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CN118243911A - Urine physics multiparameter composite quality control material and preparation method thereof - Google Patents

Urine physics multiparameter composite quality control material and preparation method thereof Download PDF

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Publication number
CN118243911A
CN118243911A CN202410267855.4A CN202410267855A CN118243911A CN 118243911 A CN118243911 A CN 118243911A CN 202410267855 A CN202410267855 A CN 202410267855A CN 118243911 A CN118243911 A CN 118243911A
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China
Prior art keywords
quality control
urine
multiparameter
physics
turbidity
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CN202410267855.4A
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Inventor
刘云鹏
陈蕊瑶
刘江
蒋庆姣
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Urit Medical Electronic Co Ltd
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Urit Medical Electronic Co Ltd
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Priority to CN202410267855.4A priority Critical patent/CN118243911A/en
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/493Physical analysis of biological material of liquid biological material urine
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/02Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance
    • G01N27/04Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating resistance
    • G01N27/06Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating resistance of a liquid
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N9/00Investigating density or specific gravity of materials; Analysing materials by determining density or specific gravity
    • G01N9/36Analysing materials by measuring the density or specific gravity, e.g. determining quantity of moisture

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Electrochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The invention relates to the technical field of in-vitro diagnostic reagents, in particular to a urine physics multiparameter composite quality control substance and a preparation method thereof, wherein the urine physics multiparameter composite quality control substance comprises the following components: 1-10 g/L of nonionic surfactant, 1-30 g/L of suspending agent, 2-50 g/L of chloride, 0.1-10 g/L of pigment and 1-30 mL/L of particulate matters, and the problem that the turbidity quality control substances are easy to settle is solved by screening turbidity quality control substances and adding the suspending agent and the protecting agent, so that the accuracy, reliability and repeatability of the turbidity quality control items are improved; the simulated quality control matters of the color, turbidity, conductivity and specific gravity are compounded into the same quality control agent to prepare the compound quality control matters, so that the convenience of use of a user is improved while the quality control matters are compounded in use requirement, and the problem that the turbidity quality control matters are easy to settle and result is inaccurate and unstable is solved.

Description

Urine physics multiparameter composite quality control material and preparation method thereof
Technical Field
The invention relates to the technical field of in-vitro diagnostic reagents, in particular to a urine physics multiparameter composite quality control substance and a preparation method thereof.
Background
With development of urine analysis technology, the items of full-automatic urine analysis and detection are more and more perfect, and more detection items are covered. The detection of the physical module is a necessary selection module of many full-automatic analyzer instruments, and the detection of the physical module can mainly detect the conductivity, specific gravity, turbidity and color of urine components, and provide more physical parameters for clinicians so as to perform more comprehensive auxiliary diagnosis.
However, for quality control of detection of the physics module, although independent quality control products are available in the market, the quality control products have certain use defects, especially in turbidity quality control substances. The main problem is that the mixture is settled in the process of waiting for sample injection test after uniform mixing, thereby leading to inaccurate and unreliable quality control result, poor repeatability and losing the quality control effect.
Disclosure of Invention
The invention aims to provide a urine physics multiparameter composite quality control material and a preparation method thereof, and aims to solve the problems that turbidity quality control material is easy to settle and results are inaccurate and unstable.
In order to achieve the above object, in a first aspect, the present invention provides a urine physics multiparameter 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.
The nonionic surfactant is one or two of fatty alcohol polyoxyethylene ether, polyethylene glycol p-isooctyl phenyl 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 G, sunset yellow, fuchsin and carmine, and the particulate matter is one of latex particles, fulmalizine suspension and solidified pig red cells.
Wherein the PH of the urine physics multiparameter composite quality control material is between 5.8 and 7.2.
The solidification method of the solidified pig red blood cells comprises the following steps:
Taking anticoagulated pig red blood cells, and washing the anticoagulated pig red blood cells with physiological saline with the anticoagulants for 2-3 times to obtain a cell suspension;
Adding formaldehyde, curing for 24 hours in a constant temperature shaking table, adding glutaraldehyde, and continuing curing for 3 days;
centrifuging to remove supernatant, and adding physiological saline to obtain solidified pig erythrocyte suspension.
In a second aspect, the invention also provides a preparation method of the urine physics multiparameter composite quality control material, which comprises the following steps:
Adding a nonionic surfactant, a suspending agent, chloride and pigment into purified water with the volume of 90%, and stirring until the nonionic surfactant, the suspending agent, the chloride and the pigment are completely dissolved to obtain a precipitation mixed solution;
filtering the precipitate mixed solution with a nylon filter membrane with a pore diameter of 0.8 microns, and filtering and removing insoluble substances to obtain a mixed solution;
and adding the particles into the mixed solution according to a proportion to obtain the composite physical quality control material.
The invention relates to a urine physics multiparameter composite quality control substance, which comprises the following components: 1-10 g/L of nonionic surfactant, 1-30 g/L of suspending agent, 2-50 g/L of chloride, 0.1-10 g/L of pigment and 1-30 mL/L of particulate matters, and the problem that the turbidity quality control substances are easy to settle is solved by screening turbidity quality control substances and adding the suspending agent and the protecting agent, so that the accuracy, reliability and repeatability of the turbidity quality control items are improved; the simulated quality control substances with the color, turbidity, conductivity and specific gravity are compounded into the same quality control agent to prepare a compound quality control substance, so that the convenience of use of a user is improved while the quality control substance is compounded in use requirement, and the compound quality control substance is preferably a turbidity quality control substance and is more similar to clinic; the process of solidifying the pig red blood cells in two steps is adopted to obtain stable cell suspension, and the stable cell suspension is used for controlling the turbidity and is consistent with the turbidity generated by clinical sample cell suspension; through the mode of adding the surfactant and the suspending agent, the turbidity substances can be uniformly suspended in the liquid for 15 days after being uniformly mixed, so that the repeatability of a test result is better, and then 4 quality control parameters including specific gravity, conductivity, color and turbidity are compounded in one quality control agent in a mode of controlling the concentration of salt, the concentration of the suspending agent and the proportion of pigment, and can be traced back to a conductivity meter, a refraction type densimeter and a turbidity meter, so that the complexity of user operation and the use cost are reduced. Clinically, the specific gravity, conductivity and turbidity of yellow and low values are at normal levels; the specific gravity, conductivity and turbidity of red and high value are pathological levels, and the problems that turbidity quality control substances are easy to settle and result is inaccurate and unstable are solved.
Drawings
In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a flow chart of a method for solidifying pig erythrocytes used for the urine multi-parameter composite quality control substance.
FIG. 2 is a flow chart of a preparation method of a urine physics multiparameter composite quality control material.
Detailed Description
Embodiments of the present invention are described in detail below, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to like or similar elements or elements having like or similar functions throughout. The embodiments described below by referring to the drawings are illustrative and intended to explain the present invention and should not be construed as limiting the invention.
In a first aspect, the present invention provides a urine physics multiparameter 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.
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 G, sunset yellow, fuchsin and carmine, the particulate matter is one of latex particles, a foomazine suspension and solidified pig red blood cells, and the urine physical multiparameter composite quality control PH is between 5.8 and 7.2.
The solidification method of the solidified pig red blood cells comprises the following steps:
s1, taking anticoagulated pig red blood cells, and washing the anticoagulated pig red blood cells with physiological saline with an anticoagulant for 2-3 times to obtain a cell suspension;
Specifically, anticoagulated pig red blood cells are washed for 2-3 times by using physiological saline with an anticoagulant, supernatant is removed after centrifugation at 2500-3500 rpm each time, and then the supernatant is diluted to about 10% -30% by using the physiological saline with the anticoagulant, so that cell suspension is obtained.
S2, adding formaldehyde, curing for 24 hours in a constant temperature shaking table, adding glutaraldehyde, and continuing curing for 3 days;
Specifically, 0.5mL of formaldehyde (about 37%) was added per 10mL, and the mixture was cured at 60-100 rpm in a constant temperature shaker at 2-8deg.C for 24 hours, after which 0.5mL of glutaraldehyde (about 37%) was added and the curing under the same conditions was continued for 3 days.
S3, centrifuging to remove the supernatant, and adding physiological saline to obtain the solidified pig erythrocyte suspension.
Referring to fig. 1 to 2, in a second aspect, the present invention further provides a preparation method of a urine physics multiparameter composite quality control material, which includes the following steps:
s01, adding a nonionic surfactant, a suspending agent, chloride and pigment into purified water with the volume of 90%, and stirring until the nonionic surfactant, the suspending agent, the chloride and the pigment are completely dissolved to obtain a precipitation mixed solution;
specifically, each formulation was formulated at 1.1 times the required formulation volume.
S02, filtering the precipitate mixed solution with a nylon filter membrane with the aperture of 0.8 microns, and filtering and removing insoluble substances to obtain mixed solution;
S03, adding particles into the mixed solution according to a proportion to obtain the composite physical quality control material.
The urine physics multiparameter composite quality control substance is applied to clinic, and the specific gravity, conductivity and turbidity of yellow and low values are at normal levels; specific gravity, conductivity, turbidity of red and high value are pathological levels.
For a better understanding of the present technical solution, the following examples are now provided for further illustration:
The preparation method and the dosage of the preparation table are adopted for preparation.
Table 1 table of formulation of composite quality control substances
And verifying and selecting a with-physics detection module Ulipte full-automatic urine analysis system (model US 1680) to perform result accuracy and continuous daytime repeatability test.
The testing method comprises the following steps:
unified calibration of the physical module with the matched calibrator of the instrument is unified before testing.
The test alignment was performed using commercially available quality controls of the same type.
Opening the quality control material, mixing, testing, closing the bottle cap, storing according to the required storage condition (2-8 ℃), taking out at the time intervals of 2,3, 5, 7, 15 and 30 days, and observing the sedimentation condition of the turbidity quality control material; if no detail sedimentation exists, directly testing; if there is a significant sedimentation, the test is terminated.
The test results are shown in tables 2-8
TABLE 2 quality control sedimentation degree results
TABLE 3 results of turbidity sedimentation levels on the market independently
TABLE 4 physical projects-turbidity quality control results
TABLE 5 physical projects-turbidity quality control results
TABLE 6 physical project-color quality control results
TABLE 7 physical items-conductivity quality control results
TABLE 8 physical terms-specific gravity quality control results
As can be seen from tables 2-4, the commercial turbidity solutions settle more rapidly, and after being mixed evenly, the solutions are put into a test tube rack, and the solutions begin to settle before the tests are started, so that the solutions are unfavorable for being used in the tests. The composite physical quality control adopting the technical scheme is within a preset value, and the turbidity quality control object can keep uniform suspension property for a long time without influencing the use and the result.
Tables 5-8 show that the expected use equipment of the composite parameters also meets the requirement of preset values, and the parameters are not influenced by each other, so that the effect of independent quality control is achieved.
The foregoing disclosure is illustrative of a preferred embodiment of a urine multi-parameter composite quality control material, and it is not intended to limit the scope of the invention thereto, but it is to be understood by those skilled in the art that all or part of the above-described embodiments may be implemented and equivalents thereof may be modified according to the scope of the invention.

Claims (5)

1. A urine physics multiparameter composite quality control object is characterized in that,
Comprises 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.
2. The urine physics multiparameter composite quality control substance of claim 1, wherein,
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 G, sunset yellow, fuchsin and carmine, and the particulate matter is one of latex particles, a Fulmahydrazine suspension and solidified pig red cells.
3. The urine physics multiparameter composite quality control substance of claim 1, wherein,
The PH of the urine physical multiparameter composite quality control substance is between 5.8 and 7.2.
4. The urine physics multiparameter composite quality control substance of claim 2, wherein,
The solidification method of the solidified pig red blood cells comprises the following steps:
Taking anticoagulated pig red blood cells, and washing the anticoagulated pig red blood cells with physiological saline with the anticoagulants for 2-3 times to obtain a cell suspension;
Adding formaldehyde, curing for 24 hours in a constant temperature shaking table, adding glutaraldehyde, and continuing curing for 3 days;
centrifuging to remove supernatant, and adding physiological saline to obtain solidified pig erythrocyte suspension.
5. A method for preparing the urine-based multiparameter composite quality control material according to claim 4, comprising the steps of:
Adding a nonionic surfactant, a suspending agent, chloride and pigment into purified water with the volume of 90%, and stirring until the nonionic surfactant, the suspending agent, the chloride and the pigment are completely dissolved to obtain a precipitation mixed solution;
filtering the precipitate mixed solution with a nylon filter membrane with a pore diameter of 0.8 microns, and filtering and removing insoluble substances to obtain a mixed solution;
and adding the particles into the mixed solution according to a proportion to obtain the composite physical quality control material.
CN202410267855.4A 2024-03-08 2024-03-08 Urine physics multiparameter composite quality control material and preparation method thereof Pending CN118243911A (en)

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CN202410267855.4A CN118243911A (en) 2024-03-08 2024-03-08 Urine physics multiparameter composite quality control material and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202410267855.4A CN118243911A (en) 2024-03-08 2024-03-08 Urine physics multiparameter composite quality control material and preparation method thereof

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CN118243911A true CN118243911A (en) 2024-06-25

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