WO-2026091362-A1 - USE OF S100A8/A9 IN ASSESSING SEVERITY OF INFECTIOUS DISEASES

WO2026091362A1WO 2026091362 A1WO2026091362 A1WO 2026091362A1WO-2026091362-A1

Abstract

A use of S100A8/A9 in assessing the severity of infectious diseases, and a use of a biomarker (S100A8/A9) and/or a substance for detecting the biomarker in the preparation of a product for assessing the severity of infectious diseases. By detecting the level of S100A8/A9 in serum or plasma, the severity of infectious diseases is rapidly and accurately assessed, thereby simplifying an assessment process and improving accuracy, and the present invention is suitable for various infectious diseases. The biomarker exhibits high sensitivity and good specificity; by assessing the severity of diseases, the present invention provides decision-making support for clinicians, and provides more precise treatment schemes for patients, thereby improving therapeutic efficacy and the quality of life of the patients; and additionally, optimal disease management is achieved, the medical burden on patients' families and society is reduced, and the present invention has favorable and broad clinical application value.

Inventors

SHEN, Adong
LI, XU
BI, Jing
JIANG, TINGTING
TANG, He
TIAN, Xue

Assignees

首都医科大学附属北京儿童医院保定医院

Dates

Publication Date: 20260507
Application Date: 20250307
Priority Date: 20241030

Claims (20)

The use of biomarkers and/or substances that detect said biomarkers in the preparation of products having any of the following functions: A1) Used to assess the severity of infectious diseases; A2) Used to predict or assist in predicting the progression of infectious diseases; The biomarker is S100A8/A9.
According to the application of claim 1, the substance for detecting the biomarker comprises reagents and/or instruments for detecting the expression level of S100A8/A9 by means of Western blotting, immunofluorescence, radioimmunoassay, immunoprecipitation, immunohistochemistry, enzyme-linked immunosorbent assay, double-antibody sandwich ELISA, fluorescence-linked immunosorbent assay, enzyme immunoassay, flow cytometry, chromatography, mass spectrometry, polyacrylamide gel electrophoresis, capillary electrophoresis, near-infrared spectroscopy, immunochemiluminescence, colloidal gold immunochromatography, colloidal gold immunochromatography, fluorescence immunochromatography, surface plasmon resonance, immuno-PCR, or biotin-avidin technology.
The application according to claim 1 or 2 is characterized in that the substance for detecting the biomarker includes a reagent for detecting the expression level of S100A8/A9.
According to claim 3, the application is characterized in that the reagent comprises an antibody, peptide, protein, or nucleic acid molecule that specifically binds to S100A8/A9.
According to any one of claims 1-4, the infectious disease includes diseases caused by viral, bacterial, fungal, mycoplasmal, chlamydial, rickettsial, spirochetal, and parasitic infections.
The application according to any one of claims 1-5 is characterized in that the infectious disease is a lower respiratory tract infection and/or pneumonia caused by various pathogens.
The application according to any one of claims 1-6 is characterized in that the product comprises reagents, reagent kits, detection chips, test strips, test cards, and immunosensors.
The kit is characterized in that it comprises the substance for detecting the biomarker as described in any one of claims 1-4, and the kit has at least one of the following uses: B1) Used to assess the severity of infectious diseases; B2) is used to predict or assist in predicting the progression of infectious diseases.
The kit according to claim 8 is characterized in that the test sample of the kit is serum or plasma.
An apparatus for assessing the severity of infectious diseases, characterized in that the apparatus comprises a data receiving module, a data processing module, and an output module; the data receiving module is used to receive data on the expression levels of S100A8/A9 in the serum or plasma of patients with infectious diseases; the data processing module is used to assess the severity of infectious diseases based on the detection results of S100A8/A9 expression levels; and the output module is used to display the assessment results.
The use of biomarkers and/or substances that detect said biomarkers in the preparation of products having any of the following functions: C1) is used to assist in the diagnosis of whether a subject has an infectious disease; C2) is used to assess the improvement of symptoms in infectious diseases; The biomarker is S100A8/A9.
A method for assessing the severity of an infectious disease, characterized in that the method includes assessing the severity of the infectious disease based on the expression level or content of S100A8/A9 in the serum or plasma of patients with the infectious disease.
The method according to claim 12, characterized in that the method comprises the following steps: (1) Detect the expression level or content of S100A8/A9 in the serum or plasma of patients with infectious diseases; (2) Compare the expression level of S100A8/A9 with the evaluation threshold, and evaluate the severity of infectious disease based on the comparison results.
According to the method of claim 13, the assessment of the severity of the infectious disease based on the comparison results is as follows: when the expression level of S100A8/A9 in the serum or plasma of a patient with an infectious disease is greater than or equal to the assessment threshold, the severity of the infectious disease is predicted to be high; when the expression level of S100A8/A9 in the serum or plasma of a patient with an infectious disease is less than the assessment threshold, the severity of the infectious disease is predicted to be low.
A method for predicting or assisting in the prediction of the progression of an infectious disease, the method comprising predicting or assisting in the prediction of the progression of an infectious disease based on the expression level or content of S100A8/A9 in the serum or plasma of patients with an infectious disease.
The method according to claim 15, characterized in that the method comprises the following steps: (1) Detect the expression level or content of S100A8/A9 in the serum or plasma of patients with infectious diseases; (2) Compare the expression level of S100A8/A9 with the evaluation threshold, and predict or assist in the prediction of the progression of infectious diseases based on the comparison results.
According to the method of claim 16, the step of predicting or assisting in predicting the progression of infectious diseases based on the comparison results is as follows: when the expression level of S100A8/A9 in the serum or plasma of patients with infectious diseases is greater than or equal to the assessment threshold, the progression of infectious diseases to severe pneumonia is predicted; when the expression level of S100A8/A9 in the serum or plasma of patients with infectious diseases is less than the assessment threshold, the progression of infectious diseases to mild pneumonia is predicted.
A method for assisting in the diagnosis of whether a subject has an infectious disease, the method comprising assisting in the diagnosis of whether a subject has an infectious disease based on the expression level or content of S100A8/A9 in the subject's serum or plasma.
The method according to claim 18, characterized in that the method comprises the following steps: (1) Detect the expression level or content of S100A8/A9 in the serum or plasma of the subjects; (2) Compare the expression level of S100A8/A9 with the assessment threshold, and make an auxiliary diagnosis on whether the subject has an infectious disease based on the comparison results.
According to the method of claim 19, the auxiliary diagnosis of whether the subject has an infectious disease based on the comparison results is as follows: when the expression level of S100A8/A9 in the subject's serum or plasma is greater than or equal to the assessment threshold, it is determined that the subject has an infectious disease or is highly likely to have an infectious disease; when the expression level of S100A8/A9 in the subject's serum or plasma is less than the assessment threshold, it is determined that the subject does not have an infectious disease or is very unlikely to have an infectious disease.

Description

Application of S100A8/A9 in assessing the severity of infectious diseases Technical Field This invention belongs to the field of biomedical diagnostic technology, specifically relating to the application of S100A8/A9 in assessing the severity of infectious diseases. Background Technology Infectious diseases, as a class of diseases caused by pathogens invading the human body and causing pathological changes, are diverse in type and have complex transmission routes, posing a serious threat to human health. These diseases not only affect an individual's quality of life but can also trigger epidemics, causing significant impacts on the socio-economic system. The pathogens of infectious diseases are wide-ranging, including but not limited to viruses, bacteria, Mycoplasma pneumoniae, Mycobacterium tuberculosis, fungi, and parasites. Viruses such as influenza virus, SARS-CoV-2, adenovirus, and respiratory syncytial virus spread rapidly through the air and can cause large-scale infections in populations; bacteria such as Mycobacterium tuberculosis, Mycoplasma pneumoniae, and Streptococcus pneumoniae spread through respiratory routes, causing infections and regional epidemics; fungal and parasitic infections are mostly related to personal hygiene and environmental sanitation. During the development of infectious diseases, pathogens interact with the body's immune system, leading to a series of complex pathophysiological changes. These changes not only affect the site of infection but may also affect multiple systems throughout the body, such as the respiratory, digestive, and nervous systems. Therefore, the clinical manifestations of infectious diseases are diverse, ranging from mild fever and cough to severe respiratory failure and multiple organ failure. In the diagnosis and treatment of infectious diseases, accurately assessing whether an infection has occurred and the severity of the disease is crucial for developing appropriate and effective treatment plans, predicting disease progression, and evaluating prognosis. Traditionally, physicians rely primarily on a patient's clinical symptoms and signs, laboratory tests (such as complete blood count and C-reactive protein), and imaging examinations (such as X-rays and CT scans) to make a comprehensive judgment. However, these methods may have limitations in certain situations, such as atypical early infection symptoms and individual differences in response, thus affecting the accuracy of the assessment. Therefore, researching and developing biomarkers that can more sensitively and specifically reflect the immune response and pathophysiological changes in the body during infection and accurately assess the severity of infectious diseases is one of the urgent problems to be solved in clinical practice. This can provide strong support for the diagnosis and treatment of infectious diseases and is of great significance for guiding personalized and standardized treatment of infectious diseases and improving treatment outcomes. Invention Overview The purpose of this invention is to provide an accurate, specific, and sensitive biomarker for assessing the severity of infectious diseases. The technical problem to be solved is not limited to the described technical subject matter; other technical subjects not mentioned herein will be clearly understood by those skilled in the art through the following description. To achieve the above objectives, the present invention first provides the use of biomarkers and/or substances for detecting said biomarkers in the preparation of products having any of the following functions: A1) Used to assess the severity of infectious diseases; A2) Used to predict or assist in predicting the progression of infectious diseases; The biomarker may be S100A8/A9. In the above applications, the substances used to detect the biomarkers may include reagents and/or instruments for detecting the expression levels of S100A8/A9 using Western blotting, immunofluorescence, radioimmunoassay (RIA), immunoprecipitation, immunohistochemistry (IHC), enzyme-linked immunosorbent assay (ELISA), double-antibody sandwich ELISA, fluorescence-linked immunosorbent assay (FLISA), enzyme immunoassay (EIA), flow cytometry (FACS), chromatography, mass spectrometry, polyacrylamide gel electrophoresis, capillary electrophoresis, near-infrared spectroscopy, immunochemiluminescence, colloidal gold immunochromatography (GIC), colloidal gold immunochromatography (GICA), fluorescence immunochromatography, surface plasmon resonance, immuno-PCR, or biotin-avidin technology. In the above applications, the substance used to detect the biomarker may include reagents for detecting the expression level (or content) of S100A8/A9. In the above applications, the reagent may include antibodies, peptides, proteins, or nucleic acid molecules that specifically bind to S100A8/A9. Furthermore, the antibody may be a monoclonal antibody, polyclonal antibody, bispecific antibody, multispecific antibody