CN114814246A - Triple color development tumor disease detection device - Google Patents

Abstract

The invention relates to the technical field of medical instruments, in particular to a triple color development tumor disease detection device; the kit comprises a detection kit body, wherein a human hemoglobin chemochromic detection window, a human hemoglobin immunological detection window and a biomarker detection window are respectively arranged on the detection kit body, a sample isolation rib is arranged in the detection kit body, first detection test paper is arranged in the human hemoglobin chemochromic detection window, a detection result chromogenic detection line is arranged on the first detection test paper, second detection test paper is arranged in the human hemoglobin immunological detection window, and an immunological chromogenic detection line and an immunological detection result chromogenic control line are arranged on the second detection test paper; the invention has simple structure, no wound detection, high accuracy of detection result and simple and convenient operation, is suitable for common people to carry out self detection at home or automatic detection in hospitals by means of matched special equipment, and can be widely applied to the field of early screening and detection of various tumor diseases.

Description

Triple color development tumor disease detection device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a triple color development tumor disease detection device.

Background

Human tumors are cancers with high morbidity and extremely high mortality. At present, the best method for diagnosing gastric cancer, rectal cancer and lung cancer is gastroscope, enteroscope, chest radiography and CT examination, but the examination acceptance rate is low and the cost is high, so that large-scale screening and detection are difficult to carry out on common people.

There are about 1900 or more ten thousand cancer patients and about 1000 ten thousand patients dying from various tumor diseases in 2020 worldwide. There are three major factors currently controlling mortality from neoplastic disease: one is risk factor management, such as diabetes, weight, exercise, alcohol abuse, smoking, living environment, etc. The second is to improve the treatment method. And thirdly, improving the screening method. The screening has important significance for early discovery of tumor diseases and reduction of mortality.

At present, the applied screening means are mainly human hemoglobin immunoassay (FIT) and human hemoglobin chemochromic assay (FOBT) to measure the catalase activity of hemoglobin. Meanwhile, the detection of tumor proteomics (proteomics), related genes and microbial biomarkers has been highlighted in recent years, for example: PKM2, mutant and methylated DNA, and the like. These assays need to be performed by highly sensitive analytical techniques and extensive platforms of biomarker information, and there are problems in how to deal with the problems of screening management due to high cost and low specificity, and further research is needed to determine their value in clinical applications.

The establishment of a high-precision noninvasive screening method is the key for reducing tumor disease death, FIT and FOBT are independently used for detecting whether human hemoglobin screens gastrointestinal tumors, and FIT, FOBT and PKM2 are jointly used to play a role in balancing sensitivity and specificity, so that the positive detection rate of tumor neoplasms including polyps and adenomas which cannot bleed or bleed intermittently is improved.

In conclusion, the combined use of the multiple methods achieves the characteristics of higher sensitivity, higher specificity, simple operation, high detection speed, low cost and easy acceptance by people, and regular screening of common people can reduce the death rate of tumor diseases.

Disclosure of Invention

Aiming at the defects in the prior art, the invention provides a triple color development tumor disease detection device, a manager inputs a flow of a work to be processed through an engine system, fills in contents, stores the flow into a database, simultaneously sends the flow contents to a worker, so that the worker can timely receive the work contents, can adjust the flow, and resends the readjusted flow to a handheld mobile terminal, thereby realizing the adjustment requirement of the manager on the flow, and also enabling the worker to timely receive information and complete the flow work, furthermore, a set flow reminding module can also acquire the flow information from the database, and send the information to a responsible person in each step according to the completion time set in the flow information to remind the responsible person to complete the corresponding work within the completion time, the invention adopts the memory database, effectively ensures the read-write speed, and can greatly improve the application performance.

In order to achieve the purpose, the invention provides the following technical scheme:

for better illustration of the invention:

occult blood (also called occult blood) refers to a trace or small amount of bleeding existing in a biological sample (stool, urine, sputum, semen and the like), and because the amount of bleeding is small, the existence of the bleeding cannot be confirmed under the naked eye and microscope, and most of tumor diseases are accompanied by bleeding symptoms caused by tissue damage in the early stage, occult blood detection is a main method for screening and diagnosing the tumor diseases in the early stage.

Tumor cells are also present in biological samples of tumor patients, and the positivity caused by polyps and adenomas is detected by an acetone kinase recombinant protein.

A triple color development tumor disease detection device comprises a detection kit body, wherein a human hemoglobin chemochromic detection window, a human hemoglobin immune detection window and a biomarker detection window are respectively arranged on the detection kit body, a sample isolation rib is arranged in the detection kit body, a first detection test paper is arranged in the human hemoglobin chemochromic detection window, a detection result color development detection line is arranged on the first detection test paper, a second detection test paper is arranged in the human hemoglobin immune detection window, a third detection test paper is arranged in the biomarker detection window, a liquid feeding port is arranged on the front side of the detection kit body, a liquid guide hole communicated with the liquid feeding port is arranged in the detection kit body, a sample liquid storage bin communicated with the liquid guide hole is arranged in the detection kit body, the sample storage bin is communicated with a human hemoglobin chemochromic detection window, a human hemoglobin immunity detection window and a biomarker detection window.

The invention is further configured to: the first test paper consists of a first sample pad, a first nitrocellulose membrane and a first absorption pad, wherein the first nitrocellulose membrane is positioned between the first sample pad and the first absorption pad.

The invention is further configured to: and a detection result color development detection line is arranged on the first nitrocellulose membrane.

The invention is further configured to: the second detection test paper is composed of a second sample pad, a first gold-labeled pad, a second nitrocellulose membrane and a second absorption pad, wherein the second sample pad, the first gold-labeled pad, the second nitrocellulose membrane and the second absorption pad are sequentially connected.

The invention is further configured to: and the first gold label pad is sprayed with a first gold label liquid.

The invention is further configured to: and the second nitrocellulose membrane is provided with a first colorless detection line and a first colorless contrast line.

The invention is further configured to: the third test paper is composed of a third sample pad, a second gold-labeled pad, a third nitrocellulose membrane and a third absorption pad, wherein the third sample pad, the second gold-labeled pad, the third nitrocellulose membrane and the third absorption pad are sequentially connected.

The invention is further configured to: and a second gold label liquid is arranged on the second gold label pad.

The invention is further configured to: and a second colorless detection line and a second colorless contrast line are arranged on the third nitrocellulose membrane.

Advantageous effects

Compared with the known public technology, the technical scheme provided by the invention has the following beneficial effects:

the chemochromic detection method has the advantages of quick and convenient detection, semi-quantitative detection, low detection sensitivity (the content of hemoglobin is more than 2mg/L) due to the influence of diet, ferrous ions and medicines; the immunoassay method has the advantages of strong specificity, no influence of interference factors such as diet, medicines and the like, high sensitivity and large detection range (the content of hemoglobin is 0.2-2000mg/L), and has the defects that a large amount of bleeding can cause anterior lag reaction, the detection result is false negative, and false detection is caused; the PKM2 detection method adopts an isoform of acetone kinase, which is highly expressed in tumor and used for the growth of tumor cells, and features high positive detection rate of tumor neoformations including polyp and adenoma without bleeding or intermittent bleeding. The invention displays the result of color change on the corresponding detection window on the same detection device by the three different detection methods at one time, thereby avoiding the defects of single detection method and improving the sensitivity and accuracy of early screening and detection of tumor diseases.

Drawings

FIG. 1 is a top view of a triple chromogenic neoplastic disease detection device;

fig. 2 is a schematic structural diagram of a triple chromogenic tumor disease detection device.

The reference numbers in the figures illustrate:

1. a detection kit body; 2. a liquid adding port; 3. a drain hole; 4. a sample liquid storage bin; 5. a detection window of a human hemoglobin chemical color development method; 6. a first test paper; 7. a detection result color development detection line; 8. a human hemoglobin immunoassay detection window; 9. a second test paper; 10. a first colorless detection line; 11. a biomarker detection window; 12. a second colorless detection line; 13. a third test paper; 14. a second colorless control line; 15. a first colorless control line; 16. a sample isolation rib; 17. a first sample pad; 18. a second sample pad; 19. a third sample pad; 20. a first gold pad; 21. a second gold pad; 22. a first nitrocellulose membrane; 23. a second nitrocellulose membrane; 24. a third nitrocellulose membrane; 25. a first absorbent pad; 26. a second absorbent pad; 27. a third absorbent pad.

Detailed Description

The technical solution in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention; it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments, and all other embodiments obtained by those skilled in the art without any inventive work are within the scope of the present invention.

In the description of the present invention, it should be noted that the terms "upper", "lower", "inner", "outer", "top/bottom", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, and thus should not be construed as limiting the present invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "disposed," "sleeved/connected," "connected," and the like are to be construed broadly, e.g., "connected," which may be fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; the two elements can be directly connected or indirectly connected through an intermediate medium, and the two elements can be communicated with each other; the specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

Example (b):

referring to fig. 1-2, a triple color development tumor disease detection device comprises a detection kit body 1, wherein a human hemoglobin chemo-color development detection window 5, a human hemoglobin immunity detection window 8 and a biomarker detection window 11 are respectively arranged on the detection kit body 1, a sample isolation rib 16 is arranged in the detection kit body 1, a first detection test paper 6 is arranged in the human hemoglobin chemo-color development detection window 5, a detection result color development detection line 7 is arranged on the first detection test paper 6, a second detection test paper 9 is arranged in the human hemoglobin immunity detection window 8, a third detection test paper 13 is arranged in the biomarker detection window 11, a liquid filling opening 2 is arranged on the front surface of the detection kit body 1, a liquid guide hole 3 communicated with the liquid filling opening 2 is arranged in the detection kit body 1, a sample liquid storage bin 4 communicated with the liquid guide hole 3 is arranged in the detection kit body 1, the sample storage bin 4 is communicated with a human hemoglobin chemochromic detection window 5, a human hemoglobin immunity detection window 8 and a biomarker detection window 11.

In this embodiment, the sample liquid in the sample storage chamber 4 is blocked by the sample isolation rib 16, so that the detected sample is in contact with the first sample pad 17, the second sample pad 18, and the third sample pad 19 corresponding to the first test paper 6, the second test paper 9, and the third test paper 13, and does not directly leak to the lower part of the test strip; the triple chromogenic tumor disease detection device is a combination of three detection methods of a human hemoglobin chemical chromogenic detection method (FOBT), a human hemoglobin immune detection method (FIT) and a tumor cell proteomics, and detection of biomarkers generated by related genes (PKM2), wherein a liquid adding port 2 is opposite to detection kits of different tumor types to be detected, a sample to be detected is correspondingly added after being diluted by human saliva, urine or excrement, and the like, the sample enters a human hemoglobin chemical chromogenic detection window 5, a human hemoglobin immune detection window 8 and a biomarker detection window 11 through a liquid guide hole 3 and a sample storage bin 4 respectively on a first sample pad 17, a second sample pad 18 and a third sample pad 19 of three detection test paper, and the corresponding first detection test paper 6, second detection test paper 9 and third detection test paper 13 in the three windows immediately and quickly complete chemical reaction, the color of different classes is displayed, the detection result is judged to be negative or positive by observing the color change of the color development detection line 7, the first colorless detection line 10 and the second colorless detection line 12, and whether the detection is effective is judged by the color development change of the first colorless control line 15 and the second colorless control line 14. The detection device can be automatically grabbed by the equipment, enters an imaging and scanning cabin of the equipment, automatically reads and prints out a detection report of a detected sample according to different changes of the color displayed by the test paper, and realizes data sharing through a network.

It should be noted that, in the present invention, the shape of the detection kit body 1 may be a filling opening 2 of various shapes and a sample storage bin 4 of various shapes and structures, the human hemoglobin chemo-chromogenic detection window 5, the human hemoglobin immune detection window 8 and the biomarker detection window 11 may be a combination of multiple windows, the first detection test paper 6, the second detection test paper 9 and the third detection test paper 13 coated with different detection reagents as color lines are placed in the human hemoglobin chemo-chromogenic detection window 5, the human hemoglobin immune detection window 8 and the biomarker detection window 11, the color lines on the detection test papers may be single or multiple, and the color of the color lines may be a primary color or other colored test paper.

In the present invention, the first test strip 6 is composed of a first sample pad 17, a first nitrocellulose membrane 22, and a first absorbent pad 25, the first nitrocellulose membrane 22 being located between the first sample pad 17 and the first absorbent pad 25.

Further, the first nitrocellulose membrane 22 is provided with a detection result color development detection line 7.

In this example, the test sample is absorbed by the first sample pad 17 and slowly moved toward the first nitrocellulose membrane 22 and the first absorbent pad 25, and after 5 minutes, the color of the detection line 7(T) is changed, and the test sample is negative when it is colorless, positive when it is blue, and strong positive when it is yellow.

In the present invention, the second test strip 9 is composed of a second sample pad 18, a first gold-labeled pad 20, a second nitrocellulose membrane 23, and a second absorbent pad 26, and the second sample pad 18, the first gold-labeled pad 20, the second nitrocellulose membrane 23, and the second absorbent pad 26 are connected in this order.

Further, the first gold label pad 20 is sprayed with a first gold label solution.

Further, the second nitrocellulose membrane 23 is provided with a first colorless detection line 10 and a first colorless control line 15.

In this embodiment, the first gold-labeled solution is composed of distilled water, chemical buffer, colloidal gold solution, and animal anti-human hemoglobin monoclonal antibody, the first colorless detection line 10(T1) is composed of distilled water, chemical buffer, and animal anti-human hemoglobin monoclonal antibody, and the first colorless control line 15(C1) is composed of distilled water, chemical buffer, and animal anti-animal monoclonal antibody; during detection, the detected sample is absorbed by the second sample pad 18 and slowly moves towards the first gold-labeled pad 20, the second nitrocellulose membrane 23 and the second absorption pad 26, and after 5 minutes, the color change of the first colorless detection line 10(T1) is observed, wherein the colorless is negative, and the red color is positive; the color change of the first colorless contrast line 15(C1) is observed to turn red, which indicates that the detection result is valid, and the detection is still colorless, thereby determining that the detection is invalid or the detection strip is invalid.

In the present invention, the third test strip 13 is composed of a third sample pad 19, a second gold-labeled pad 21, a third nitrocellulose membrane 24, and a third absorbent pad 27, and the third sample pad 19, the second gold-labeled pad 21, the third nitrocellulose membrane 24, and the third absorbent pad 27 are connected in this order.

Further, a second gold marker solution is disposed on the second gold marker pad 21.

Further, a second colorless detection line 12 and a second colorless control line 14 are disposed on the third nitrocellulose membrane 24.

In this embodiment, the second gold-labeled solution is composed of distilled water, chemical buffer, colloidal gold solution, animal anti-human hemoglobin clone antibody containing PKM2 acetone kinase, the second colorless detection line 12(T2) is composed of distilled water, chemical buffer, animal anti-human hemoglobin clone antibody containing PKM2 acetone kinase, and the second colorless control line 14(C2) is composed of distilled water, chemical buffer, animal anti-animal clone antibody containing PKM2 acetone kinase; during detection, the detected sample is absorbed by the third sample pad 19 and slowly moves towards the second gold-labeled pad 21, the third nitrocellulose membrane 24 and the third absorption pad 27, and after 5 minutes, the color change of the second colorless detection line 12(T2) is observed, wherein the colorless is negative, and the red color is positive; and observing the color change of the second colorless control line 14(C), wherein the color change is red, which indicates that the detection result is valid, and the color is still colorless, which determines that the detection is invalid or the detection strip is invalid.

When the kit needs to be used, the package is opened, the detection kit device is taken out, and the colors of the detection test paper in the three detection windows are observed to be consistent with the colors of the color development lines of the test paper, so that the kit device can be normally used for detection. The detected sample liquid is dropped or immersed into the liquid adding port 2, flows to the sample pads of the detection test paper through the liquid guide hole 3 and the sample liquid storage bin 4 respectively, and reacts with the antibody and the reagent substance of the chromogenic detection line and the chromogenic contrast line on the detection test paper, so that different color lines are displayed, and whether the detection result is negative or positive and whether the detection is effective or not is judged according to different color conditions.

When the color change of the detection result color detection line 7(T) of the human hemoglobin chemical color development detection window 5(FOBT) is negative, the color change into blue is positive, and the color change into yellow is strong positive; when the first colorless control line 15(C1) of the human hemoglobin immunoassay detection window 8(FIT) becomes red and the first colorless detection line 10(T1) does not change color, the first colorless control line 15(C1) becomes red and the first colorless detection line 10(T1) becomes red, the first colorless control line is positive; similarly, it is positive when the second colorless control line 14(C2) of the biomarker detection window 11(PKM2) turns red and the second colorless detection line 12(T2) does not change color, and the second colorless control line 14(C2) and the second colorless detection line 12(T2) turn red. In addition, when the first colorless control line 15(C1) of the human hemoglobin immunoassay detection window 8(FIT) changes to red and the second colorless control line 14 of the biomarker detection window 11(PKM2) does not show red, the detection kit is invalid or the detection is invalid. Special cases are as follows: when the color detection line 7 shows yellow in the detection result of the human hemoglobin chemo-chromogenic detection window 5(FOBT), and the first colorless control line 15(C1) of the human hemoglobin immunoassay detection window 8(FIT) changes to red, and the first colorless detection line 10(T1) does not change color, the detection result is determined to be positive because of the high hemoglobin content in the sample, which is specifically shown in table 1 below.

TABLE 1 determination of test results

The above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; such modifications and substitutions do not depart from the spirit and scope of the corresponding technical solutions.

Claims (9)

1. A triple chromogenic tumor disease detection device is characterized by comprising a detection kit body (1), wherein a human hemoglobin chemochromic detection window (5), a human hemoglobin immunological detection window (8) and a biomarker detection window (11) are respectively arranged on the detection kit body (1), a sample isolation rib (16) is arranged in the detection kit body (1), a first detection test paper (6) is arranged in the human hemoglobin chemochromic detection window (5), a detection result chromogenic detection line (7) is arranged on the first detection test paper (6), a second detection test paper (9) is arranged in the human hemoglobin immunological detection window (8), a third detection test paper (13) is arranged in the biomarker detection window (11), a liquid adding opening (2) is arranged on the front side of the detection kit body (1), the detection kit comprises a detection kit body (1), wherein a liquid guide hole (3) communicated with a liquid feeding port (2) is formed in the detection kit body (1), a sample liquid storage bin (4) communicated with the liquid guide hole (3) is formed in the detection kit body (1), and the sample liquid storage bin (4) is communicated with a human hemoglobin chemochromic detection window (5), a human hemoglobin immunological detection window (8) and a biomarker detection window (11).

2. The triple chromogenic tumor disease detection device according to claim 1, wherein the first test strip (6) is composed of a first sample pad (17), a first nitrocellulose membrane (22) and a first absorbent pad (25), and the first nitrocellulose membrane (22) is located between the first sample pad (17) and the first absorbent pad (25).

3. The triple chromogenic tumor disease detection device according to claim 2, wherein the first nitrocellulose membrane (22) is provided with a detection result chromogenic detection line (7).

4. The triple chromogenic tumor disease detection device according to claim 1, wherein the second detection test paper (9) comprises a second sample pad (18), a first gold-labeled pad (20), a second nitrocellulose membrane (23) and a second absorbent pad (26), and the second sample pad (18), the first gold-labeled pad (20), the second nitrocellulose membrane (23) and the second absorbent pad (26) are sequentially connected.

5. The triple chromogenic tumor disease detection device according to claim 4, wherein the first gold label pad (20) is sprayed with a first gold label solution.

6. The triple chromogenic tumor disease detection device according to claim 4, wherein the second nitrocellulose membrane (23) is provided with a first colorless detection line (10) and a first colorless control line (15).

7. The triple chromogenic tumor disease detection device according to claim 1, wherein the third test strip (13) comprises a third sample pad (19), a second gold-labeled pad (21), a third nitrocellulose membrane (24) and a third absorbent pad (27), and the third sample pad (19), the second gold-labeled pad (21), the third nitrocellulose membrane (24) and the third absorbent pad (27) are sequentially connected.

8. The triple chromogenic tumor disease detection device according to claim 7, wherein the second gold label pad (21) is provided with a second gold label solution.

9. The triple chromogenic tumor disease detection device according to claim 7, wherein a second colorless detection line (12) and a second colorless control line (14) are disposed on the third nitrocellulose membrane (24).

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