, the concentration of uric acid in the artificial urine buffer matrix is ​​0.1-0.4 mmol / L.

[0014] The specific point values ​​in the above 0.1-0.4 mmol / L range can be selected as 0.1 mmol / L, 0.12 mmol / L, 0.13 mmol / L, 0.2 mmol / L, 0.3 mmol / L, 0.36 mmol / L, 0.37 mmol / L, 0.4 mmol / L, etc.

[0015] Preferably, the volume percentage of α-hydroxy acids in the artificial urine buffer matrix is ​​0.1-0.5%.

[0016] The specific point values ​​in the above 0.1-0.5% range can be 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, etc.

[0017] Preferably, the α-hydroxy acid includes any one or a combination of at least two of lactic acid, citric acid, or glycolic acid.

[0018] Preferably, the α-hydroxy acid is a combination of lactic acid, citric acid and glycolic acid.

[0019] Preferably, the concentration of citric acid in the artificial urine buffer matrix is ​​50-70 mM.

[0020] The specific point values ​​in the above 50-70mM range can be selected as 50mM, 52mM, 56mM, 60mM, 64mM, 66mM, 68mM, 69mM, 70mM, etc.

[0021] Preferably, the concentration of lactic acid in the artificial urine buffer matrix is ​​10-30 mM.

[0022] The specific point values ​​in the above 10-30mM range can be selected as 10mM, 11mM, 12mM, 15mM, 20mM, 25mM, 26mM, 28mM, 29mM, 30mM, etc.

[0023] Preferably, the concentration of glycolic acid in the artificial urine buffer matrix is ​​1-5 mM.

[0024] The specific point values ​​in the above 1-5mM range can be selected as 1mM, 2mM, 3mM, 4mM, 5mM, etc.

[0025] Preferably, the ions include any one or a combination of at least two of sodium ions, potassium ions, calcium ions, magnesium ions, or ammonium ions.

[0026] Preferably, the amino acid includes glutamine.

[0027] Preferably, the sugars include glucose.

[0028] Preferably, the concentration of urea in the artificial urine buffer matrix is ​​0.1-0.18 mol / L.

[0029] The specific point values ​​in the range of 0.1-0.18 mol / L can be selected from 0.1 mol / L, 0.12 mol / L, 0.13 mol / L, 0.14 mol / L, 0.15 mol / L, 0.16 mol / L, 0.17 mol / L, 0.18 mol / L, etc.

[0030] Preferably, the concentration of sodium ions in the artificial urine buffer matrix is ​​50-170 mmol / L.

[0031] The specific point values ​​in the 50-100 mmol / L range can be selected as 50 mmol / L, 55 mmol / L, 60 mmol / L, 65 mmol / L, 70 mmol / L, 75 mmol / L, 80 mmol / L, 90 mmol / L, 150 mmol / L, 160 mmol / L, 165 mmol / L, 170 mmol / L, etc.

[0032] Preferably, the concentration of potassium ions in the artificial urine buffer matrix is ​​10-30 mmol / L.

[0033] The specific point values ​​in the above 10-30 mmol / L range can be selected as 10 mmol / L, 15 mmol / L, 20 mmol / L, 25 mmol / L, 26 mmol / L, 27 mmol / L, 28 mmol / L, 29 mmol / L, 30 mmol / L, etc.

[0034] Preferably, the concentration of magnesium ions in the artificial urine buffer matrix is ​​2-10 mmol / L.

[0035] The specific point values ​​in the above 2-10 mmol / L range can be selected as 2 mmol / L, 3 mmol / L, 4 mmol / L, 5 mmol / L, 6 mmol / L, 7 mmol / L, 8 mmol / L, 9 mmol / L, 10 mmol / L, etc.

[0036] Preferably, the concentration of calcium ions in the artificial urine buffer matrix is ​​0.5-3 mmol / L.

[0037] The specific values ​​within the 0.5-3 mmol / L range can be selected as 0.5 mmol / L, 0.8 mmol / L, 1 mmol / L, 1.4 mmol / L, 2 mmol / L, 2.4 mmol / L, 2.7 mmol / L, 3 mmol / L, etc.

[0038] Preferably, the concentration of amino acids in the artificial urine buffer matrix is ​​1-2 mmol / L.

[0039] The specific values ​​in the 1-2 mmol / L range can be selected from 1 mmol / L, 1.2 mmol / L, 1.5 mmol / L, 1.6 mmol / L, 1.7 mmol / L, 1.8 mmol / L, 1.9 mmol / L, 2 mmol / L, etc.

[0040] Preferably, the concentration of sugars in the artificial urine buffer matrix is ​​1-5 mmol / L.

[0041] The specific values ​​in the 1-5 mmol / L range can be selected as 1 mmol / L, 1.5 mmol / L, 2 mmol / L, 2.5 mmol / L, 3 mmol / L, 3.5 mmol / L, 4 mmol / L, 4.8 mmol / L, 4.9 mmol / L, 5 mmol / L, etc.

[0042] Preferably, the artificial urine buffer matrix further includes a preservative.

[0043] Preferably, the volume percentage of preservative in the artificial urine buffer matrix is ​​0.04-0.06%.

[0044] The specific point values ​​in the above 0.04-0.06% range can be 0.04%, 0.042%, 0.043%, 0.048%, 0.05%, 0.055%, 0.058%, 0.0559%, 0.06%, etc.

[0045] Preferably, the preservative includes PC-300 and / or sodium azide.

[0046] In a second aspect, the present invention provides a method for preparing the artificial urine buffer matrix described in the first aspect, the method comprising:

[0047] Urea, uric acid, α-hydroxy acid, amino acids, ions and sugars are mixed and homogenized, and the pH is adjusted to 5.5-6.0 to obtain the artificial urine buffer matrix.

[0048] The specific point values ​​in 5.5-6.0 above can be selected as 5.5, 5.6, 5.7, 5.8, 5.9, 6.0, etc.

[0049] Thirdly, the present invention provides a kit containing the artificial urine buffer matrix described in the first aspect.

[0050] Fourthly, the present invention provides the application of the artificial urine buffer matrix described in the first aspect in the detection of urine.

[0051] Preferably, the method for detecting urine includes immunoturbidimetry or immunochromatography.

[0052] Preferably, the components of the urine include both protein and non-protein components.

[0053] Preferably, the protein class includes any one or a combination of at least two of albumin, microalbumin, neutrophil gelatinase-associated lipotransferase, β2-microglobulin, immunoglobulin, and human chorionic gonadotropin.

[0054] Preferably, the non-protein substances include creatinine, HIV, or drugs.

[0055] Compared with the prior art, the present invention has the following beneficial effects:

[0056] (1) The artificial urine buffer matrix of the present invention can be used as a buffer in the detection of specific components in urine, which can greatly reduce the matrix effect and improve the accuracy and reliability of the detection. The artificial urine buffer matrix of the present invention is completely prepared in the laboratory and does not contain human or other biological samples, thus avoiding the risk of pathogen infection.

[0057] (2) The artificial urine buffer solution of the present invention has good stability and is suitable as a buffer solution in the development stage of urine immunoassay reagents and as a product quality control buffer matrix.

[0058] (3) The artificial urine buffer matrix in this invention is most consistent with the real urine sample and can replace the sample as a buffer in the development stage of the detection reagent and as a buffer matrix for quality control. Detailed Implementation

[0059] To further illustrate the technical means and effects of this invention, the following embodiments are provided for further explanation. It should be understood that the specific embodiments described herein are merely illustrative of the invention and not intended to limit it.

[0060] Where specific techniques or conditions are not specified in the examples, they shall be performed in accordance with the techniques or conditions described in the literature in this field, or in accordance with the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels.

[0061] Example 1

[0062] This embodiment provides an artificial urine buffer matrix, specifically:

[0063] 50 mmol / L sodium chloride, 0.15 mol / L urea, 2 mmol / L glutamine, 25 mmol / L ammonium chloride, 1 mmol / L glucose, 2 mmol / L magnesium sulfate, 6 mmol / L sodium nitrate, 10 mmol / L sodium sulfate, 2.5 mmol / L calcium chloride, 10 mmol / L sodium bicarbonate, 0.05% PC-300 (v / v), 50 mM citric acid, 20 mM lactic acid, 2 mM glycolic acid, and 0.2 mM uric acid.

[0064] The preparation method is as follows: Sodium chloride, urea, glutamine, ammonium chloride, glucose, magnesium sulfate, sodium nitrate, sodium sulfate, calcium chloride, sodium bicarbonate, PC-300, citric acid, lactic acid, glycolic acid, and uric acid are mixed and homogenized, and the pH is adjusted to 6.0 to obtain the artificial urine buffer matrix.

[0065] Example 2

[0066] This embodiment provides an artificial urine buffer matrix, specifically:

[0067] 100 mmol / L sodium chloride, 0.1 mol / L urea, 1 mmol / L glutamine, 15 mmol / L ammonium chloride, 2 mmol / L glucose, 10 mmol / L magnesium sulfate, 1 mmol / L sodium nitrate, 5 mmol / L sodium sulfate, 0.5 mmol / L calcium chloride, 30 mmol / L sodium bicarbonate, 0.05% PC-300 (v / v), 70 mM citric acid, 30 mM lactic acid, and 0.4 mM uric acid.

[0068] Example 3

[0069] This embodiment provides an artificial urine buffer matrix, specifically:

[0070] 50 mmol / L sodium chloride, 0.18 mol / L urea, 1.5 mmol / L glutamine, 25 mmol / L ammonium chloride, 5 mmol / L glucose, 5 mmol / L magnesium sulfate, 8 mmol / L sodium nitrate, 15 mmol / L sodium sulfate, 3 mmol / L calcium chloride, 20 mmol / L sodium bicarbonate, 0.05% sodium azide (v / v), 100 mM citric acid, and 0.1 mM uric acid.

[0071] Example 4

[0072] The only difference between this embodiment and Embodiment 1 is that it does not contain citric acid, but its weight proportions are allocated to the weight of lactic acid and glycolic acid.

[0073] Example 5

[0074] The only difference between this embodiment and Embodiment 1 is that it does not contain lactic acid, but its weight proportions are allocated to the weights of citric acid and glycolic acid.

[0075] Example 6

[0076] The only difference between this embodiment and Embodiment 1 is that it does not contain glycolic acid, but its weight proportions are allocated to the weight of citric acid and lactic acid.

[0077] Example 7

[0078] The only difference between this embodiment and Embodiment 1 is that it does not contain citric acid and lactic acid, but their weight proportions are allocated to the weight of glycolic acid.

[0079] Example 8

[0080] The only difference between this embodiment and Embodiment 1 is that it does not contain citric acid and glycolic acid, but their weight proportions are allocated to the weight of lactic acid.

[0081] Example 9

[0082] The only difference between this embodiment and Embodiment 1 is that it does not contain lactic acid and glycolic acid, but their weight proportions are allocated to the weight of citric acid.

[0083] Example 10

[0084] The only difference between this embodiment and Embodiment 1 is that the concentration of uric acid is changed to 0.1 mM.

[0085] Example 11

[0086] The only difference between this embodiment and Embodiment 1 is that the concentration of uric acid is changed to 0.5 mM.

[0087] Example 12

[0088] The only difference between this embodiment and Embodiment 1 is that the concentration of citric acid is changed to 20mM.

[0089] Example 13

[0090] The only difference between this embodiment and Embodiment 1 is that the concentration of citric acid is changed to 100mM.

[0091] Example 14

[0092] The only difference between this embodiment and Embodiment 1 is that the concentration of glycolic acid is changed to 0.1 mM.

[0093] Example 15

[0094] The only difference between this embodiment and Example 1 is that the concentration of glycolic acid is changed to 10mM.

[0095] Example 16

[0096] The only difference between this embodiment and Embodiment 1 is that the concentration of lactic acid is changed to 5mM.

[0097] Example 17

[0098] The only difference between this embodiment and Embodiment 1 is that the concentration of lactic acid is changed to 50mM.

[0099] Test Example 1

[0100] Relative deviation test.

[0101] Urine samples were collected clinically, placed at 2-8℃ after collection, and tested within 2 hours. The test reagents were a urine microalbumin / creatinine test kit (fluorescent immunochromatography) and supporting instruments.

[0102] High-concentration antigen 1 (human serum albumin) and antigen 2 (creatinine) were diluted with artificial urine buffer solutions prepared in Examples 1-17 to prepare a series of antigen test solutions with different concentration gradients. The above antigens were tested with a urine microalbumin / creatinine detection kit (fluorescent immunochromatography). The series of results obtained for each buffer solution were used to calibrate the reagents. Five real urine samples were tested with the calibrated reagents, and the urine samples were also calibrated with commercially available products. The results of the calibrated test reagents were compared with the sample target values. The results are shown in Table 1. The relative deviation was calculated and the results are shown in Table 2.

[0103] Table 1

[0104]

[0105]

[0106] Using the artificial urine buffer solutions prepared in Examples 1-3, the levels of microalbumin and creatinine in the urine samples were found to be close to the target values. Examples 4-6 lacked one of lactic acid, citric acid, or glycolic acid, respectively. The results of Example 4 showed that both microalbumin and creatinine levels were higher than the target values; the results of Example 5 showed that both microalbumin and creatinine levels were lower than the target values; the results of Example 6 indicated that microalbumin levels might be too high and creatinine levels might be too low. Examples 7-9 lacked two of lactic acid, citric acid, and glycolic acid, respectively, and the measured values ​​of microalbumin and creatinine in the urine samples were higher than the target values. Examples 10 and 11 showed that uric acid was outside the concentration range specified in this invention, and the measured values ​​of creatinine were lower than the target values. Examples 12-17 showed that lactic acid, citric acid, and glycolic acid were outside the concentration range specified in this invention, and the measured values ​​of microalbumin or creatinine differed significantly from the target values. This invention demonstrates that the artificial urine buffer matrix can target specific proteins or small molecules in urine, eliminate background interference, and ensure that the detection of immune responses to small molecules, proteins, and other biomarkers in urine is not affected, with minimal matrix effect.

[0107] Table 2

[0108]

[0109]

[0110] Using the artificial urine buffer solutions prepared in Examples 1-3, the deviations in microalbumin and creatinine levels in the urine samples were found to be within ±15%. Examples 4-6 lacked one of lactic acid, citric acid, or glycolic acid, respectively. The results of Example 4 showed that the deviations in microalbumin and creatinine levels in the urine samples could potentially exceed 15%; the results of Example 5 showed that the deviations in microalbumin and creatinine levels could potentially be less than -15%; the results of Example 6 showed that the deviation in microalbumin levels could potentially exceed 15%, and the deviation in creatinine levels could potentially be less than -15%. Examples 7-9 lacked two of lactic acid, citric acid, and glycolic acid, respectively. The results showed that the overall deviations in microalbumin and creatinine levels in the urine samples were higher, with most results exceeding 15%. Examples 10 and 11 involved uric acid outside the concentration range specified in this invention, and the results showed that the deviations in most creatinine levels were greater than -15%. Examples 12-17 show that lactic acid, citric acid, and glycolic acid are not within the concentration range specified in this invention, and the results show that the content deviation of trace albumin or creatinine is relatively large. This indicates that the artificial urine buffer matrix of this invention can target specific proteins or small molecules in urine, eliminate background interference, and ensure that the detection of immune responses to small molecules, proteins, and other biomarkers in urine is not affected, with a small matrix effect.

[0111] Test Example 2

[0112] This test case demonstrates the stability of Examples 1-17.

[0113] After the artificial urine buffer solutions from Examples 1-17 were sealed and stored at 37°C for 2 months, they were taken out and used to dilute high-concentration antigen 1 (human serum albumin) and antigen 2 (creatinine) into a series of antigen test solutions with different concentration gradients. The above antigens were tested using a urine microalbumin / creatinine detection kit (fluorescent immunochromatography). The series of results obtained for each buffer solution were used to calibrate the reagents. Five real urine samples were tested using the calibrated reagents, and the urine samples were also calibrated using commercially available products. The results of the calibrated test reagents were compared with the sample target values, and the results are shown in Table 3. The relative deviation was calculated, and the results are shown in Table 4.

[0114] Table 3

[0115]

[0116]

[0117] Stability tests were conducted using artificial urine buffer solutions prepared in each example and stored at 37°C for two months. For examples 1-3, the artificial urine buffer solutions were used to measure urine samples, and the levels of microalbumin and creatinine were close to the target values. Examples 4-6 lacked one of lactic acid, citric acid, or glycolic acid, respectively. In example 4, the results for microalbumin and creatinine in the urine sample were higher than the target values; in example 5, the results for microalbumin and creatinine were lower than the target values; and in example 6, the results for microalbumin and creatinine may deviate from the target values. Examples 7-9 lacked two of lactic acid, citric acid, and glycolic acid, respectively, and the measured results for microalbumin and creatinine in the urine sample were higher than the target values. In examples 10 and 11, uric acid was outside the concentration range specified in this invention, and the results showed that the measured creatinine values ​​may be lower than the target values. In examples 12-17, lactic acid, citric acid, and glycolic acid were outside the concentration range specified in this invention, and the results showed that the measured microalbumin or creatinine values ​​differed significantly from the target values. This invention demonstrates that the artificial urine buffer matrix can target specific proteins or small molecules in urine, eliminate background interference, and ensure that the detection of immune responses to small molecules, proteins, and other biomarkers in urine is not affected, with minimal matrix effect.

[0118] Table 4

[0119]

[0120]

[0121] Stability tests were conducted using artificial urine buffer solutions prepared in each example and stored at 37°C for two months. Using the artificial urine buffer solutions prepared in Examples 1-3 to measure urine samples revealed that the deviations in microalbumin and creatinine levels were all within ±15%. Examples 4-6 lacked one of lactic acid, citric acid, or glycolic acid, respectively. In Example 4, the deviations in microalbumin and creatinine levels in urine samples could potentially exceed 15%; in Example 5, the deviations could potentially be less than -15%; and in Example 6, the deviations could potentially exceed ±15%. Examples 7-9 lacked two of lactic acid, citric acid, and glycolic acid, respectively. The overall deviations in microalbumin and creatinine levels in urine samples were higher, with most results exceeding 15%. In Examples 10 and 11, uric acid was outside the concentration range specified in this invention, and the results showed that most creatinine levels had deviations greater than -15%. Examples 12-17 show that lactic acid, citric acid, and glycolic acid are not within the concentration range specified in this invention, and the results show that the content deviations of trace albumin or creatinine are relatively large. This indicates that the artificial urine buffer matrix of this invention can target specific proteins or small molecules in urine, eliminate background interference, and ensure that the detection of immunoreactions of small molecules, proteins, and other biomarkers in urine is not affected, with a small matrix effect. In summary, the artificial urine buffer matrix of this invention can target specific proteins or small molecules in urine, eliminate background interference, and ensure that the detection of immunoreactions of small molecules, proteins, and other biomarkers in urine is not affected, with a small matrix effect.

[0122] The applicant declares that the detailed method of the present invention is illustrated by the above embodiments, but the present invention is not limited to the above detailed method, that is, it does not mean that the present invention must rely on the above detailed method to be implemented. Those skilled in the art should understand that any improvements to the present invention, equivalent substitutions of the raw materials of the product of the present invention, addition of auxiliary components, selection of specific methods, etc., all fall within the protection scope and disclosure scope of the present invention.

Claims

1. An artificial urine buffer matrix, characterized in that, The artificial urine buffer matrix includes: urea, uric acid, α-hydroxy acids, amino acids, ions, and sugars; The concentration of uric acid in the artificial urine buffer matrix is ​​0.1-0.4 mmol / L; The α-hydroxy acid is a combination of citric acid, lactic acid and glycolic acid; The concentration of citric acid in the artificial urine buffer matrix is ​​50-70 mM; The concentration of lactic acid in the artificial urine buffer matrix is ​​10-30 mM; The concentration of glycolic acid in the artificial urine buffer matrix is ​​1-5 mM; The ions include any one or a combination of at least two of sodium ions, potassium ions, calcium ions, magnesium ions, or ammonium ions; The amino acid is glutamine; The sugar is glucose.

2. The artificial urine buffer matrix according to claim 1, characterized in that, The volume percentage of uric acid in the artificial urine buffer matrix is ​​0.1-0.5%.

3. The artificial urine buffer matrix according to claim 1, characterized in that, The volume percentage of α-hydroxy acids in the artificial urine buffer matrix is ​​0.1-0.5%.

4. The artificial urine buffer matrix according to claim 1, characterized in that, The concentration of urea in the artificial urine buffer matrix is ​​0.1-0.18 mol / L.

5. The artificial urine buffer matrix according to claim 1, characterized in that, The concentration of sodium ions in the artificial urine buffer matrix is ​​50-170 mmol / L.

6. The artificial urine buffer matrix according to claim 1, characterized in that, The concentration of potassium ions in the artificial urine buffer matrix is ​​10-30 mmol / L.

7. The artificial urine buffer matrix according to claim 1, characterized in that, The concentration of magnesium ions in the artificial urine buffer matrix is ​​2-10 mmol / L.

8. The artificial urine buffer matrix according to claim 1, characterized in that, The concentration of calcium ions in the artificial urine buffer matrix is ​​0.5-3 mmol / L.

9. The artificial urine buffer matrix according to claim 1, characterized in that, The concentration of amino acids in the artificial urine buffer matrix is ​​1-2 mmol / L.

10. The artificial urine buffer matrix according to claim 1, characterized in that, The concentration of carbohydrates in the artificial urine buffer matrix is ​​1-5 mmol / L.

11. The artificial urine buffer matrix according to claim 1, characterized in that, The artificial urine buffer matrix also includes preservatives.

12. The artificial urine buffer matrix according to claim 11, characterized in that, The volume percentage of preservative in the artificial urine buffer matrix is ​​0.04-0.06%.

13. The artificial urine buffer matrix according to claim 11, characterized in that, The preservatives include PC-300 and / or sodium azide.

14. A method for preparing the artificial urine buffer matrix according to any one of claims 1-13, characterized in that, The method includes: Urea, uric acid, α-hydroxy acid, amino acids, ions and sugars are mixed and homogenized, and the pH is adjusted to 5.5-6.0 to obtain the artificial urine buffer matrix.

15. A reagent kit, characterized in that, The kit contains the artificial urine buffer matrix as described in any one of claims 1-13.

16. The use of the artificial urine buffer matrix according to any one of claims 1-13 in the detection of urine.

17. A method for detecting urine containing the artificial urine buffer matrix according to any one of claims 1-13, characterized in that, The method includes immunoturbidimetry or immunochromatography.

18. The detection method according to claim 17, characterized in that, The components of urine include both protein and non-protein components.

19. The detection method according to claim 18, characterized in that, The proteins include any one or a combination of at least two of the following: albumin, microalbumin, neutrophil gelatinase-associated lipotransferase, human chorionic gonadotropin, β2-microglobulin, or immunoglobulins.

20. The detection method according to claim 18, characterized in that, The non-protein substances include HIV, creatinine, or drugs.

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