CN110862881B - Special cleaning solution or diluent for full-automatic chemiluminescence determinator and preparation method thereof - Google Patents
Special cleaning solution or diluent for full-automatic chemiluminescence determinator and preparation method thereof Download PDFInfo
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D1/00—Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
- C11D1/66—Non-ionic compounds
- C11D1/83—Mixtures of non-ionic with anionic compounds
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/0005—Other compounding ingredients characterised by their effect
- C11D3/0073—Anticorrosion compositions
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/02—Inorganic compounds ; Elemental compounds
- C11D3/04—Water-soluble compounds
- C11D3/046—Salts
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/02—Inorganic compounds ; Elemental compounds
- C11D3/04—Water-soluble compounds
- C11D3/06—Phosphates, including polyphosphates
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/16—Organic compounds
- C11D3/24—Organic compounds containing halogen
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/16—Organic compounds
- C11D3/34—Organic compounds containing sulfur
- C11D3/349—Organic compounds containing sulfur additionally containing nitrogen atoms, e.g. nitro, nitroso, amino, imino, nitrilo, nitrile groups containing compounds or their derivatives or thio urea
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/76—Chemiluminescence; Bioluminescence
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D1/00—Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
- C11D1/02—Anionic compounds
- C11D1/04—Carboxylic acids or salts thereof
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D1/00—Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
- C11D1/02—Anionic compounds
- C11D1/12—Sulfonic acids or sulfuric acid esters; Salts thereof
- C11D1/14—Sulfonic acids or sulfuric acid esters; Salts thereof derived from aliphatic hydrocarbons or mono-alcohols
- C11D1/146—Sulfuric acid esters
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- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D1/00—Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
- C11D1/66—Non-ionic compounds
- C11D1/74—Carboxylates or sulfonates esters of polyoxyalkylene glycols
Abstract
The invention relates to the field of in-vitro diagnostic reagents for medical instruments, in particular to a special cleaning solution or diluent thereof for a full-automatic chemiluminescence determinator and a preparation method thereof. The cleaning solution comprises inorganic salt, a phosphate buffer system, a surfactant 1, a surfactant 2, a preservative and water; the inorganic salt consists of sodium chloride and potassium chloride; the phosphate buffer system is one of a disodium hydrogen phosphate-potassium dihydrogen phosphate system and sodium dihydrogen phosphate-dipotassium hydrogen phosphate; the surfactant 1 is one of tween-20 and tween-80; the surfactant 2 is one of sodium dodecyl sulfate and sodium laurate; the preservative consisted of Proclin300 and Bronidox. The cleaning solution provided by the invention is simple in preparation process, low in cost, suitable for full-automatic chemiluminescence testers of different manufacturers, suitable for detection of different detection principle items, good in accuracy, high in precision and good in corrosion resistance.
Description
Technical Field
The invention relates to the field of in-vitro diagnostic reagents for medical instruments, in particular to a special cleaning solution or diluent thereof for a full-automatic chemiluminescence determinator and a preparation method thereof.
Background
Chemiluminescence immunoassay (CLIA) is a detection and analysis technique which combines chemiluminescence assay technology with high sensitivity and high specificity immunoreaction and is used for various antigens, haptens, antibodies, hormones, enzymes, fatty acids, vitamins, medicaments and the like, is a new immunoassay technology developed after enzyme immunoassay, radioimmunoassay, fluorescence immunoassay and time-resolved fluorescence immunoassay, and has important and wide application in the field of in vitro diagnosis.
Based on the principle, the full-automatic chemiluminescence determinator is applied. The full-automatic chemiluminescence determinator has become one of the most frequently used instruments in clinical laboratory of hospitals due to the advantages of simple and convenient operation, reliable result, stable performance and the like. According to the detection result of the full-automatic chemiluminescence determinator on the serum and the plasma of the patient, a clinician can rapidly make accurate fragments of the disease of the patient.
The cleaning solution is used as a general reagent of a full-automatic chemiluminescence determinator, is matched with an immunoassay kit for use or is used as a component of the immunoassay kit. The washing device is used for washing substances which do not participate in specific reaction in the reaction cup after the immune reaction is finished so as to avoid interference influence on subsequent detection results, and belongs to consumable materials.
CN108546602A discloses a cleaning solution for chemiluminescence immunoassay, which comprises the following components: anionic surfactants, polyoxyethylene ether surfactants, amide nonionic surfactants, nonreducing saccharides and choline protein protectors, citrate, sodium chloride, potassium chloride, Proclin300, and the like. However, the cleaning solution has complex components, and due to the use of the amide nonionic surfactant, foams are easily generated in the washing process, the liquid level height of the detection probe is misjudged, and the hole jump rate is increased.
CN105754733A discloses a cleaning solution for chemiluminescence immunoassay analyzer, which comprises the following components: sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, sodium chloride, potassium chloride, a surfactant (Triton X-100 or Tween-20), and a preservative (Proclin 300 or sodium azide). The cleaning solution uses a mild single-type nonionic surfactant, has weak cleaning capability, and causes false positive results because protease and other non-specific adsorption substances which do not participate in specific reaction cannot be completely washed away when the cleaning solution is applied to an enzymatic chemiluminescence detection system with low detection sensitivity or a clinical detection item with low detection sensitivity (for example, an item of magnetic particles HBsAg by horseradish peroxidase luminescence method). In addition, the cleaning solution uses a single-anticorrosion Proclin300 anticorrosion system, and cannot meet the requirement of anticorrosion effect.
CN107118865A discloses a cleaning solution, which comprises the following components: phosphate buffer, inorganic salt (sodium chloride or potassium chloride), surfactant A (Triton X-100 or Tween-20), surfactant B (sodium cholate), and antiseptic (Proclin 300 or Proclin 950). The cleaning solution is only suitable for detection items of detection principles of a sandwich method, a competition method and an indirect method. The surfactant sodium cholate used in the cleaning solution is commonly used for dissolving cell membranes, has strong cleaning capability, and is easy to wash away antigens or antibodies which are subjected to specific binding, thereby causing false negative or false positive. The molecular structure of the sodium cholate contains nitrogen hydrogen bonds with reactivity, and nonspecific reaction is easy to occur during immunoassay. In addition, the preservatives Proclin300 and Proclin950 used in the cleaning solution are of the same series, and cannot meet the requirement of preservative effect.
At present, the cleaning solution used by various domestic hospitals is original cleaning solution, the consumption is huge, the price is high, the detection cost is greatly increased, and the cleaning solution used by full-automatic chemiluminiscence testers of different manufacturers and different models cannot be generally used. Therefore, the cleaning solution which is low in cost and suitable for full-automatic chemiluminescence testers of different manufacturers and different models is developed, and meanwhile, the cleaning solution is suitable for detection of different detection principle projects and has important application and market values.
Disclosure of Invention
In view of this, the invention provides a cleaning solution or a diluent thereof specially used for a full-automatic chemiluminescence determinator and a preparation method thereof. The cleaning fluid has good accuracy, precision and anti-corrosion effect.
In order to achieve the above object, the present invention provides the following technical solutions:
the invention provides a special cleaning solution or diluent thereof for a full-automatic chemiluminescence determinator, wherein the cleaning solution comprises inorganic salt, a phosphate buffer system, a surfactant 1, a surfactant 2, a preservative and water;
the inorganic salt consists of sodium chloride and potassium chloride;
the phosphate buffer system is one of a disodium hydrogen phosphate-potassium dihydrogen phosphate system and sodium dihydrogen phosphate-dipotassium hydrogen phosphate;
the surfactant 1 is one of tween-20 and tween-80;
the surfactant 2 is one of sodium dodecyl sulfate and sodium laurate;
the preservative consisted of Proclin300 and Bronidox.
Preferably, the concentration of each component in the cleaning solution is as follows:
35-60 g/L sodium chloride
145-185 g/L potassium chloride
In terms of phosphate radical, the phosphate radical is,
0.15-0.55 mol/L phosphate buffer system
12-24 g/L of surfactant
20.5-6 g/L of surfactant
Proclin300 0.5~18 g/L
Bronidox 0.2~2 g/L
And (5) supplementing water.
Preferably, the concentration of each component in the cleaning solution is:
35-60 g/L sodium chloride
145-185 g/L potassium chloride
In terms of phosphate radical, the phosphate radical is,
disodium hydrogen phosphate 0.15-0.55 mol/L
Monopotassium phosphate 0.001-0.004 mol/L
0.001-0.004 mol/L sodium dihydrogen phosphate
0.15-0.55 mol/L of dipotassium hydrogen phosphate;
tween-2015-24 g/L
Tween-802-10 g/L
2-6 g/L sodium dodecyl sulfate
Sodium laurate of 0.5-4 g/L
Proclin300 0.5~18 g/L
Bronidox 0.2~2 g/L
And (5) supplementing water.
In a specific embodiment provided by the present invention, the concentration of each component in the cleaning solution is:
35 g/L sodium chloride
185g/L potassium chloride
In terms of phosphate radical, the phosphate radical is,
disodium hydrogen phosphate 0.15mol/L
0.001 mol/L of monopotassium phosphate;
tween-2024 g/L
Sodium laurate of 0.5g/L
Proclin300 10 g/L
Bronidox 0.4 g/L
And (5) supplementing water.
In a specific embodiment provided by the present invention, the concentration of each component in the cleaning solution is:
35 g/L sodium chloride
185g/L potassium chloride
In terms of phosphate radical, the phosphate radical is,
disodium hydrogen phosphate 0.55mol/L
0.0034 mol/L of monopotassium phosphate;
tween-802 g/L
Sodium dodecyl sulfate 6g/L
Proclin300 0.5 g/L
Bronidox 2 g/L
And (5) supplementing water.
In a specific embodiment provided by the present invention, the concentration of each component in the cleaning solution is:
60g/L sodium chloride
145g/L potassium chloride
In terms of phosphate radical, the phosphate radical is,
0.0026 mol/L sodium dihydrogen phosphate
Dipotassium phosphate is 0.55 mol/L;
tween-2015 g/L
Sodium dodecyl sulfate 2g/L
Proclin300 18 g/L
Bronidox 0.2 g/L
And (5) supplementing water.
In a specific embodiment provided by the present invention, the concentration of each component in the cleaning solution is:
sodium chloride 40 g/L
170 g/L potassium chloride
In terms of phosphate radical, the phosphate radical is,
disodium hydrogen phosphate 0.24 mol/L
0.0011 mol/L potassium dihydrogen phosphate;
tween-8010 g/L
Sodium laurate 4g/L
Proclin300 10 g/L
Bronidox 0.9 g/L
And (5) supplementing water.
Preferably, the pH value of the cleaning liquid is 7.2 to 8.3.
Preferably, the diluent is a solution obtained by diluting the cleaning solution by 1 to 25 times.
Preferably, the diluent is a solution diluted 15 to 25 times by the cleaning solution.
The invention also provides a preparation method of the cleaning solution or the diluent thereof, and the preparation method of the cleaning solution is to dissolve inorganic salt, a phosphate buffer system, a surfactant 1, a surfactant 2 and a preservative into water;
the preparation method of the diluent is to dilute the cleaning solution or directly prepare the cleaning solution according to the diluted concentration.
The invention provides a special cleaning solution or a diluent thereof for a full-automatic chemiluminescence determinator and a preparation method thereof. The cleaning solution comprises inorganic salt, a phosphate buffer system, a surfactant 1, a surfactant 2, a preservative and water; the inorganic salt consists of sodium chloride and potassium chloride; the phosphate buffer system is one of a disodium hydrogen phosphate-potassium dihydrogen phosphate system and sodium dihydrogen phosphate-dipotassium hydrogen phosphate; the surfactant 1 is one of tween-20 and tween-80; the surfactant 2 is one of sodium dodecyl sulfate and sodium laurate; the preservative consisted of Proclin300 and Bronidox. Compared with the prior art, the invention has the following technical effects:
the cleaning solution provided by the invention is simple in preparation process, low in cost, suitable for full-automatic chemiluminescence testers of different manufacturers, suitable for detection of different detection principle items, good in accuracy, high in precision and good in corrosion resistance.
The research on the corrosion resistance shows that the single preservative Proclin300 cannot completely play a role in corrosion prevention, and the introduction of the saccharides and the nitrogen-containing compounds into the cleaning solution increases the risk of microbial pollution of the cleaning solution. The preservative disclosed by the invention is a double-preservative system consisting of Proclin300 and Bronidox, and has a good preservative effect.
Detailed Description
The invention discloses a cleaning solution or a diluent thereof special for a full-automatic chemiluminescence determinator and a preparation method thereof. It is expressly intended that all such similar substitutes and modifications which would be obvious to one skilled in the art are deemed to be included in the invention. While the methods and applications of this invention have been described in terms of preferred embodiments, it will be apparent to those of ordinary skill in the art that variations and modifications in the methods and applications described herein, as well as other suitable variations and combinations, may be made to implement and use the techniques of this invention without departing from the spirit and scope of the invention.
The invention aims to provide a cleaning liquid. The cleaning solution has low cost, is suitable for full-automatic chemiluminescence testers of different manufacturers and different models, and has high test accuracy, good precision, good stability and good corrosion resistance.
The cleaning solution comprises inorganic salt, a phosphate buffer system, a surfactant 1, a surfactant 2 and a preservative.
The pH value of the cleaning liquid is 7.2-8.3.
The inorganic salt is sodium chloride or potassium chloride.
The buffer system is one of a disodium hydrogen phosphate-potassium dihydrogen phosphate system and sodium dihydrogen phosphate-dipotassium hydrogen phosphate;
the surfactant 1 is one of tween-20 and tween-80;
the surfactant 2 is one of sodium dodecyl sulfate and sodium laurate;
the preservative is Proclin300 and Bronidox.
The concentration of sodium chloride in the inorganic salt is 35-60 g/L, and the concentration of potassium chloride in the inorganic salt is 145-185 g/L.
The concentration of the phosphate buffer system is 0.15-0.55 mol/L calculated by phosphate radical.
The concentration of the surfactant 1 is 2 g/L-24 g/L.
The concentration of the surfactant 2 is 0.5-6 g/L.
The concentration of Proclin300 in the preservative is 0.5-18 g/L, and the concentration of Bronidox is 0.2-2 g/L;
weighing the raw materials according to the concentration, adding purified water, and stirring to dissolve. When in use, the solution is diluted by 15-25 times with purified water.
The cleaning solution or the diluent thereof specially used for the full-automatic chemiluminescence determinator and the reagent or the instrument used in the preparation method thereof provided by the invention can be purchased from the market.
The invention is further illustrated by the following examples:
examples 1 to 4
The formula proportion of the cleaning solution and the dilution times in use in the examples 1-4 of the invention are shown in Table 1.
Table 1 examples 1-4 formula tables and dilution factor when used
Taking 1L of the cleaning solution of example 1 as an example, the preparation method is as follows:
weighing 35g of sodium chloride, 185g of potassium chloride, 53.72g of disodium hydrogen phosphate dodecahydrate, 0.13g of monopotassium phosphate, 24g of tween-20, 0.5g of sodium laurate, 10g of Proclin300 and 0.4g of Bronidox, adding purified water, stirring and dissolving, and fixing the volume to 1L. The pH value of the prepared cleaning liquid is 7.2-8.3. When in use, the solution is diluted by 15 times by using purified water to be used as a working solution.
The preparation technical parameters of the examples 2-4 are the same as those of the example 1.
Test example 1
The chemiluminescence immunoassay was performed in yapei i2000SR using the washing solution of the present invention and the original washing solution. The method comprises the following specific steps:
(1) the cleaning solution was prepared and diluted to prepare a working solution according to the preparation method of example 1. Diluting original cleaning solution 15 times into working solution, namely adding 1400mL of purified water into 100mL of original cleaning solution for dilution;
(2) the washing solution was placed at the designated position of the yapei i2000SR chemiluminescence immunoassay analyzer at room temperature.
(3) The sample to be detected and the diagnostic reagent are placed at the designated position of the yapei i2000SR chemiluminescence immunoassay analyzer, and the automatic detection program of the yapei i2000SR chemiluminescence immunoassay analyzer is started.
(4) Adding the reactants in sequence, reacting for a period of time, adding cleaning solution, cleaning, adding pre-excitation solution and excitation solution, and measuring.
(5) And reading the result after the detection is finished.
Experiment of accuracy
The original washing solution and the washing solution of example 1 were measured using yapei i2000SR chemiluminescence immunoassay analyzer, 20 samples were measured for each item, and selected items were hepatitis b virus surface antigen (HBsAg) and Thyroid Stimulating Hormone (TSH) in the sandwich method, estradiol (E2) in the competition method, IgG antibody type 2 in the indirect method (HSV-2 IgG), and rubella virus antibody (IGM) in the capture method, respectively, and the results are shown in table 2:
table 2 example 1 cleaning solution and original cleaning solution accuracy test results
In example 1, the deviation of the measured values of the cleaning solution and the original cleaning solution sample is within 3%, which shows that the cleaning solution of the invention has good test accuracy and is consistent with the measurement result of the original cleaning solution.
Precision experiment
The measurement was carried out using yapei i2000SR chemiluminescence immunoassay analyzer for the original cleaning solution and the cleaning solution of example 1, and the precision quality control product was measured for each item (20 times), and the items selected were hepatitis b virus surface antigen (HBsAg) and Thyroid Stimulating Hormone (TSH) by the sandwich method, estradiol (E2) by the competition method, IgG antibody type 2 by indirect herpes simplex virus (HSV-2 IgG) by the indirect method, and rubella virus antibody (IGM) by the capture method, respectively, and the precision measurement results are shown in table 3.
Table 3 results of testing precision of cleaning solution and original cleaning solution in example 1
The precision index test results of four items of the cleaning solution in the embodiment 1 are less than 5 percent and are consistent with the original cleaning solution; meets the requirement that the precision of the general reagent is less than 10 percent.
Test example 2
Chemiluminescent immunoassay assays were performed in siemens AVDIA Centaur XP using the wash and the bulk wash of the present invention. The method comprises the following specific steps:
(1) the cleaning solution was prepared and diluted to prepare a working solution according to the preparation method of example 1. Original cleaning liquid and working liquid.
(2) The wash solution was placed at room temperature on a Siemens AVDIA Centaur XP chemiluminescent immunoassay analyzer at the indicated position.
(3) Placing the sample to be detected and the diagnostic reagent on a designated position of the Siemens AVDIA Centaur XP chemiluminescence immunoassay analyzer, and starting an automatic detection program of the Siemens AVDIA Centaur XP chemiluminescence immunoassay analyzer.
(4) And reading the result after the detection is finished.
Experiment of accuracy
The original washing solution and the washing solution of example 1 were measured using a siemens AVDIA Centaur XP chemiluminescence immunoassay analyzer, 20 samples were measured for each item, and selected items were hepatitis b virus surface antigen (HBsAg) and Thyroid Stimulating Hormone (TSH) by the sandwich method, estradiol by the competition method (E2), IgG antibody by the indirect method (HSV-2 IgG), and rubella virus antibody by the capture method (IGM) as shown in table 4:
table 4 results of accuracy tests of cleaning solution and original cleaning solution in example 1
In example 1, the deviation of the measured values of the cleaning solution and the original cleaning solution sample is within 3%, which shows that the cleaning solution of the invention has good test accuracy and is consistent with the measurement result of the original cleaning solution.
Precision experiment
The original washing solution and the washing solution of example 1 were measured by using a siemens AVDIA Centaur XP chemiluminescence immunoassay analyzer, and the precision quality control product was measured for each item (20 times), and the selected items were hepatitis b virus surface antigen (HBsAg) and Thyroid Stimulating Hormone (TSH) by the sandwich method, estradiol by the competition method (E2), IgG antibody by herpes simplex virus type 2 (HSV-2 IgG) by the indirect method, and the precision measurement results of rubella virus antibody (IGM) by the capture method are shown in table 5:
table 5 results of testing precision of cleaning solution and original cleaning solution in example 1
The precision index test results of four items of the cleaning solution in the embodiment 1 are less than 5 percent and are consistent with the original cleaning solution; meets the requirement that the precision of the general reagent is less than 10 percent.
The corrosion resistance challenge test proves that the bacteriostasis rate of the cleaning solution in the embodiment 1 to different strains can reach 100 percent.
Test example 3
Chemiluminescence immunoassay was performed in yapei i2000SR using the wash of the present invention and the original wash. The method comprises the following specific steps:
(1) the cleaning solution was prepared and diluted to a working solution according to the preparation method of example 2. Diluting the original cleaning solution by 20 times into working solution, namely adding 1900mL of purified water into 100mL of original cleaning solution for dilution;
(2) the washing solution was placed at the designated position of the yapei i2000SR chemiluminescence immunoassay analyzer at room temperature.
(3) The sample to be detected and the diagnostic reagent are placed at the designated position of the yapei i2000SR chemiluminescence immunoassay analyzer, and the automatic detection program of the yapei i2000SR chemiluminescence immunoassay analyzer is started.
(4) Adding the reactants in sequence, reacting for a period of time, adding cleaning solution, cleaning, adding pre-excitation solution and excitation solution, and measuring.
(5) And reading the result after the detection is finished.
Experiment of accuracy
The original washing solution and the washing solution of example 2 were measured using yapei i2000SR chemiluminescence immunoassay analyzer, 20 samples were measured for each item, and selected items were hepatitis b virus surface antigen (HBsAg) and Thyroid Stimulating Hormone (TSH) in the sandwich method, estradiol (E2) in the competition method, IgG antibody type 2 in the indirect method (HSV-2 IgG), and rubella virus antibody (IGM) in the capture method, respectively, and the results are shown in table 6:
table 6 example 2 cleaning solution and original cleaning solution accuracy test results
In example 2, the deviation of the measured values of the cleaning solution and the original cleaning solution sample is within 3%, which shows that the cleaning solution of the invention has good test accuracy and is consistent with the measurement result of the original cleaning solution.
Precision experiment
The measurement was carried out using yapei i2000SR chemiluminescence immunoassay analyzer for the original cleaning solution and the cleaning solution of example 2, and the precision quality control product was measured for each item (20 times), and the items selected were hepatitis b virus surface antigen (HBsAg) and Thyroid Stimulating Hormone (TSH) by the sandwich method, estradiol (E2) by the competition method, IgG antibody type 2 by indirect herpes simplex virus (HSV-2 IgG) by the indirect method, and rubella virus antibody (IGM) by the capture method, respectively, and the precision measurement results are shown in table 7.
Table 7 results of testing precision of cleaning solution and original cleaning solution in example 2
In the embodiment 2, the precision index test results of four items of the cleaning solution are less than 5 percent and are consistent with those of the original cleaning solution; meets the requirement that the precision of the general reagent is less than 10 percent.
Test example 4
Chemiluminescent immunoassay assays were performed in siemens AVDIA Centaur XP using the wash and the bulk wash of the present invention. The method comprises the following specific steps:
(1) the cleaning solution was prepared and diluted to a working solution according to the preparation method of example 2. Original cleaning liquid and working liquid.
(2) The wash solution was placed at room temperature on a Siemens AVDIA Centaur XP chemiluminescent immunoassay analyzer at the indicated position.
(3) Placing the sample to be detected and the diagnostic reagent on a designated position of the Siemens AVDIA Centaur XP chemiluminescence immunoassay analyzer, and starting an automatic detection program of the Siemens AVDIA Centaur XP chemiluminescence immunoassay analyzer.
(4) And reading the result after the detection is finished.
Experiment of accuracy
The original washing solution and the washing solution of example 2 were measured using a siemens AVDIA Centaur XP chemiluminescence immunoassay analyzer, 20 samples were measured for each item, and selected items were hepatitis b virus surface antigen (HBsAg) and Thyroid Stimulating Hormone (TSH) by the sandwich method, estradiol by the competition method (E2), IgG antibody by the indirect method (HSV-2 IgG), and rubella virus antibody by the capture method (IGM) as shown in table 8:
table 8 results of accuracy test of cleaning solution and original cleaning solution in example 2
In example 2, the deviation of the measured values of the cleaning solution and the original cleaning solution sample is within 3%, which shows that the cleaning solution of the invention has good test accuracy and is consistent with the measurement result of the original cleaning solution.
Precision experiment
The original washing solution and the washing solution of example 2 were measured by using a siemens AVDIA Centaur XP chemiluminescence immunoassay analyzer, and the precision quality control product was measured for each item (20 times), and the selected items were hepatitis b virus surface antigen (HBsAg) and Thyroid Stimulating Hormone (TSH) by the sandwich method, estradiol by the competition method (E2), IgG antibody by herpes simplex virus type 2 (HSV-2 IgG) by the indirect method, and the precision measurement results of rubella virus antibody (IGM) by the capture method are shown in table 9:
TABLE 9 results of testing precision of cleaning solution and original cleaning solution in example 2
In the embodiment 2, the precision index test results of four items of the cleaning solution are less than 5 percent and are consistent with those of the original cleaning solution; meets the requirement that the precision of the general reagent is less than 10 percent.
The corrosion resistance challenge test proves that the bacteriostasis rate of the cleaning solution in the embodiment 2 to different strains can reach 100 percent.
Test example 5
Chemiluminescence immunoassay was performed in yapei i2000SR using the wash of the present invention and the original wash. The method comprises the following specific steps:
(1) the cleaning solution was prepared and diluted to prepare a working solution according to the preparation method of example 3. Diluting original cleaning solution by 25 times to obtain working solution, namely adding 2400mL of purified water into 100mL of original cleaning solution for dilution;
(2) the washing solution was placed at the designated position of the yapei i2000SR chemiluminescence immunoassay analyzer at room temperature.
(3) The sample to be detected and the diagnostic reagent are placed at the designated position of the yapei i2000SR chemiluminescence immunoassay analyzer, and the automatic detection program of the yapei i2000SR chemiluminescence immunoassay analyzer is started.
(4) Adding the reactants in sequence, reacting for a period of time, adding cleaning solution, cleaning, adding pre-excitation solution and excitation solution, and measuring.
(5) And reading the result after the detection is finished.
Experiment of accuracy
The original washing solution and the washing solution of example 3 were measured using yapei i2000SR chemiluminescence immunoassay analyzer, 20 samples were measured for each item, and selected items were hepatitis b virus surface antigen (HBsAg) and Thyroid Stimulating Hormone (TSH) in the sandwich method, estradiol (E2) in the competition method, IgG antibody type 2 in the indirect method (HSV-2 IgG), and rubella virus antibody (IGM) in the capture method, respectively, and the results are shown in table 10:
TABLE 10 accuracy test results of example 3 cleaning solution and original cleaning solution
In example 3, the deviation of the measured values of the cleaning solution and the original cleaning solution sample is within 3%, which shows that the cleaning solution of the invention has good test accuracy and is consistent with the measurement result of the original cleaning solution.
Precision experiment
The measurement was carried out using yapei i2000SR chemiluminescence immunoassay analyzer for the original cleaning solution and the cleaning solution of example 3, and the precision quality control product was measured for each item (20 times), and the items selected were hepatitis b virus surface antigen (HBsAg) and Thyroid Stimulating Hormone (TSH) by the sandwich method, estradiol (E2) by the competition method, IgG antibody type 2 by indirect herpes simplex virus (HSV-2 IgG) by the indirect method, and rubella virus antibody (IGM) by the capture method, respectively, and the precision measurement results are shown in table 11.
TABLE 11 results of testing precision of cleaning solution and original cleaning solution in example 3
In the embodiment 3, the precision index test results of four items of the cleaning solution are less than 5 percent and are consistent with those of the original cleaning solution; meets the requirement that the precision of the general reagent is less than 10 percent.
Test example 6
Chemiluminescent immunoassay assays were performed in siemens AVDIA Centaur XP using the wash and the bulk wash of the present invention. The method comprises the following specific steps:
(1) the cleaning solution was prepared and diluted to prepare a working solution according to the preparation method of example 3. Original cleaning liquid and working liquid.
(2) The wash solution was placed at room temperature on a Siemens AVDIA Centaur XP chemiluminescent immunoassay analyzer at the indicated position.
(3) Placing the sample to be detected and the diagnostic reagent on a designated position of the Siemens AVDIA Centaur XP chemiluminescence immunoassay analyzer, and starting an automatic detection program of the Siemens AVDIA Centaur XP chemiluminescence immunoassay analyzer.
(4) And reading the result after the detection is finished.
Experiment of accuracy
The original washing solution and the washing solution of example 3 were measured using a siemens AVDIA Centaur XP chemiluminescence immunoassay analyzer, 20 samples were measured for each item, and selected items were hepatitis b virus surface antigen (HBsAg) and Thyroid Stimulating Hormone (TSH) by the sandwich method, estradiol by the competition method (E2), IgG antibody by the indirect method (HSV-2 IgG), and rubella virus antibody by the capture method (IGM) as shown in table 12:
TABLE 12 example 3 cleaning solution and original cleaning solution accuracy test results
In example 3, the deviation of the measured values of the cleaning solution and the original cleaning solution sample is within 3%, which shows that the cleaning solution of the invention has good test accuracy and is consistent with the measurement result of the original cleaning solution.
Precision experiment
The original washing solution and the washing solution of example 3 were measured by using siemens AVDIA Centaur XP chemiluminescence immunoassay analyzer, and the precision quality control product was measured for each item (20 times), and the selected items were hepatitis b virus surface antigen (HBsAg) and Thyroid Stimulating Hormone (TSH) by the sandwich method, estradiol by the competition method (E2), IgG antibody by herpes simplex virus type 2 (HSV-2 IgG) by the indirect method, and the precision measurement results of rubella virus antibody (IGM) by the capture method are shown in table 13:
TABLE 13 results of testing precision of cleaning solution and original cleaning solution in example 3
In the embodiment 3, the precision index test results of four items of the cleaning solution are less than 5 percent and are consistent with those of the original cleaning solution; meets the requirement that the precision of the general reagent is less than 10 percent.
The corrosion resistance challenge test proves that the bacteriostasis rate of the cleaning solution in the embodiment 3 to different strains can reach 100 percent.
Test example 7
Chemiluminescence immunoassay was performed in yapei i2000SR using the wash of the present invention and the original wash. The method comprises the following specific steps:
(2) the cleaning solution was prepared and diluted to prepare a working solution according to the preparation method of example 4. Diluting original cleaning solution 15 times into working solution, namely adding 1400mL of purified water into 100mL of original cleaning solution for dilution;
(2) the washing solution was placed at the designated position of the yapei i2000SR chemiluminescence immunoassay analyzer at room temperature.
(3) The sample to be detected and the diagnostic reagent are placed at the designated position of the yapei i2000SR chemiluminescence immunoassay analyzer, and the automatic detection program of the yapei i2000SR chemiluminescence immunoassay analyzer is started.
(4) Adding the reactants in sequence, reacting for a period of time, adding cleaning solution, cleaning, adding pre-excitation solution and excitation solution, and measuring.
(5) And reading the result after the detection is finished.
Experiment of accuracy
The original washing solution and the washing solution of example 4 were measured using yapei i2000SR chemiluminescence immunoassay analyzer, 20 samples were measured for each item, and selected items were hepatitis b virus surface antigen (HBsAg) and Thyroid Stimulating Hormone (TSH) in the sandwich method, estradiol (E2) in the competition method, IgG antibody type 2 in the indirect method (HSV-2 IgG), and rubella virus antibody (IGM) in the capture method, respectively, and the results are shown in table 14:
TABLE 14 results of accuracy test of cleaning solution and original cleaning solution in example 4
In example 4, the deviation of the measured values of the cleaning solution and the original cleaning solution sample is within 3%, which shows that the cleaning solution of the invention has good test accuracy and is consistent with the measurement result of the original cleaning solution.
Precision experiment
The measurement was carried out using yapei i2000SR chemiluminescence immunoassay analyzer for the original cleaning solution and the cleaning solution of example 4, and the precision quality control product was measured for each item (20 times), and the items selected were hepatitis b virus surface antigen (HBsAg) and Thyroid Stimulating Hormone (TSH) by the sandwich method, estradiol (E2) by the competition method, IgG antibody type 2 by indirect herpes simplex virus (HSV-2 IgG) by the indirect method, and rubella virus antibody (IGM) by the capture method, respectively, and the precision measurement results are shown in table 15.
TABLE 15 results of testing precision of cleaning solution and original cleaning solution in example 4
In the embodiment 4, the precision index test results of four items of the cleaning solution are less than 5 percent and are consistent with those of the original cleaning solution; meets the requirement that the precision of the general reagent is less than 10 percent.
Test example 8
Chemiluminescent immunoassay assays were performed in siemens AVDIA Centaur XP using the wash and the bulk wash of the present invention. The method comprises the following specific steps:
(1) the cleaning solution was prepared and diluted to prepare a working solution according to the preparation method of example 4. Original cleaning liquid and working liquid.
(2) The wash solution was placed at room temperature on a Siemens AVDIA Centaur XP chemiluminescent immunoassay analyzer at the indicated position.
(3) Placing the sample to be detected and the diagnostic reagent on a designated position of the Siemens AVDIA Centaur XP chemiluminescence immunoassay analyzer, and starting an automatic detection program of the Siemens AVDIA Centaur XP chemiluminescence immunoassay analyzer.
(4) And reading the result after the detection is finished.
Experiment of accuracy
The original washing solution and the washing solution of example 4 were measured using a siemens AVDIA Centaur XP chemiluminescence immunoassay analyzer, 20 samples were measured for each item, and selected items were hepatitis b virus surface antigen (HBsAg) and Thyroid Stimulating Hormone (TSH) by the sandwich method, estradiol by the competition method (E2), IgG antibody by the indirect method (HSV-2 IgG), and rubella virus antibody by the capture method (IGM) as shown in table 16:
TABLE 16 results of accuracy test of cleaning solution and original cleaning solution in example 4
In example 4, the deviation of the measured values of the cleaning solution and the original cleaning solution sample is within 3%, which shows that the cleaning solution of the invention has good test accuracy and is consistent with the measurement result of the original cleaning solution.
Precision experiment
The original washing solution and the washing solution of example 4 were measured by using siemens AVDIA Centaur XP chemiluminescence immunoassay analyzer, and the precision quality control product was measured for each item (20 times), and the selected items were hepatitis b virus surface antigen (HBsAg) and Thyroid Stimulating Hormone (TSH) by the sandwich method, estradiol by the competition method (E2), IgG antibody by herpes simplex virus type 2 (HSV-2 IgG) by the indirect method, and the precision measurement results of rubella virus antibody (IGM) by the capture method are shown in table 17:
TABLE 17 results of testing precision of cleaning solution and original cleaning solution in example 4
In the embodiment 4, the precision index test results of four items of the cleaning solution are less than 5 percent and are consistent with those of the original cleaning solution; meets the requirement that the precision of the general reagent is less than 10 percent.
The corrosion resistance challenge test proves that the bacteriostasis rate of the cleaning solution in the embodiment 4 to different strains can reach 100 percent.
Test example 9
In this test example, comparative tests were conducted on the preservative effect of the cleaning solution containing a single preservative (Proclin 300 or Bronidox) and the preservative effects of both Proclin300 and Bronidox. The amount of the single preservative added was the same as the total amount of the preservative added in example 1, and the other components and amounts were the same as in example 1.
Experimental verification shows that only the preservative Proclin300 or Bronidox is used, and bacteria grow and become turbid in the laboratory environment in the third week after the cleaning solution is used after the bottle is opened; and the use of the double-preservative Proclin300 and Bronidox system has a synergistic effect, and bacteria still do not grow within 16 weeks after the use of the bottle.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (5)
1. The special cleaning solution for the full-automatic chemiluminescence determinator is characterized by comprising inorganic salt, a phosphate buffer system, a surfactant 1, a surfactant 2, a preservative and water;
the inorganic salt consists of sodium chloride and potassium chloride;
the phosphate buffer system is one of a disodium hydrogen phosphate-potassium dihydrogen phosphate system and a sodium dihydrogen phosphate-dipotassium hydrogen phosphate system;
the surfactant 1 is one of tween-20 and tween-80;
the surfactant 2 is one of sodium dodecyl sulfate and sodium laurate;
the preservative consists of Proclin300 and Bronidox;
the concentration of each component in the cleaning solution is as follows:
35-60 g/L sodium chloride
145-185 g/L potassium chloride
In terms of phosphate radical, the phosphate radical is,
0.15-0.55 mol/L phosphate buffer system
12-24 g/L of surfactant
20.5-6 g/L of surfactant
Proclin300 0.5~18 g/L
Bronidox 0.2~2 g/L
Water is added to complement 1L;
the pH value of the cleaning liquid is 7.2-8.3.
2. The cleaning solution as claimed in claim 1, wherein the concentration of each component in the cleaning solution is:
35 g/L sodium chloride
185g/L potassium chloride
In terms of phosphate radical, the phosphate radical is,
disodium hydrogen phosphate 0.15mol/L
0.001 mol/L of monopotassium phosphate;
tween-2024 g/L
Sodium laurate of 0.5g/L
Proclin300 10 g/L
Bronidox 0.4 g/L
Water make up to 1L.
3. The cleaning solution as claimed in claim 1, wherein the concentration of each component in the cleaning solution is:
sodium chloride 40 g/L
170 g/L potassium chloride
In terms of phosphate radical, the phosphate radical is,
disodium hydrogen phosphate 0.24 mol/L
0.0011 mol/L potassium dihydrogen phosphate;
tween-8010 g/L
Sodium laurate 4g/L
Proclin300 10 g/L
Bronidox 0.9 g/L
Water make up to 1L.
4. The method for preparing the cleaning solution according to any one of claims 1 to 3, wherein the cleaning solution is prepared by dissolving inorganic salt, a phosphate buffer system, a surfactant 1, a surfactant 2, and a preservative in water.
5. A special cleaning solution diluent for a full-automatic chemiluminescence determinator, which is characterized in that the diluent is a solution obtained by diluting the cleaning solution of any one of claims 1 to 3 by 1-25 times.
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| CN111607465B (en) * | 2020-06-08 | 2021-09-21 | 珠海丽珠试剂股份有限公司 | Chemiluminescent cleaning solution and preparation method and application thereof |
| CN112924438A (en) * | 2021-01-26 | 2021-06-08 | 金华市鑫科医疗器械有限公司 | Chemiluminescent cleaning buffer solution |
| CN113136269A (en) * | 2021-03-26 | 2021-07-20 | 宁波紫园医疗器械有限公司 | Cleaning solution for chemiluminescence immunoassay |
| CN113337348B (en) * | 2021-05-31 | 2022-12-30 | 济南迪曼生物科技有限公司 | Acridinium ester chemiluminescence cleaning fluid |
| CN113484306B (en) * | 2021-07-02 | 2022-03-29 | 山东中鸿特检生物科技有限公司 | Magnetic particle chemiluminescence cleaning solution and preparation method and application thereof |
| CN114181779B (en) * | 2021-12-07 | 2023-09-29 | 郑州安图生物工程股份有限公司 | Cleaning liquid and application thereof in cleaning liquid chemical full-automatic chemiluminescence determinator sampling needle |
| CN114410390A (en) * | 2022-01-25 | 2022-04-29 | 武汉艾迪康医学检验所有限公司 | Cleaning solution for chemiluminescence reaction system and preparation method thereof |
| CN115340910B (en) * | 2022-09-06 | 2023-05-05 | 武汉生之源生物科技股份有限公司 | Cleaning solution suitable for alkaline phosphatase chemiluminescence system |
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