CN115436615A - A dry analysis reagent for total cholesterol detection - Google Patents

Abstract

A dry-type analytical reagent for detecting total cholesterol comprises an upper support layer, a diffusion layer, a reagent layer, a support and a lower support layer from top to bottom, wherein the diffusion layer, the reagent layer and the support are sequentially arranged at the middle position between the upper support layer and the lower support layer from top to bottom, the pores at the two ends of the upper support layer and the lower support layer are bonded through the middle support layer, the middle positions of the upper support layer and the lower support layer are respectively provided with a sample adding hole and a test hole, the diffusion layer is an isotropic porous diffusion film, and the porosity of the diffusion layer is 50-85%; the diffusion layer consists of polystyrene microspheres, an adhesive and a surfactant, wherein the particle size of the polystyrene microspheres is 0.1-1 mu m; the reagent layer comprises a surfactant, cholesterol esterase, cholesterol oxidase, horseradish peroxidase, a colorless dye, a buffer solution, a stabilizer and a water-soluble high-molecular polymer. The diffusion layer prepared by the invention has a diffusion channel of tens to hundreds of nanometers, and can rapidly absorb, uniformly distribute, meter and rapidly transmit various analytes.

Description

A dry analysis reagent for total cholesterol detection

technical field

The invention relates to a dry analysis reagent for detecting total cholesterol, which belongs to the field of clinical diagnosis.

Background technique

With the development of social economy and the improvement of people's living standards, the prevalence of chronic diseases related to cardiovascular and cerebrovascular diseases is on the rise, and it is becoming more and more youthful. Excessive total cholesterol levels in the human body are closely related to the occurrence of cardiovascular diseases, which can easily lead to coronary heart disease and other atherosclerotic diseases. Normalized preventive detection of cholesterol levels and instant, accurate and rapid diagnosis can effectively prevent cardiovascular diseases. occur and worsen. Cholesterol clinical detection methods include wet chemical method and dry chemical method. Among them, the wet chemical method is suitable for the scenario where a large number of samples are entered at one time in the central laboratory. One preparation of reagents can analyze a large number of clinical samples at the same time. However, with the outbreak of the new crown epidemic With the improvement of the demand for emergency and emergency testing, the clinic puts forward shorter requirements for the reporting time of biochemical analysis, which promotes the gradual development of emergency biochemical testing technology from traditional wet chemistry to dry biochemistry. Different from the conventional wet chemical method, the dry chemical analysis method has the advantages of fast detection speed, easy storage of detection reagents, no need to configure any liquid reagents, low detection threshold requirements, and strong adaptability to occasions. Personalized item combination testing is especially suitable for scenarios such as emergency departments, primary clinics, blood stations, medical examination institutions, and inspection laboratories.

At present, most of the commonly used dry analysis reagents are multi-layer film dry films. This product continues the coating technology of photosensitive film, and various required functional layers such as diffusion layer, light blocking layer, reagent layer, and reaction indicator layer are in order. Sequentially or simultaneously coated on a transparent support, the sampling hole is on the diffusion layer, the test hole is on the opposite side of the support, and the concentration of the analyte is analyzed by measuring the change of the reflected optical density. The test results of this kind of multilayer film dry film are accurate, but the production process is complicated. The production of the diffusion layer requires the use of various organic solvents, which generates a large amount of organic waste gas, which is harmful to the environment and increases the danger of the production process. Another type of dry chemical analysis reagent consists of a plastic support layer, one end of which is a reaction zone including a sample layer and a reagent layer, and the reagent layer uses fabric as a reagent carrier, and sample addition and testing are performed on the upper part.

At present, the commonly used dry chemical urine test strips and blood sugar analysis test strips are relatively simple qualitative and semi-quantitative analysis, and cannot be highly quantitatively analyzed. Patent No. 201911056555.7 discloses a dry chemical multilayer membrane reagent for in vitro biochemical diagnosis. This method still uses a variety of organic solvents and produces a lot of organic waste that is harmful to the environment. Patent 201810050191.0 discloses a method for detecting total cholesterol, in which the blood filter membrane is a commercially available product, and the reaction layer is soaked and dried in liquid. The blood filter layer and the reagent layer need to be made separately and then assembled. Only semi-quantitative analysis can be done, and no quantitative analysis.

Contents of the invention

In order to overcome the drawbacks of the prior art, the invention provides a dry analysis reagent for total cholesterol detection.

The technical solution adopted by the present invention to solve its technical problems is:

A dry analysis reagent for total cholesterol detection, the dry analysis reagent sequentially includes an upper support layer, a diffusion layer, a reagent layer, a support and a lower support layer from top to bottom, the diffusion layer, reagent layer and support It is arranged in the middle position between the upper support layer and the lower support layer sequentially from top to bottom, the gaps at both ends of the upper support layer and the lower support layer are bonded by the middle support layer, and the upper support layer and the lower support layer The middle position of the support layer is respectively provided with a sampling hole and a test hole, and the diffusion layer is an isotropic porous diffusion membrane with a porosity of 50-85%; the diffusion layer is made of polystyrene microspheres, bonded agent and surfactant, the particle size of the polystyrene microspheres is 0.1-1 μm, the binder concentrates on the area adjacent to the surface of the polystyrene microspheres and the adjacent microspheres, and the polystyrene The microspheres are bonded into a coherent three-dimensional lattice; the reagent layer includes surfactants, cholesterol esterase, cholesterol oxidase, horseradish peroxidase, leuco dyes, buffers, stabilizers and water-soluble polymers polymer.

In the above dry analysis reagent for detecting total cholesterol, the polystyrene microsphere component is a polystyrene homopolymer or copolymer.

The above-mentioned dry analysis reagent for total cholesterol detection, the components of the polystyrene microspheres are polystyrene, poly(styrene-methacrylic acid), poly(styrene-divinylbenzene), poly(styrene ethylene-butyl acrylate) or poly(styrene-hydroxyethyl methacrylate-divinylbenzene).

The above-mentioned total cholesterol detection uses a dry analysis reagent, and the binder is one or more of pure acrylic emulsion or styrene-acrylic emulsion, and the styrene-acrylic emulsion is poly(butyl acrylate-styrene), poly(acrylic acid ethyl ester-styrene) or poly(vinyltoluene-tert-butylstyrene-methacrylic acid).

The above-mentioned dry analysis reagent for total cholesterol detection, the addition amount of the polystyrene microspheres per unit square meter is 20-500g, and the addition amount of the adhesive per unit square meter accounts for 2-10% of the volume.

In the above dry analysis reagent for detecting total cholesterol, the leuco dye is one of diarylimidazole dye, triarylimidazole dye and benzidine, preferably 3,3'-dimethoxybenzidine.

In the above-mentioned dry analytical reagent for total cholesterol detection, the surfactant is a nonionic surfactant, and the nonionic surfactant is a chain structure composed of 8 to 15 oxyethylene or oxypropylene groups connected to each other, In particular it is alkylphenoxypolyethoxyethanol.

The above-mentioned dry analysis reagent for total cholesterol detection, the buffer solution has a pH value of 5.5-9.0 and contains tris (hydroxymethyl) aminomethane (tris), phosphate, borate, citric acid or citrate , lysine, N, N-bis(2-hydroxyethyl) glycine, sodium or potassium salt of N-2-hydroxyethylpiperazine-N'-2-hydroxypropane-3-sulfonic acid, N- Sodium or potassium salt of 2-hydroxyethylpiperazine-N'-3-sulfonic acid, sodium or potassium salt of N-[tris(hydroxymethyl)methyl]-3-aminopropanesulfonic acid, N- The sodium or potassium salt of 2-hydroxyethylpiperazine-N'-2-ethanesulfonic acid, and one of the acids, bases, or salts in combination with any of the above compounds.

The above-mentioned dry analysis reagent for total cholesterol detection, the stabilizer is one or more of ascorbate oxidase, EDTA, polyethylene glycol, magnesium chloride, sodium cholate; the water-soluble high molecular polymer is gelatin, gelatin derivative One or more mixtures of substances, agarose, dextran, polyvinyl alcohol, polyacrylamide, and hydrophilic cellulose derivatives.

The above-mentioned dry analysis reagent for total cholesterol detection, the upper support, the lower support and the intermediate support are all transparent plastic substrates with a light transmittance of more than 80% under light with a wavelength of 200nm-900nm, including polyethylene terephthalate One of ethylene glycol formate, polycarbonate, polypropylene and polyethylene, the thickness of which is 50-300 μm, preferably 100-200 μm.

The beneficial effects of the present invention are:

No organic solvent is used in the preparation process of the dry analysis reagent for total cholesterol detection of the present invention, and the production and preparation process is environmentally friendly. The diffusion layer is mainly composed of polystyrene microspheres and adhesives, and the particle size distribution of polystyrene microspheres is controlled. Form tens to hundreds of nanometer-scale diffusion pathways with the amount of binder added, which can quickly absorb, uniformly distribute, measure and quickly transmit various analytes such as ions, uric acid, creatinine, glucose and cholesterol, so as to analyze biological fluids. Substances to be tested with different molecular weight distributions and compositions have high test result accuracy and a wide measurement range, meeting the needs of instant diagnosis and on-site diagnosis, and have great clinical application value.

Description of drawings

Fig. 1 is the structural representation of multilayer film dry chemical reagent sheet of the present invention;

Fig. 2 is the analysis result of the correlation of multiple detection samples for the method of the present invention and utilizing Abell-Kendall method of embodiment 1;

Fig. 3 is the method for the present invention of embodiment 2 and utilizes the analysis result of a plurality of detection sample correlations of Abell-Kendall method;

Fig. 4 is the analysis result of the correlation of multiple detection samples for the method of the present invention and the Abell-Kendall method in Example 3.

In the figure: 1, upper support layer; 1-1, sample injection hole; 2, diffusion layer; 3, reagent layer; 4, support body; 5, lower support layer; 5-1, test hole; 6, middle support layer .

detailed description

In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments It is a part of embodiments of the present invention, but not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection scope of the present invention.

The dry analytical reagent for detecting total cholesterol of the present invention can measure the total cholesterol in body fluid samples. The body fluid may be blood, urine, or the like. As a body fluid sample, blood or urine may be used as it is, or a sample subjected to an appropriate pretreatment may be used.

The dry analysis reagent for total cholesterol detection of the present invention comprises an upper support layer 1, a diffusion layer 2, a reagent layer 3, a support 4 and a lower support layer 5 from top to bottom, and the diffusion layer, the reagent layer and the support are formed from the upper It is arranged in the middle position between the upper support layer and the lower support layer successively from bottom to bottom, and the gaps at both ends of the upper support layer and the lower support layer are bonded by the middle support layer 6, and the upper support layer 1 and the lower support layer The middle position of the support layer 5 is respectively provided with a sample injection hole 1-1 and a test hole 5-1. The reagent layer and the diffusion layer distributed on the support body are the structural layers for the dripping and diffusion of the sample to be tested to generate biochemical reactions. The support layer It is a structural layer that plays a supporting role and is a light-transmitting carrier. The upper support layer, the lower support layer and the middle support layer are the internal packaging structures that play the role of fixing and protecting the support distributed with the reagent layer and the diffusion layer.

The diffusion layer is an isotropic porous diffusion membrane with a porosity of 50-85%; the diffusion layer is composed of polystyrene microspheres, adhesives and surfactants, and the polystyrene microspheres The particle size is 0.1-1 μm, and the binder concentrates on the area adjacent to the surface of the polystyrene microspheres and the adjacent microspheres, and bonds the polystyrene microspheres into a coherent three-dimensional lattice, forming a high porosity structure, so that the diffusion layer has the function of efficiently diffusing liquids containing analytes with different molecular weight components, which can evenly distribute, diffuse and quickly transfer the samples to be tested containing multiple analytes inside, and make the water in the liquid to be tested , ions, uric acid, creatinine, glucose, cholesterol and other small molecular substances diffuse and transfer to the reagent layer in fluid form; the amount of polystyrene microspheres per unit square meter is 20-500g, preferably 50-300g, the The amount of binder added per unit square meter accounts for 2-10% of the amount added per unit square meter of the polystyrene microspheres, so as to control the formation of an isotropic porous diffusion layer with different porosity and pore size distribution, for rapid Absorb, uniformly distribute, meter, and rapidly transport multiple analytes to analyze analytes of different molecular weight distributions and compositions in biological fluids.

The total cholesterol to be detected in the present invention belongs to small biological molecules, and the diffusion layer with nanoscale to submicron pore size distribution and high porosity structure can satisfy the rapid distribution and anisotropic transmission of the sample to be tested, thereby providing a basis for subsequent accurate reaction and The detection function provides the basis. The invention adopts the soap-free emulsion polymerization technology to synthesize submicron polystyrene microspheres, avoids the addition of organic solvents such as emulsifiers, and the prepared polystyrene microspheres have high purity, uniform particle size, good monodispersity, and can Differently modified functional microspheres are prepared by comonomers. During the preparation of the diffusion layer, a three-dimensional lattice structure with polystyrene microspheres as the lattice center is formed by controlling the amount of binder added and the preparation process. The aligned three-dimensional lattice structure constitutes the transport channel for the rapid distribution of biological fluids.

The reagent layer 3 includes surfactant, cholesterol esterase, cholesterol oxidase, peroxidase, leuco dye, buffer, stabilizer and water-soluble polymer. Among them, 3,3'-dimethoxybenzidine is selected as the leuco dye (chromogenic substrate). It can specifically combine with the hydrogen peroxide generated by the enzyme-linked reaction in an equal molar ratio (1:1) to generate a high-density chromogenic substance, thereby improving the accurate detection range of total cholesterol. Conventional total cholesterol detection kits basically use Trinder reaction reagent as the chromogenic substrate to detect the content of hydrogen peroxide produced by the enzyme-catalyzed reaction of total cholesterol, but Trinder reaction reagent has high detection limit, poor substrate specificity and low color density. And other disadvantages, every 2 mol of hydrogen peroxide generated by the catalytic reaction can be correspondingly produced with a maximum of 1 mol of red quinone imine compound, and vitamin C, uric acid, glutathione, various drugs and bilirubin will all interact with chromogen The substrate competes with the hydrogen peroxide generated by the catalytic reaction, resulting in the inability of hydrogen peroxide to specifically bind to the chromogen substrate, and the detection result is not accurate enough. The 3,3'-dimethoxybenzidine of the present invention has better specificity than Trinder, thereby improving the specificity and accuracy of determination.

The surfactant in the reagent layer is commercially available from Rohm and Haas Co. under the Triton trademark (X-100, 102, 165, 305 and 405 are particularly useful), preferably Triton X-100, in an amount of 1 -25g, more preferably 2-15g per square meter.

Cholesterol esterase, cholesterol oxidase and peroxidase in the reagent layer have no limitation on their source, and the usage amount is 2-100KU, 0.2-50KU, 2-100KU per unit square meter, preferably 5-100KU per unit square meter. 20KU, 0.5-20KU, 5-20KU.

The buffer in the reagent layer is preferably phosphate buffer or tris buffer, and the pH of the buffer is determined according to the activity range of the enzyme used, and adjusted to pH 5.0-8.0, preferably 6.0-7.0.

The stabilizer in the reagent layer is preferably EDTA and polyethylene glycol, and the usage amount is 0.05-5g, 0.5-20g per unit square meter, preferably 0.1-2.5g, 1-10g per unit square meter.

The water-soluble polymer in the reagent layer is preferably gelatin, and the usage amount is 1-50 g per square meter, preferably 2-25 g per square meter.

Preparation method of the present invention:

(1) Reagent layer The reagent solution is coated on the support, and the coating method can use known methods, preferably wire bar coating, knife coating, extrusion coating, and the wet film thickness of the reagent layer is preferably 50-500 μm, Dry in the range of 10°C-60°C, and the dry film thickness of the reagent layer is preferably 5-50 μm.

(2) The diffusion layer slurry is coated on the (1) reagent layer, and the coating method can use known methods, preferably wire bar coating, blade coating, extrusion coating, and the wet film thickness of the diffusion layer is preferably 60 -600μm, dry in the range of 10°C-60°C, the dry film thickness of the diffusion layer is preferably 20-200μm.

(3) Cut the materials prepared in step (2) into small pieces of 1.2 cm ² , use custom-made white PET plastic sheets as the upper support layer, lower support layer and middle support layer, fix and assemble them into dry analysis reagents.

The total cholesterol detection of the present invention uses the dry analysis reagent detection method as follows:

Drop about 5 μL-25 μL of the liquid to be tested on the homogeneous porous diffusion layer, and incubate for 1 minute to 15 minutes at a constant temperature in the range of about 25°C-50°C, the liquid to be tested will pass through the diffusion layer quickly and uniformly in four directions While diffusing, it diffuses longitudinally to the reagent layer to form a uniform concentration distribution. The total cholesterol is separated from the lipoprotein complex under the action of the surfactant TRITON X-100, and the free total cholesterol is catalyzed by cholesterol esterase and cholesterol oxidase. Hydrogen peroxide is generated under the action, and hydrogen peroxide reacts with leuco dye under the catalysis of peroxidase to form a compound of specific color. Reflection density detection is performed on the color change reaction produced by the dry analysis reagent from the support side, and the concentration of total cholesterol in the liquid to be tested is calculated using a pre-made calibration curve. The equation for the reaction of the target substance total cholesterol with the corresponding substance in the dry analysis reagent is as follows:

The preparation process of the dry analysis reagent for detecting total cholesterol does not require organic solvents, is environmentally friendly, has good stability, is easy to store and keep, and has high detection accuracy and wide linear range.

The present invention will be further described below in conjunction with embodiment.

Example 1

On a colorless and transparent PET film support 4 with a thickness of 175 μm, the reagent layer coating liquid composed of the following Table 1 was coated and dried at a constant temperature of 40° C., so that the thickness after drying reached 15 μm. Next, the diffusion layer coating solution with the composition shown in Table 2 below was coated on the above coating layer and dried at a constant temperature of 35° C., so that the thickness after drying was 100 μm. Cut into small pieces of ^1.2 cm after drying, and then use white PET plastic sheets as the upper support layer 1, the lower support layer 5 and the middle support layer 6, which can be used for measurement after assembly.

Table 1 Reagent Layer Recipe

Reagent Coating amount/m² gelatin 10g Triton X-100 8g cholesterol esterase 15kU cholesterol oxidase 4KU peroxidase 6.4KU 3,3'-Dimethoxybenzidine 0.64g Tris buffer pH7.0 EDTA 0.7g polyethylene glycol 3.6g

Table 2 Diffusion layer formulation

Material Coating amount/m² Carboxyl-modified polystyrene microspheres (0.2μm) 150g Poly(butyl acrylate-styrene) emulsion 3g Surfactant 1.5g

For 50 clinical serum samples, the method of the present invention was used to analyze the correlation of multiple detection samples using the Abell-Kendall method. The results are shown in Fig. 2, and the present invention can obtain a good correlation compared with the benchmark reference method.

Example 2

On a colorless and transparent PET film support 4 with a thickness of 175 μm, the reagent layer coating liquid composed in Table 3 below was coated and dried at a constant temperature of 37° C., so that the thickness after drying reached 10 μm. Next, the diffusion layer coating solution with the composition shown in Table 4 below was coated on the above coating layer and dried at a constant temperature of 40° C., so that the thickness after drying was 150 μm. Cut into small pieces of ^1.2 cm after drying, and then use white PET plastic sheets as the upper support layer 1, the lower support layer 5 and the middle support layer 6, which can be used for measurement after assembly.

Table 3 Reagent Layer Recipe

Reagent Coating amount/m² gelatin 5g Triton X-100 8g cholesterol esterase 15kU cholesterol oxidase 4KU peroxidase 6.4KU 3,3'-Dimethoxybenzidine 0.64g Phosphate buffer pH7.6 EDTA 0.7g polyethylene glycol 3.6g

Table 4 Diffusion Layer Recipe

Material Coating amount/m² Polystyrene microspheres (0.5μm) 100g Poly(butyl acrylate-styrene) emulsion 1.5g Surfactant 1g

For 50 clinical serum samples, the method of the present invention was used to analyze the correlation of multiple detection samples using the Abell-Kendall method. The results are shown in Fig. 3, and the present invention can obtain a good correlation with the benchmark reference method.

Example 3

On a colorless and transparent PET film support 4 with a thickness of 175 μm, the reagent layer coating liquid composed in Table 5 below was coated and dried at a constant temperature of 40° C., so that the thickness after drying reached 20 μm. Next, the diffusion layer coating solution with the composition shown in Table 6 below was coated on the above coating layer and dried at a constant temperature of 45° C., so that the thickness after drying was 100 μm. Cut into small pieces of ^1.2 cm after drying, and then use white PET plastic sheets as the upper support layer 1, the lower support layer 5 and the middle support layer 6, which can be used for measurement after assembly.

Table 5 Reagent Layer Recipe

Reagent Coating amount/m² gelatin 15g Triton X-100 8g cholesterol esterase 15kU cholesterol oxidase 4KU peroxidase 6.4KU 3,3'-Dimethoxybenzidine 0.64g Phosphate buffer pH6.8 EDTA 0.7g polyethylene glycol 3.6g

Table 6 Diffusion layer formulation

Material Coating amount/m² Carboxyl-modified polystyrene microspheres (0.8μm) 150g Poly(butyl acrylate-styrene) emulsion 4g Surfactant 2g

For 50 clinical serum samples, the method of the present invention was used to analyze the correlation of multiple detection samples using the Abell-Kendall method. The results are shown in Fig. 4. Compared with the reference method, the present invention can obtain a good correlation.

The above-mentioned embodiments are only to illustrate the technical concept and characteristics of the present invention, and its purpose is to enable those of ordinary skill in the art to understand the content of the present invention and based on the facts, and cannot limit the protection scope of the present invention. All equivalent replacements or improvements made according to the essence of the content of the present invention shall be included within the scope of the claims of the present invention.

Claims (10)

1. The utility model provides a total cholesterol detects uses dry-type analytical reagent, dry-type analytical reagent includes from top to bottom in proper order and goes up support layer (1), diffusion layer (2), reagent layer (3), support (4) and support layer (5) down, diffusion layer, reagent layer and support set gradually from top to bottom go up the intermediate position between support layer and the support layer down, go up the both ends hole department of support layer and support layer down and bond through middle support layer (6), go up support layer (1) and support layer (5) intermediate position down and be provided with application of sample hole (1-1) and test hole (5-1) respectively, its characterized in that: the diffusion layer is an isotropic porous diffusion film, and the porosity of the diffusion layer is 50-85%; the diffusion layer consists of polystyrene microspheres, an adhesive and a surfactant, the particle size of the polystyrene microspheres is 0.1-1 mu m, the adhesive is concentrated on the surface of the polystyrene microspheres and adjacent to the adjacent microspheres, and the polystyrene microspheres are bonded into a coherent three-dimensional lattice; the reagent layer (3) comprises a surfactant, cholesterol esterase, cholesterol oxidase, horseradish peroxidase, a colorless dye, a buffer solution, a stabilizer and a water-soluble high-molecular polymer.

2. The dry analytical reagent for total cholesterol detection according to claim 1, wherein: the polystyrene microsphere component is a homopolymer or copolymer of polystyrene.

3. The dry analytical reagent for total cholesterol detection according to claim 2, wherein: the polystyrene microsphere comprises one of polystyrene, poly (styrene-methacrylic acid), poly (styrene-divinylbenzene), poly (styrene-butyl acrylate) or poly (styrene-hydroxyethyl methacrylate-divinylbenzene).

4. The dry analytical reagent for total cholesterol detection according to claim 3, wherein: the adhesive is one or more of pure acrylic emulsion or styrene-acrylic emulsion, and the styrene-acrylic emulsion is poly (butyl acrylate-styrene), poly (ethyl acrylate-styrene) or poly (vinyl toluene-tert-butyl styrene-methacrylic acid).

5. The dry analytical reagent for total cholesterol detection according to claim 4, wherein: the addition amount of the polystyrene microspheres per unit square meter is 20-500g, and the addition amount of the adhesive per unit square meter accounts for 2-10% of the addition amount of the polystyrene microspheres per unit square meter.

6. The dry analytical reagent for total cholesterol detection according to claim 5, wherein: the leuco dye is one of diaryl imidazole dye, triaryl imidazole dye and benzidine.

7. The dry analytical reagent for total cholesterol detection according to claim 6, wherein: the surfactant is a nonionic surfactant, and the nonionic surfactant is a chain structure consisting of 8 to 15 ethylene oxide or propylene oxide groups which are connected with each other, and specifically is alkyl phenoxy polyethoxyethanol.

8. The dry analytical reagent for total cholesterol detection according to claim 7, wherein: the buffer has a pH of 5.5 to 9.0 and comprises one of tris (hydroxymethyl) aminomethane (tris), phosphate, borate, citric acid or citrate, lysine, N, N-bis (2-hydroxyethyl) glycine, sodium or potassium N-2-hydroxyethylpiperazine-N ' -2-hydroxypropane-3-sulfonic acid, sodium or potassium N-2-hydroxyethylpiperazine-N ' -3-sulfonic acid, sodium or potassium N- [ tris (hydroxymethyl) methyl ] -3-aminopropane-sulfonic acid, sodium or potassium N-2-hydroxyethylpiperazine-N ' -2-ethane-sulfonic acid, and an acid, base, or salt in combination with any of the above compounds.

9. The dry analytical reagent for total cholesterol detection according to claim 8, wherein: the stabilizer is one or more of ascorbic acid oxidase, EDTA, polyethylene glycol, magnesium chloride and sodium cholate; the water-soluble high molecular polymer is one or more of gelatin, gelatin derivative, agarose, dextran, polyvinyl alcohol, polyacrylamide and hydrophilic cellulose derivative.

10. The dry analytical reagent for total cholesterol detection according to claim 9, wherein: the upper support, the lower support and the middle support are transparent plastic base materials with light transmittance of more than 80% under the wavelength of light with the wavelength of 200nm-900nm, comprise one of polyethylene terephthalate, polycarbonate, polypropylene and polyethylene, and have the thickness of 50-300 mu m, preferably 100-200 mu m.

Images