CN117871869A - Liquid composite quality control material shared by different thrombus detection projects and preparation method thereof - Google Patents
Liquid composite quality control material shared by different thrombus detection projects and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the technical field of thrombus in-vitro diagnosis, and particularly discloses a liquid composite quality control material shared by different thrombus detection projects and a preparation method thereof, wherein the liquid composite quality control material comprises water and the following substances dissolved in the water: a thrombus detection standard substance analyte, a metal chelate, polyethylenimine, a stabilizer, a surfactant and bovine serum albumin; wherein the thrombus detection standard substance analyte is a quality control substance corresponding to a thrombus detection item, and the species of the thrombus detection standard substance analyte is greater than or equal to one species. The liquid composite quality control object provided by the invention is liquid, has stability and convenience, effectively reduces the freeze-drying cost, is suitable for a plurality of thrombus detection projects, does not need to prepare the quality control object independently, effectively reduces useless actions, improves the efficiency, and obtains experimental results more quickly.
Description
Technical Field
The invention belongs to the technical field of thrombus in-vitro diagnosis, and particularly relates to a liquid composite quality control material shared by different thrombus detection projects and a preparation method thereof.
Background
In the medical field today, chemiluminescent immunoassay has become an attractive technological breakthrough. This technique combines highly sensitive chemiluminescent assay technology with highly specific immune responses and can be used for a variety of assays including antigens, haptens, antibodies, hormones, enzymes, fatty acids, vitamins, and drugs. It is used as the latest development of immunoassay technology, and after the analysis of immunity, enzyme immunity, fluorescence immunity and time-resolved fluorescence immunity, a new technical era is opened. With the advent of the 21 st century, this technology was continuously evolving under the push of foreign technology, gradually replacing the traditional enzyme linked immunosorbent assay, time-resolved methodology and fluorescent immunoassay. In the immunodetection market, chemiluminescent technology stands out for its uniqueness, and becomes the dominant immunodiagnostic technology.
This technique is widely used in a variety of assays, including thrombosis, cytokines, anemia, liver fibrosis, hypertension, autoimmunity, and allergens. Among them, the current thrombus detection kit contains the following 6 items, namely, plasmin- α2 Plasmin Inhibitor Complex (PIC), thrombomodulin (TM), tissue plasminogen activator-plasminogen activator inhibitor-1 complex (t-PAIC), thrombin-antithrombin III complex (TAT), fibrin (ogen) degradation product (FDP) and D-D Dimer (D-Dimer). Since these analyte components are very unstable, they are easily decomposed at normal temperature or at 2-8℃to result in a decrease in the concentration of the analyte. If some items are unstable, the accuracy of the measurement will be affected, which in turn will affect the quality control of the experiment. In clinical experiments, it is important to ensure the accuracy of the results. Therefore, quality control is a key element for guaranteeing experimental accuracy and consistency.
In addition, often multiple experiments are performed simultaneously in a clinical laboratory, and in many cases, a combination package test is required to aid in diagnosis of a condition, which can be complicated and error-prone if separate quality control substances are used for each item. Therefore, if the process of the experiment can be monitored by using only the same quality control substance when detecting a plurality of thrombus detection package items, the accuracy, stability and consistency of the detection can be ensured to the greatest extent, however, the quality control substance used in the existing thrombus detection cannot be simultaneously tested for detecting a plurality of thrombus.
Therefore, there is a need to develop a liquid composite quality control material which has good stability and can be used for different thrombus detection projects at the same time.
Disclosure of Invention
In order to solve the problems in the prior art, the invention provides the liquid composite quality control object shared by different thrombus detection items, which can simultaneously carry out quality control tests of a plurality of thrombus detection items, does not need to prepare the quality control object separately for each item, effectively reduces useless actions, greatly improves the efficiency and can obtain experimental results more quickly.
In order to achieve the above purpose, the invention adopts the following technical scheme:
a liquid composite quality control material shared by different thrombus detection projects comprises water and the following substances dissolved in the water:
a thrombus detection standard substance analyte, a metal chelate, polyethylenimine, a stabilizer, a surfactant and bovine serum albumin;
wherein the thrombus detection standard substance analyte is a quality control substance corresponding to a thrombus detection item, and the species of the thrombus detection standard substance analyte is greater than or equal to one species.
According to the invention, the liquid composite quality control material shared by different thrombus detection projects is obtained through mutual coordination of the components, the liquid composite quality control material can be stably stored at 2-8 ℃ for at least 12 months, the stability of the measured values of a plurality of projects is ensured, the reproducibility is good, reliable quality assurance is provided for the quality control of clinical experiments, and the quality control material does not need to be additionally and independently prepared for each project, so that the detection efficiency is greatly improved. Among them, the metal chelate may bind to calcium ions and reduce the activity thereof, thereby inhibiting the occurrence of blood coagulation. Polyethyleneimine (PEI) is a soluble high molecular polymer with dispersing action and liquid stabilizing properties. The polyethyleneimine can help maintain the dispersion state of various components in the quality control liquid, prevent the formation of condensation or precipitation, and help maintain the uniformity and stability of the liquid. The stability and durability of the quality control liquid can be enhanced by adopting the stabilizer, and the surfactant can enable each component to be dispersed more uniformly, so that the stability of the liquid composite quality control object is enhanced. Bovine serum albumin is used to increase the stability of the solution, especially for some proteins or biomolecules. It may reduce the likelihood of protein denaturation or precipitation due to temperature changes, pH changes, or other environmental factors. And in some cases, bovine serum albumin may protect some sensitive biomolecules from contamination with trace metal ions or other contaminants, thereby maintaining their activity and stability.
Preferably, the number of types of the analyte of the thrombus detection standard substance is 6 or less. Specifically, the standard substance analytes include PIC analytes (plasmin-. Alpha.2 plasmin inhibitor complex analytes), TM analytes (thrombomodulin analytes), t-PAIC analytes (tissue plasminogen activator-plasminogen activator inhibitor-1 complex analytes), TAT analytes (thrombin-antithrombin III complex analytes), FDP analytes (fibrin (ogen) degradation product analytes), D-Dimer analytes (D-D Dimer analytes).
It is to be readily understood that the concentration (or mass fraction) of the standard substance analyte is related to the corresponding detection item, and the present invention is not limited to various standard substance analytes.
Preferably, the metal chelate is 2, 2-bipyridine (2, 2' -bipyridine) capable of better binding with calcium ions and reducing the activity thereof, thereby inhibiting the occurrence of blood coagulation, the ratio of the mass of the metal chelate to the mass of water is greater than 0.1%, further, the ratio of the mass of the metal chelate to the mass of water is greater than 0.1% and less than or equal to 0.2%.
Preferably, the ratio of the mass of the polyethyleneimine to the mass of water is greater than 0.1%, further, the mass of the polyethyleneimine to the mass of water is greater than 0.1% and less than or equal to 0.2%.
Preferably, the stabilizer is at least one of N-butyl-2-chloroacetamide and sheep IgG.
In the present invention, the ratio of the mass of the stabilizer to the mass of water is greater than 1.0%, further, the ratio of the mass of the stabilizer to the mass of water is greater than 1.0% and less than or equal to 5.0%, specifically, the ratio of the mass of the N-butyl-2-chloroacetamide to the mass of water is greater than 1.0% and less than or equal to 5.0%, and the ratio of the mass of the sheep IgG to the mass of water is greater than 1.0% and less than or equal to 5.0%.
In the invention, N-butyl-2-chloroacetamide and sheep IgG are selected as stabilizers to enhance the stability and durability of the quality control liquid. Wherein N-butyl-2-chloroacetamide is an antibacterial agent and inhibitor, and is used as a chemical substance for preventing the growth of microorganisms in a quality control liquid. It helps to prevent contamination of the quality control liquid by bacteria or other microorganisms, thereby maintaining the water-purifying and stability of the liquid. Sheep IgG is an immunoglobulin with strong stability. It is added to the quality control liquid as a stabilizer to help maintain stability of other components in the liquid, thereby helping to extend the effective lifetime of the quality control liquid and ensure that the quality control liquid maintains its desired characteristics and properties during use by providing additional protection and stability. That is, the selection of N-butyl-2-chloroacetamide and sheep IgG as stabilizers may prevent microbial contamination and enhance the stability of the various components of the quality control fluid to ensure that the quality control fluid remains stable in its liquid state and performance during storage and use.
Preferably, the ratio of the mass of the bovine serum albumin to the mass of the water is greater than 5.0%, and further, the ratio of the mass of the bovine serum albumin to the mass of the water is greater than 5.0% and less than or equal to 10%.
Preferably, the surfactant is sodium dodecyl sulfate, and the ratio of the mass of the surfactant to the mass of water is greater than 0.5 and less than or equal to 1.0%.
In the invention, the sodium dodecyl sulfate is selected as the surfactant because the sodium dodecyl sulfate has good emulsifying property, foamability, solubility, biodegradability, alkali resistance and hardness resistance, has high stability in solution with wider pH value, is easy to synthesize and has low price.
The second aspect of the invention provides a method for configuring a liquid composite quality control object shared by different thrombus detection projects, which comprises the following specific steps:
(1) Adding a thrombus detection standard substance analyte, a metal chelate, polyethyleneimine, a stabilizer, a surfactant and bovine serum albumin into water, and uniformly stirring to obtain a liquid composite quality control substance;
(2) And (5) placing the liquid composite quality control object in an environment of 2-8 ℃ and preserving in a dark place.
In a third aspect, the present invention provides an application of a liquid composite quality control material shared by different thrombus detection items, where the liquid composite quality control material shared by different thrombus detection items is used in detection of a thrombus item in a chemiluminescent immunoassay.
Compared with the prior art, the invention has the following technical effects:
the liquid composite quality control material provided by the invention is liquid, and has the advantages of stability and convenience, and effectively reduces the freeze-drying cost. According to the invention, through mutual coordination of the components, the liquid composite quality control material shared by different thrombus detection projects is obtained, the liquid composite quality control material can be used as a sample to be directly used for detecting a plurality of thrombus projects of chemiluminescence immunoassay, after stability verification, the liquid composite quality control material can be stably stored for at least 12 months under the condition of 2-8 ℃, the measured value is stable, the reproducibility is good, reliable quality assurance is provided for quality control of clinical experiments, and 6 thrombus detection projects can be simultaneously subjected to quality control test, and the quality control material does not need to be additionally and independently prepared for each project, so that useless actions are effectively reduced, the efficiency is greatly improved, and experimental results are obtained more quickly.
Detailed Description
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following description will explain the specific embodiments of the present invention. It is obvious that the present invention is described below with respect to only some embodiments, and that other embodiments may be made by those skilled in the art without the exercise of inventive faculty.
The invention provides a liquid composite quality control material shared by different thrombus detection projects, which comprises water and the following substances dissolved in the water:
thrombus detection standard substance analyte, metal chelate, polyethylenimine, stabilizer, surfactant and bovine serum albumin.
In the present invention, the metal chelate, the stabilizer, the polyethyleneimine, the surfactant and the bovine serum albumin do not chemically react with each other and do not react with the analyte which is a thrombus detection standard substance.
In the invention, 6 types of thrombus detection standard substance analytes, specifically PIC, TM and t-PAIC, TAT, FDP, D-Dimer, can be used for simultaneously carrying out quality control test on 6 thrombus detection projects.
Further, the metal chelate of the present invention is an existing chelating agent such as 2, 2-bipyridine (2, 2' -Bipyridyl) which is capable of binding calcium ions better and reducing the activity thereof, thereby inhibiting the occurrence of blood coagulation. The ratio of the mass of the metal chelate to the mass of water is greater than 0.1% and less than or equal to 0.2%, for example, the ratio of the mass of the metal chelate to the mass of water is 0.11%, 0.12%, 0.13%, 0.14%, 0.15%, 0.16%, 0.17%, 0.18%, 0.19%, 0.2%.
Further, the mass ratio of the polyethyleneimine to the mass of water is greater than and less than or equal to 0.2%, for example, the mass ratio of the polyethyleneimine to the mass of water is 0.11%, 0.12%, 0.13%, 0.14%, 0.15%, 0.16%, 0.17%, 0.18%, 0.19%, 0.2%.
Further, the ratio of the mass of the stabilizer to the mass of water is greater than 2.0% and less than or equal to 10.0%, for example, the ratio of the mass of the stabilizer to the mass of water is 2.0%, 3.0%, 4.0%, 5.0%, 6.0%, 7.0%, 8.0%, 9.0%, 10.0%, specifically, the ratio of the mass of N-butyl-2-chloroacetamide to the mass of water is greater than 1.0% and less than or equal to 5.0%; such as 1.5%, 2.0%, 2.5%, 3.0%, 3.5%, 4.0%, 4.5%, 5.0%, specifically, the ratio of the mass of sheep IgG to the mass of water is greater than 1.0% and less than or equal to 5.0%, such as 1.5%, 2.0%, 2.5%, 3.0%, 3.5%, 4.0%, 4.5%, 5.0%.
Further, the ratio of the mass of the bovine serum albumin to the mass of water is 5.0% or more and 10% or less. For example, 6.0%, 7.0%, 8.0%, 9.0%, 10.0%.
Further, the surfactant is a conventional surfactant, either an ionic surfactant or a nonionic surfactant, preferably sodium dodecyl sulfate, and the ratio of the mass of the surfactant to the mass of water is greater than 0.5 and less than or equal to 1.0%, such as 0.6%, 0.7%, 0.8%, 0.9%, 1.0%.
Taking 6 thrombus detection standard substance analytes as an example, in each 1000g of water, specific classes of standard analytes and their concentrations are as follows:
PIC analyte (concentration 20 μg/mL), TM analyte (concentration 150 TU/mL), t-PAIC analyte (concentration 50 ng/mL), TAT analyte (concentration 80 ng/mL), FDP analyte (concentration 55 μg/mL), D-Dimer analyte (concentration 30 μg/mL).
The technical scheme of the invention is described in detail in the following by specific embodiments.
Example 1
Based on 1000g of water, 0.15% of 2,2' -Bipyridyl, 0.15% of polyethyleneimine, 2.5% of N-butyl-2-chloroacetamide, 2.5% of sheep IgG, 0.75% of sodium dodecyl sulfate and 7.5% of bovine serum albumin are added into 1000g of water, and the mixture is uniformly mixed and then stored at 2-8 ℃.
Example 2
Based on 1000g of water, 0.2% of 2,2' -bipyridil, 0.2% of polyethyleneimine, 5.0% of N-butyl-2-chloroacetamide, 5.0% of sheep IgG, 1.0% of sodium dodecyl sulfate and 10% of bovine serum albumin are added into 1000g of water, and the mixture is uniformly mixed and then stored at 2-8 ℃.
Comparative example 1
Based on 1000g of water, 0.1% of 2,2' -Bipyridyl, 0.1% of polyethylenimine, 1.0% of N-butyl-2-chloroacetamide, 1.0% of sheep IgG, 0.5% of sodium dodecyl sulfate and 5.0% of bovine serum albumin are added into 1000g of water, and the mixture is uniformly mixed and then stored at 2-8 ℃.
The mass fractions of the remaining components excluding the standard substance analyte in comparative example 1 are lower than those in examples 1 and 2.
Comparative example 2
Based on 1000g of water, 0.15% of 2,2' -Bipyridyl, 2.5% of N-butyl-2-chloroacetamide, 2.5% of sheep IgG, 0.75% of sodium dodecyl sulfate and 7.5% of bovine serum albumin are added into 1000g of water, and the mixture is uniformly mixed and then stored at 2-8 ℃.
In comparison with example 1, the polyethylene imine is absent from comparative example 2.
Comparative example 3
Based on 1000g of water, 0.15% of 2,2' -Bipyridyl, 0.15% of polyethyleneimine, 0.75% of sodium dodecyl sulfate and 7.5% of bovine serum albumin are added into 1000g of water, and the mixture is uniformly mixed and then stored at 2-8 ℃.
In comparison with example 1, comparative example 3 lacks N-butyl-2-chloroacetamide and sheep IgG.
Comparative example 4
Based on 1000g of water, 0.15% of 2,2' -Bipyridyl, 0.15% of polyethyleneimine, 2.5% of N-butyl-2-chloroacetamide, 2.5% of sheep IgG and 0.75% of sodium dodecyl sulfate are added into 1000g of water, and the mixture is uniformly mixed and then stored at 2-8 ℃.
In comparison to example 1, the bovine serum albumin was absent in comparative example 4.
The same standard substance analytes of 6 thrombus detection items are respectively added in examples 1, 2 and comparative examples 1-4 to prepare a chemiluminescent immunoassay detection kit for 6 thrombus detection, the concentrations of the 6 standard substance analytes are as described above, after calibration, the liquid composite quality control substances are respectively prepared in 0 day, 1 day, 3 days, 7 days, 14 days, 31 days, 2 months, 3 months, 6 months, 9 months, 12 months and 13 months, the measured results are compared with the prepared concentrations, if the relative deviation is within 85% -115%, the measured values are stable, the measurement can be continuously observed, and if the relative deviation is out of range, the measurement is not continuously observed.
The specific stability results were verified as follows:
table 1 example 1 experimental results
Table 2 example 2 experimental results
TABLE 3 test results for comparative example 1
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Table 4 test results of comparative example 2
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Table 5 test results of comparative example 3
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Table 6 test results of comparative example 4
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Wherein "#DIV/0-.
From the test results of example 1 and comparative example 2, comparative example 3, and comparative example 4, it is seen that the stability effect is greatly reduced when the important component is absent from the liquid composite quality control material, wherein PIC starts to decrease at 9 months, TM starts to decrease at 3 months, t-PAIC starts to decrease at 14 days, TAT starts to decrease at 3 months, FDP starts to decrease at 3 months, and D-Dimer starts to decrease at 6 months; wherein PIC begins to decline at 7 days, TM begins to decline at 2 months, t-PAIC begins to decline at 31 days, TAT begins to decline at 7 months, FDP begins to decline at 9 months, and D-Dimer begins to decline at 2 months in the absence of N-butyl-2-chloroacetamide and sheep IgG; from the above results, it can be analyzed that, when the liquid composite quality control material lacks several important components, the stability of the contained test substance is greatly affected, and the quality monitoring requirement of the 6 clinical experiment cannot be satisfied, when the bovine serum albumin is absent, only the D-Dimer is reduced at 12 months compared with the example 1.
From the test results of examples 1 and 2 and comparative example 1, it is understood that when the contents of the respective components in the liquid composite quality control material are insufficient, stability for a part of the analytes therein is poor, for example, the concentration of t-PAIC starts to decrease at 31 days, TAT starts to decrease at 6 months, and the stability requirement of each item for at least 12 months cannot be maintained.
The liquid composite quality control materials prepared in the embodiment 1 and the embodiment 2 can be stably stored for at least 12 months, meets the stability requirement, and the cost of the embodiment 1 is lower than that of the embodiment 2, so that the liquid composite quality control material shared by multiple thrombus detection prepared in the embodiment 1 has good performance and lowest cost, and can meet the quality monitoring requirement of clinical experiments.
The foregoing is an example of the present application, and the protective enclosure of the present application is not limited by these specific examples, but is defined by the claims of the present application. It will be apparent to those skilled in the art that the present invention is not limited to the embodiments described herein, but is intended to cover such alternatives and modifications as may be included within the spirit and scope of the invention.
Claims (4)
1. The liquid composite quality control material shared by different thrombus detection projects is characterized by comprising water and the following substances dissolved in the water:
a thrombus detection standard substance analyte, a metal chelate, polyethylenimine, a stabilizer, a surfactant and bovine serum albumin;
wherein the thrombus detection standard substance analyte is a quality control substance corresponding to a thrombus detection item, and the species of the thrombus detection standard substance analyte is greater than or equal to one species;
the metal chelate is 2, 2-bipyridine, and the ratio of the mass of the metal chelate to the mass of water is more than 0.1% and less than or equal to 0.2%;
the ratio of the mass of the polyethyleneimine to the mass of the water is more than 0.1% and less than or equal to 0.2%;
the ratio of the mass of the stabilizer to the mass of the water is more than 2.0% and less than or equal to 10.0%, and the stabilizer is at least one of N-butyl-2-chloroacetamide and sheep IgG;
the ratio of the mass of the N-butyl-2-chloroacetamide to the mass of water is greater than 1.0% and less than or equal to 5.0%; the ratio of the mass of the sheep IgG to the mass of the water is more than 1.0% and less than or equal to 5.0%;
the ratio of the mass of bovine serum albumin to the mass of water is greater than 5.0% and less than or equal to 10%;
the surfactant is sodium dodecyl sulfate, and the ratio of the mass of the surfactant to the mass of water is more than 0.5 and less than or equal to 1.0%.
2. The liquid composite quality control material shared by different thrombus detection items according to claim 1, wherein the kinds of thrombus detection standard substance analytes are 6 or less, and the thrombus detection standard substance analytes include plasmin- α2 plasmin inhibitor complex analyte, thrombomodulin analyte, tissue plasminogen activator-plasminogen activator inhibitor-1 complex analyte, thrombin-antithrombin iii complex analyte, fibrin (ogen) degradation product analyte, D-D dimer analyte.
3. A method for preparing a liquid composite quality control material shared by different thrombus detection projects is characterized by comprising the steps of adding a thrombus detection standard substance analyte, a metal chelate, polyethylenimine, a stabilizer, a surfactant and bovine serum albumin into water, and uniformly stirring to obtain the liquid composite quality control material.
4. The application of the liquid composite quality control material shared by different thrombus detection items, which is characterized in that the liquid composite quality control material shared by different thrombus detection items as claimed in claim 1 or 2 is used for detecting thrombus items of chemiluminescence immunoassay.
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