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US 2026/0259223 A1Published application
Collagen Type VI Alpha-6 Assay
AssigneeNordic Bioscience A/S
InventorsSigne Holm Nielsen, Cecilie Hausgaard Møller, Anne-Christine Bay-Jensen, Morten Asser Karsdal
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Abstract
Disclosed herein are methods of immunoassay for detecting and/or monitoring a skin disease in a patient and/or determining the severity of a skin disease in a patient. The methods detect and quantify the levels of a biomarker that has an N-terminus sequence of collagen type VI alpha-6, in a blood-based sample, such as whole blood, plasma or serum, from the patient. Also disclosed are antibodies suitable for use in the methods and immunoassay kits suitable for carrying out the methods.
Claims15
1:
- A method of immunoassay for detecting and/or monitoring a skin disease and/or determining the severity of a skin disease in a patient, the method comprising:
- i) contacting a patient sample, selected from blood, serum or plasma, with a monoclonal antibody that specifically binds to the N-terminus amino acid sequence DSGPEYADVV (SEQ ID NO:
- 1);
- ii) detecting and determining the amount of binding between said monoclonal antibody and peptides in the sample;
- and
- iii) correlating said amount of binding with values associated with normal healthy subjects and/or values associated with known disease severity and/or values obtained from said patient at a previous time point and/or with a predetermined cut-off value.
3 more elements
2:
- The method of claim 1, wherein the monoclonal antibody does not specifically bind to a peptide having the N-terminus amino acid sequence QDSGPEYADVV (SEQ ID NO:
- 2).
3:
- The method of claim 1, wherein the monoclonal antibody does not specifically bind to a peptide having the N-terminus amino acid sequence SGPEYADVV (SEQ ID NO:
- 3).
4:
- The method of claim 1, wherein the monoclonal antibody is raised against a synthetic peptide having the N-terminus amino acid sequence DSGPEYADVV (SEQ ID NO:
- 1).
5:
- The method of claim 1, wherein the skin disease is atopic dermatitis, melanoma, psoriasis, hidradenitis suppurativa or systemic lupus erythematosus.
6:
- The method of claim 1, wherein the immunoassay is a competition assay or a sandwich assay.
7:
- The method of claim 1, wherein the immunoassay is a radio-immunoassay or an enzyme-linked immunosorbent assay.
8:
- An immunoassay kit comprising a monoclonal antibody that specifically binds to the N-terminus amino acid sequence DSGPEYADVV (SEQ ID NO:
- 1), and at least one of:
- a streptavidin coated well plate;
- a biotinylated peptide DSGPEYADVV-L-Biotin (SEQ ID NO:
- 14), wherein L is an optional linker;
- a secondary antibody for use in a sandwich immunoassay;
- a calibrator protein comprising the N-terminus amino acid sequence DSGPEYADVV (SEQ ID NO:
- 1);
- an antibody biotinylation kit;
- an antibody HRP labelling kit;
- an antibody radiolabelling kit;
- or
- an assay visualisation kit.
10 more elements
9:
- The immunoassay kit of claim 8, wherein the monoclonal antibody does not specifically bind to a peptide having the N-terminus amino acid sequence QDSGPEYADVV (SEQ ID NO:
- 2).
10:
- The immunoassay kit of claim 8, wherein the monoclonal antibody does not specifically bind to a peptide having the N-terminus amino acid sequence SGPEYADVV (SEQ ID NO:
- 3).
11:
- The immunoassay kit of claim 8, wherein the monoclonal antibody is raised against a synthetic peptide having the N-terminus amino acid sequence DSGPEYADVV (SEQ ID NO:
- 1).
12:
- A monoclonal antibody that specifically binds to the N-terminus amino acid sequence DSGPEYADVV (SEQ ID NO:
- 1).
13:
- The monoclonal antibody of claim 12, wherein the monoclonal antibody does not specifically bind to a peptide having the N-terminus amino acid sequence QDSGPEYADVV SEQ ID NO:
- 2).
14:
- The monoclonal antibody of claim 12, wherein the monoclonal antibody does not specifically bind to a peptide having the N-terminus amino acid sequence SGPEYADVV (SEQ ID NO:
- 3).
15:
- The monoclonal antibody of claim 12, wherein the monoclonal antibody is raised against a synthetic peptide having the N-terminus amino acid sequence DSGPEYADVV SEQ ID NO:
- 1).