CN113985029A - Composition suitable for improving stability of immunoturbidimetric reagent - Google Patents
Composition suitable for improving stability of immunoturbidimetric reagent Download PDFInfo
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Images
Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/573—Immunoassay; Biospecific binding assay; Materials therefor for enzymes or isoenzymes
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/5306—Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/775—Apolipopeptides
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/81—Protease inhibitors
- G01N2333/8107—Endopeptidase (E.C. 3.4.21-99) inhibitors
- G01N2333/811—Serine protease (E.C. 3.4.21) inhibitors
- G01N2333/8121—Serpins
- G01N2333/8125—Alpha-1-antitrypsin
Abstract
The invention discloses a composition suitable for improving the stability of an immunoturbidimetric reagent, which comprises a surfactant, a carbohydrate, an alcohol and an amino acid, wherein the surfactant is selected from at least one of Tween-80, Tween-20 or Triton X-100; the saccharide substance is at least one of glucose, sucrose or trehalose; the alcohol substance is at least one selected from sorbitol, mannitol or glycerol; the amino acid is at least one of glutamine, glycine or glutamic acid. According to the invention, specific combination of saccharides, amino acids, alcohols and surfactants is added into the immunoturbidimetric reagent R2, so that the stability of the antibody in the reagent R2 can be improved, the stability (including thermal stability and bottle opening stability) of the reagent is further remarkably improved, and the service life of the reagent is prolonged.
Description
Technical Field
The invention relates to the field of medical inspection, in particular to a composition suitable for improving the stability of an immunoturbidimetric reagent.
Background
Immunoturbidimetry (Immunoturbidimetric Assays) is an antigen-antibody binding kinetic assay. The basic principle is as follows: when the antigen and antibody react in a special dilution system and the ratio is appropriate (generally, it is specified that the antibody is in excess), the formed soluble immune complex precipitates from the liquid phase under the action of a polymerization promoter (polyethylene glycol or the like) in the dilution system to form microparticles, and turbidity appears in the reaction solution. In the case where the antibody is immobilized in a slight excess amount, the formed immune complex increases with the increase in the amount of the antigen, and the turbidity of the reaction solution also increases, that is, the amount of the antigen to be measured is positively correlated with the turbidity of the reaction solution. The content of the antigen in the sample can be calculated by measuring the turbidity of the reaction solution and comparing with a series of standard products. In particular, the method can be classified into a general immunoturbidimetry method and an immunolatex turbidimetry method.
The immunoturbidimetric assay is mainly used for detecting specific protein series, such as immunoglobulin IgG, IgA, IgM and immunoglobulin subclasses; complement C3, complement C4; plasma proteins such as Prealbumin (PAB), Albumin (ALB), alpha 1-antitrypsin (AAT), beta 2-microglobulin (beta 2-MG), C-reactive protein (CRP), apolipoprotein ApoAI, ApoB, ApoE, as well as the urinary trace protein range and certain therapeutic drug concentrations, and the like. At present, because the common immunoturbidimetry has the characteristics of simple and rapid operation, high detection sensitivity and the like, the method is conventionally applied to the detection of clinical specific humoral protein, and related instruments are widely applied to various domestic hospitals and become one of important means of clinical immunodetection. The common immunoturbidimetry reagent is generally a double reagent and is divided into a reagent R1 and a reagent R2, wherein the reagent R1 is mainly a reaction buffer solution system and specifically contains a procoagulant component, an anti-interference component and the like; the reagent R2 is mainly a detection antibody system. The existing common immunoturbidimetric kit generally has the problem of low stability because the instability of the structure of the antibody or environmental conditions (such as oxygen, carbon dioxide, light or temperature and the like) existing in the preparation process of the reagent can influence the stability of the antibody in the reagent and further influence the stability of the reagent.
Disclosure of Invention
In light of the above requirements, the inventors have unexpectedly found that the stability of a reagent can be significantly improved by adding a composition of a specific surfactant, an amino acid, a saccharide and an alcohol to the reagent R2 of an immunoturbidimetric immunoassay kit.
The invention provides a composition suitable for improving the stability of an immunoturbidimetric reagent, which is characterized by comprising a surfactant, a saccharide substance, an alcohol substance and amino acid.
Preferably, the surfactant is selected from at least one of Tween-80, Tween-20 or Triton X-100; the saccharide substance is at least one of glucose, sucrose or trehalose; the alcohol substance is at least one selected from sorbitol, mannitol or glycerol; the amino acid is at least one of glutamine, glycine or glutamic acid.
Preferably, the surfactant is Tween-80, the saccharide substance is glucose, the alcohol substance is sorbitol, and the amino acid is glutamine.
Preferably, the concentration of the surfactant is 1-2 g/L; the concentration of the saccharide is 50-100 g/L; the concentration of the alcohol substance is 50-100 g/L; the concentration of the amino acid is 10-50 mmol/L.
Preferably, the concentration of the surfactant is 1.5-2 g/L; the concentration of the saccharide is 75-100 g/L; the concentration of the alcohol substance is 75-100 g/L; the concentration of the amino acid is 10-20 mmol/L.
An immunoturbidimetric kit, wherein the reagent R2 of the kit comprises the composition for improving the stability of the immunoturbidimetric reagent according to any one of the above.
Preferably, the immunoturbidimetric kit is used for detecting at least one of alpha 1-antitrypsin, apolipoprotein E or alpha 1-acid glycoprotein.
Preferably, the kit is an alpha 1-antitrypsin detection kit, which comprises a reagent R1 and a reagent R2, wherein the reagent R1 comprises 30-50mmol/L buffer solution, 100-400mmol/L inorganic salt ions, 40-90g/L coagulant, 1-2g/L surfactant and 0.5-1.5g/L preservative; the reagent R2 also comprises 30-300mmol/L buffer solution, 100-400mmol/L inorganic salt ions, 20-60% AAT antibody and 0.5-1.5g/L preservative.
Preferably, the buffer is selected from at least one of phosphate, Tris, PBS or BICINE; the inorganic salt ions are selected from at least one of sodium chloride or potassium chloride; the coagulant is selected from at least one of polyethylene glycol-6000 or polyethylene glycol-3000; the preservative is selected from at least one of sodium azide and Proclin.
Preferably, the buffer solution is phosphate buffer solution, the inorganic salt ion is sodium chloride, the coagulant is polyethylene glycol-6000, and the preservative is sodium azide. The invention has the beneficial effects that: according to the invention, specific saccharide, amino acid, alcohol and surfactant combination, especially the composition of glucose, sorbitol, glutamine and Tween-80, are added into the immunoturbidimetric reagent R2, so that the stability of the antibody in the reagent R2 can be improved, the stability (including thermal stability and open bottle stability) of the reagent is further remarkably improved, and the service life of the reagent is prolonged.
Drawings
FIG. 1 is a graph of validation data for the effect of adding different compositions on the thermal stability of a kit according to example 3 of the present invention;
FIG. 2 is a graph of data demonstrating the effect of the addition of different compositions on the open vial stability of a kit according to example 3 of the present invention;
FIG. 3 is a graph of data demonstrating the effect of different additive concentrations of the composition described in example 3 on the thermal stability of a kit according to the present invention;
FIG. 4 is a graph of data demonstrating the effect of different additive concentrations of the composition described in example 3 on the open vial stability of the kit according to the present invention;
FIG. 5 is a graph of two kit thermal stability verification data according to example 5 of the present invention;
FIG. 6 is a graph of the open vial stability verification data for two kits according to example 5 of the present invention;
FIG. 7 is a graph of two kit thermal stability verification data according to example 7 of the present invention;
FIG. 8 is a graph of the open vial stability verification data for two kits according to example 7 of the present invention.
DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION
The following examples are included to more clearly and clearly illustrate the technical solutions of the present invention by way of illustration. Those of skill in the art should, in light of the present disclosure, appreciate that many changes can be made in the specific embodiments which are disclosed and still obtain a like or similar result without departing from the spirit and scope of the invention. The specific embodiments of the present invention are merely illustrative of the invention and are not intended to limit the invention in any way.
EXAMPLE 1 preparation of AAT assay kit
The alpha 1-antitrypsin detection kit comprises a reagent R1 and a reagent R2 which are independent of each other.
Preparation of AAT detection kit
(1) Preparation of reagent R1
The preparation is carried out according to the following formula, fully stirred and uniformly mixed, and stored at 2-8 ℃.
Reagent R1:
the solvent is purified water
(2) Preparation of reagent R2
The solvent is purified water
Use method of AAT detection kit
In this embodiment, a full-automatic biochemical analyzer (hitachi 7180) is used in combination with the kit of the present invention to perform sample detection, and the specific steps are as follows:
1. instrument parameter setting
(a) Mixing a sample to be detected with a reagent R1 and a reagent R2 (the volume ratio of the sample to be detected, the reagent R1 and the reagent R2 is 4:200:40) to enable the sample to be detected to fully react;
(b) measuring the absorbance difference after reaction by using a full-automatic biochemical analyzer (the dominant wavelength is 340nm, and the reading point of Hitachi 7180 full-automatic biochemical analyzer is 16-34 points);
(c) and calculating the concentration of AAT in the sample according to the absorbance change value.
The detection principle of the invention is as follows: the AAT in the sample can be combined with the anti-AAT antibody in the reagent to form an antigen-antibody complex, a certain turbidity is generated, the turbidity is proportional to the content of the antigen when a certain antibody exists, the turbidity is measured at a certain wavelength, and the AAT can be quantitatively measured through a multi-point calibration curve.
AAT (mg/dL) ═ Δ A in the sampleT/ΔAS×CS(mg/dL)
In the formula: delta ATAbsorbance variation, Delta A, of sample tube with blank tube absorbance as referenceSCalibration of the value of the change in absorbance of the tubes, C, against the absorbance of the blank tubesSConcentration of AAT in the calibration solution.
Example 2 kit Performance test
(1) The accuracy is as follows: and (3) carrying out accuracy test on the two groups of quality control products by using the kit, repeating the test for 3 times, reading signals by using a full-automatic biochemical analyzer, and calculating the relative deviation between the measured mean value and the target value. The experimental result shows that the relative deviation of the test value of the kit and the target value of the quality control product can be controlled within 1.5 percent, and the kit has higher accuracy.
(2) Repeatability: selecting a clinical AAT low-value sample, a clinical AAT medium-value sample and a clinical AAT high-value sample, testing the samples by using the kit, setting 10 times of repetition, reading signals by using a full-automatic biochemical analyzer, and respectively calculating a determination mean value and a standard deviation. The experimental result shows that the variation coefficient of the kit can be controlled within 2% when detecting low-value samples, medium-value samples and high-value samples, and the kit has high repeatability.
(3) Stability: standing at 2-8 deg.C for 2, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20 months respectively for detection; the uncapping stability test is carried out according to the test of placing for 0 day, 7 days, 14 days, 16 days, 18 days, 20 days, 22 days, 24 days, 26 days, 28 days, 30 days and 32 days at the temperature of 2-8 ℃. The result shows that the kit is stored in a light-proof environment at the temperature of 2-8 ℃ and has the validity period of 18 months. The product is stored in a dark environment at the temperature of 2-8 ℃ after being uncovered, and the validity period is 30 days.
Example 3 kit stability verification
1. Effect of the addition of 4 compositions on the stability of the kits
In order to verify that the heat stability and the decap stability of the reagent can be effectively improved by adding a specific surfactant, glucose, amino acid and alcohol composition into the reagent R2 of the AAT detection kit, 4 groups of kits are provided for performance verification, and the preparation methods of the 4 groups of kits are only different from the preparation method of the kit in the embodiment 1 in the concrete types and addition of the saccharides, the alcohols, the amino acids and the surfactant in the reagent R2, and are specifically provided as follows:
TABLE 1
Note: "√" indicates the addition of this component; "-" indicates that the component was not added.
(1) Verification of thermal stability
The deviation of the detection value of the 4 groups of kits from the initial measurement value every day when detecting the low value, the median value and the high value samples is detected by carrying out thermal acceleration on the 4 groups of kits at 37 ℃ for 11 days. The results of the experiments are shown in the following table:
TABLE 2 verification of thermal stability
The experimental results are shown in fig. 1, wherein the detection values of the low value, the median and the high value samples of the kit in group D show a significant decrease trend within 11 days under the condition of acceleration at 37 ℃, and particularly, the relative deviation of the detection value of the low value sample after 3 days from the initial value is more than 20%. Under the acceleration condition, the relative deviation of the detection values of the low value sample, the middle value sample and the high value sample of the kit in the groups A, B and C and the initial value sample in 11 days is controlled within 10%, especially the relative deviation of the kit in the group B is controlled within 2%.
(2) Open bottle stability verification
And (3) performing stability verification on the 4 groups of kits in a biochemical analyzer after 19 days of bottle opening, and detecting the deviation of the detection value of the 4 groups of kits from the initial detection value every day when the 4 groups of kits detect low-value, medium-value and high-value samples. The results of the experiments are shown in the following table:
TABLE 3 open bottle stability verification
The experimental results are shown in fig. 2, wherein the detection values of the low value, the medium value and the high value samples of the kit in group D show a significant decrease trend within 19 days under the bottle-opening condition, and particularly, the relative deviation of the detection values from the initial values is more than 10% after the bottle-opening condition of the low value sample and the medium value sample is 15 days. Under the condition of opening bottles, the relative deviation of the detection values of the low value, the middle value and the high value samples of the kit in the groups A, B and C and the initial value in 19 days is controlled within 10%, especially the relative deviation of the kit in the group B is controlled within 4%.
2. Effect of adding different compositions on the stability of the kit
In order to verify the influence of different combinations of surfactants, saccharides, amino acids and alcohols added in the reagent R2 of the AAT detection kit on the thermal stability and the stability of the reagent in the bottle opening process, 12 groups of kits are arranged for performance verification, and the preparation methods of the 12 groups of kits are only different from the preparation method of the kit in the embodiment 1 in the concrete types and addition of saccharides, alcohols, amino acids and surfactants in the reagent R2, and the concrete settings are as follows:
TABLE 4
Note: "√" indicates the addition of this component; "-" indicates that the component was not added.
(1) Verification of thermal stability
The deviation of the detection value of the 12 groups of kits from the initial measurement value on the 11 th day when the median sample is detected by carrying out thermal acceleration on the 12 groups of kits at 37 ℃ for 11 days. The results of the experiments are shown in the following table:
TABLE 5 verification of thermal stability
The experimental results show that the relative deviation of the detection value and the measured value of the 12 groups of kits on the 11 th day is higher, and the relative deviation of the lowest group I kit also reaches-4.49%.
(2) Open bottle stability verification
The stability of the 12 groups of kits in a biochemical analyzer is verified after the kits are opened for 19 days, and the deviation of the detection value of the 12 groups of kits on the 19 th day relative to the initial detection value when the median sample is detected. The results of the experiments are shown in the following table:
TABLE 6 decap stability verification
The experimental results show that the relative deviation of the detection value and the measured value of the 12 groups of kits on the 19 th day is higher, and the relative deviation of the L groups of kits with the lowest value reaches-6.23%. From the above experimental results, it was found that the addition of only one, two or three of the four substances of surfactant, saccharide, amino acid and alcohol to the reagent R2 did not improve the stability of the kit.
3. Effect of additive concentration on stability of kit
In order to verify the influence of the concentration of a specific composition added into the reagent R2 on the stability of the kit, 4 groups of kits are arranged for performance verification, and the preparation methods of the 4 groups of kits are only different from the preparation method of the kit in the embodiment 1 in the specific concentrations of Tween-80, glucose, sorbitol and glutamine in the reagent R2, and are specifically arranged as follows:
TABLE 7
| A | B | C | D | |
| Glucose (g/L) | 20 | 50 | 100 | 150 |
| Sorbitol (g/L) | 20 | 50 | 100 | 150 |
| Glutamine (mmol/L) | 5 | 20 | 50 | 100 |
| Tween-80(g/L) | 0.5 | 1 | 1.5 | 3 |
(1) Verification of thermal stability
The deviation of the detection value of the 4 groups of kits from the initial measurement value every day when detecting the low value, the median value and the high value samples is detected by carrying out thermal acceleration on the 4 groups of kits at 37 ℃ for 11 days. The experimental results are as follows:
TABLE 8 verification of thermal stability
The experimental results are shown in fig. 3, wherein the detection values of the low value, the middle value and the high value samples of the kits in the A group and the D group show a significant decrease trend within 11 days under the condition of acceleration at 37 ℃. Under the acceleration condition, the relative deviation of the detection values of the low value, the median value and the high value samples of the kit in the group B and the kit in the group C in 11 days and the initial value is controlled within 3 percent.
(2) Open bottle stability verification
And (3) performing stability verification on the 4 groups of kits in a biochemical analyzer after 19 days of bottle opening, and detecting the deviation of the detection value of the 4 groups of kits from the initial detection value every day when the 4 groups of kits detect low-value, medium-value and high-value samples. The results of the experiments are shown in the following table:
TABLE 9 open bottle stability verification
The experimental results are shown in fig. 4, wherein the detection values of the low value sample, the medium value sample and the high value sample of the group a and the group D kits show a significant decrease trend within 19 days under the condition of decapping, and particularly, the relative deviation of the detection values of the group D kits from the initial values is more than 10% after 17 days of decapping of the low value sample and the high value sample. And the relative deviation of the detection values of the low value, the median value and the high value samples of the kit in the group B and the kit in the group C and the kit in the group B are controlled within 4 percent within 19 days under the condition of bottle opening.
The experimental results show that when 50-100g/L of carbohydrate, 50-100g/L of alcohol, 10-50mmo/L of amino acid and 1-2g/L of surfactant composition are added into the reagent R2, the thermal stability and the bottle-opening stability of the kit are better, and especially when 75-100g/L of carbohydrate, 75-100g/L of alcohol, 10-20mmo/L of amino acid and 1.5-2g/L of surfactant composition are added, the thermal stability and the bottle-opening stability of the AAT detection kit can be remarkably improved.
Example 4 preparation of apolipoprotein E Immunoturbidimetric kit
The apolipoprotein E detection kit comprises a reagent R1 and a reagent R2 which are independent of each other.
Preparation of ApoE detection kit
(1) Preparation of reagent R1
The preparation is carried out according to the following formula, fully stirred and uniformly mixed, and stored at 2-8 ℃.
Reagent R1:
the solvent is purified water
(2) Preparation of reagent R2
The solvent is purified water
Example 5 verification of the Apolipoprotein E detection kit Performance
In order to verify that the specific surfactant, saccharide, amino acid and alcohol composition added into the reagent R2 of the ApoE detection kit can effectively improve the thermal stability and the decap stability of the reagent, 2 groups of kits are set for performance verification, and the specific settings are as follows:
group A: the kit was prepared as described in example 4;
group B: the preparation method of the kit is different from that of example 4 only in that glucose, sorbitol, glutamine and Tween-80 are not added to the reagent R2.
(1) Verification of thermal stability
And detecting the deviation of the detection value of the two groups of kits from the initial detection value every day when the two groups of kits detect low-value, medium-value and high-value samples in a thermal acceleration environment at 37 ℃ for 11 days. The results of the experiments are shown in the following table:
TABLE 10 verification of thermal stability
The experimental results are shown in fig. 5, wherein the detection values of the low value, the medium value and the high value sample of the kit in group B show a significant decrease trend within 11 days under the thermal acceleration condition, especially the relative deviation of the detection value of the high value sample from the initial value after the 9 th day is more than 10%, and the detection values of the low value, the medium value and the high value sample of the kit in group a show a relative deviation within 4% within 11 days under the acceleration condition of 37 ℃.
(2) Open bottle stability verification
And (3) performing stability verification on the two groups of kits in a biochemical analyzer after 19 days of bottle opening, and detecting the deviation of the detection value of the two groups of kits relative to the initial detection value every day when the two groups of kits detect low-value, medium-value and high-value samples. The results of the experiments are shown in the following table:
TABLE 11 open bottle stability verification
The experimental results are shown in fig. 6, wherein the detection values of the low value, the medium value and the high value samples of the kit in group B show a significant decrease trend within 19 days under the bottle-opening condition, especially the relative deviation of the detection values of the medium value and the low value samples from the initial values after 19 days is more than 10%. And the relative deviation of the detection values of the kit in the group A and the initial values of the kit in the group A in 19 days is controlled within 4 percent under the condition of bottle opening.
EXAMPLE 6 preparation of alpha 1-acid glycoprotein immunoturbidimetric kit
The alpha 1-acid glycoprotein detection kit comprises a reagent R1 and a reagent R2 which are independent of each other, and a double liquid component.
Preparation of AAG detection kit
(1) Preparation of reagent R1
The preparation is carried out according to the following formula, fully stirred and uniformly mixed, and stored at 2-8 ℃.
Reagent R1:
the solvent is purified water
(2) Preparation of reagent R2
The solvent is purified water
Example 7 validation of the Performance of the alpha 1-acid glycoprotein assay kit
In order to verify that the specific surfactant, saccharide, amino acid and alcohol composition added into the reagent R2 of the detection kit can effectively improve the thermal stability and the decap stability of the reagent, 2 groups of kits are arranged for performance verification, and the specific settings are as follows:
group A: the kit was prepared as described in example 6;
group B: the preparation method of the kit is different from that of example 6 only in that glucose, sorbitol, glutamine and Tween-80 are not added to the reagent R2.
(1) Verification of thermal stability
And detecting the deviation of the detection value of the two groups of kits from the initial detection value every day when the two groups of kits detect low-value, medium-value and high-value samples in a thermal acceleration environment at 37 ℃ for 11 days. The results of the experiments are shown in the following table:
TABLE 12 verification of thermal stability
The experimental results are shown in fig. 7, wherein the detection values of the low, medium and high samples of the group B kit showed a significant decrease trend within 11 days under the thermal acceleration condition, especially the relative deviation of the detection values of the low, medium and high samples from the initial values after 11 days was more than 5%, while the detection values of the low, medium and high samples of the group a kit were controlled within 3% of the relative deviation from the initial values within 11 days under the acceleration condition of 37 ℃.
(2) Open bottle stability verification
And (3) performing stability verification on the two groups of kits in a biochemical analyzer after 19 days of bottle opening, and detecting the deviation of the detection value of the two groups of kits relative to the initial detection value every day when the two groups of kits detect low-value, medium-value and high-value samples. The results of the experiments are shown in the following table:
TABLE 13 open bottle stability verification
The experimental results are shown in fig. 8, wherein the detection values of the low value, the medium value and the high value samples of the kit in group B under the bottle-opening condition show a significant decrease trend within 19 days, especially the relative deviation of the detection values of the low value, the medium value and the high value samples from the initial values exceeds 5% after 13 days. And the relative deviation of the detection values of the kit in the group A and the initial values of the kit in the group A in 19 days is controlled within 4 percent under the condition of bottle opening.
From the above experimental results, it is known that when glucose, glutamine, Tween-80 and a sorbitol composition are added to the reagent R2 of the immunoturbidimetric kit, the thermal stability and the open-bottle stability of the kit can be significantly improved.
Although embodiments of the present invention have been shown and described above, it should be understood that the above embodiments are exemplary and not to be construed as limiting the present invention, and that those skilled in the art can make changes, modifications, substitutions and alterations to the above embodiments without departing from the principles and spirit of the present invention.
Claims (10)
1. The composition is suitable for improving the stability of an immunoturbidimetric reagent and comprises a surfactant, a saccharide substance, an alcohol substance and amino acid.
2. The composition for improving the stability of an immunoturbidimetric reagent of claim 1, wherein the surfactant is at least one selected from Tween-80, Tween-20 or Triton X-100; the saccharide substance is at least one of glucose, sucrose or trehalose; the alcohol substance is at least one selected from sorbitol, mannitol or glycerol; the amino acid is at least one of glutamine, glycine or glutamic acid.
3. The composition for improving the stability of an immunoturbidimetric reagent of claim 2, wherein the surfactant is Tween-80, the saccharide is glucose, the alcohol is sorbitol, and the amino acid is glutamine.
4. The composition for improving the stability of immunoturbidimetric reagents according to claim 3, wherein the concentration of the surfactant is 1-2 g/L; the concentration of the saccharide is 50-100 g/L; the concentration of the alcohol substance is 50-100 g/L; the concentration of the amino acid is 10-50 mmol/L.
5. The composition for improving the stability of immunoturbidimetric reagents according to claim 4, wherein the concentration of the surfactant is 1.5-2 g/L; the concentration of the saccharide is 75-100 g/L; the concentration of the alcohol substance is 75-100 g/L; the concentration of the amino acid is 10-20 mmol/L.
6. An immunoturbidimetric kit, wherein the reagent R2 of the kit comprises the composition suitable for improving the stability of the immunoturbidimetric reagent according to any one of claims 1 to 5.
7. The immunoturbidimetric kit of claim 6, wherein the immunoturbidimetric kit is used for detecting at least one of alpha 1-antitrypsin, apolipoprotein E or alpha 1-acid glycoprotein.
8. The immunoturbidimetric kit of claim 7, wherein the kit is an α 1-antitrypsin detection kit comprising a reagent R1 and a reagent R2, wherein the reagent R1 comprises 30-50mmol/L buffer solution, 100-400mmol/L inorganic salt ion, 40-90g/L coagulant, 1-2g/L surfactant, 0.5-1.5g/L preservative; the reagent R2 also comprises 30-300mmol/L buffer solution, 100-400mmol/L inorganic salt ions, 20-60% AAT antibody and 0.5-1.5g/L preservative.
9. The immunoturbidimetric kit of claim 8, wherein the buffer is selected from at least one of phosphate, Tris, PBS or BICINE; the inorganic salt ions are selected from at least one of sodium chloride or potassium chloride; the coagulant is selected from at least one of polyethylene glycol-6000 or polyethylene glycol-3000; the preservative is selected from at least one of sodium azide and Proclin.
10. The immunoturbidimetric kit according to claims 7-9, wherein the buffer is phosphate buffer, the inorganic salt ion is sodium chloride, the coagulant is polyethylene glycol-6000, and the preservative is sodium azide.
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