Composition and test paper for detecting bladder injury

Abstract

The invention relates to the field of biological detection, in particular to a composition for detecting bladder injury and bladder injury detection test paper. The composition for detecting bladder injury comprises an anti-bladder epithelial antigen, an anti-cytokeratin 18 and an anti-albumin. The composition for detecting the bladder injury provided by the embodiment of the invention can quickly provide a preliminary diagnosis basis for the bladder injury through simple urine detection, is simple to operate and high in sensitivity, and does not need professional equipment. The technology realizes a new breakthrough in diagnosis and treatment of BPH secondary bladder injury, and has important significance in early screening of bladder injury.

Description

Technical Field

[0001] The present invention relates to the field of biological detection, and particularly to a composition and a test strip for detecting bladder injury. Background Art

[0002] Benign prostatic hyperplasia (BPH) is a common urological disease in elderly men, manifested as an enlarged prostate that compresses the urethra, resulting in urinary flow obstruction and difficulty in urination. As the course of BPH continues, urinary tract obstruction may cause adaptive changes in the bladder, and then cause bladder injury. The manifestations of bladder injury include bladder wall thickening, bladder emptying dysfunction, bladder distension, etc., which can further lead to complications such as urinary retention, urinary tract infection, bladder stones, etc. If not treated in time, bladder injury may cause serious urological dysfunction and affect the quality of life of patients.

[0003] At present, the commonly used clinical detection methods for BPH secondary bladder injury include routine urine test, urine cytology examination, CT scan, cystoscopy, etc. Although these detection methods can be used to evaluate bladder function and its degree of injury, they all have certain limitations. Routine urine test and urine cytology examination are mainly used to detect whether there are infections or abnormal cells in urine, but they cannot provide effective diagnosis for direct injury of the bladder wall or bladder muscle. Although CT scan can help detect bladder distension and bladder stones, due to its radiation risk and high cost, and it cannot reflect early functional injury of the bladder in real time, it is not suitable for routine screening. Although cystoscopy can directly observe the inner cavity of the bladder, it is complicated in operation, high in cost and has certain invasiveness to patients, so it is difficult to be widely used in early screening.

[0004] Therefore, the existing detection means still have certain deficiencies and cannot detect early signs of bladder injury in time and accurately. In order to overcome these deficiencies, it is urgent to develop a simple, rapid and non-invasive detection tool that can conveniently detect the presence and severity of bladder injury at an early stage, so as to provide earlier intervention and treatment for BPH patients. Therefore, proposing a test strip for detecting bladder injury, as an innovative detection tool, has important clinical significance. Summary of the Invention

[0005] The present invention solves at least one of the problems of the related art from the following aspects.

[0006] In a first aspect embodiment of the present application, a composition for diagnosing bladder injury comprises anti-bladder epithelial antigen, anti-cytokeratin 18 and anti-albumin.

[0007] In some embodiments, the ratio of the anti-bladder epithelial antigen, the anti-cytokeratin 18 and the anti-albumin is (1 - 3):(1 - 3):1.

[0008] In some embodiments, the ratio of the anti-bladder epithelial antigen, the anti-cytokeratin 18, and the anti-albumin is 1:1:1.

[0009] In some embodiments, the bladder injury is a bladder injury secondary to benign prostatic hyperplasia.

[0010] The second aspect of the present application provides a bladder injury detection test strip, which includes a reaction color-changing area and a staining comparison area.

[0011] The reaction color-changing area includes an antibody fixation layer, and the antibody fixation layer is fixed with an anti-bladder epithelial antigen, an anti-cytokeratin 18, and an anti-albumin.

[0012] In some embodiments, the staining comparison area includes a first comparison area, a second comparison area, and a third comparison area, wherein the color of the first comparison area represents severe bladder injury, the color of the second comparison area represents moderate bladder injury, and the color of the third comparison area represents mild bladder injury.

[0013] In some embodiments, the ratio of the anti-bladder epithelial antigen, the anti-cytokeratin 18, and the anti-albumin is (1-3):(1-3):1.

[0014] In some embodiments, the ratio of the anti-bladder epithelial antigen, the anti-cytokeratin 18, and the anti-albumin is 1:1:1.

[0015] In some embodiments, the bladder injury is a bladder injury secondary to benign prostatic hyperplasia.

[0016] The third aspect of the present application provides the use of the composition for diagnosing bladder injury according to any one of the above first aspects in the preparation of a kit for detecting bladder injury.

[0017] Compared with the related art, the embodiments of the present invention at least achieve the following beneficial effects:

[0018] The composition for detecting bladder injury provided by the embodiments of the present invention can quickly provide a preliminary diagnosis basis for bladder injury through simple urine detection, with simple operation, high sensitivity, and no need for professional equipment. This technology has achieved a new breakthrough in the diagnosis and treatment of BPH secondary bladder injury and is of great significance for the early screening of bladder injury. Detailed Embodiments

[0019] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some of the embodiments of the present invention, rather than all. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0020] As used in the present invention, "comprising" or "including" is an open-ended term. When used to describe the sequence of a protein or nucleic acid, the protein or nucleic acid may consist of the sequence, or may have additional amino acids or nucleotides at one or both ends, but still have the same or similar activity as the original sequence.

[0021] As used in the present invention, "comprising" or "including" is an open-ended description, including the specified components or steps described, as well as other specified components or steps that do not substantially affect.

[0022] In an embodiment of the first aspect of the present application, a composition for diagnosing bladder injury comprises anti-bladder epithelial antigen, anti-cytokeratin 18, and anti-albumin.

[0023] In the embodiments of the present application, anti-bladder epithelial antigen (Bladder Epithelial Antigen), anti-cytokeratin 18 (CK18), and anti-albumin are used as detection markers for bladder injury, and have the following advantages. First, anti-bladder epithelial antigen has the characteristic of strong specificity, can effectively indicate the injury or shedding of bladder epithelial cells, and reflect the degree of bladder injury. Second, cytokeratin 18 is an important structural protein in epithelial cells, and its release amount is closely related to the degree of cell injury, so it can be used as a sensitive indicator of bladder epithelial injury. Third, anti-albumin can detect the leakage of albumin after the bladder wall is damaged, and help evaluate the integrity of the bladder barrier function. Compared with other known markers or combinations of markers, the combined detection of these three antigens can not only improve the sensitivity of early diagnosis of bladder injury, but also more comprehensively evaluate the type and degree of injury, providing a more accurate diagnostic basis for clinical practice. In addition, their detection in urine or blood is relatively simple and non-invasive, facilitating clinical application.

[0024] In some embodiments, the ratio of the anti-bladder epithelial antigen, the anti-cytokeratin 18, and the anti-albumin is (1-3):(1-3):1 (for example, 1:1:1, 2:1:1, 3:1:1, 1:2:1, 1:3:1, 1:1:2, 1:1:3).

[0025] In some embodiments, the ratio of the anti-bladder epithelial antigen, the anti-cytokeratin 18, and the anti-albumin is 1:1:1.

[0026] In some embodiments, the bladder injury is secondary bladder injury caused by benign prostatic hyperplasia.

[0027] In an embodiment of the second aspect of the present application, a bladder injury detection test strip is provided, comprising a reaction color-changing area and a staining comparison area.

[0028] The reaction color change region includes an antibody immobilization layer, and the antibody immobilization layer is immobilized with anti-bladder epithelial antigen, anti-cytokeratin 18, and anti-albumin.

[0029] In some embodiments, the staining contrast region includes a first contrast region, a second contrast region, and a third contrast region, wherein the color of the first contrast region represents severe bladder injury, the color of the second contrast region represents moderate bladder injury, and the color of the third contrast region represents mild bladder injury.

[0030] In some embodiments, the ratio of the anti-bladder epithelial antigen, the anti-cytokeratin 18, and the anti-albumin is (1 - 3):(1 - 3):1 (such as 1:1:1, 2:1:1, 3:1:1, 1:2:1, 1:3:1, 1:1:2, 1:1:3).

[0031] In some embodiments, the ratio of the anti-bladder epithelial antigen, the anti-cytokeratin 18, and the anti-albumin is 1:1:1.

[0032] In some embodiments, the bladder injury is secondary bladder injury caused by benign prostatic hyperplasia.

[0033] An embodiment of the third aspect of the present application provides the use of the composition for diagnosing bladder injury according to any embodiment of the first aspect above in the preparation of a kit for detecting bladder injury.

[0034] From the above description, it should be noted and understood that various modifications and improvements can be made to the present invention described in detail above without departing from the spirit and scope of the present invention as claimed in the appended claims. Therefore, the scope of the claimed technical solution is not limited by any specific exemplary teachings given.

[0035] The applicant declares that the above content is a further detailed description of the present invention in combination with specific preferred embodiments, and it cannot be determined that the specific implementation of the present invention is only limited to these descriptions. For those of ordinary skill in the technical field to which the present invention pertains, without departing from the concept of the present invention, several simple deductions or substitutions can be made, which should all be regarded as belonging to the protection scope of the present invention.

Claims

1. A composition for diagnosing bladder damage, characterized in that: Contains anti-bladder epithelial antigen, anti-cytokeratin 18, and anti-albumin.

2. The composition for diagnosing bladder injury according to claim 1, characterized in that: The ratio of the anti-bladder epithelial antigen, the anti-cytokeratin 18 and the anti-albumin is (1-3):(1-3):

1.

3. The composition for diagnosing bladder injury according to claim 1, characterized in that: The ratio of the anti-bladder epithelial antigen, the anti-cytokeratin 18 and the anti-albumin is 1:1:

1.

4. The composition for diagnosing bladder injury according to claim 1, characterized in that: The bladder injury is bladder injury secondary to benign prostatic hyperplasia.

5. A bladder injury detection test strip, characterized in that: Including reaction color change area and dyeing contrast area, The reaction color changing area comprises an antibody fixing layer, and the antibody fixing layer is fixed with anti-bladder epithelial antigen, anti-cytokeratin 18 and anti-albumin.

6. The bladder injury detection test paper according to claim 5, characterized in that: The dyed contrast area comprises a first contrast area, a second contrast area and a third contrast area, wherein the color of the first contrast area indicates severe bladder damage, the color of the second contrast area indicates moderate bladder damage, and the color of the third contrast area indicates mild bladder damage.

7. The bladder test strip according to claim 5, characterized in that: The ratio of the anti-bladder epithelial antigen, the anti-cytokeratin 18 and the anti-albumin is (1-3):(1-3):

1.

8. The bladder test strip according to claim 5, characterized in that: The ratio of the anti-bladder epithelial antigen, the anti-cytokeratin 18 and the anti-albumin is 1:1:

1.

9. The bladder test strip according to claim 5, characterized in that: The bladder injury is bladder injury secondary to benign prostatic hyperplasia.

10. Use of the composition for diagnosing bladder injury according to any one of claims 1 to 4 in the preparation of a kit for detecting bladder injury.