CN-121995064-A - Application of one or more of aspergillus fumigatus allergen components and detection reagents of specific IgE in preparation of detection products of ABPA and detection products of ABPA

Abstract

The application relates to the field of biological detection, in particular to application of one or more of aspergillus fumigatus allergen components and detection reagents of specific IgE thereof in preparation of detection products of ABPA and detection products of ABPA. The Aspergillus fumigatus allergen component comprises component 1 or comprises a combination 1 and component 2, wherein component 1 comprises one or more of Asp-f-A, B, C, D, E, F, G with amino acid sequences shown as SEQ ID NO.2, 4, 6, 8, 10, 12 and 14, and component 2 comprises Asp-f-22 and/or Asp-f-27. The application selects proper aspergillus fumigatus allergen component, and realizes the disease diagnosis of ABPA caused by aspergillus fumigatus by detecting the positive condition of the specificity IgE of the aspergillus fumigatus allergen component in the blood sample of a patient.

Inventors

• KANG LE
• DU BAOZHEN
• ZHANG HAOTIAN
• CHEN RUCHONG
• Yang Chaowai
• Hu Qiurong

Assignees

• 广州国家实验室
• 广州医科大学附属第一医院（广州呼吸中心）

Dates

Publication Date

20260508

Application Date

20260408

Claims (15)

1. 1. The use of one or more of an aspergillus fumigatus allergen component and a specific IgE detection reagent for the preparation of a detection product for ABPA; The aspergillus fumigatus allergen component comprises a component 1 or comprises a component 1 and a component 2; The component 1 comprises one or more of Asp-F-A, asp-F-B, asp-F-C, asp-F-D, asp-F-E, asp-F-F and Asp-F-G; the component 2 comprises one or more of Asp-f-22 and Asp-f-27; The amino acid sequence of Asp-f-A comprises the amino acid sequence shown in SEQ ID NO.2, or the nucleotide sequence of the nucleic acid encoding Asp-f-A comprises the nucleotide sequence shown in SEQ ID NO. 1; the amino acid sequence of Asp-f-B comprises the amino acid sequence shown in SEQ ID NO.4, or the nucleotide sequence of the nucleic acid encoding Asp-f-B comprises the nucleotide sequence shown in SEQ ID NO. 3; The amino acid sequence of Asp-f-C comprises the amino acid sequence shown in SEQ ID NO.6, or the nucleotide sequence of the nucleic acid encoding Asp-f-C comprises the nucleotide sequence shown in SEQ ID NO. 5; The amino acid sequence of Asp-f-D comprises the amino acid sequence shown in SEQ ID NO.8, or the nucleotide sequence of the nucleic acid encoding Asp-f-D comprises the nucleotide sequence shown in SEQ ID NO. 7; The amino acid sequence of the Asp-f-E comprises the amino acid sequence shown in SEQ ID NO.10, or the nucleotide sequence of the nucleic acid encoding the Asp-f-E comprises the nucleotide sequence shown in SEQ ID NO. 9; The amino acid sequence of Asp-F-F comprises the amino acid sequence shown in SEQ ID NO.12, or the nucleotide sequence of the nucleic acid encoding Asp-F-F comprises the nucleotide sequence shown in SEQ ID NO. 11; The amino acid sequence of Asp-f-G comprises the amino acid sequence shown in SEQ ID NO.14 or the nucleotide sequence of the nucleic acid encoding Asp-f-G comprises the nucleotide sequence shown in SEQ ID NO. 13.
2. 2. The use according to claim 1, wherein said component 1 comprises said at least three of Asp-F-A, asp-F-B, asp-F-C, asp-F-D, asp-F-E and Asp-F and Asp-F-G.
3. 3. The use according to claim 2, wherein said component 1 comprises said Asp-F-C, asp-F and Asp-F-G.
4. 4. A use according to any one of claims 1 to 3, wherein component 1 is as shown in any one of (A1) to (A7): (A1) Said component 1 comprises said Asp-F-A, asp-F-B, asp-F-C, asp-F-D, asp-F-E, asp-F-F and Asp-F-G; (A2) Said component 1 comprises said Asp-F-B, asp-F-C, asp-F-D, asp-F-E, asp-F-F and Asp-F-G; (A3) Said component 1 comprises said Asp-F-A, asp-F-C, asp-F-D, asp-F-E, asp-F-F and Asp-F-G; (A4) Said component 1 comprises said Asp-F-D, asp-F-E, asp-F-F and Asp-F-G; (A5) Said component 1 comprises said Asp-F-B, asp-F-C, asp-F-E, asp-F-F and Asp-F-G; (A6) Said component 1 comprises said Asp-F-C, asp-F-E, asp-F-F and Asp-F-G; (A7) Said component 1 comprises said Asp-F-C, asp-F-D, asp-F-F and Asp-F-G.
5. 5. The use according to claim 2, wherein said component 1 comprises said Asp-f-C, asp-f-E and Asp-f-G.
6. 6. The use according to any one of claims 1 to 2 and 5, wherein said component 1 comprises said Asp-f-A, asp-f-B, asp-f-C, asp-f-D, asp-f-E and Asp-f-G.
7. 7. The use according to claim 2, wherein said component 1 comprises said Asp-F-D, asp-F-E and Asp-F.
8. 8. The use according to any one of claims 1 to 2 and 7, wherein component 1 is as shown in any one of (B1) to (B3): (B1) Said component 1 comprises said Asp-F-A, asp-F-B, asp-F-D, asp-F-E, asp-F-F and Asp-F-G; (B2) Said component 1 comprises said Asp-F-A, asp-F-C, asp-F-D, asp-F-E and Asp-F-F; (B3) Said component 1 comprises said Asp-F-B, asp-F-D, asp-F-E and Asp-F-F.
9. 9. A use according to any one of claims 1 to 3, wherein the aspergillus fumigatus allergen component comprises Asp-f-A, asp-f-B, asp-f-C, asp-f-D, asp-f-E, asp-f-F, asp-f-G, asp-f-22 and Asp-f-27 as indicated.
10. 10. The use according to any one of claims 1 to 3, 5 and 7, wherein the detection product detects the specific IgE by ELISA, protein chip, magnetic particle chemiluminescence, flow fluorescence and chemiluminescent immunoassay.
11. 11. The use according to any one of claims 1 to 3,5 and 7, wherein the sample to be tested by the test product comprises a blood sample.
12. 12. The use according to any one of claims 1 to 3, 5 and 7, wherein the detection reagent comprises one or more of the aspergillus fumigatus allergen component, a blocking solution, a washing solution, an enzymatic chromogenic reagent and an enzymatic reaction terminating reagent, wherein the enzymatic chromogenic reagent comprises an enzyme-labeled antibody and a chromogenic substrate.
13. 13. An ABPA test product comprising one or more of the aspergillus fumigatus allergen components as defined in any one of claims 1 to 12 and a test reagent for its specific IgE.
14. 14. The ABPA detection product of claim 13, wherein the detection reagent comprises one or more of the aspergillus fumigatus allergen component, a blocking solution, a washing solution, an enzymatic chromogenic reagent and a chromogenic terminating reagent, wherein the enzymatic chromogenic reagent comprises an enzyme-labeled antibody and a chromogenic substrate.
15. 15. An aspergillus fumigatus allergen, characterized in that the aspergillus fumigatus allergen is a composition; The composition comprising at least two of Asp-F-A, asp-F-B, asp-F-C, asp-F-D, asp-F-E, asp-F-F and Asp-F-G as defined in any one of claims 1 to 12, or The composition comprises component 1 and component 2 as defined in any one of claims 1 to 12.

Description

Application of one or more of aspergillus fumigatus allergen components and detection reagents of specific IgE in preparation of detection products of ABPA and detection products of ABPA Technical Field The application relates to the field of biological detection, in particular to application of one or more of aspergillus fumigatus allergen components and detection reagents of specific IgE thereof in preparation of detection products of ABPA and detection products of ABPA. Background Aspergillus fumigatus (Aspergillus fumigatus) is a conditionally pathogenic fungus that can induce allergic reactions in humans. Allergic bronchopulmonary aspergillosis (Allergic Bronchopulmonary Aspergillosis, ABPA) caused by this bacterium is a type of pulmonary disease caused by the body's highly allergic reaction to aspergillus (mainly aspergillus fumigatus). ABPA patients often show poor control of asthma, recurrent pulmonary infections, and are accompanied by varying degrees of bronchiectasis. Currently, clinical diagnosis of ABPA is mainly dependent on the combined criteria of clinical manifestations, imaging features and serological indicators. Wherein, judging whether the aspergillus fumigatus allergy exists in the patient is the basis of the diagnosis of ABPA, and the core method of the judgment is to adopt the aspergillus fumigatus crude extract to detect the specific IgE. However, crude aspergillus fumigatus extracts contain various antigen components, which are prone to cause extensive immunological cross reactions, affecting diagnostic specificity. In the aspect of clinical manifestation, ABPA symptoms are various and lack of specificity, overlap with symptoms of other fungi related pulmonary diseases such as fungal sensitization severe asthma, are clinically characterized by refractory asthma, and are common in symptoms such as cough, expectoration, wheezing and the like. In terms of imaging detection, ABPA patients also behave imagewise similarly to bronchiectasis, chronic aspergillosis, etc., e.g. bronchiectasis is a common feature, and chronic aspergillosis, such as cavitation or fibrosis, can also occur in advanced ABPA. In terms of serological index detection, in addition to ABPA patients, serum aspergillus fumigatus specific IgE can be detected in serum of structural lung disease patients such as bronchiectasis, chronic Obstructive Pulmonary Disease (COPD) and Cystic Fibrosis (CF) to be positive, but the positive result may only represent the colonization or sensitization state of fungi in damaged airways, but the inactive ABPA further increases the difficulty of diagnosis. In conclusion, ABPA has diverse clinical manifestations and wide overlap in symptoms, imaging features and serological indicators with other fungus-related lung diseases. However, ABPA has substantial differences from the therapeutic pathways and intervention strategies for other different types of diseases, and the ambiguity of diagnosis will directly lead to deviations in the therapeutic direction, leaving the patient with the best opportunity for intervention. Therefore, ABPA is very common in clinical practice with missed diagnosis, misdiagnosis and delayed diagnosis, which has become a common problem in clinical practice in various countries. Currently, the latest standards for ABPA diagnosis are based mainly on the diagnostic guidelines issued by the international society for human and animal fungi (ISHAM) -ABPA expert group in 2024. The diagnostic guidelines contain a number of detection indicators, such as clinical manifestations, aspergillus fumigatus specific IgE content, serum total IgE content, serum IgG detection, haemoeosinophil count, chest CT imaging manifestations, lung induced phlegm fungus culture, and the like. Thus, it can be seen that for patients with Aspergillus fumigatus allergy (positive for Aspergillus fumigatus specific IgE), especially those accompanied by pulmonary underlying diseases, it is necessary to determine whether ABPA is diagnosed by combining multiple indexes. Currently, there is a lack of a simple, effective ABPA diagnostic product. Therefore, the method has the advantages of simple and effective diagnosis product development, and important clinical significance and application value for improving the diagnosis accuracy of the ABPA and simplifying the diagnosis process. Disclosure of Invention Based on this, one or more embodiments of the present application provide the use of one or more of an aspergillus fumigatus allergen component and a detection reagent for its specific IgE in the preparation of a detection product of ABPA, a detection product of ABPA. The method comprises the following technical scheme: One or more embodiments of the present application provide for the use of one or more of an aspergillus fumigatus allergen component and a detection reagent for specific IgE thereof in the preparation of a detection product for ABPA; The aspergillus fumigatus allergen component comprises a co