Urine physics multi-parameter composite quality control and preparation method
By preparing a multi-parameter composite quality control material for urine physiology, the problem of easy sedimentation of turbidity quality control materials was solved, the accuracy and repeatability of turbidity quality control materials were improved, user operation was simplified and costs were reduced.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- URIT MEDICAL ELECTRONICS CO LTD
- Filing Date
- 2024-03-08
- Publication Date
- 2026-07-03
AI Technical Summary
The existing urine physiology module turbidity control material tends to settle during the waiting period for sample injection and testing, resulting in inaccurate results and poor repeatability.
A multi-parameter composite quality control material for urine physiology was used, which included nonionic surfactants, suspending agents, chloride salts, pigments, and particulate matter. A stable cell suspension was prepared by a two-step solidification process for porcine red blood cells. The four quality control parameters of turbidity, conductivity, specific gravity, and color were combined in the same quality control material. Surfactants and suspending agents were added to maintain homogeneity.
It improves the accuracy and repeatability of turbidity control materials, reduces user operation complexity and cost, and ensures that the control materials remain uniformly suspended over a long period of time, resulting in stable and reliable test results.
Smart Images
Figure CN118243911B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of in vitro diagnostic reagent technology, and in particular to a urine physical multi-parameter composite quality control material and its preparation method. Background Technology
[0002] With the development of urine analysis technology, the range of tests available for fully automated urine analysis has become increasingly comprehensive, covering a wider range of parameters. Physiological module testing has become an essential optional module for many fully automated analyzers. It primarily measures the conductivity, specific gravity, turbidity, and color of urine components, providing clinicians with more physiological parameters for more comprehensive diagnostic support.
[0003] However, while there are independent quality control products available on the market for the testing of physical modules, they all have certain shortcomings in use, especially in turbidity control materials. The main problem is that after mixing, the material settles while waiting for the sample to be injected for testing, resulting in inaccurate and unreliable quality control results, poor repeatability, and rendering the quality control ineffective. Summary of the Invention
[0004] The purpose of this invention is to provide a multi-parameter composite quality control material for urine physiology and its preparation method, aiming to solve the problem that the easy sedimentation of turbidity quality control materials leads to inaccurate and unstable results.
[0005] To achieve the above objectives, in a first aspect, the present invention provides a urine physical multi-parameter composite quality control material, comprising the following components: 1-10 g / L of nonionic surfactant, 1-30 g / L of suspending agent, 2-50 g / L of chloride salt, 0.1-10 g / L of pigment, and 1-30 mL / L of particulate matter.
[0006] The nonionic surfactant is one or two of fatty alcohol polyoxyethylene ether, polyethylene glycol p-isooctylphenyl ether, and Tween 20; the chloride salt is sodium chloride or potassium chloride; the suspending agent is one or more of gelatin, sodium carboxymethyl cellulose, and polyvinylpyrrolidone; the pigment is one or two of orange yellow G, sunset yellow, magenta, and carmine; and the particulate matter is one of latex particles, formalin suspension, and solidified porcine red blood cells.
[0007] The pH of the urine physical multi-parameter composite quality control material is between 5.8 and 7.2.
[0008] The method for solidifying porcine red blood cells includes the following steps:
[0009] Take anticoagulated porcine red blood cells and wash them 2-3 times with physiological saline containing anticoagulant to obtain a cell suspension;
[0010] After adding formaldehyde and curing in a constant temperature shaker for 24 hours, add glutaraldehyde and continue curing for 3 days.
[0011] After centrifugation to remove the supernatant, physiological saline was added to obtain a solidified porcine red blood cell suspension.
[0012] Secondly, the present invention also provides a method for preparing a multi-parameter composite quality control compound for urine physiology, comprising the following steps:
[0013] Nonionic surfactant, suspending agent, chloride salt and pigment are added to 90% of the volume of purified water and stirred until completely dissolved to obtain a precipitate mixture.
[0014] The precipitate mixture was filtered through a 0.8-micron pore size nylon filter membrane to remove insoluble matter, thus obtaining the mixture.
[0015] Add particulate matter to the mixture in a certain proportion to obtain complex physicochemical quality control material.
[0016] This invention discloses a multi-parameter composite quality control material for urine physiology, comprising the following components: 1-10 g / L nonionic surfactant, 1-30 g / L suspending agent, 2-50 g / L chloride salt, 0.1-10 g / L pigment, and 1-30 mL / L particulate matter. By screening turbidity control materials and adding suspending agents and protective agents, the problem of easy sedimentation of turbidity control materials is solved, thereby improving the accuracy, reliability, and repeatability of turbidity control items. By combining simulated quality control materials for color, turbidity, conductivity, and specific gravity into the same quality control agent, a composite quality control material is prepared, which meets the requirements of use while improving user convenience. The composite quality control material is a carefully selected turbidity control substance, more closely resembling clinical results. It employs a two-step process to solidify porcine red blood cells, yielding a stable cell suspension for turbidity control, consistent with the turbidity of clinical sample cell suspensions. By adding surfactants and suspending agents, the turbidity substance can remain uniformly suspended in the liquid for up to 15 days after mixing, resulting in good repeatability of test results. Furthermore, by controlling salt concentration, suspending agent concentration, and pigment ratio, four quality control parameters—specific gravity, conductivity, color, and turbidity—are combined into a single quality control agent, traceable to conductivity meters, refractometers, and turbidimeters, reducing user complexity and operating costs. Corresponding to clinical levels, yellow and low values for specific gravity, conductivity, and turbidity represent normal levels; red and high values represent pathological levels, addressing the issue of turbidity control materials easily settling, which can lead to inaccurate and unstable results. Attached Figure Description
[0017] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0018] Figure 1 This is a flowchart of a method for solidifying porcine red blood cells used in a multi-parameter composite quality control material for urine physiology provided by the present invention.
[0019] Figure 2 This is a flowchart of a method for preparing a multi-parameter composite quality control material for urine physiology provided by the present invention. Detailed Implementation
[0020] Embodiments of the present invention are described in detail below, examples of which are illustrated in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the present invention, and should not be construed as limiting the present invention.
[0021] In a first aspect, the present invention provides a urine physical multi-parameter composite quality control material, comprising the following components: 1-10 g / L of nonionic surfactant, 1-30 g / L of suspending agent, 2-50 g / L of chloride salt, 0.1-10 g / L of pigment and 1-30 mL / L of particulate matter.
[0022] In this embodiment, the nonionic surfactant is one or two of fatty alcohol polyoxyethylene ether, polyethylene glycol p-isooctylphenyl ether, and Tween 20; the chloride salt is sodium chloride or potassium chloride; the suspending agent is one or more of gelatin, sodium carboxymethyl cellulose, and polyvinylpyrrolidone; the pigment is one or two of orange yellow G, sunset yellow, magenta, and carmine; the particulate matter is one of latex particles, formalin suspension, and solidified porcine red blood cells; and the pH of this urine physiology multi-parameter composite quality control material is between 5.8 and 7.2.
[0023] The method for solidifying porcine red blood cells includes the following steps:
[0024] S1. Take anticoagulated porcine red blood cells and wash them 2-3 times with physiological saline containing anticoagulant to obtain a cell suspension.
[0025] Specifically, anticoagulated porcine red blood cells are washed 2-3 times with physiological saline containing anticoagulant. After centrifugation at 2500-3500 rpm each time, the supernatant is removed. The cells are then diluted with physiological saline containing anticoagulant to a solid content of approximately 10%-30% to obtain a cell suspension.
[0026] S2 is added with formaldehyde and cured in a constant temperature shaker for 24 hours. Then glutaraldehyde is added and the curing continues for 3 days.
[0027] Specifically, add 0.5 mL of formaldehyde (approximately 37%) per 10 mL of solution, and cure for 24 hours in a constant temperature shaker at 2-8℃ with a rotation speed of 60-100. Then, add 0.5 mL of glutaraldehyde (approximately 37%) and continue curing under the same conditions for 3 days.
[0028] After centrifugation to remove the supernatant in S3, physiological saline was added to obtain a solidified porcine red blood cell suspension.
[0029] Please see Figures 1 to 2 Secondly, the present invention also provides a method for preparing a multi-parameter composite quality control compound for urine physiology, comprising the following steps:
[0030] S01 adds nonionic surfactant, suspending agent, chloride salt and pigment to 90% of the volume of purified water and stirs until completely dissolved to obtain a precipitate mixture;
[0031] Specifically, each preparation should be made at 1.1 times the required volume.
[0032] S02 filters the precipitate mixture through a 0.8-micron pore size nylon filter membrane to remove insoluble matter, thus obtaining the mixture;
[0033] S03 is added to the mixture in a certain proportion to obtain a complex physicochemical quality control material.
[0034] This urine physical multi-parameter composite quality control material is applied clinically. Yellow and low values of specific gravity, conductivity, and turbidity are considered normal levels; red and high values of specific gravity, conductivity, and turbidity are considered pathological levels.
[0035] To better understand this technical solution, the following embodiments are provided for further explanation:
[0036] Prepare according to the preparation method and the dosage in the preparation table.
[0037] Table 1. Preparation of Rigaku Composite Quality Control Materials
[0038]
[0039]
[0040] The accuracy and continuous day-to-day repeatability of the results were tested using the Unirit fully automated urine analysis system (model US1680) with a physical detection module.
[0041] Test method:
[0042] Before testing, the physical module is uniformly calibrated using the calibration materials provided with the instrument.
[0043] The test comparison was conducted using commercially available quality control systems of the same type.
[0044] After opening a new quality control sample, mix it thoroughly and then test it. Then tighten the cap and store it under the required storage conditions (2℃-8℃). Take it out at the same time on the 2nd, 3rd, 5th, 7th, 15th and 30th days and observe the sedimentation of the turbidity quality control sample. If there is no obvious sedimentation, test directly. If there is obvious sedimentation, stop the test.
[0045] The test results are shown in Table 2-8.
[0046] Table 2 Results of Quality Control on Settlement Degree
[0047]
[0048] Table 3 Results of Turbidity Sedimentation of Commercially Available Independent Products
[0049]
[0050]
[0051] Table 4. Turbidity Quality Control Results for Science Projects
[0052]
[0053] Table 5. Turbidity Quality Control Results for Science Projects
[0054]
[0055]
[0056] Table 6. Color Quality Control Results for Science Projects
[0057]
[0058] Table 7. Quality Control Results of Electrical Conductivity in Science Projects
[0059]
[0060] Table 8. Quality Control Results of Science Items - Specific Gravity
[0061]
[0062] As shown in Table 2-4, commercially available turbidity solutions settle relatively quickly. After mixing and placing them in the test tube rack, they begin to settle even before the test begins, which is not conducive to their use in the test. However, the complex physicochemical quality control using this technical solution remains within the preset values, and the turbidity control material maintains uniform suspension for a longer period of time, without affecting its use or results.
[0063] Table 5-8 shows that the composite parameters are expected to meet the preset values in the equipment being used, and they do not affect each other, achieving the effect of independent quality control.
[0064] The above description is merely a preferred embodiment of a multi-parameter composite quality control material for urine physiology according to the present invention. Of course, it should not be construed as limiting the scope of the present invention. Those skilled in the art can understand that all or part of the processes for implementing the above embodiments, and equivalent changes made in accordance with the claims of the present invention, still fall within the scope of the invention.
Claims
1. A multi-parameter composite quality control compound for urine physiology, characterized in that, It consists of the following components: 1–10 g / L of nonionic surfactant, 1–30 g / L of suspending agent, 2–50 g / L of chloride salt, 0.1–10 g / L of pigment and 1–30 mL / L of particulate matter; The preparation method of the urine physical multi-parameter composite quality control material includes the following steps: Nonionic surfactant, suspending agent, chloride salt and pigment are added to 90% of the volume of purified water and stirred until completely dissolved to obtain a precipitate mixture. The precipitate mixture was filtered through a 0.8-micron pore size nylon filter membrane to remove insoluble matter, thus obtaining the mixture. Add particulate matter to the mixture in a certain proportion to obtain a multi-parameter composite quality control material for urine physiology; The nonionic surfactant is one or two of fatty alcohol polyoxyethylene ether, polyethylene glycol p-isooctylphenyl ether, and Tween 20; the chloride salt is sodium chloride or potassium chloride; the suspending agent is one or more of gelatin, sodium carboxymethyl cellulose, and polyvinylpyrrolidone; the pigment is one or two of orange yellow G, sunset yellow, magenta, and carmine; and the particulate matter is one of latex particles, formalin suspension, and solidified porcine red blood cells. The pH of the urine physical multi-parameter composite quality control compound is between 5.8 and 7.2; The method for solidifying porcine red blood cells includes the following steps: Take anticoagulated porcine red blood cells and wash them 2-3 times with physiological saline containing anticoagulant to obtain a cell suspension; After adding formaldehyde and curing in a constant temperature shaker for 24 hours, add glutaraldehyde and continue curing for 3 days. After centrifugation to remove the supernatant, physiological saline was added to obtain a solidified porcine red blood cell suspension.