Preparation method of compound type quality control product for urine analysis

Abstract

The invention discloses a preparation method of a compound type quality control product for urine analysis, which comprises the following steps: taking a cell preservation solution into a large beaker, sequentially adding disodium hydrogen phosphate, sodium chloride, monopotassium phosphate and a preservative into the beaker, and stirring to obtain a matrix solution of the compound type quality control product for urine analysis; adding 2, 5-dimethyl pyrrole and ethyl acetoacetate, dissolving, adding albumin, glucose, esterase and hemoglobin, and dissolving for later use; extracting red blood cells by using a red blood cell extraction kit, and performing hydroformylation immobilization after extraction to obtain red blood cell mother liquor; carrying out hydroformylation immobilization on the CEM / C1 cells to prepare a white blood cell mother solution; and adding the red blood cell mother liquor and the white blood cell mother liquor into the matrix liquid, fixing the volume, and subpackaging to obtain the urine analysis composite quality control product. Urine dry chemical analysis quality control and urine visible components are integrated in one bottle, so that the problem of errors caused by replacement of a quality control product during calibration quality control of a urine analyzer is solved.

Description

Technical Field

[0001] The present invention relates to the technical field of urine testing, and in particular to a method for preparing a composite quality control product for urine analysis. Background Art

[0002] Urinalysis is one of the routine clinical examinations, and its results are of great significance for the identification and diagnosis of various diseases such as the urinary system, digestive system, cardiovascular system, and endocrine system. Urine composition is complex and there are many influencing factors, so it is particularly difficult to ensure the accuracy of urine analysis. In addition, urine analysis is divided into dry chemical analysis and formed component analysis, which further increases the difficulty of quality control of urine analysis.

[0003] Dry chemical analysis technology is relative to wet chemical technology. It refers to a type of chemical analysis method that adds liquid test samples directly to commercial dry reagent strips produced specifically for different projects, uses the moisture in the sample to be tested as a solvent to induce a specific chemical reaction, and uses enzyme method as the basis, through reflectance photometry or differential electrode method as the measurement means to obtain results in a short time.

[0004] Urine formed element analysis is also called urine sediment analysis, or further called urine particle count. It plays an important role in the diagnosis and differentiation of kidney diseases, urinary tract diseases, circulatory system diseases and infectious diseases in clinical practice. It can make up for the missed diagnosis caused by insufficient urine physical and chemical examinations and is known as "in vitro renal biopsy". Its detection parameters include various formed elements such as cells, tubular shapes, crystals, bacteria, sperm, etc.

[0005] Although urine dry chemical method and urine formed component analysis method have been used for a long time, there has been no good quality control method for the accuracy of the test results of these two methods. Currently, most of the existing urine analysis quality control products are single urine dry chemical quality control products or urine formed component analysis quality control products. Replacing the quality control products during the quality control process will introduce too many influencing factors, resulting in quality control failure, and it is impossible to simulate the test samples most realistically, making quality control lose its own meaning. However, the existing urine analysis composite quality control products are all taken from real clinical samples, which have the possibility of biological hazards, and are limited by changes in the patient's condition, resulting in inconsistent values ​​of each batch of quality control products, which increases the difficulty of quality control for the testing unit, and this composite quality control product prepared from real samples cannot be mass-produced and cannot be popularized. Therefore, the current urine analysis field is in urgent need of a simulated quality control material that can compound urine dry chemistry and urine formed components.

[0006] Chinese patent CN111638106B discloses a urine dry chemical analysis quality control material for quality control of a urine analyzer and a urine analysis test strip during urine analysis, which includes: esterase, sodium nitrite, anhydrous glucose, urobilinogen substitute, hemoglobin, ketone body substitute, bovine serum albumin, direct bilirubin, creatinine, anhydrous calcium chloride, urea, sodium chloride, pigment, preservative, etc. When performing urine analysis, the test strip used is quality controlled, and the quality of multiple test strips such as leukocytes, nitrite, urobilinogen, protein, pH, occult blood, urine specific gravity, ketone bodies, bilirubin, glucose, creatinine, urine calcium, and micro-white are monitored. However, considering that existing products often cause instrument pipeline blockage after entering the instrument, and there is no urine dry chemical and urine formed component analysis composite quality control product, which increases the time cost and economic cost for inspectors, the existing technology appears to be slightly insufficient. Summary of the invention

[0007] Technical issues solved:

[0008] The purpose of the present invention is to overcome the problem in the prior art that urine analysis quality control materials cannot simultaneously take into account the quality control of both urine dry chemical analysis and urine formed component analysis, and solve the technical problems that composite quality control products prepared based on real clinical samples cannot be mass-produced and have large batch differences. The present application provides a method for preparing a composite quality control product for urine analysis.

[0009] Technical solution:

[0010] To achieve the above objectives, this application is implemented through the following technical solutions:

[0011] A method for preparing a composite quality control product for urine analysis comprises the following steps:

[0012] Step 1: Weigh 800 mL of cell preservation solution into a 2L beaker according to the mass-to-volume ratio, add 14 g of disodium hydrogen phosphate, 5 g of sodium chloride, 3.4 g of potassium dihydrogen phosphate and 1 mL of preservative, stir to dissolve them all, and obtain the matrix solution of urine analysis composite quality control product:

[0013] Step 2: first add 0.25-1g 8-phenylamino-1-naphthalenesulfonic acid ammonium salt, 62.5-250mg sodium nitrite, 100-400mg 2,5-dimethylpyrrole, and 1-4g ethyl acetoacetate to the matrix solution, stir to dissolve them completely, and then add 0.75-3g albumin, 10-40g glucose, 0.3-1.2g esterase and 100-400mg hemoglobin to it after it returns to room temperature, stir until it is completely dissolved, and place it at 4°C for use to obtain the matrix solution added with urine dry chemical positive control;

[0014] Step 3: Take 10 mL of whole blood and use the red blood cell extraction kit to extract red blood cells. Immediately add to 30 mL

[0015] The cells were fixed with 4% formaldehyde solution and fixed for 24 hours at 4°C and 20 rpm. The cells were then washed twice with PBS and once with cell preservation solution. After washing, 5 mL of cell preservation solution was added to the cells for resuspending to obtain a red blood cell mother solution. The cells were then counted and the result was 1.24 × 10 8 Pieces / mL;

[0016] Step 4: CEM / C1 cells were cultured in a complete medium containing 90% RPMI 1640 medium and 10% fetal bovine serum. When the cells were expanded to the fifth generation, 5 T75 cell culture flasks were centrifuged at 1000 r / min for 5 minutes to enrich the cells. The supernatant was discarded and immediately precipitated in a centrifuge tube and 30 mL of a 2% formaldehyde-2.5% glutaraldehyde mixed solution was added. The cells were fixed for 48 hours at 4°C and 20 r / min under repeated inversion conditions. The cells were then washed twice with PBS and once with a cell preservation solution. After washing, 5 mL of a cell preservation solution was added to the cells for resuspending to obtain a leukocyte mother solution, which was then counted. The count result was 3.53 × 10 7 Pieces / mL;

[0017] Step 5: Add 5-10 μL of red blood cell mother solution or the concentrated solution of red blood cell mother solution diluted by one-fold gradient, and 5-10 μL of white blood cell mother solution or the concentrated solution of white blood cell mother solution diluted by one-fold gradient to the matrix solution to which urine dry chemical positive control has been added. Then transfer the liquid from the 2L beaker to a 1L volumetric flask, make up to volume with cell preservation solution, and then divide it into 6mL per bottle to obtain the composite quality control product for urine analysis.

[0018] Preferably, in the first step, the mass ratio of disodium hydrogen phosphate, sodium chloride and potassium dihydrogen phosphate is 70:25:17.

[0019] Preferably, the preservative in the first step is Proclin 300 preservative.

[0020] Preferably, in the second step, the mass ratio of esterase to 2,5-dimethylpyrrole is 3:1.

[0021] Preferably, the mass ratio of ethyl acetoacetate to sodium nitrite in the second step is 16:1.

[0022] Preferably, the whole blood in the third step is of human, horse or porcine origin.

[0023] Preferably, the counting in the third step and the fourth step uses one or two of a cell counter, a microscope counting method, and a scanning electron microscope counting method.

[0024] Preferably, the counting in the third and fourth steps is performed using a microscope counting method.

[0025] Beneficial effects:

[0026] The present application provides a method for preparing a composite quality control product for urine analysis, which has the following beneficial effects:

[0027] 1. The composite quality control product for urine analysis of this application integrates urine dry chemical analysis quality control and urine formed component analysis quality control in one bottle, solving the error problem caused by replacing quality control products when the urine analyzer is calibrated for quality control;

[0028] 2. The composite quality control product for urine analysis of the present application uses esterase, ethyl acetoacetate, 2,5-dimethylpyrrole, 8-phenylamino-1-naphthalenesulfonic acid ammonium salt, hemoglobin, etc. for dry chemical detection, and uses in vitro cultured leukocytes instead of whole blood to extract leukocytes, which solves the problem that the original composite quality control product for urine analysis cannot be mass-produced;

[0029] 3. The urine dry chemical quality control material and the urine formed component analysis quality control material are compounded to prepare a composite quality control material that can be used for the quality control of both the urine dry chemical analyzer and the urine formed component analyzer. This quality control material can significantly shorten the instrument startup quality control time. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 The target value table of the composite quality control product for urine analysis in Example 1;

[0031] Figure 2 This is the test result of the urine analysis composite quality control product in Example 1 on the Ulti US1680 urine analyzer. DETAILED DESCRIPTION

[0032] The present invention is described in detail below in conjunction with specific embodiments. The following embodiments will help those skilled in the art to further understand the present invention, but are not intended to limit the present invention in any form. It should be noted that, for those of ordinary skill in the art, several variations and improvements may be made without departing from the concept of the present invention. These all belong to the protection scope of the present invention.

[0033] CEM / C1 cells were purchased from the Cell Bank of the Chinese Academy of Sciences;

[0034] The cell preservation medium was purchased from Nanjing Sansheng Biotechnology Co., Ltd. The product name is Genyou (cell preservation medium XBBC-06) and the item number is YB060050.

[0035] The red blood cell extraction kit is a commercial gradient centrifugation principle red blood cell extraction kit purchased from Tianjin Haoyang Biological Products Technology Co., Ltd., with the product number RBC2014TBD.

[0036] Example 1: A method for preparing a composite quality control product for urine analysis, comprising the following steps:

[0037] Step 1: Weigh 800 mL of cell preservation solution into a 2L beaker according to the mass-to-volume ratio, add 14 g of disodium hydrogen phosphate, 5 g of sodium chloride, 3.4 g of potassium dihydrogen phosphate and 1 mL of Proclin300 preservative, stir to dissolve them all, and obtain the matrix solution of urine analysis composite quality control product:

[0038] Step 2: first add 1g of 8-phenylamino-1-naphthalenesulfonic acid ammonium salt, 250mg of sodium nitrite, 400mg of 2,5-dimethylpyrrole, and 4g of ethyl acetoacetate to the matrix solution, stir to dissolve them all, wait until the solution returns to room temperature, then add 3g of albumin, 40g of glucose, 1.2g of esterase, and 400mg of hemoglobin, stir to dissolve them, and place at 4°C for use to obtain a matrix solution with urine dry chemical positive control added;

[0039] Step 3: Take 10 mL of human whole blood and extract human red blood cells using a commercial red blood cell extraction kit based on gradient centrifugation principle. Immediately after extraction, add it to 30 mL of 4% formaldehyde solution for formaldehyde fixation. Fix it for 24 hours under repeated inversion conditions at 4°C and 20 r / min. Then wash it twice with PBS and once with cell preservation solution. After washing, add 5 mL of cell preservation solution to resuspend it to obtain red blood cell mother solution, and then count it under a microscope. The counting result is 1.24×10 8 Pieces / mL;

[0040] Step 4: CEM / C1 cells were cultured in complete medium containing 90% RPMI 1640 medium and 10% fetal bovine serum. Seed cells were purchased from the cell bank of the Chinese Academy of Sciences. When the cells were expanded to the fifth generation, 5 T75 cell culture flasks were centrifuged at 1000 r / min for 5 minutes to enrich them. The supernatant was discarded and immediately precipitated in a centrifuge tube and 30 mL of a 2% formaldehyde-2.5% glutaraldehyde mixed solution was added. The cells were fixed for 48 hours at 4°C and 20 r / min under repeated inversion conditions. The cells were then washed twice with PBS and once with a cell preservation solution. After washing, 5 mL of a cell preservation solution was added to the cells for resuspending.

[0041] The white blood cell stock solution was prepared and then counted under a microscope, and the count result was 3.53×10 7 Pieces / mL;

[0042] Step 5: Add 10 μL of red blood cell stock solution and 10 μL of white blood cell stock solution to the matrix solution to which the urine dry chemical positive control has been added, then transfer the liquid from the 2L beaker to a 1L volumetric flask, make up to volume with cell preservation solution, and then divide it into 6mL per bottle to obtain a urine analysis composite quality control product (high value).

[0043] The composite quality control product for urine analysis includes 11 test items in urine dry chemistry and 2 test items in urine formed element analysis. The 11 test items in urine dry chemistry are specific gravity, pH, leukocytes, nitrite, protein, glucose, ketone bodies, urobilinogen, bilirubin, occult blood, and ascorbic acid. The 2 test items in urine formed element analysis are erythrocytes and leukocytes.

[0044] In the urine dry chemistry test, substitutes are used to add white blood cells, ketone bodies, urobilinogen, bilirubin and occult blood. The substitute for white blood cells in the dry chemistry part is esterase, the substitute for ketone bodies is ethyl acetoacetate, the substitute for urobilinogen is 2,5-dimethylpyrrole, the substitute for bilirubin is 8-phenylamino-1-naphthalenesulfonic acid ammonium salt, and the substitute for occult blood is hemoglobin.

[0045] The leukocytes in the formed component part of the composite quality control product for urine analysis are prepared by in vitro cultured cell lines, and the erythrocytes are prepared by whole blood separation. The leukocytes in the formed component part are human acute lymphoblastic leukemia cells (CEM / C1 cells). The erythrocytes in the formed component part are one of the human, horse, and porcine erythrocytes.

[0046] The white blood cells and red blood cells of the formed components were treated with formaldehyde fixation. The red blood cells were treated with 4% formaldehyde solution at 4°C and 20r / min for 24 hours; the white blood cells were treated with a 2% formaldehyde-2.5% glutaraldehyde mixed solution at 4°C and 20r / min for 48 hours.

[0047] The matrix liquid of the composite quality control product for urine analysis is a cell preservation liquid, to which inorganic salts and preservatives are added to adjust the specific gravity and prevent bacterial growth. The inorganic salts are disodium hydrogen phosphate, sodium chloride and potassium dihydrogen phosphate, with a mass ratio of 70:25:17; the added preservative is proclin300.

[0048] The composite quality control product for urine analysis was verified for applicability on multiple urine analyzers. The experiment showed that the composite quality control product has good interchangeability and can be applied to instrument platforms of different manufacturers and models.

[0049] Example 2: A method for preparing a composite quality control product for urine analysis, comprising the following steps:

[0050] Step 1: Weigh 800 mL of cell preservation solution into a 2L beaker according to the mass-to-volume ratio, add 14 g of disodium hydrogen phosphate, 5 g of sodium chloride, 3.4 g of potassium dihydrogen phosphate and 1 mL of Proclin300 preservative, stir to dissolve them all, and obtain the matrix solution of urine analysis composite quality control product:

[0051] Step 2: first add 0.5 g of 8-phenylamino-1-naphthalenesulfonic acid ammonium salt, 125 mg of sodium nitrite, 200 mg of 2,5-dimethylpyrrole, and 2 g of ethyl acetoacetate to the matrix solution, stir to dissolve them all, wait until the solution returns to room temperature, then add 1.5 g of albumin, 20 g of glucose, 0.6 g of esterase, and 200 mg of hemoglobin, stir to dissolve them, and place at 4°C to obtain a matrix solution with urine dry chemical positive control added for use;

[0052] Step 3: Take 10 mL of human whole blood and extract human red blood cells using a commercial red blood cell extraction kit based on gradient centrifugation principle. Immediately after extraction, add it to 30 mL of 4% formaldehyde solution for formaldehyde fixation. Fix it for 24 hours under repeated inversion conditions at 4°C and 20 r / min. Then wash it twice with PBS and once with cell preservation solution. After washing, add 5 mL of cell preservation solution to resuspend it to obtain red blood cell mother solution, and then count it under a microscope. The counting result is 1.24×10 8 Pieces / mL;

[0053] Step 4: CEM / C1 cells were cultured in complete medium containing 90% RPMI 1640 medium and 10% fetal bovine serum. Seed cells were purchased from the cell bank of the Chinese Academy of Sciences. When the cells were expanded to the fifth generation, 5 T75 cell culture flasks were centrifuged at 1000 r / min for 5 minutes to enrich them. The supernatant was discarded and immediately precipitated in a centrifuge tube and 30 mL of a 2% formaldehyde-2.5% glutaraldehyde mixed solution was added. The cells were fixed for 48 hours at 4°C and 20 r / min under repeated inversion conditions. The cells were then washed twice with PBS and once with a cell preservation solution. After washing, 5 mL of a cell preservation solution was added to the cells for resuspending.

[0054] The white blood cell stock solution was prepared and then counted under a microscope, and the count result was 3.53×10 7 Pieces / mL;

[0055] Step 5: Add 5 μL of red blood cell stock solution and 5 μL of white blood cell stock solution to the matrix solution to which the urine dry chemical positive control has been added, then transfer the liquid from the 2L beaker to a 1L volumetric flask, make up to volume with cell preservation solution, and then divide it into 6mL per bottle to obtain the urine analysis composite quality control product (median).

[0056] Example 3: A method for preparing a composite quality control product for urine analysis, comprising the following steps:

[0057] Step 1: Weigh 800 mL of cell preservation solution into a 2L beaker according to the mass-to-volume ratio, add 14 g of disodium hydrogen phosphate, 5 g of sodium chloride, 3.4 g of potassium dihydrogen phosphate and 1 mL of Proclin300 preservative, stir to dissolve them all, and obtain the matrix solution of urine analysis composite quality control product:

[0058] Step 2: first add 0.25 g of 8-phenylamino-1-naphthalenesulfonic acid ammonium salt, 62.5 mg of sodium nitrite, 100 mg of 2,5-dimethylpyrrole, and 1 g of ethyl acetoacetate to the matrix solution, stir to dissolve them all, wait until the solution returns to room temperature, then add 0.75 g of albumin, 10 g of glucose, 0.3 g of esterase, and 100 mg of hemoglobin, stir to dissolve them, and place at 4°C to obtain a matrix solution with urine dry chemical positive control added for use;

[0059] Step 3: Take 10 mL of human whole blood and extract human red blood cells using a commercial red blood cell extraction kit based on gradient centrifugation principle. Immediately after extraction, add it to 30 mL of 4% formaldehyde solution for formaldehyde fixation. Fix it for 24 hours under repeated inversion conditions at 4°C and 20 r / min. Then wash it twice with PBS and once with cell preservation solution. After washing, add 5 mL of cell preservation solution to resuspend it to obtain red blood cell mother solution, and then count it under a microscope. The counting result is 1.24×10 8 Pieces / mL;

[0060] Step 4: CEM / C1 cells were cultured in complete medium containing 90% RPMI 1640 medium and 10% fetal bovine serum. Seed cells were purchased from the cell bank of the Chinese Academy of Sciences. When the cells were expanded to the fifth generation, 5 T75 cell culture flasks were centrifuged at 1000 r / min for 5 minutes to enrich them. The supernatant was discarded and immediately precipitated in a centrifuge tube and 30 mL of a 2% formaldehyde-2.5% glutaraldehyde mixed solution was added. The cells were fixed for 48 hours at 4°C and 20 r / min under repeated inversion conditions. The cells were then washed twice with PBS and once with a cell preservation solution. After washing, 5 mL of a cell preservation solution was added to the cells for resuspending.

[0061] The white blood cell stock solution was prepared and then counted under a microscope, and the count result was 3.53×10 7 Pieces / mL;

[0062] Step 5: Add 5 μL of the concentrated solution of the red blood cell stock solution diluted by one-fold gradient dilution and 5 μL of the concentrated solution of the white blood cell stock solution diluted by one-fold gradient dilution to the matrix solution to which the urine dry chemical positive control has been added. Then transfer the liquid from the 2L beaker to a 1L volumetric flask, make up to volume with cell preservation solution, and then divide it into 6mL per bottle to obtain the urine analysis composite quality control product (low value).

[0063] Embodiment 4:

[0064] Take 800mL of cell preservation solution to a 2L beaker, add 14g of disodium hydrogen phosphate, 5g of sodium chloride, 3.4g of potassium dihydrogen phosphate and 1mL of Proclin300 preservative, stir to dissolve all of them, and obtain the matrix solution of urine analysis composite quality control product. Then transfer the liquid from the 2L beaker to a 1L volumetric flask, make up to volume with cell preservation solution, and then divide it into 6mL per bottle to obtain the urine analysis composite quality control product (negative).

[0065] The above description of the examples is to facilitate the understanding and use of the invention by those skilled in the art. It is obvious that those skilled in the art can easily make various modifications to these embodiments and apply the general principles described herein to other embodiments without creative work. Therefore, the present invention is not limited to the above embodiments, and improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the present invention should be within the scope of protection of the present invention.

Claims

1. A method for preparing a composite quality control product for urine analysis, characterized in that: The following steps are involved: Step 1: Weigh 800 mL of cell preservation solution into a 2L beaker according to the mass-to-volume ratio, add 14 g of disodium hydrogen phosphate, 5 g of sodium chloride, 3.4 g of potassium dihydrogen phosphate and 1 mL of preservative, stir to dissolve them all, and obtain the matrix solution of urine analysis composite quality control product: Step 2: first add 0.25-1g 8-phenylamino-1-naphthalenesulfonic acid ammonium salt, 62.5-250mg sodium nitrite, 100-400mg 2,5-dimethylpyrrole, and 1-4g ethyl acetoacetate to the matrix solution, stir to dissolve them completely, and then add 0.75-3g albumin, 10-40g glucose, 0.3-1.2g esterase and 100-400mg hemoglobin to it after it returns to room temperature, stir until it is completely dissolved, and place it at 4°C for use to obtain the matrix solution added with urine dry chemical positive control; Step 3: Take 10 mL of whole blood and use a red blood cell extraction kit to extract red blood cells. Immediately after extraction, add it to 30 mL of 4% formaldehyde solution for formaldehyde fixation. Fix it for 24 hours under repeated inversion conditions at 4°C and 20 r / min. Then wash it twice with PBS and once with cell preservation solution. After washing, add 5 mL of cell preservation solution to resuspend it to obtain red blood cell mother solution, and then count it. The counting result is 1.24×10 8 Pieces / mL; Step 4: CEM / C1 cells were cultured in a complete medium containing 90% RPMI 1640 medium and 10% fetal bovine serum. When the cells were expanded to the fifth generation, 5 T75 cell culture flasks were centrifuged at 1000 r / min for 5 minutes to enrich the cells. The supernatant was discarded and immediately precipitated in a centrifuge tube and 30 mL of a 2% formaldehyde-2.5% glutaraldehyde mixed solution was added. The cells were fixed for 48 hours under repeated inversion conditions at 4°C and 20 r / min. The cells were then washed twice with PBS and once with a cell preservation solution. After washing, 5 mL of a cell preservation solution was added to the cells for resuspending to obtain a leukocyte mother solution, which was then counted. The count result was 3.53 × 10 7 Pieces / mL; Step 5: Add 5-10 μL of red blood cell mother solution or the concentrated solution of red blood cell mother solution diluted by one-fold gradient, and 5-10 μL of white blood cell mother solution or the concentrated solution of white blood cell mother solution diluted by one-fold gradient to the matrix solution to which urine dry chemical positive control has been added. Then transfer the liquid from the 2L beaker to a 1L volumetric flask, make up to volume with cell preservation solution, and then divide it into 6mL per bottle to obtain the composite quality control product for urine analysis.

2. The method for preparing the composite quality control product for urine analysis according to claim 1, characterized in that: In the first step, the mass ratio of disodium hydrogen phosphate, sodium chloride and potassium dihydrogen phosphate is 70:25:

17.

3. The method for preparing the composite quality control product for urine analysis according to claim 1, characterized in that: The preservative in the first step is Proclin 300 preservative.

4. The method for preparing the composite quality control product for urine analysis according to claim 1, characterized in that: In the second step, the mass ratio of esterase to 2,5-dimethylpyrrole is 3:

1.

5. The method for preparing the composite quality control product for urine analysis according to claim 1, characterized in that: The mass ratio of ethyl acetoacetate to sodium nitrite in the second step is 16:

1.

6. The method for preparing the composite quality control product for urine analysis according to claim 1, characterized in that: In the third step, the whole blood is of human, horse or porcine origin.

7. The method for preparing the composite quality control product for urine analysis according to claim 1, characterized in that: The counting in the third step and the fourth step uses one or two of a cell counter, a microscope counting method, and a scanning electron microscope counting method.

8. The method for preparing the composite quality control product for urine analysis according to claim 7, characterized in that: The counting in the third and fourth steps is performed by a microscope counting method.

Images