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US 9,879,091 B2Granted
Assays for TIMP2 having improved performance in biological samples
AssigneeAstute Medical, Inc.
InventorsRavi A. Vijayendran, Srivatsa Venkatasubbarao
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Abstract
The invention provides TIMP2 immunoassays with improved clinical performance, particularly when used in the evaluation of renal injuries. The immunoassays rely on the selection and use of antibodies and antibody pairs that exhibit improved assay performance when used in complex clinical specimens such as biological fluids, and particularly when used in rapid assay formats such as lateral flow test devices.
Claims11
A method for determining the presence or amount of human TIMP2 in a biological sample, comprising:
- performing an immunoassay on the biological sample with a first monoclonal antibody and a second monoclonal antibody which together form sandwich complexes with human TIMP2, wherein the immunoassay provides a detectable signal that is related to the presence or amount of human TIMP2 in the biological sample bound in the sandwich complexes;
- and
- relating the detectable signal to the presence or amount of human TIMP2 in the biological sample, wherein one or both of the first monoclonal antibody and second monoclonal antibody—is a monoclonal antibody that binds with an affinity of at least 108 M−1 to a polypeptide, wherein the sequence of said polypeptide consists of a sequence selected from the group consisting of:
- (SEQ ID NO:
- 1)
- QAFCNADVVIRAKAVSEKEVD,
- (SEQ ID NO:
- 2)
- IYGNPIKRIQYEIKQI,
- (SEQ ID NO:
- 3)
- YEIKQIKMFKGPEKDIEFIYTAPSSAVC
- GVSLDVGGKKEYLIAGKAEGDG,
- (SEQ ID NO:
- 4)
- YEIKQIKMFKGPEKDIEFIYTAPSSAV,
- (SEQ ID NO:
- 5)
- EFIYTAPSSAVCGVS,
- (SEQ ID NO:
- 6)
- TAPSSAVCGVSLDVGGKKEYLIAGKA,
- (SEQ ID NO:
- 7)
- SLDVGGKKEYLIAGKAEGDGK,
- (SEQ ID NO:
- 8)
- SSPDECLWMDWVTEKNINGHQ,
- and
- (SEQ ID NO:
- 9)
- CAWYRGAAPPKQEFLDIEDP.
29 more elements
Dependencies are inferred from the claim text.