Methods and devices for detecting cerebrospinal fluid leakage
AssigneeIntegrated Neurologics LLC
InventorsTodd FLOWER, David MATZILEVICH
Life of this patent
Estimating the term…
Abstract
Disclosed are methods and devices for detecting the presence or absence of cerebrospinal fluid (CSF) in a biological sample which normally does not contain CSF, in particular to the detection of the presence or absence of a tau protein in the biological sample. Also disclosed are devices and assays for the detection of the presence or absence of a tau protein indicating the presence or absence of CSF in a sample.
Claims39
A method of detecting a cerebrospinal fluid (CSF) leakage in a subject, said method comprising:
- a1) contacting a rhinorrhea or otorrhea sample from the subject with a first anti-tau antibody that binds to a first epitope of a human tau protein, wherein the first epitope comprises the amino acid sequence of QEFEVMEDHAGTY (SEQ ID NO:
- 1), and a second anti-tau antibody that binds to a second epitope of the human tau protein, wherein the second epitope comprises the amino acid sequence of AAPPGQKGQANA (SEQ ID NO:
- 2);
- and
- b1) detecting the presence or absence of at least one tau protein in the rhinorrhea or otorrhea sample from the subject, wherein the at least one tau protein binds to both the first anti-tau antibody and the second anti-tau antibody, and wherein detecting the presence of the at least one tau protein in the rhinorrhea or otorrhea sample indicates that the subject has the CSF leakage and detecting the absence of the at least one tau protein in the rhinorrhea or otorrhea sample indicates that the subject does not have the CSF leakage;
- or
- a2) contacting a rhinorrhea or otorrhea sample from the subject with a first anti-tau antibody and a second anti-tau antibody, where the first and second anti-tau antibodies bind to at least one tau fragment, wherein the at least one tau fragment comprises at least amino acids 6-168 of SEQ ID NO:
- 7;
- and
- b2) detecting the presence or absence of at least one tau protein in the rhinorrhea or otorrhea sample from the subject, wherein detecting the presence of the at least one tau protein in the rhinorrhea or otorrhea sample indicates that the subject has the CSF leakage and detecting the absence of the at least one tau protein in the rhinorrhea or otorrhea sample indicates that the subject does not have the CSF leakage.
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A method of diagnosing a traumatic brain injury (TBI) or concussion in a subject in need thereof, said method comprising:
- a1) contacting a biological sample from the subject with a first anti-tau antibody that binds to a first epitope of a human tau protein, wherein the first epitope comprises the amino acid sequence of QEFEVMEDHAGTY (SEQ ID NO:
- 1) and a second anti-tau antibody that binds to a second epitope of the human tau protein, wherein the second epitope comprises the amino acid sequence of AAPPGQKGQANA (SEQ ID NO:
- 2);
- and
- b1) detecting the presence or absence of at least one tau protein in the biological sample from the subject, wherein the at least one tau protein binds to both the first anti-tau antibody and the second anti-tau antibody, and wherein detecting the presence of the at least one tau protein in the biological sample indicates that the subject has the TBI and detecting the absence of the at least one tau protein in the biological sample indicates that the subject does not have the TBI;
- or
- a2) contacting biological sample from the subject with a first anti-tau antibody and a second anti-tau antibody, where the first and second anti-tau antibodies bind to at least one tau fragment, wherein the at least one tau fragment comprises at least amino acids 6-168 of SEQ ID NO:
- 7;
- and
- b2) detecting the presence or absence of at least one tau protein in the biological sample from the subject, wherein detecting the presence of the at least one tau protein in the biological sample indicates that the subject has the TBI and detecting the absence of the at least one tau protein in the biological sample indicates that the subject does not have the TBI.
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A device comprising:
- a) a non-immobilized antibody area;
- b) a lateral flow membrane downstream of and configured for fluid communication with the non-immobilized antibody area;
- c) a first anti-tau antibody that binds to a first epitope of the human tau protein, wherein the first epitope comprises the amino acid sequence of QEFEVMEDHAGTY (SEQ ID NO:
- 1);
- and
- d) a second anti-tau antibody that binds to a second epitope of the human tau protein, wherein the second epitope comprises the amino acid sequence of AAPPGQKGQANA (SEQ ID NO:
- 2).
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Dependencies are inferred from the claim text.