Methods and systems for multiplex assays
Inventors
Tsao, Dean • Huang, Chin-Shiou • CHUNG, Yao-Kuang
Assignees
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Publication Number
US-11796535-B2
Publication Date
2023-10-24
Expiration Date
Abstract
Disclosed herein are compositions comprising beads with unique analog code identifiers for storing information about a multiplex assay as well as methods for using the same in multiplex chemical and biological assays.
Core Innovation
The invention provides a method for conducting a multiplex assay using beads in an assay system, where each bead includes a substantially transparent polymer layer with parallel first and second surfaces. A substantially non-transparent polymer layer is affixed to the first surface and encloses a center portion of the substantially transparent polymer layer. The substantially non-transparent polymer layer comprises one or more rings enclosing the center portion and represents an analog code, and at least one ring comprises a discontinuity.
In the assay system, at least one bead with an analog code is recognized by an imaging processor as a specific assay, specific analyte, manufacturing lot, individual, locational identifier, or calibration signal and does not correspond to a capture agent associated with that bead. A plurality of beads each comprises a capture agent that specifically binds to an analyte, with the capture agent immobilized on at least one of the first surface and the second surface in at least the center portion of the substantially transparent polymer layer. Each bead includes an analog code corresponding to the capture agent.
The method includes identifying the analog code recognized by the imaging processor as the specific assay, and detecting analyte binding in the sample by analyzing binding of the analyte to the capture agent immobilized on the surface of the bead based on the identification of the analog code corresponding to the capture agent.
Claims Coverage
The independent claim coverage centers on a multiplex assay method with five inventive features: bead structure, ring-based analog code, imaging-processor recognition, capture-agent immobilization matched to the code, and analyte-binding detection.
Transparent polymer layer with affixed non-transparent analog-code rings
Each bead comprises a substantially transparent polymer layer having a first surface and a second surface, and a substantially non-transparent polymer layer affixed to the first surface and enclosing a center portion of the substantially transparent polymer layer.
Analog code represented by one or more rings with discontinuity
The substantially non-transparent polymer layer comprises one or more rings enclosing the center portion of the substantially transparent polymer layer and represents an analog code, and at least one ring comprises a discontinuity.
Imaging processor recognition of analog code as assay or identifier information
At least one bead with an analog code is recognized by an imaging processor as a specific assay, specific analyte, manufacturing lot, individual, locational identifier, or calibration signal and does not correspond to a capture agent associated with the at least one bead.
Capture-agent immobilization matched to analog code for detecting binding
A plurality of beads each comprises a capture agent that specifically binds to an analyte, the capture agent is immobilized on at least one of the first surface and the second surface in at least the center portion, and each bead includes an analog code corresponding to the capture agent.
Analog code identification followed by analyte-binding detection
Identifying the analog code recognized by the imaging processor as the specific assay and detecting analyte binding in the sample by analyzing binding of the analyte to the capture agent immobilized on the surface of the bead based on the identification of the analog code corresponding to the capture agent.
The claim coverage centers on a coded bead structure, imaging-processor recognition of the analog code, and analyte detection linked to the capture agent corresponding to that code.
Stated Advantages
Documented Applications
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