CN217543126U - Double-linkage fecal occult blood quick diagnosis chromatography test paper box - Google Patents

Abstract

The utility model provides a pair method just occult blood rapid diagnosis chromatography test paper box, including box body and test paper strip, the box body is formed by the mutual block of bar bottom plate and bar apron, and the apron top surface sets up two observation windows along length both sides, sets up the application of sample hole between two observation windows, and the bottom plate position that the application of sample hole corresponds is provided with the triangle-shaped cushion, and the apron lower surface is provided with the briquetting, the position that the briquetting corresponds the triangle-shaped cushion is provided with the triangle-shaped recess, the test paper strip includes the plastic substrate, and the hydrophobic barrier film both sides that set up on the plastic substrate overlap joint chemical method just occult blood test paper and immunity method just occult blood test paper respectively, and hydrophobic barrier film is just to adding the application of sample hole when the test paper strip is fixed inside the box body. The duplex fecal occult blood rapid diagnosis chromatography test paper box can simultaneously realize the detection of the fecal occult blood by applying a chemical method and an immunological method, reduces the cost and has simple operation.

Description

Double-linkage fecal occult blood quick diagnosis chromatography test paper box

Technical Field

The utility model relates to the technical field of in vitro diagnosis, in particular to a chromatography test paper box for rapid diagnosis of occult blood by a duplex method.

Background

The examination of fecal occult blood means that the amount of bleeding in the digestive tract is very small, the naked eye does not see the blood color, and a small amount of red blood cells are digested and decomposed, so that no bleeding can be found under the microscope. The color of the excrement can not be changed due to a small amount of bleeding in the digestive tract of the occult blood, and the color can be determined only by an excrement occult blood test. All the digestive tract diseases cause a small amount of bleeding and can be provided with occult blood stool, so occult blood examination has important value for diagnosing various digestive tract hemorrhagic diseases, is an effective means for screening the digestive tract diseases in general, and occult blood experiments become hot spots for continuous and intensive research of people.

The main detection methods of the occult blood of the stool comprise a chemical method and an immunological method: the chemical methods are various, and the o-toluidine method, the reduced phenolphthalein method, the benzidine method, the pilamellar method, and the guaiac method are commonly used. The experimental design principle is based on the fact that the iron-containing hemoxanthin in human hemoglobin has the effect of catalyzing peroxide decomposition, the peroxide in a reagent can be catalyzed to decompose and release nascent oxygen, the chromogen is oxidized to generate color, and the color depth reflects the amount of hemoglobin. Chemical methods lack accuracy and specificity. The exogenous food contains hemoglobin and myoglobin, the effect of heme of the exogenous food can make the experiment positive, and a large amount of uncooked vegetables containing active plant peroxide can also catalyze the decomposition of peroxide to generate positive reaction. If the blood stays in the intestinal tract for too long and hemoglobin is denatured, a negative result inconsistent with the disease condition will be obtained. In addition, if the patient takes a large amount of vitamin C or other drug with reducing properties, the peroxide can be reduced in the experiment, and thus the chromogen substance cannot be oxidized, and the experiment can also be false negative.

The immunological method mainly comprises an immune monoclonal antibody method, an immune spot method, a latex immunochemical agglutination method, a radioimmunodiffusion method, a reverse indirect hemagglutination method, a colloidal gold-labeled sandwich immunoassay method and the like. Antibodies used in such tests are classified into two major classes, namely anti-human hemoglobin antibodies and anti-human erythrocyte stroma antibodies, and currently anti-human hemoglobin antibodies are generally used. In recent years, a colloidal gold immunochromatography method is developed, wherein a monoclonal technology is combined with a colloidal gold technology, and fecal occult blood is detected by utilizing the characteristic that a monoclonal antibody of anti-human hemoglobin can be highly specifically combined with human hemoglobin. The method is not affected by blood, meat, fresh vegetable containing peroxidase, ferralia, and vitamin C of animals, has high sensitivity and rapid response, and has good effect in clinical diagnosis of hemorrhage caused by various diseases. However, the detection omission still exists, and the reasons are mainly as follows:

(1) the hemoglobin is degraded by digestive enzyme and denatured, and has no original immunogenicity;

(2) excessive massive hemorrhage causes excessive antigen in a reaction system and a posterior banding phenomenon;

(3) the patient's hemoglobin antigen is mismatched with the monoclonal antibody.

So far, the sensitivity and specificity of a single fecal occult blood FOB diagnostic method are required to be further improved, and two or more methods are often required to be combined for detection clinically, so that sampling and sample adding are required for multiple times, and the method is inconvenient.

SUMMERY OF THE UTILITY MODEL

The utility model aims at the not enough of prior art, provide a pair method occult blood rapid diagnosis chromatography test paper box, the dual detection of chemical method and immunity can be realized to the application of sample once, and testing result mutually noninterfere.

In order to realize the above object, the technical scheme of the utility model being realized like this, a duplex is just latent blood and is diagnosed chromatography test paper box fast, including box body and test paper strip, the box body is formed by bar bottom plate and the mutual block of bar apron, and the apron top surface sets up two observation windows along length both sides, is used for observing chemical method testing result and immunity method testing result respectively, sets up the application of sample hole between two observation windows, and the bottom plate position that the application of sample hole corresponds is provided with the triangle-shaped cushion, and the apron lower surface is provided with the briquetting, the position that the briquetting corresponds the triangle-shaped cushion is provided with the triangle-shaped recess, the test paper strip includes the plastic substrate, and hydrophobic barrier film both sides that set up on the plastic substrate overlap joint chemical method just is latent blood test paper and immunity method just is latent blood test paper respectively, and the test paper strip is fixed when the box body is inside just to adding the application of sample hole to hydrophobic barrier film.

Specifically, the immunoassay fecal occult blood test paper comprises a sample loading pad, a colloidal gold pad, a chromatography pad and a sample sucking pad which are sequentially overlapped, wherein the colloidal gold pad is coated with a labeled human hemoglobin monoclonal antibody, the chromatography pad comprises a detection T line and a quality control C line which are mutually separated, the T line is the human hemoglobin monoclonal antibody coated on the chromatography pad, and the C line is a goat anti-mouse IgG antibody coated on the chromatography pad.

Specifically, be provided with the limit stop unanimous with bottom plate width direction on the bottom plate, limit stop's quantity is two, and the length when distance between two limit stop and test paper strip are in the exhibition flat state is unanimous and limit stop's the height that highly is higher than the triangle-shaped cushion.

Specifically, a guide sleeve is further arranged on the bottom plate or the cover plate, and correspondingly, a guide post is arranged on the cover plate or the bottom plate.

The chromatography test paper box for rapid diagnosis of occult blood by the duplex method, which is obtained by the technical scheme, has the beneficial effects that:

the chemical method and the immunological method for detecting the fecal occult blood are integrated and separated by the isolating membrane, so that the cost is reduced, the two detection methods are ensured not to interfere with each other, and the accuracy of the detection result is improved; the isolation membrane is bent to form a slope surface through the triangular cushion block, the simultaneous detection of a chemical method and an immunological method can be realized through one-time sample adding, and the operation is simple and rapid.

Drawings

FIG. 1 is a schematic structural diagram of the rapid diagnosis chromatographic test paper box for occult blood in the duplex method.

FIG. 2 is an exploded view of a double-panel process occult blood rapid diagnosis chromatography test paper box.

FIG. 3 is a schematic diagram of the test strip.

In the figure, 100, a cartridge; 110. a base plate; 111. a triangular cushion block; 112. a limit stop block; 113. a guide cylinder; 120. a cover plate; 121. an observation window; 122. a sample application hole; 200. a test strip; 210. a plastic substrate; 220. chemical fecal occult blood test paper; 230. an isolation film; 240. an immunological method fecal occult blood detection test paper; 241. a sample loading pad; 242. a colloidal gold pad; 243. a chromatographic pad; 244. and (4) a sample sucking pad.

Detailed Description

It should be noted that, in the present invention, the embodiments and features of the embodiments may be combined with each other without conflict.

In the description of the present invention, it is to be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore, are not to be construed as limiting the present invention. Furthermore, the terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first," "second," etc. may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless otherwise specified.

In the description of the present invention, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted", "connected" and "disposed" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; the connection may be direct or indirect via an intermediate medium, and may be a communication between the two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art through specific situations.

As shown in fig. 1, the utility model provides a pair method occult blood rapid diagnosis chromatography test paper box, including box body 100 and test paper strip 200, wherein box body 100 is formed by bar bottom plate 110 and the mutual block of bar apron 120, test paper strip 200 is fixed in box body 100, and apron 120 top surface all is provided with observation window 121 along length both sides, is used for observing chemical method testing result and immunity method testing result respectively, sets up application of sample hole 122 between two observation windows 121, and is concrete, and application of sample hole 122 is close to observation window 121 one side that is used for observing chemical method testing result.

As shown in fig. 2, the test strip 200 includes a plastic substrate 210, a hydrophobic isolation film 230 is disposed on the plastic substrate 210, the left side of the isolation film 230 is lapped with the test strip 220 for detecting occult blood by chemical method, the right side of the isolation film 230 is lapped with a sample loading pad 241, a colloidal gold pad 242, a chromatography pad 243 and a sample sucking pad 244 in sequence, the colloidal gold pad 242 is coated with a labeled human hemoglobin monoclonal antibody, the chromatography pad 243 is made of nitrocellulose membrane, the upper side of the nitrocellulose membrane includes a detection T-line and a quality control C-line which are separated from each other, the T-line is the human hemoglobin monoclonal antibody coated on the chromatography pad 243, the C-line is the goat anti-mouse igg antibody coated on the chromatography pad 243, and the sample loading pad 241, the colloidal gold pad 242, the chromatography pad 243 and the sample sucking pad 244 constitute the test strip 240 for detecting occult blood by immunological method.

When the test strip 200 is located inside the cartridge 100, the isolation film 230 faces the sample hole 122, the lines t and C are located within the observation range of the observation window 121 far from the sample hole 122, and the test strip 220 for chemical-method occult blood detection is located within the observation range of the observation window 121 near the sample hole 122.

The isolation film 230 may be made of polyethylene or polypropylene or polyvinyl chloride having hydrophobic property.

The chemical fecal occult blood test paper 220 contains 6.6% w/w of cumene hydroperoxide and 4.0w/w of tetramethylbenzidine; 89.4w/w buffer and non-reactive substance, and the result was judged by observing the color change after the sample was applied.

As shown in fig. 3, a triangular cushion block 111 consistent with the width direction of the bottom plate 110 is disposed on the upper surface of the bottom plate 110, the projection of the sampling hole 122 on the bottom plate 110 is on the same straight line with the triangular cushion block 111, pressing blocks consistent with the length direction of the cover plate 120 are disposed on the lower surface of the cover plate 120, triangular grooves are disposed at positions of the pressing blocks corresponding to the triangular cushion block 111, and two pressing blocks are disposed to press both sides of the width of the test strip 200 respectively.

When the test paper box is assembled, the test paper strip 200 is placed in the box body 100, the isolation film 230 is opposite to the triangular cushion block 111, the cover plate 120 is clamped towards the bottom plate 110 until the pressing block pushes the test paper strip 200 to be abutted against the bottom plate 110, in the clamping process, the triangular cushion block 111 bends the isolation film 230 to form a slope, and samples added from the sampling holes 122 roll down on the immune stool occult blood test paper 240 and the chemical stool occult blood test paper 220 along with the slope respectively.

In order to ensure that the isolating film 230 does not generate displacement along the length direction of the bottom plate 110 during the assembling process of the test paper box, the isolating film 230 is always opposite to the triangular cushion block 111, the bottom plate 110 is further provided with two limit stops 112 which are consistent with the width direction of the bottom plate 110, the number of the limit stops 112 is two, the distance between the two limit stops 112 is consistent with the length of the test paper strip 200 in the flattening state, and the height of the limit stop 112 is higher than that of the triangular cushion block 111.

Furthermore, in order to improve the assembly precision of the cover plate 120 and the base plate 110 and ensure that the projection of the sampling hole 122 on the base plate 110 and the triangular cushion block 111 are in the same straight line, a guide sleeve is further arranged on the base plate 110 or the cover plate 120, correspondingly, guide posts are arranged on the cover plate 120 or the base plate 110, and when the cover plate 120 and the base plate 110 are clamped, the guide posts are inserted into the guide sleeve 113, specifically, the number of the guide posts is not less than four, and the guide posts are respectively arranged at the four corners of the base plate 110 or the cover plate 120.

During detection, the uniformly mixed sample is balanced to room temperature, the test paper box is horizontally placed, a 50-80u l sample is added into a sample adding hole, the sample falls to the bending part of the isolating membrane and respectively rolls down to the chemical method occult blood test paper and the sample loading pad along the slope surfaces on two sides, the sample rolled down on the sample loading pad sequentially flows through the colloidal gold pad and the chromatographic pad under the action of the sample sucking pad, for the chemical method, if the sample contains a certain amount of human hemoglobin, the iron-containing hemoglobin part in the human hemoglobin can catalyze peroxide to decompose and release nascent oxygen, the tetramethylbenzidine is oxidized to generate color reaction, and the color depth reflects the amount of the human hemoglobin; for an immunity method, if a sample contains human hemoglobin, the sample is combined with colloidal gold marked with human hemoglobin monoclonal antibodies on a colloidal gold pad to form a compound, the compound is diffused to a chromatographic pad to further react, when the compound meets another human hemoglobin monoclonal antibody coated on a T line on the chromatographic pad, the compound is combined with the coated human hemoglobin monoclonal antibodies and captured in a baby, when the captured colloidal gold compound reaches a certain amount, a T line visible to the naked eye is formed, if the sample does not contain the human hemoglobin, the T line cannot be formed, the C line is used as a quality control standard, positive and negative samples are detected, and finally, the final detection result is determined by combining the results of two detection methods.

According to the duplex-method test paper box for rapid diagnosis of occult blood, the isolation membrane is adopted to enable the chemical method and the immunological method not to influence each other, and meanwhile, the isolation membrane is bent through the triangular cushion block, so that simultaneous detection can be realized through one-step sample adding, and the convenience and the rapidness are realized.

Above-mentioned technical scheme has only embodied the utility model discloses technical scheme's preferred technical scheme, some changes that this technical field's technical personnel probably made to some parts wherein have all embodied the utility model discloses a principle belongs to within the protection scope of the utility model.

Claims (4)

1. The utility model provides a pair method occult blood rapid diagnosis chromatography test paper box, includes box body and test paper strip, its characterized in that, the box body is formed by the mutual block of bar bottom plate and bar apron, and the apron top surface sets up two observation windows along length both sides, sets up the application of sample hole between two observation windows, and the bottom plate position that the application of sample hole corresponds is provided with the triangle-shaped cushion, and the apron lower surface is provided with the briquetting, the position that the briquetting corresponds the triangle-shaped cushion is provided with the triangle-shaped recess, the test paper strip includes the plastic substrate, and the hydrophobic barrier film both sides that set up on the plastic substrate overlap joint chemistry method occult blood test paper and immunity method occult blood test paper respectively, and hydrophobic barrier film is just to adding the application of sample hole when the test paper strip is fixed inside the box body.

2. The duplex fecal occult blood rapid diagnosis chromatography test paper box of claim 1, wherein the immunoassay fecal occult blood test paper comprises a sample loading pad, a colloidal gold pad, a chromatography pad and a sample sucking pad which are sequentially overlapped, wherein the colloidal gold pad is coated with a labeled human hemoglobin monoclonal antibody, the chromatography pad comprises a detection T line and a quality control C line which are mutually separated, the T line is the human hemoglobin monoclonal antibody coated on the chromatography pad, and the C line is a goat anti-mouse IgG antibody coated on the chromatography pad.

3. A duplex test strip box for rapid diagnosis of occult blood in accordance with claim 1, wherein the bottom plate is provided with two limit stops corresponding to the width direction of the bottom plate, the distance between the two limit stops is corresponding to the length of the test strip in the flattened state, and the height of the limit stop is higher than that of the triangular cushion block.

4. The kit for rapid diagnosis of occult blood chromatography according to claim 1, wherein the bottom plate or the cover plate is provided with a guide sleeve, and the cover plate or the bottom plate is provided with a guide post at a corresponding position.

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