Monoclonal antibody against D-dimer and diagnosis agent for detecting D-dimer, crosslinked fibrin and its derivatives containing D-dimer by using the antibody
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Publication Number
US-11506674-B2
Publication Date
2022-11-22
Expiration Date
Abstract
Disclosed are an immunochemical assay device and a method of using the immunochemical assay device for detecting one or more targets or markers such as Cardiac Troponin I, NT-pro-BNP, D-dimer and/or cross-linked fibrin in a fluid sample.
Core Innovation
The invention relates to murine monoclonal antibodies that specifically bind human D-dimer and cross-linked fibrin, including derivatives containing D-dimer, while showing no cross-reactivity to fibrinogen. Specific binding is defined by epitopes in the D-domain beta-chain (amino acids 134–142 of SEQ ID NO:1) and/or alpha-chain (amino acids 124–214 of SEQ ID NO:2).
The described antibodies are used to form immuno-complexes for immunochemical detection of D-dimer and/or cross-linked fibrin in a fluid sample. The disclosed binding specificity supports immunochemical assay formats that include a first immunochemical antibody conjugated to a first label and a second immunochemical antibody conjugated to an indicia label, with the indicia label different from the first label. The assay indication is generated in an assay indicia zone by an immobilized substance that binds the first label in the immuno-complex.
The invention further provides an immunochemical assay device architecture for detecting the target of interest. The device includes a base member, an array, a reservoir pad, a distal wicking membrane, and a dye zone impregnated with the second immunochemical antibody conjugated to the indicia label. Downstream of the reservoir pad, an assay indicia zone includes an immobilized substance disposed for providing assay indication, and the document also describes quantitative assay implementations using sandwich ELISA and immunochemical test strip/cassette systems, with configurations supporting reflectance/absorption reader quantification and calibration.
Claims Coverage
The relevant disclosure is grounded by one independent claim (an immunochemical assay device) that specifies a multi-zone assay format with two different labeled immunochemical antibodies, followed by an assay indicia zone using an immobilized substance. The independent claim includes one inventive feature set focused on the device structure and label/indicia relationships, while dependent claims further narrow the inventive feature set by specifying control zones, epitope-defined antibody binding, and selected label/immobilized-substance pairings and indicia label types.
Multi-zone immunochemical assay device for D-dimer and/or cross-linked fibrin
An immunochemical assay device comprising a base member with an array including a reservoir pad impregnated with a first immunochemical antibody conjugated to a first label to specifically bind D-dimer and/or cross-linked fibrin, a distal wicking membrane to absorb sample, and a dye zone impregnated with a second immunochemical antibody conjugated to an indicia label different from the first label; and an assay indicia zone disposed in the wicking membrane downstream of the reservoir pad with an immobilized substance that is specific and binding to the first label in the immuno-complex to form assay indicia.
Downstream control zone for control assay indicia
The assay device further includes an assay indicia zone in a wicking membrane with an additional downstream control zone wherein a third immobilized immunochemical antibody binds the second antibody conjugated to an indicia label to form control assay indicia.
Epitope-defined antibody binding to specified D-domain residue ranges
The assay device includes two immunochemical antibodies configured so that each independently binds to specified amino-acid residue sites on beta-chain sequences defined as SEQ ID NO:1 or SEQ ID NO:2, including amino acid residue ranges of 134th to 142nd on the beta-chain and 124th to 214th on the beta-chain.
Biotin indicia label with avidin immobilized substance
The assay device uses an indicia label of biotin and an immobilized substance of avidin.
Indicia label selection limited to specified label formats
The assay device specifies that the indicia label is selected from metallic colloidal gold sol, fluorescent dye, and chromogenic dye encapsulated micro-particles or fibers.
Across the claims, the core inventive coverage centers on a structured immunochemical assay device that distinguishes a first label and a different indicia label for two immunochemical antibodies targeting D-dimer and/or cross-linked fibrin, with assay indication produced downstream by an immobilized substance that binds the first label in an immuno-complex. Dependent features narrow the device by adding a downstream control zone, defining antibody binding specificity via amino-acid residue ranges/SEQ IDs, and selecting particular label/immobilized-substance pairs and indicia label formats.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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