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CN-122016986-A - Application of urine IgA-C3 in IgA nephropathy diagnosis and treatment effect prediction markers

CN122016986ACN 122016986 ACN122016986 ACN 122016986ACN-122016986-A

Abstract

The invention belongs to the technical field of medical detection and diagnosis, and relates to application of urine IgA-C3 in IgA nephropathy diagnosis and treatment effect prediction markers, and the invention applies the urine IgA-C3 to IgA nephropathy auxiliary diagnosis products, thereby bringing a new breakthrough for IgA nephropathy diagnosis and treatment. The reliable and stable urine IgA-C3 compound ELISA detection method established by the invention can effectively detect the level of the compound in urine of a patient, provides a powerful tool for early diagnosis of diseases, and confirms the advantages of urine IgA-C3 in the aspect of differential diagnosis of IgA nephropathy and other nephropathy through detection and analysis of a large number of patients and control groups, and the area under an ROC curve shows good diagnosis efficiency.

Inventors

  • XIE XINFANG
  • LI HUIXIAN
  • LU WANHONG

Assignees

  • 西安交通大学医学院第一附属医院

Dates

Publication Date
20260512
Application Date
20260209

Claims (5)

  1. 1. The application of urine IgA-C3 in IgA nephropathy diagnosis and treatment effect prediction markers.
  2. 2. An ELISA kit for assisting in diagnosing IgA nephropathy, which is characterized in that the ELISA kit is an ELISA kit for detecting urine IgA-C3.
  3. 3. The ELISA kit for aiding diagnosis of IgA nephropathy according to claim 2, wherein the ELISA kit comprises an anti-human C3 antibody and an HRP-labeled IgA antibody.
  4. 4. The ELISA kit for aiding diagnosis of IgA nephropathy according to claim 2, wherein the ELISA kit comprises an IgA standard, a washing solution, a chromogenic substrate and a stop solution.
  5. 5. An IgA nephropathy detection method using the enzyme-linked immunosorbent kit for aiding diagnosis of IgA nephropathy as claimed in any one of claims 2 to 4, comprising the steps of: step 1, taking an ELISA plate coated with a functional protein anti-human C3 antibody, and adding a urine supernatant to be detected for incubation; Step 2, after the incubation in the step 1 is completed, washing the plate by adopting a washing liquid, and then adding an HRP-marked IgA antibody for incubation; step 3, after the incubation in the step 2 is completed, color development, termination and value reading are carried out; step 4, adopting IgA standard substances with different concentrations to perform the operations from the step 1 to the step 3, and manufacturing a standard curve; Step 5, calculating to obtain the IgA-C3 compound level which can be combined with the functional protein anti-human C3 antibody in urine to be detected according to the standard curve prepared in the step 4; And 6, comparing the IgA-C3 compound level which can be combined with the functional protein anti-human C3 antibody in the urine of the patient to be tested with the urine of the disease control, and if the IgA-C3/UTP level in the urine of the patient to be tested is greater than the 80 th percentile of the IgA-C3/UTP level in the urine of the disease control, judging that the patient to be tested has IgA nephropathy.

Description

Application of urine IgA-C3 in IgA nephropathy diagnosis and treatment effect prediction markers Technical Field The invention belongs to the technical field of medical detection and diagnosis, and particularly relates to application of urine IgA-C3 in IgA nephropathy diagnosis and treatment effect prediction markers. Background IgA nephropathy is the most common primary glomerular disease worldwide, and its incidence is particularly prominent in Asian population, accounting for 30% -40% of the primary glomerular disease. The disease takes the deposition of IgA immune complexes in glomerular mesangial regions as a core pathological feature, clinical phenotypes are highly heterogeneous, patients can be expressed as asymptomatic hematuria and proteinuria, partial patients can rapidly progress to renal insufficiency, and finally about 30% -40% of patients progress to end-stage renal disease within 20 years after diagnosis, and life needs to be maintained by means of dialysis or kidney transplantation, thus bringing heavy burden to families of patients and social medical systems. The current diagnostic gold standard of IgA nephropathy is still kidney puncture biopsy, and although the method can clearly determine pathological typing and pathological changes, the method has the limitations of invasive wounds, potential complications (such as bleeding and infection), incapability of repeated detection and the like, and is difficult to be used for early screening of diseases, dynamic monitoring of diseases and evaluation of treatment effects. However, the difference of the response of different patients to treatment is large, a part of patients have treatment resistance, the sensitivity of the traditional monitoring indexes (such as creatinine and urine protein quantification) is low, the obvious change is usually generated when the kidney is obviously damaged, and the patients with ineffective treatment are difficult to identify early and the scheme is adjusted timely, so that the part of patients miss the optimal intervention time. Based on the current situation, relevant clinical guidelines at home and abroad at present clearly indicate that specific biomarkers which can be used for IgA nephropathy early diagnosis, illness state dynamic assessment, treatment scheme guidance and prognosis accurate prediction are still lacking at present. The biomarker is used as a detectable index capable of objectively reflecting pathological processes and evaluating treatment response, and has irreplaceable effects in early diagnosis, prognosis judgment and personalized treatment of kidney diseases, so that the development of the noninvasive biomarker is always a research hotspot in the field of IgA nephropathy. The ideal IgA nephropathy biomarker has the characteristics of non-invasiveness, high sensitivity, high specificity and the like, can make up for the deficiency of kidney puncture biopsy, and realizes early diagnosis, disease severity assessment, treatment response prediction and prognosis judgment of diseases. In recent years, galactose-deficient IgA1 (Gd-IgA 1) is a core biomarker accepted in the current field, however, the clinical transformation and scientific research application of the index still have a plurality of bottlenecks. In terms of detection level, the index lacks standardized universal detection reagent, different research teams mostly adopt self-grinding reagent or improved method to carry out detection, so that the consistency of a detection system is difficult to guarantee, meanwhile, the sensitivity and the specificity of the existing detection method are poor, the detection result has obvious center-to-center difference, the existing data show that the diagnostic efficiency of Gd-IgA1 detected by different experimental centers on IgAN fluctuates greatly, the area under a subject working characteristic curve (AUC) can be as low as 0.4, and the ideal diagnostic threshold is far not reached. From the clinical application value, the correlation between Gd-IgA1 and disease prognosis is not unified in the existing research, and the expression level change of the index after treatment is dry is only weakly correlated with the improvement degree of patient proteinuria, so that the correlation is difficult to be used as a reliable basis for evaluating treatment response. In addition, although the expression of other candidate markers such as urine CD163, urine monocyte chemotactic protein-1 (MCP-1) and the like is increased in the active phase of IgAN, the up-regulation of the markers is not special to IgAN, similar changes can occur in the active phase of various kidney diseases, and the lack of enough disease specificity further limits the popularization and application of the IgAN biomarkers in clinical management. Other potential biomarkers such as IgA-IgG complex, anti-GdIgA 1 anti-glycoantibodies, secretory IgA, dimeric IgA and the like can be reported, but most of the markers have the problems of ins