CN114740209A - D-dimer buffer reagent with sample diluent function - Google Patents
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Abstract
The invention discloses a D-dimer buffer reagent with a sample diluent effect, which comprises the following components in percentage by volume of 1L: 10-100 mmol of basic buffer solution, 30-100 g of coagulant, 0.02-0.1 g of blocking agent, 2-5 g of alkali metal chloride, 30-90 g of inert protein, 0.5-0.8 g of metal ion chelate and 0.3-0.8 mL of preservative; and the pH value of the D-dimer buffer reagent is 6.0-8.0. The invention has the function of sample diluent on the basis of the buffer function, does not need additional sample diluent, can ensure the accuracy and reliability of the test result of the client, does not need to worry about the influence and the interference of the sample diluent on the test result, and can eliminate the interference caused by heterophile antibodies in the test sample; compared with the prior art, the method is simple and convenient to operate, high in realizability and beneficial to market popularization and customer use.
Description
Technical Field
The invention relates to the technical field of medical in-vitro diagnosis, in particular to a D-dimer buffer reagent with the function of a sample diluent.
Background
The human fibrinolytic system plays a vital role in maintaining normal permeability of blood vessel walls, maintaining the flowing state of blood and repairing tissues. Wherein the D-dimer is a specific degradation product generated by hydrolyzing crosslinked fibrin by plasmin. Therefore, the change of D-dimer can reflect the coagulation and fibrinolysis processes, and when the level is increased, the frequent fibrin degradation processes exist in the body, which are often seen in secondary hyperfibrinolysis, such as hypercoagulable state, disseminated intravascular coagulation, kidney diseases, organ transplant rejection and the like. Therefore, in theory, the quantitative detection of D-dimer is a key index of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE) and Disseminated Intravascular Coagulation (DIC), and can also reflect the thrombolytic effect of the drug. At present, the clinical methodologies are agglutination, enzyme-linked immunosorbent assay, colloidal gold assay, immunoturbidimetry and the like, and compared with other diagnostic methods, the immunoturbidimetry is widely applied due to the advantages of simple operation, rapidness, accurate quantification and the like.
The immunoturbidimetry is to make D-dimer antigen in a plasma sample to be detected and latex microspheres coated with D-dimer monoclonal antibody undergo antigen-antibody reaction to produce agglutination to raise turbidity so as to raise absorbance, so that the D-dimer level in the test sample can be reflected by the change of absorbance. In clinical examination, due to the limited linear range of detection, excessive antigen and other situations, the detection result exceeds the upper limit of the linear range, and accurate detection result can be obtained only by diluting the detection result in a certain proportion. Therefore, when detecting on a blood coagulation analyzer, a D-dimer buffer solution, a D-dimer reagent and a diluent are usually included in combination for testing the D-dimer item. Wherein the D-dimer buffer comprises a buffer, a coagulant, a blocking agent, a stabilizer, a preservative, and the like; the D-dimer reagent comprises latex microspheres coated with D-dimer monoclonal antibodies and a buffer solution; the diluent mainly comprises alkali metal chloride, inert protein, metal ion chelate, preservative and the like. Often, the kit of the manufacturer does not contain diluent, so that the diluent needs to be purchased additionally or prepared separately by a hospital or a client, and the use difficulty and the complexity of a consumer are greatly increased. Meanwhile, since the diluent is not contained in the kit, the diluent used by the client cannot be judged correctly, and the accuracy and reliability of the result can be directly influenced if the diluent is properly selected. In addition, the dilution liquid inevitably affects the reaction environment, the test speed, new interference factors and the like in the process of diluting the sample.
In summary, it is an urgent need to provide a D-dimer buffer solution that can act as a sample diluent.
Disclosure of Invention
The technical problem to be solved by the invention is to provide a D-dimer buffer solution with the function of a sample diluent, aiming at the problem that a D-dimer detection kit in the prior art does not contain a diluent.
The technical scheme adopted by the invention for solving the technical problems is as follows: a D-dimer buffer reagent with the function of sample diluent comprises the following components by taking the total volume of the reagent as 1L: 10-100 mmol of basic buffer solution, 30-100 g of coagulant, 0.02-0.1 g of blocker, 2-5 g of alkali metal chloride, 30-90 g of inert protein, 0.5-0.8 g of metal ion chelate and 0.3-0.8 mL of preservative; and the pH value of the D-dimer buffer reagent is 6.0-8.0.
Preferably, the basic buffer solution is at least one of HEPES buffer solution, MES buffer solution and Tris buffer solution, and the content of the basic buffer solution is 25-65 mmol.
Preferably, the coagulant is at least one of polyethylene glycol 2000, polyethylene glycol 4000, polyethylene glycol 6000 and polyethylene glycol 8000, and the content of the coagulant is 40-80 g.
Preferably, the blocking agent is one of mouse lgG, mouse lgM and mouse serum, and the content of the blocking agent is 0.04-0.08 g.
Preferably, the alkali metal chloride is at least one of sodium chloride and potassium chloride, and the content of the alkali metal chloride is 3-4 g.
Preferably, the inert protein is at least one of human serum albumin, bovine serum albumin and horse serum albumin, and the content of the inert protein is 45-75 g.
Preferably, the metal ion chelate is at least one of EDTA and EDTA derivatives, and the content of the metal ion chelate is 0.6-0.7 g.
Preferably, the preservative is at least one of sodium azide and ProClin300, and the content of the preservative is 0.3-0.5 mL.
Preferably, the pH value of the D-dimer buffer reagent is 7.0-7.5.
The invention has the beneficial effects that:
(1) according to the invention, the matching dosage of the coagulant, the blocking agent and the alkali metal chloride is adjusted, and the coordination is realized through the selected dosage, so that the D-dimer buffer reagent has a good sample diluent effect on the basis of the buffer function, the problem that a client needs to buy a sample diluent separately and additionally is solved, the client is convenient to use and operate, and the confusion condition is not easy to occur.
(2) In the invention, because additional sample diluent is not needed, the accuracy and reliability of the test result of the client are ensured, the influence and interference of the sample diluent on the test result are not needed to be worried about, and the D-dimer buffer reagent can eliminate the interference caused by heterophile antibodies in the test sample.
(3) The invention can be applied to other projects of which the methodology is immunoturbidimetry, has simple and convenient operation and strong realizability, and is beneficial to market popularization and customer use.
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FIG. 1 is a linear range correlation analysis of example 1 of the present invention.
Detailed Description
In order to make the technical features, objects and effects of the present invention more clearly understood, the present invention will be further described in detail with reference to the following examples, which are provided for illustration only and are not intended to limit the scope of the present invention.
The invention provides a D-dimer buffer reagent with the function of a sample diluent, which comprises the following components in percentage by volume of 1L: 10-100 mmol of basic buffer solution, 30-100 g of coagulant, 0.02-0.1 g of blocking agent, 2-5 g of alkali metal chloride, 30-90 g of inert protein, 0.5-0.8 g of metal ion chelate and 0.3-0.8 mL of preservative; and the pH value of the D-dimer buffer reagent is 6.0-8.0, preferably 7.0-7.5. As the peracid or alkali environment is not suitable for the antigen-antibody reaction in the reaction system, the pH value is selected to be 7.0-7.5.
Wherein the basic buffer solution is at least one of HEPES buffer solution, MES buffer solution and Tris buffer solution, and the content of the basic buffer solution is preferably 25-65 mmol. The basic buffer solution has certain buffer capacity, high solubility and good biocompatibility, and the pH value of the basic buffer solution is slightly changed along with the external influence. The basic buffer solution is added into the D-dimer buffer reagent to provide a proper reaction environment (pH, osmotic pressure, ionic strength and the like) for subsequent antigen-antibody reaction. In the long-term storage process of the D-dimer buffer reagent, a proper amount of basic buffer solution is beneficial to maintaining the stable state of the D-dimer buffer reagent, and the conditions of reagent sedimentation, pH value floating, reaction signal value reduction and the like are not easy to occur, so that the content of the selected buffer solution is 25-65 mL.
The coagulant is at least one of polyethylene glycol 2000, polyethylene glycol 4000, polyethylene glycol 6000 and polyethylene glycol 8000, and the content of the coagulant is preferably 40-80 g. The coagulant is added to facilitate the rapid reaction of antigen and antibody and improve the testing speed, but if the addition amount is too large, the non-tested immune complex in the sample is easy to precipitate, the testing result is interfered, the false positive is caused, and the positive testing result is increased. Especially when the D-dimer buffer reagent plays a role of a sample diluent, the addition amount of the coagulant is very critical, and the dilution effect of the reagent is influenced. Therefore, the content of the organic silicon compound is 40-80 g.
The blocking agent is one of mouse lgG, mouse lgM and mouse serum, and the content of the blocking agent is preferably 0.04-0.08 g. The detection of D-dimers by immunoturbidimetry is susceptible to interference by heterophile antibodies in the test sample. Heterophile antibodies are antibodies in plasma samples that bind to other heterologous antibodies and interfere with the immunoassay system, causing false positives. The blocking agent can be combined with the heterophilic antibody to generate a steric hindrance effect, so that the heterophilic antibody cannot react with the labeled antibody, and the interference is eliminated, therefore, the blocking agent is beneficial to understanding the real test result of the D-dimer, and the situation that the test result is inaccurate due to the heterophilic antibody is avoided.
The alkali metal chloride is at least one of sodium chloride and potassium chloride, and the content of the alkali metal chloride is preferably 3-4 g. The addition of the alkali metal chloride in the D-dimer buffer reagent is beneficial to maintaining the conductivity, osmotic pressure and optimal ionic strength of the buffer solution and maintaining the optimal reaction conditions required by the antigen and the antibody, thereby ensuring the accuracy and reliability of the D-dimer test result in the plasma sample.
The inert protein is at least one of human serum albumin, bovine serum albumin and horse serum albumin, and the content of the inert protein is 45-75 g.
The metal ion chelate is at least one of EDTA and EDTA derivatives, and the content of the metal ion chelate is 0.6-0.7 g. Wherein the EDTA derivative is alkali metal salt of EDTA, such as sodium salt, potassium salt or magnesium salt, and the metal ion chelate can form stable complex with metal ion to prevent interference of metal ion in D-dimer reagent.
The preservative is at least one of sodium azide and ProClin300, and the content of the preservative is 0.3-0.5 mL.
According to the invention, by adjusting the matching dosage of the coagulant, the blocking agent and the alkali metal chloride and realizing the synergy among the selected dosages, the D-dimer buffer reagent has a good sample diluent effect on the basis of the buffering function, the problem that a client needs to buy a sample diluent independently and additionally is solved, the client is convenient to use and operate, the confusion condition is not easy to occur, and the accuracy and the reliability of the test result of the client are ensured. In addition, the D-dimer buffer reagent can eliminate interference caused by heterophile antibodies in a test sample, so that the influence and interference of a sample diluent on a test result are not required to be worried about.
The following is illustrated by specific examples:
example 1
A D-dimer buffer reagent with the function of sample diluent comprises the following components by taking the total volume of the reagent as 1L: HEPES buffer solution (50 mmol), polyethylene glycol 6000 (40 g), mouse lgG (0.05 g), sodium chloride (4.5 g), bovine serum albumin (65 g), EDTA (0.6 g), and ProClin (0.3 mL) 300 (0.5 mmol) were added to the buffer solution, and the pH of the buffer solution was adjusted to 7.5.
The above reagents were prepared as follows:
50mmol of HEPES buffer was prepared, and 40g of polyethylene glycol 6000, 0.05g of mouse lgG, 4.5g of sodium chloride, 65g of bovine serum albumin, 0.6g of EDTA, and 0.3mL of ProClin300 were mixed with the HEPES buffer so that the total volume was 1L, and the pH was measured to be 7.5.
The following examples were prepared in the same manner as described above.
According to the invention, through the embodiment 1, on the basis of the basic buffer solution, the coagulant, the blocking agent, the alkali metal chloride, the inert protein, the metal ion chelate and the like are added, and corresponding performance tests are carried out, so that the buffer solution has a buffer function and simultaneously has good dilution performance.
Dilution test of Mono, D-dimer buffer reagent
The test instrument: full-automatic blood coagulation analyzer
The testing steps are as follows: three high-value samples containing the analyte, including a sample 1 with a concentration of 20 +/-5.0 mug/mL (FEU), a sample 2 with a concentration of 40 +/-5.0 mug/mL (FEU), and a sample 3 with a concentration of 70 +/-10.0 mug/mL (FEU), were diluted 1:6, 1:8, 1:10, the concentration of the diluted sample was detected, the concentration of each sample was repeatedly measured 3 times, the measurement results were recorded, the dilution relative deviation of the individual samples was calculated according to the formula relative deviation = (the concentration of the sample after dilution-the concentration of the sample before dilution)/the concentration of the sample before dilution, and the test results are shown in the following table 1.
TABLE 1 dilution test results
As can be seen from Table 1, the relative deviation between the sample concentration before dilution and the calculated concentration after dilution is no more than 10% after the samples with different concentrations are diluted by 1:6, 1:8 and 1:10 by using the D-dimer buffer reagent of the present invention, which shows that the dilution effect of the present invention is good.
Linear range correlation assay for di, D-dimer buffer reagents
The test instrument: full-automatic blood coagulation analyzer
The test steps are as follows: a sample with a theoretical concentration of 11 mug/mL (FEU) is diluted to different concentrations by using the D-dimer buffer reagent of example 1, the concentration of the diluted sample is detected, the measurement is repeated 3 times at each concentration, and the measurement result is recorded. Performing linear regression analysis on the average value of the measured concentration and the theoretical value, calculating an estimation value of the theoretical concentration of each sample through a regression equation, and calculating the relative deviation (the sample concentration is higher than 2 mug/mL (FEU)) and the absolute difference (the sample concentration is lower than 2 mug/mL (FEU)) of the estimation value and the measurement average value of the concentration of the corresponding sample, wherein the test result is shown in the following table 2, and the linear regression equation is shown in the figure 1.
TABLE 2 Linear Range correlation test results
As can be seen from FIG. 1, the regression equation of the theoretical value of the sample concentration and the measured mean value is y =0.9943x +0.1811, and the correlation coefficient r =0.9990 ≥ 0.98, which indicates that the D-dimer buffer reagent of the present invention has a good correlation in the linear range of the sample concentration of 0.6875 μ g/ml to 11 μ g/ml. In YY _ T1255-2015 immune turbidimetric assay test reagents (cassettes) (transmission method), the linear indexes are described: the deviation of the linearity within the linear interval should be specified and can be expressed in terms of relative deviation or absolute difference in different segments of the linear interval, depending on the actual situation. According to the technical requirements of the product, the relative deviation of 2-11 mu g/mL (FEU) is +/-10%; the absolute difference between 0.25 and 2 μ g/mL (FEU) is within + -0.2. As can be seen from Table 2, the relative deviation between the sample measurement mean value with the concentration of more than 2 mug/mL (FEU) and the estimation value does not exceed 10%, which indicates that the accuracy of the measurement result using the D-dimer buffer reagent of the invention is high.
Anti-interference test of tri-D-dimer buffer reagent
The test instrument: full-automatic blood coagulation analyzer
The test steps are as follows: adding interfering substance rheumatoid factor or HAMA with the same volume and different concentrations into two human plasma samples (including low-value plasma samples and high-value plasma samples) with different D-dimer concentrations to serve as interfering groups; distilled water was added to the two plasma samples in the same volume as the interfering substance, and used as a control group. Detecting the concentrations of the samples containing interferents with different concentrations, repeating the detection for 3 times for each sample, recording the detection results, calculating the mean value, and calculating the relative deviation between each interference group and the control group, wherein the detection results are shown in tables 3-4.
TABLE 3 anti-interference test result 1
As can be seen from Table 3, in the low-value plasma sample or the high-value plasma sample, when the concentration of the rheumatoid factor reaches 500IU/mL, the relative deviation of the sample detection results of the interference group and the control group does not exceed 10%, so that the D-dimer buffer reagent has a good anti-interference effect on the rheumatoid factor.
TABLE 4 anti-interference test result 2
As can be seen from Table 4, in the low value plasma sample or the high value plasma sample, when the concentration of HAMA reaches 100ng/mL, the relative deviation of the sample detection results of the interference group and the control group does not exceed 10%, so the D-dimer buffer reagent of the present invention has a good anti-interference effect on HAMA.
In conclusion, the D-dimer buffer reagent has good sample diluent effect, good correlation in linear range and high accuracy of sample detection results, and can eliminate interference of heterophile antibodies in a sample to be detected on the detection results.
Example 2
A D-dimer buffer reagent with the function of sample diluent comprises the following components by taking the total volume of the reagent as 1L: HEPES buffer solution (50 mmol), polyethylene glycol 6000 (100 g), mouse lgG (0.1 g), sodium chloride (5 g), bovine serum albumin (65 g), EDTA (0.6 g) and ProClin (0.3 mL) 300 (0.5 mmol) were added to the buffer solution, and the pH of the buffer solution was adjusted to 7.5. After six-fold, eight-fold and ten-fold dilution through detection, the relative deviation of the sample concentration before dilution and the calculated concentration after dilution is 3.56%, 8.39% and 9.77% respectively.
Example 3
A D-dimer buffer reagent with the function of a sample diluent comprises the following components based on the total volume of the reagent of 1L: HEPES buffer solution with the content of 50mmol, 20g of polyethylene glycol 6000, 0.02g of mouse lgG, 2g of sodium chloride, 65g of bovine serum albumin, 0.6g of EDTA and 0.45mL of ProClin300, and the pH value of the buffer reagent is adjusted to 7.5. After six-fold, eight-fold and ten-fold dilution through detection, the relative deviation of the sample concentration before dilution and the calculated concentration after dilution is 4.12%, 7.21% and 9.59% respectively.
Example 4
A D-dimer buffer reagent with the function of sample diluent comprises the following components by taking the total volume of the reagent as 1L: HEPES buffer solution (25 mmol), polyethylene glycol 2000 (40 g), mouse lgM (0.08 g), potassium chloride (3 g), human serum albumin (30 g), potassium salt of EDTA (0.5 g), and sodium azide (0.55 mL) were added to the buffer solution, and the pH of the buffer solution was adjusted to 6.6. After six-fold, eight-fold and ten-fold dilution through detection, the relative deviation of the sample concentration before dilution and the calculated concentration after dilution is-2.85%, 0.89% and 7.25% respectively.
Example 5
A D-dimer buffer reagent with the function of a sample diluent comprises the following components based on the total volume of the reagent of 1L: MES buffer solution with a content of 90mmol, 70g polyethylene glycol 4000, 0.04g mouse serum, 5g sodium chloride, 45g horse serum albumin, 0.6g sodium salt of EDTA, 0.8mL ProClin300, and the pH value of the buffer reagent was adjusted to 7.9. After six-fold, eight-fold and ten-fold dilution through detection, the relative deviation of the sample concentration before dilution and the calculated concentration after dilution is-2.46%, 5.29% and 8.21% respectively.
Example 6
A D-dimer buffer reagent with the function of sample diluent comprises the following components by taking the total volume of the reagent as 1L: tris buffer solution with the content of 65mmol, 40g of polyethylene glycol 8000, 40g of polyethylene glycol 4000, 0.06g of mouse lgM, 5g of potassium chloride, 30g of bovine serum albumin, 35g of horse serum albumin, 25g of human serum albumin, 0.7g of magnesium salt of EDTA and 0.5mL of sodium azide, and the pH value of the buffer reagent is adjusted to be 7.6. After six-fold, eight-fold and ten-fold dilution through detection, the relative deviation of the sample concentration before dilution and the calculated concentration after dilution is respectively-3.22%, 8.21% and 9.02%.
Example 7
A D-dimer buffer reagent with the function of sample diluent comprises the following components by taking the total volume of the reagent as 1L: HEPES buffer solution (10 mmol), polyethylene glycol 2000 (35 g), mouse lgM (0.045 g), sodium chloride (5 g), human serum albumin (20 g), bovine serum albumin (55 g), EDTA (0.5 g) and sodium azide (0.4 mL) in an amount of 10mmol, and the pH of the buffer solution was adjusted to 6.1. After six-fold, eight-fold and ten-fold dilution through detection, the relative deviation of the sample concentration before dilution and the calculated concentration after dilution is 3.56%, 7.29% and 8.70% respectively.
The experiments in examples 2-7 also verify that the pH value of the reagent is between 6.0 and 8.0, the reagent has good buffering performance, and after the reagent is used as a diluent and is subjected to high-power dilution, the relative deviation between the concentration of a sample before dilution and the concentration calculated after dilution is not more than 10%, and the good dilution effect is proved.
The above description is only an embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications of equivalent structures and equivalent processes, which are made by the present specification, or directly or indirectly applied to other related technical fields, are included in the scope of the present invention.
Claims (9)
1. A D-dimer buffer reagent with the function of sample diluent is characterized by comprising the following components by taking the total volume of the reagent as 1L: 10-100 mmol of basic buffer solution, 30-100 g of coagulant, 0.02-0.1 g of blocker, 2-5 g of alkali metal chloride, 30-90 g of inert protein, 0.5-0.8 g of metal ion chelate and 0.3-0.8 mL of preservative; and the pH value of the D-dimer buffer reagent is 6.0-8.0.
2. The D-dimer buffer reagent with sample dilution function according to claim 1, wherein the base buffer is at least one of HEPES buffer, MES buffer and Tris buffer, and the content thereof is 25-65 mmol.
3. The D-dimer buffer reagent with the function of a sample diluent, according to claim 1, wherein the coagulant is at least one of polyethylene glycol 2000, polyethylene glycol 4000, polyethylene glycol 6000 and polyethylene glycol 8000, and the content of the coagulant is 40-80 g.
4. The D-dimer buffer reagent having a function as a sample diluent according to claim 1, wherein the blocking agent is one of mouse lgG, mouse lgM and mouse serum, and the content thereof is 0.04 to 0.08 g.
5. The D-dimer buffer reagent according to claim 1, wherein the alkali metal chloride is at least one of sodium chloride and potassium chloride, and the content of the alkali metal chloride is 3 to 4 g.
6. The D-dimer buffer reagent of claim 1, wherein the inert protein is at least one of human serum albumin, bovine serum albumin and horse serum albumin, and the content of the inert protein is 45-75 g.
7. The D-dimer buffer reagent having a function as a sample diluent according to claim 1, wherein the metal ion chelate is at least one of EDTA and EDTA derivative, and the content thereof is 0.6 to 0.7 g.
8. The D-dimer buffer reagent serving as a sample diluent according to claim 1, wherein the preservative is at least one of sodium azide and ProClin300, and the content of the preservative is 0.3-0.5 mL.
9. The D-dimer buffer reagent having a function as a sample diluent according to claim 1, wherein the pH of the D-dimer buffer reagent is 7.0 to 7.5.
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| CN116026666A (en) * | 2023-03-29 | 2023-04-28 | 珠海科域生物工程股份有限公司 | Plasma sample diluent for D-dimer magnetic particle enzymatic chemiluminescence kit and preparation method thereof |
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| CN116026666A (en) * | 2023-03-29 | 2023-04-28 | 珠海科域生物工程股份有限公司 | Plasma sample diluent for D-dimer magnetic particle enzymatic chemiluminescence kit and preparation method thereof |
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