A dry chemical reagent tablet for quantitative detection of albumin and preparation method thereof

Abstract

The present invention proposes a dry chemical reagent sheet for quantitatively detecting albumin and a preparation method thereof, and relates to the field of dry chemical reagent sheets. The dry chemical reagent sheet for quantitatively detecting albumin comprises a support layer, a reagent layer and a diffusion layer, wherein the reagent layer is arranged above the support layer, the diffusion layer is arranged above the reagent layer, the diffusion layer comprises a diffusion layer reagent or is formed by a diffusion layer reagent, the diffusion layer reagent comprises an adhesive, a surfactant and particulate matter, and the particulate matter comprises a first particulate matter and a second particulate matter; the number ratio of the first particulate matter to the second particulate matter is 1:(0.25‑4), and the difference in particle size between the first particulate matter and the second particulate matter is 10‑40 μm. The dry chemical reagent sheet for quantitatively detecting albumin provided by the present invention is used for in vitro diagnosis, and its detection result is accurate, storage is stable, and it has the advantages of rapid diagnosis, simple operation, cost saving, etc.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] The present invention claims the priority of Chinese patent application CN 202411438688.1 filed on October 15, 2024, entitled “A dry chemical reagent sheet for quantitative detection of albumin and its preparation method”, and the entire contents of the above application are incorporated herein by reference. Technical Field

[0003] The invention relates to the field of dry chemical reagent tablets, and in particular to a dry chemical reagent tablet for quantitatively detecting albumin and a preparation method thereof. Background Art

[0004] Albumin is the most abundant protein in human plasma and serum, accounting for approximately 60% of the total serum protein content, with a normal concentration range of 30-50 mg / mL. Albumin concentration is an important indicator for evaluating liver function, nutritional status and disease diagnosis. Clinical tests are often related to conditions such as liver dysfunction, malnutrition or chronic inflammation. Its test results can help doctors evaluate liver function and nutritional status, and can also play an important role in disease diagnosis, treatment monitoring and prognosis assessment. However, the wet method commonly used in clinical practice usually requires a large number of manual operation steps such as sample preparation, reagent addition, and reaction monitoring. The operation is complicated and has a high risk of error. At the same time, the detection process usually takes a long time to complete and the cost is relatively high. Its application has always been relatively limited.

[0005] Quantitative dry film testing belongs to dry chemical analysis, which is a technical method widely used in clinical testing and biochemical research. Its core feature is to pre-dry a variety of reaction reagents and fix them on paper or other carriers. Then, during the actual test, the liquid in the sample (such as whole blood, serum, plasma, urine, etc.) is used as the reaction medium to make the components to be tested in the sample react directly with the dry reagent. This reaction usually produces a color change, and qualitative or quantitative analysis is performed through naked eye observation or instrument detection. Compared with traditional wet chemistry, quantitative dry film testing has many advantages such as simple and convenient operation, fast results, low cost, small dosage, easy storage, easy to combine with automated equipment, strong adaptability, and environmental friendliness.

[0006] To this end, we hope to develop a dry film for quantitative albumin detection, which can not only effectively simplify the albumin detection process and reduce the cost of use, but also optimize the application environment and realize convenient and fast POCT (point-of-care testing). Summary of the invention

[0007] In view of the above analysis, the present invention aims to provide a dry chemical reagent sheet for quantitative detection of albumin and a preparation method thereof, so as to simplify the detection process of albumin and reduce the cost of use.

[0008] The purpose of the present invention is mainly achieved through the following technical solutions:

[0009] In the first aspect, the present invention provides a dry chemical reagent sheet for quantitative detection of albumin, comprising a support layer, a reagent layer and a diffusion layer, wherein the reagent layer is arranged above the support layer, and the diffusion layer is arranged above the reagent layer, and is characterized in that the diffusion layer includes a diffusion layer reagent or is formed by a diffusion layer reagent, and the diffusion layer reagent includes an adhesive, a surfactant and particulate matter, and the particulate matter includes first particulate matter and second particulate matter; the number ratio of the first particulate matter to the second particulate matter is 1:(0.25-4), preferably 1:(0.5-1.5), and the difference in particle size between the first particulate matter and the second particulate matter is 10-40μm, preferably 15-25μm.

[0010] Preferably, the first particulate matter comprises polystyrene microspheres with a particle size ranging from 40 to 80 μm, preferably 45 to 55 μm.

[0011] Preferably, the second particulate matter comprises polystyrene microspheres with a particle size ranging from 10 to 40 μm, preferably 25 to 35 μm.

[0012] Preferably, the amount of surfactant in the diffusion layer reagent is 0.5-0.9 g / m 2 ; preferably 0.68-0.73g / m 2 ; The amount of adhesive is 12.5-75g / m 2 , preferably 37.5-62.5g / m 2 ; The dosage of particles is 400-600g / m 2 .

[0013] Preferably, the amount of the first particles is 200-300 g / m 2 , preferably 265-280g / m 2 ; and / or, the amount of the second particulate matter is 200-300g / m 2 , preferably 210-220g / m 2 .

[0014] Preferably, in the diffusion layer reagent, the adhesive comprises polyisobutylene; and in the diffusion layer reagent, the surfactant comprises a fluorine surfactant.

[0015] Preferably, the reagent layer comprises a reagent layer reagent or is formed by a reagent layer reagent, and the reagent layer reagent comprises a reaction color developing reagent, a hydrophilic polymer, a surfactant and a buffer system.

[0016] Preferably, the amount of the reaction color developing reagent in the reagent layer is 1-2 g / m 2, preferably 1.4-1.8g / m 2 Preferably, the reaction color developing reagent includes sodium bromocresol green; the amount of the hydrophilic polymer is 30-150g / m 2 , preferably 90-110g / m 2 ; Preferably, the hydrophilic polymer includes at least one of PVA, PAA, PAM, and PVP.

[0017] Preferably, in the reagent layer reagent, the surfactant includes a first surfactant and a second surfactant. Preferably, the first surfactant includes polyoxyethylene lauryl ether; and the second surfactant includes a fluorine surfactant.

[0018] Preferably, the amount of the first surfactant is 5-30 g / m 2 , preferably 14-16g / m 2 .

[0019] Preferably, the amount of the second surfactant is 1-10 g / m 2 ; preferably 4-6g / m 2 .

[0020] Preferably, in the reagent layer reagent, the buffer system includes tris (hydroxymethyl)aminomethane (Tris) and malic acid, and the pH is 3-4.

[0021] Preferably, the support layer comprises transparent resin plastic; the film thickness of the support layer is 30-200 μm; the thickness of the diffusion layer is 200-300 μm; and the thickness of the reagent layer is 200-300 μm.

[0022] In a second aspect, the present invention provides a method for preparing the reagent sheet, comprising the following steps:

[0023] Step 1: coating the reagent layer reagent on the support layer and drying to obtain the reagent layer;

[0024] Step 2: Spread the diffusion layer reagent on the reagent layer and dry it to obtain a dry chemical reagent sheet.

[0025] Beneficial effects:

[0026] The dry chemical reagent sheet for quantitatively detecting albumin provided by the present invention is a dry chemical multilayer film reagent dry sheet for in vitro diagnosis, which has accurate detection results, stable storage, and has the advantages of rapid diagnosis, simple operation, cost saving, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 This is a schematic structural diagram of a dry chemical reagent sheet for quantitatively detecting albumin provided by the present invention.

[0028] Figure 2 The test diagrams are of the dry chemical reagent sheet of Example 1 provided by the present invention after adding serum and changing color, wherein (a) is the color development effect of a 13 g / L serum sample; (b) is the color development effect of a 35 g / L serum sample; and (c) is the color development effect of a 62 g / L serum sample.

[0029] Among them, 1-diffusion layer, 2-reagent layer, 3-support layer. DETAILED DESCRIPTION

[0030] Preferred embodiments of the present invention will be described in detail below in conjunction with the accompanying drawings, wherein the accompanying drawings constitute a part of the present invention and are used to explain the principles of the present invention together with the embodiments of the present invention.

[0031] The present invention provides a dry chemical reagent sheet for quantitatively detecting albumin and a preparation method thereof. After the dry chemical reagent sheet is dripped with serum, the albumin in the serum will quickly react with the bromocresol green component in the dry sheet to generate a colored complex attached to the dry sheet, and the amount of the colored complex is proportional to the concentration of albumin in the sample. The dry sheet after the reaction is tested by an instrument using a reflected light photometry method, and the quantitative concentration of albumin in the test serum can be quickly obtained through a concentration curve corresponding to the standard test.

[0032] Hereinafter, the present invention will be described in detail.

[0033] In a first aspect, the present invention provides a dry chemical reagent sheet for quantitatively detecting albumin, comprising a support layer and a reagent layer, wherein the reagent layer is arranged on the support layer, the reagent layer is the area where a chemical reaction occurs in a substance to be detected, the reagent layer comprises a reagent layer reagent or is formed by a reagent layer reagent, and the reagent layer reagent comprises a reaction color developing reagent that can bind to albumin to produce a color change, a hydrophilic polymer, a surfactant and a buffer system.

[0034] As a specific embodiment of the present invention, in the reagent layer reagent, the amount of the reaction color developing reagent is 1-2g / m 2 , preferably 1.4-1.8g / m 2 , more preferably 1.65 g / m 2 ; The reaction color developing reagent is selected from sodium bromocresol green.

[0035] As a specific embodiment of the present invention, in the reagent layer reagent, the hydrophilic polymer can be selected from at least one of polyvinyl pyrrolidone (PVP), polyvinyl alcohol (PVA), polyacrylic acid (PAA), and polyacrylamide (PAM), and the amount of the hydrophilic polymer is 30-150 g / m 2 , preferably 90-110g / m 2 , most preferably 100g / m 2 .

[0036] As a specific embodiment of the present invention, in the reagent layer reagent, the model of PVA can be selected from at least one of PVA-205, PVA-103, PVA-117, PVA-203, and PVA-217; the model of PAA can be at least one of Mn2000, Mn3000, and Mn5000; the model of PAM can be at least one of 20% ionicity, 30% ionicity, and 50% ionicity; the model of PVP can be selected from at least one of K90 (average molecular weight 1300000), K60 (average molecular weight 335000), K30 (average molecular weight 51500), and K15 (average molecular weight 10000). Among them, in the reagent layer reagent, the hydrophilic polymer is preferably PVA-205, which is used as the reagent layer for the clearest color development.

[0037] As a specific embodiment of the present invention, in the reagent layer reagent, the surfactant includes a first surfactant and a second surfactant, wherein:

[0038] The dosage of the first surfactant is 5-30 g / m 2 , preferably 14-16g / m 2 , more preferably 15g / m 2 , the first surfactant is selected from polyoxyethylene lauryl ether, and the model may be at least one of Brij-35 and Brij-30;

[0039] The dosage of the second surfactant is 1-10 g / m 2 ; preferably 4-6g / m 2 , more preferably 5g / m 2 The second surfactant is selected from fluorosurfactants, and the model can be at least one of FS-31, FS-30, FS-50, FS-60, and FS-81.

[0040] As a specific embodiment of the present invention, in the reagent layer reagent, the buffer system is a malic acid-Tris buffer system, including tris (hydroxymethyl)aminomethane (Tris) and malic acid, with a pH of 3-4, wherein:

[0041] The dosage of Tris is 1-10g / m 2 ; preferably 4-8g / m 2 , the best is 6g / m 2 ;

[0042] The dosage of malic acid is 5-30g / m 2 ; preferably 15-17g / m 2 , most preferably 16g / m 2 .

[0043] In the present invention, in the reagent layer reagent, tris(hydroxymethyl)aminomethane and malic acid form a malic acid-Tris buffer system. Under this buffer system, bromocresol green generated by the reaction of bromocresol green sodium and malic acid binds to proteins and develops color with good differentiation.

[0044] In the present invention, in the reagent layer reagent, the first surfactant Brij-35 not only has a surface active effect, but also can improve the binding property of bromocresol green and protein and their solubility, and play a role in stabilizing color development. The addition of the second surfactant can further improve the homogeneity and uniformity of color development.

[0045] As a specific embodiment of the present invention, the wet film thickness of the reagent layer is 300-500 μm, and the dry film thickness is 200-300 μm. It should be noted that the optimized wet film thickness of the reagent layer is 300-500 μm, and within this thickness range, the display effect is relatively better.

[0046] As a specific embodiment of the present invention, the reagent sheet further includes a diffusion layer disposed above the reagent layer.

[0047] As a specific embodiment of the present invention, the diffusion layer includes a diffusion layer reagent or is formed by a diffusion layer reagent, and the diffusion layer reagent includes an adhesive, a surfactant, and particulate matter.

[0048] As a specific embodiment of the present invention, in the diffusion layer reagent, the adhesive is selected from polyisobutylene, and the amount of the adhesive is 12.5-75g / m 2 , preferably 37.5-62.5g / m 2 , more preferably 50g / m 2 As a specific embodiment of the present invention, the molecular weight of polyisobutylene is in the range of 200-3000, preferably 2400.

[0049] As a specific embodiment of the present invention, in the diffusion layer reagent, the surfactant can be selected from fluorosurfactants, and the model can be at least one of FS-31, FS-30, FS-50, FS-60, and FS-81. The amount of the surfactant is 0.5-0.9 g / m 2 ; preferably 0.68-0.73g / m 2 .

[0050] As a specific embodiment of the present invention, in the diffusion layer reagent, the particles include first particles and second particles. The amount of the particles is 400-600 g / m 2 The dosage of the first particle is 200-300g / m 2 , preferably 265-280g / m 2; The dosage of the second particle is 200-300g / m 2 , preferably 210-220g / m 2 .

[0051] As a specific embodiment of the present invention, the first particulate matter can be selected from polystyrene microspheres; the average particle size is 40-80 μm, such as 45, 50, 55, 60, 65, 70, 75 μm, etc., preferably 45-55 μm, and more preferably 50 μm.

[0052] As a specific embodiment of the present invention, the second particulate matter can be selected from polystyrene microspheres; the average particle size is 10-40 μm, such as 15, 20, 25, 30, 35 μm, etc., preferably 25-35 μm, and more preferably 30 μm.

[0053] It should be noted that, in the present invention, unless otherwise specified, the particle size of the particulate matter is the average particle size.

[0054] In the present invention, the polystyrene microspheres may be hydrophilic polystyrene microspheres, where carboxyl groups are modified on the surface of the polystyrene microspheres to enhance the adsorption of proteins.

[0055] As a specific embodiment of the present invention, the number ratio of the first particles to the second particles is 1:(0.25-4), preferably 1:(0.5-1.5), and more preferably 1:1.

[0056] As a specific embodiment of the present invention, the difference in particle size between the first particle and the second particle is 10-40 μm, such as 15, 20, 25, 30, 35 μm, etc., preferably 15-25 μm. It should be noted that the difference in the present invention refers to an absolute value.

[0057] In the present invention, the diffusion layer is mainly composed of particulate polystyrene microspheres, which are fixed by polyisobutylene as an adhesive. The main functions of the diffusion layer include uniformly diffusing the sample, filtering macromolecular substances and interfering substances in the sample, and protecting the reagent layer.

[0058] In the present invention, a serum sample is dropped onto a dry sheet, albumin is enriched on the first particles and the second particles, the liquid penetrates into the reagent layer, the bromocresol green dye therein penetrates into the diffusion layer and combines with the albumin in the sample, and the gap difference caused by the particle size control of the first particles and the second particles can more effectively ensure the uniformity and rate of serum diffusion.

[0059] As a specific embodiment of the present invention, the wet film thickness of the diffusion layer is 400-600 μm, and the dry film thickness is 200-300 μm. It should be noted that different film thicknesses will affect the effect, and within this thickness range, the display effect is relatively better.

[0060] As a specific embodiment of the present invention, the support layer includes a transparent resin plastic with a transmittance in the visible light range of more than 85%. The specific material includes at least one of polyethylene PE, polypropylene PP, polyester methyl methacrylate PMMA, polystyrene PS, polycarbonate PC and polyethylene terephthalate PET, preferably PET.

[0061] As a specific embodiment of the present invention, the film thickness of the support layer is 30-200 μm. It should be noted that within this thickness range, the display effect is relatively better, ensuring that both the incident light source and the reflected light can pass through the support layer.

[0062] As a specific embodiment of the present invention, Figure 1 As shown, the reagent sheet provided by the present invention comprises a diffusion layer 1, a reagent layer 2 and a support layer 3, which are laminated together in sequence from top to bottom through a coating process.

[0063] The working principle of the present invention is to drop the serum sample on the dry sheet and evenly distribute it to the reagent layer below through the diffusion layer. The liquid penetrates into the reagent layer, which contains dry chemical reagents. The bromocresol green dye in the reagent layer will penetrate into the diffusion layer and bind to the albumin in the sample, thereby shifting the wavelength of the maximum reflected light of the free dye. Because the amount of dye bound to albumin is proportional to the concentration of albumin in the sample, the amount of colored complex generated can be determined by reflected light photometry, and then the quantitative concentration of albumin in the serum sample can be calculated based on the sample curve. The specific reaction steps are as follows:

[0064] Albumin + bromocresol green → bromocresol green-albumin complex.

[0065] In a second aspect, the present invention provides a method for preparing a dry chemical reagent sheet for quantitatively detecting albumin, comprising the following steps:

[0066] Step 1: coating the reagent layer reagent on the support layer and drying to obtain the reagent layer;

[0067] Step 2: Spread the diffusion layer reagent on the reagent layer and dry it to obtain a dry chemical reagent sheet.

[0068] As a specific embodiment of the present invention, a method for preparing a dry chemical reagent tablet comprises the following steps:

[0069] Step 1: Preparation and coating of reagent layer

[0070] Prepare respectively a bromocresol green sodium aqueous solution, a polyvinyl alcohol (PVA) aqueous solution, a polyoxyethylene lauryl ether (Brij-35) aqueous solution, a fluorosurfactant FS-31 aqueous solution, a tris (hydroxymethyl) aminomethane (Tris) aqueous solution, and a malic acid aqueous solution. After mixing the above solutions, remove bubbles and surface foam in the mixed solvent, and coat the selected supporting layer film with a coating machine. The optional film material of the supporting layer is at least one of polyethylene PE, polypropylene PP, polyester methyl methacrylate PMMA, polystyrene PS, polycarbonate PC, and polyethylene terephthalate PET, preferably with a wet film coating thickness of 300-500 μm, and dry to obtain a dry sheet coated with a reagent layer.

[0071] Step 2: Preparation and coating of diffusion layer

[0072] Polyisobutylene and fluorosurfactant FS-31 are prepared into a mixed liquid; then, the first particulate matter and the second particulate matter are added; the mixture is stirred evenly and quickly coated on a prepared dry sheet coated with a reagent layer, wherein the preferred ratio of 50 μm and 30 μm polystyrene microspheres is 1:1, the wet film coating thickness is 400-600 μm, and the dry sheet for quantitative albumin detection for in vitro diagnosis is obtained after drying.

[0073] The detection method of the albumin quantitative detection dry sheet for in vitro diagnosis provided by the present invention is as follows:

[0074] The dry film is taken out as needed, 10 μL of serum sample is directly added, and after waiting for 5 minutes, the optical density value is tested at a wavelength of 630 nm using an optical densitometer, and the albumin concentration in the tested serum sample is calculated based on the relationship curve between the albumin concentration of the dry film and the optical density value provided by the present invention drawn by the standard at different concentrations. Detection limit range: albumin concentration 10-60 g / L.

[0075] The preferred embodiments of the present invention are described in detail below to illustrate the principles of the present invention, but are not intended to limit the scope of the present invention.

[0076] In the present invention, the amount of each component in the reagent layer reagent and the diffusion layer reagent is the amount of the listed substances, and does not include the amount of the solvent for dissolving the component.

[0077] Unless otherwise specified, the reagents used in the embodiments of the present invention are all commercially available products.

[0078] Example 1

[0079] 1. Preparation and coating of reagent layer

[0080] Sodium bromocresol green aqueous solution, polyvinyl alcohol (PVA) aqueous solution, polyoxyethylene lauryl ether (Brij-35) aqueous solution, fluorosurfactant FS-31 aqueous solution, tris (Tris) aqueous solution, and malic acid aqueous solution were prepared respectively, and the amount of each component was shown in Table 1. After the above solutions were mixed, the bubbles and surface foam in the mixed solvent were removed, and the coating was carried out on the support layer film made of polyethylene terephthalate PET film by a coating machine, preferably the wet film coating thickness was 400 μm, and the dry film thickness of the dry film coated with the reagent layer was 250 μm.

[0081] 2. Preparation and coating of diffusion layer

[0082] Polyisobutylene (molecular weight 2400) and fluorinated surfactant FS-31 were prepared into a mixed solution. Then, polystyrene microspheres with particle sizes of 50 μm and 30 μm were added in a ratio of 1:1. The amount of each component is shown in Table 2. The mixture was stirred evenly and quickly coated on the prepared dry film coated with the reagent layer. The wet film coating thickness was 500 μm and the dry film thickness was 250 μm. The dry film was dried to obtain a quantitative albumin detection dry film for in vitro diagnosis.

[0083] Table 1 Reagent layer formula

[0084]

[0085]

[0086] Table 2 Diffusion layer formula

[0087]

[0088] Example 2

[0089] This embodiment is basically the same as embodiment 1, except that in the preparation process of the reagent layer, the amount of the hydrophilic polymer is 90 g / m 2 ; The dosage of the first surfactant is 14g / m 2 ; The dosage of the second surfactant is 4g / m 2 ; The dosage of tris(hydroxymethyl)aminomethane is 4g / m 2 ; The dosage of malic acid is 15g / m 2 .

[0090] Example 3

[0091] This embodiment is basically the same as embodiment 1, except that in the process of preparing the diffusion layer, the amount of polyisobutylene (molecular weight 2400) used is 50 g / m 2 The dosage of surfactant (FS-31) is 0.9 g / m 2 , configured into a mixed liquid.

[0092] Example 4

[0093] This embodiment is basically the same as the embodiment 1, except that, during the preparation of the diffusion layer, polystyrene microspheres with particle sizes of 50 μm and 30 μm are added in a quantity ratio of 1:2.

[0094] Example 5

[0095] This embodiment is basically the same as the embodiment 1, except that, during the preparation of the diffusion layer, polystyrene microspheres with particle sizes of 60 μm and 20 μm are added in a quantity ratio of 1:1.

[0096] Example 6

[0097] This embodiment is basically the same as the embodiment 1, except that, during the preparation of the diffusion layer, polystyrene microspheres with particle sizes of 90 μm and 50 μm are added in a quantity ratio of 1:1.

[0098] Example 7

[0099] This embodiment is basically the same as the embodiment 1, except that, during the preparation of the diffusion layer, polystyrene microspheres with particle sizes of 50 μm and 30 μm are added in a quantity ratio of 1:5.

[0100] Comparative Example 1

[0101] This comparative example is substantially the same as Example 1, except that polyoxyethylene lauryl ether (Brij-35) is not included during the preparation of the reagent layer.

[0102] Comparative Example 2

[0103] This comparative example is basically the same as Example 1, except that, during the preparation of the diffusion layer, only polystyrene microspheres with a particle size of 30 μm are added as particulate matter.

[0104] Comparative Example 3

[0105] This comparative example is basically the same as Example 1, except that, during the preparation of the diffusion layer, only polystyrene microspheres with a particle size of 50 μm are added as particulate matter.

[0106] Experimental example: Evaluation of the ability of the prepared dry film to detect serum albumin concentration

[0107] Take 4 small pieces (each piece size 1.5cm*1.5cm) of the same batch of albumin quantitative detection dry pieces prepared by the present invention and can be used for in vitro diagnosis, and add serum samples with albumin standard concentrations of 13g / L, 20g / L, 35g / L, 46g / L and 62g / L respectively (wherein, serum samples with concentrations of 13g / L, 35g / L and 62g / L are commercially available composite calibrators, and the remaining concentrations are the dilution concentrations of commercially available composite calibrators), wait for 5min, and then test the optical density value at a wavelength of 630nm with an optical densitometer, wherein the corresponding optical density value also presents a gradient change relationship. The test results of the embodiment and the comparative example are shown in Table 3.

[0108] Commercially available composite calibrants with concentrations of 13 g / L, 35 g / L, and 62 g / L were added dropwise to the Example and the Comparative Example for reaction. The coefficient of variation CV was calculated by repeating 10 times. The results are shown in Table 4.

[0109] The concentrations of Example 1 are 13 g / L, 35 g / L, and 62 g / L, respectively. Figure 2 As shown, the optical density value shows a positive relationship with the albumin concentration, indicating that the albumin quantitative detection dry sheet for in vitro diagnosis of the present invention can detect and distinguish serum with different albumin concentrations.

[0110] Table 3 Test results of Examples S1-S7 and Comparative Examples D1-D3

[0111]

[0112] Table 2 Repeatability test results of Examples S1-S7 and Comparative Examples D1-D3

[0113]

[0114] As can be seen from Table 3 and Table 4, compared with Comparative Examples 1-3, the correlation coefficient r2 of Example 1 is 0.9868, indicating that the optical density and the albumin concentration present a good linear relationship, and the slope of Example 1 is 0.011, indicating that the optical density difference between high concentration and low concentration is large, and the color difference is obvious. In addition, the coefficient of variation CV value of Example 1 is lower than that of Comparative Examples 1-3, and the repeatability meets the requirements and the precision is better.

[0115] It should be noted that the embodiments described above are only used to explain the present invention and do not constitute any limitation to the present invention. The present invention has been described with reference to typical embodiments, but it should be understood that the words used therein are descriptive and explanatory words, rather than restrictive words. The present invention may be modified as specified within the scope of the claims of the present invention, and the present invention may be revised without departing from the scope and spirit of the present invention. Although the present invention described therein relates to specific methods, materials and embodiments, it does not mean that the present invention is limited to the specific examples disclosed therein, on the contrary, the present invention can be extended to all other methods and applications with the same functions.

Claims

1. A dry chemical reagent sheet for quantitative detection of albumin, characterized in that: The invention comprises a support layer, a reagent layer and a diffusion layer, wherein the reagent layer is arranged above the support layer, and the diffusion layer is arranged above the reagent layer, wherein the diffusion layer comprises a diffusion layer reagent or is formed by a diffusion layer reagent, wherein the diffusion layer reagent comprises an adhesive, a surfactant and particulate matter, and wherein the particulate matter comprises a first particulate matter and a second particulate matter; The number ratio of the first particles to the second particles is 1:(0.25-4), preferably 1:(0.5-1.5), The difference in particle size between the first particles and the second particles is 10-40 μm, preferably 15-25 μm.

2. The reagent sheet according to claim 1, characterized in that The first particulate matter includes polystyrene microspheres with a particle size of 40-80 μm, preferably 45-55 μm; And / or, the second particulate matter comprises polystyrene microspheres with a particle size of 10-40 μm, preferably 25-35 μm.

3. The reagent sheet according to any one of claims 1 to 2, characterized in that: In the diffusion layer reagent, The dosage of surfactant is 0.5-0.9g / m 2 ; preferably 0.68-0.73g / m 2 ; And / or, the amount of adhesive is 12.5-75g / m 2 , preferably 37.5-62.5g / m 2 ; And / or, the amount of particles is 400-600g / m 2 ; Preferably, The dosage of the first particle is 200-300g / m 2 , preferably 265-280g / m 2 ; and / or, the amount of the second particulate matter is 200-300g / m 2 , preferably 210-220g / m 2 .

4. The reagent sheet according to any one of claims 1 to 3, characterized in that: In the diffusion layer reagent, the binder includes polyisobutylene; And / or, in the diffusion layer reagent, the surfactant includes a fluorinated surfactant.

5. The reagent sheet according to any one of claims 1 to 4, characterized in that: The reagent layer includes a reagent layer reagent or is formed by a reagent layer reagent, and the reagent layer reagent includes a reaction color developing reagent, a hydrophilic polymer, a surfactant and a buffer system.

6. The reagent sheet according to any one of claims 1 to 5, characterized in that: In the reagent layer reagent, the amount of reaction color reagent is 1-2g / m 2 , preferably 1.4-1.8g / m 2 ; Preferably, the reaction color developing reagent includes sodium bromocresol green; And / or, the amount of hydrophilic polymer is 30-150g / m 2 , preferably 90-110g / m 2 ; Preferably, the hydrophilic polymer includes at least one of PVA, PAA, PAM, and PVP.

7. The reagent sheet according to any one of claims 1 to 6, characterized in that: In the reagent layer reagent, the surfactant includes a first surfactant and a second surfactant, preferably, the first surfactant includes polyoxyethylene lauryl ether; the second surfactant includes a fluorine surfactant; Preferably, the amount of the first surfactant is 5-30 g / m 2 , preferably 14-16g / m 2 ; Preferably, the amount of the second surfactant is 1-10 g / m 2 ; preferably 4-6g / m 2 .

8. The reagent sheet according to any one of claims 1 to 7, characterized in that: In the reagent layer reagent, the buffer system includes tris(hydroxymethyl)aminomethane and malic acid. Preferably, the pH of the buffer system is 3-4.

9. The reagent sheet according to any one of claims 1 to 8, characterized in that: The support layer comprises transparent resin plastic; preferably, the film thickness of the support layer is 30-200 μm; And / or, the diffusion layer has a thickness of 200-300 μm; And / or, the reagent layer has a thickness of 200-300 μm.

10. A method for preparing a reagent sheet according to any one of claims 1 to 9, characterized in that: The steps include: Step 1: coating the reagent layer reagent on the support layer and drying to obtain the reagent layer; Step 2: Spread the diffusion layer reagent on the reagent layer and dry it to obtain a dry chemical reagent sheet.

Images