Method for the normalization of immunological tests and kits for performing such tests
Inventors
KOCH, Isabel • BOECHER, Oliver • Soutschek, Erwin • McNamara, Steven
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11169153-B2
Publication Date
2021-11-09
Expiration Date
Abstract
Herein disclosed is a method for the normalization of an immunological test, characterized in that the presence of a comparable amount of cells is determined by a sandwich ELISA test in which the capture antibody includes at least one antibody that binds to at least one keratin selected from among keratin 4, 5, 6, 8, 10, 13 and 18 and the detection antibody includes at least one antibody that binds to the selected keratin.
Core Innovation
The invention describes a method for confirming the presence of potential oncoprotein-producing target cells in a cell-containing biological sample obtained from a human subject, so as to normalize the results of an immunoassay specific for the oncoprotein. The method confirms that the cell-containing biological sample contains the target cells by detecting and measuring keratins, thereby normalizing the results of a second oncoprotein immunoassay.
The method comprises simultaneously performing a first immunological test as a sandwich ELISA using a capture antibody and a detection antibody configured to bind to at least three keratins selected from keratin 4, 5, 6, 8, 10, 13, and 18. The first immunological test detects and measures the presence of the selected keratins in the same cell-containing biological sample.
The method also comprises a second immunological test on the same cell-containing biological sample that detects the presence of a biomarker that is an oncoprotein produced by the target cells and whose presence is indicative of cancer. The detected and measured keratins confirm that the cell-containing biological sample contains the target cells and thereby normalize the results of the second immunological test.
Claims Coverage
The independent claim describes one overall inventive method that includes two simultaneously performed immunological tests on the same cell-containing biological sample: a keratin sandwich ELISA as a sampling/target-cell presence confirmation and an oncoprotein biomarker immunoassay as the cancer-indicative assay. The inventive features include the keratin set, the sandwich ELISA configuration, and the normalization linkage between keratin detection and oncoprotein readout.
Simultaneous keratin sandwich ELISA and oncoprotein biomarker immunoassay for normalization
A method in which, for a cell-containing biological sample from a human subject, a first immunological test is simultaneously performed as a sandwich ELISA detecting and measuring at least three keratins using capture and detection antibodies, while a second immunological test detects an oncoprotein biomarker indicative of cancer; the presence of the keratins confirms target cells and thereby normalizes the results of the oncoprotein immunoassay.
Keratins as confirmed target-cell presence using antibody-configured capture and detection
The sandwich ELISA utilizes a capture antibody and a detection antibody configured to bind to the at least three keratins, with the keratins selected from keratin 4, 5, 6, 8, 10, 13, and 18.
Oncoprotein biomarker produced by target cells indicative of cancer
The second immunological test detects the presence of an oncoprotein produced by the target cells, where presence of the oncoprotein biomarker is indicative of cancer.
Across the independent claim, the coverage centers on simultaneously running a keratin-detecting sandwich ELISA and an oncoprotein biomarker immunoassay on the same cell-containing biological sample, and using keratin presence to confirm target cells and normalize the oncoprotein assay results.
Stated Advantages
The presence of the detected and measured keratins confirms that the sample contains the target cells and thereby normalizes the results of the oncoprotein-specific immunoassay.
Documented Applications
Normalization of results of an immunoassay specific for an oncoprotein by confirming presence of potential oncoprotein-producing target cells in a cell-containing biological sample obtained from a human subject.
Interested in licensing this patent?