Preparation method of potassium and sodium quality control sample in urine sample

Abstract

The invention discloses a preparation method of a potassium and sodium quality control sample in a urine sample, which comprises the following steps: collecting human urine for 24 hours, putting into a sample bag, and standing for 24 hours to obtain the urine sample; adding a stabilizer into the urine sample according to the weight ratio of 1: 10; the sample is fully homogenized by adopting ultrasonic oscillation; and filtering with a 0.22 [mu] m filter membrane, sub-packaging under a sterile condition, and storing the filtrate at 4 DEG C. According to the invention, a real sample closest to urine is established, the stability of the quality control sample is improved, the storage life is prolonged, and the accuracy and consistency of detection results are ensured.

Description

Technical Field

[0001] The invention relates to the technical field of quality control sample preparation, and in particular to a method for preparing quality control samples of potassium and sodium in urine samples. Background Art

[0002] Potassium and sodium levels in urine are important indicators for assessing electrolyte balance and kidney function. Increased or decreased potassium and sodium levels in urine have important reference value and clinical significance. Urine chemical analysis quality control products are an important part of ensuring the accuracy and reliability of urine analysis results. When selecting quality control samples, factors such as matrix matching, concentration applicability, and stability for at least 6 months are generally considered. Compared with blood and biochemical tests, urine analysis quality control is somewhat difficult. In addition to the fact that the methods are not standardized, the status, retention, collection, transportation, and storage of urine specimens are difficult to control. In addition, the sensitivity of analytical instruments from different manufacturers also varies. The use of quality control products can achieve quality control of the entire measurement process and monitor the analytical instruments.

[0003] Using normal human urine as the basic matrix liquid to prepare urine quality control products eliminates the matrix effect to a certain extent, but it is difficult to obtain a large amount of normal human urine with stable quality. At the same time, due to differences in individual living habits, normal human urine also varies, resulting in large batch differences in quality control products. Using a large amount of urine will pollute the environment, and handling pathological urine will also pose a threat to the health of operators. The cost of handling and storing urine is high. These are the shortcomings of this type of technology.

[0004] The freeze-dried powder quality control products in the prior art need to be dissolved with a certain amount of water before use, and then poured into a container for use. Such quality control products are inconvenient to use and are prone to operating errors. After being dissolved into liquid, they need to be used in time, are unstable and cannot be stored, resulting in waste.

[0005] In order to avoid the problems of difficult quality control and environmental pollution caused by using urine as the basic matrix liquid to prepare urine quality control products, current technology often uses chemical raw materials as substitutes for various urine test indicators to prepare urine quality control products. Therefore, a method for preparing potassium and sodium quality control samples in urine samples is needed. Summary of the invention

[0006] The invention aims to solve the problems in the prior art and provides a method for preparing a quality control sample of potassium and sodium in a urine sample.

[0007] In order to achieve the above object, the present invention adopts the following technical solutions:

[0008] The present invention comprises the following steps:

[0009] A collects human urine for 24 hours and puts it in a sample bag. After standing for 24 hours, a urine sample is obtained.

[0010] B. Add a stabilizer to the urine sample at a weight ratio of 1:10;

[0011] C uses ultrasonic vibration to achieve full homogenization of the sample;

[0012] D is filtered using a 0.22um filter membrane, packaged under sterile conditions, and the filtrate is stored at 4 degrees.

[0013] Furthermore, in step C, ultrasonic treatment is performed in an ultrasonic oscillator at 40-60% power.

[0014] Furthermore, in step E, 0.22 um filter membrane is used for filtration.

[0015] Furthermore, in step B, the stabilizer comprises 95% pure boric acid.

[0016] On the other hand, a quality control product for urine sample testing is prepared using the preparation method.

[0017] On the other hand, a quality control product for urine sample testing is used in the preparation of urine sample testing products.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] The present invention is close to the actual sample, improves the stability of the quality control sample, prolongs the shelf life, and ensures the accuracy and consistency of the test results. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 It is a schematic diagram of the process of the present invention; DETAILED DESCRIPTION

[0021] The present invention is described in detail below in conjunction with the embodiments and accompanying drawings. However, it should be understood that the embodiments and drawings are only used to exemplify the present invention and do not constitute any limitation on the protection scope of the present invention.

[0022] The present invention is further demonstrated below in conjunction with specific embodiments:

[0023] The present invention comprises the following steps:

[0024] Embodiment 1:

[0025] The stabilizer is boric acid, and the total weight is: assuming the urine sample volume is 100 kg, the total weight of the stabilizer is 10 kg (1:10 ratio).

[0026] Ultrasonic treatment:

[0027] Power: 40%

[0028] Time: 10 minutes

[0029] Achieve initial homogenization of the sample at a lower power. Low-power sonication helps reduce thermal damage to biomolecules in the sample but may not be sufficient to completely disperse all particles.

[0030] Embodiment 2:

[0031] The stabilizer is boric acid, and the total weight is: assuming the urine sample volume is 100 kg, the total weight of the stabilizer is 10 kg (1:10 ratio).

[0032] Ultrasonic treatment:

[0033] Power: 50%

[0034] Time: 15 minutes

[0035] Moderate power ultrasonic treatment may provide better sample protection and homogenization effect, helping to maintain the activity of biomolecules in the sample while ensuring sample homogeneity.

[0036] Embodiment 3:

[0037] Total weight: Assuming the urine sample volume is 100 kg, the total weight of the stabilizer is 10 kg (1:10 ratio).

[0038] Ultrasonic treatment:

[0039] Power: 60%

[0040] Time: 20 minutes

[0041] Prepare according to the preparation method of Examples 1-3 and the dosage in the preparation table.

[0042] The ion analyzer system (model HC-800) based on the principle of ion selective electrode was used to test the accuracy and repeatability of the results.

[0043] Test method:

[0044] Before testing, the equipment should be calibrated uniformly using the calibration materials that come with the instrument.

[0045] The test values ​​are traced back to certified reference materials to ensure the accuracy and reliability of the results.

[0046] Open new quality control materials, mix well and test, then cover the bottle cap tightly and store according to the required storage conditions (2℃-8℃). Take out at the same time on the 2nd, 3rd, 5th, 7th, 15th and 30th days and observe the sedimentation of the turbidity quality control materials first; if there is no detailed sedimentation, test directly; if there is obvious sedimentation, terminate the test, and the test results are stable without unidirectional deviation.

[0047] The test results are shown in Table 1-2

[0048] Table 1 Quality control sedimentation results

[0049] Market share ratio Example 1 Example 2 Example 3 New sample Evenly suspended Evenly suspended Evenly suspended Evenly suspended the next day Evenly suspended Evenly suspended Evenly suspended Evenly suspended Day 3 Evenly suspended Evenly suspended Evenly suspended Evenly suspended Day 4 Slight Settlement Evenly suspended Evenly suspended Evenly suspended Day 5 Slight Settlement Slight Settlement Evenly suspended Evenly suspended Day 6 Obvious stratification Slight Settlement Slight Settlement Slight Settlement Day 7 Obvious stratification Obvious stratification Slight Settlement Slight Settlement

[0050] The stability under different storage conditions was compared by comparing the effects of four urine storage conditions (-20°C, 4°C, 10% boric acid at 4°C and room temperature 20°C) on the stability of the target potassium and sodium in urine quality control samples. The results showed that the storage conditions of the sample group with 10% boric acid added at 4°C were simple, easy to achieve, and relatively stable. This shows that the stability of the urine sample was well maintained under the condition of adding stabilizers.

[0051] Different stabilizers are suitable for different test items. For example, toluene and xylene are mainly used for urine sugar and urine protein determination, while sodium carbonate is mainly used for quantitative determination of urobilinogen and urine porphyrin. This shows that the choice of stabilizer needs to be determined according to the detection purpose of the urine sample to ensure the stability of specific components during storage.

[0052] Comparison of biochemical index test results: The test results of urine creatinine, total protein, uric acid, urine sodium and urine potassium under the four urine storage conditions were similar, and there was no significant difference between the groups (P>0.05).

[0053] Urine electrolyte short-term stability: No significant differences were detected in urine sodium, potassium, and chloride compared with baseline after 24 and 48 h in all four urine storage conditions (P>0.05), indicating that urine samples can remain stable for up to 48 h at these temperatures.

[0054] Under low temperature and refrigeration conditions (-20℃ and 4℃), the stability of potassium and sodium in urine samples is relatively good, and there is no obvious effect on the test results within 6 months of storage.

[0055] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A method for preparing quality control samples of potassium and sodium in urine, characterized in that: The following steps are involved: A collects human urine for 24 hours and puts it in a sample bag. After standing for 24 hours, a urine sample is obtained. B. Add a stabilizer to the urine sample at a weight ratio of 1:10; C uses ultrasonic vibration to achieve full homogenization of the sample; D is filtered using a 0.22um filter membrane, packaged under sterile conditions, and the filtrate is stored at 4 degrees.

2. The method for preparing quality control samples of potassium and sodium in urine according to claim 1, characterized in that: In step C, sonication is performed on an ultrasonic oscillator at 40-60% power.

3. The method for preparing quality control samples of potassium and sodium in urine according to claim 1, characterized in that: In step E, 0.22 um filter membrane is used for filtration.

4. The method for preparing quality control samples of potassium and sodium in urine according to claim 1, characterized in that: In step B, the stabilizer is 95% pure boric acid.

5. A quality control product for urine sample detection, characterized in that: The method is prepared by the preparation method according to any one of claims 1 to 4.

6. Use of the quality control product for urine sample testing as claimed in claim 5 in the preparation of urine sample testing products.

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