Methods and compositions for pertussis diagnosis
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Publication Number
US-11851479-B2
Publication Date
2023-12-26
Expiration Date
Abstract
Compositions and methods for the detection and diagnosis of Bordetella pertussis are disclosed. Provided are antibodies, or antigen binding fragment thereof, specific for tracheal colonization factor A (TcfA). Also provided are compositions comprising an anti-TcfA antibody of the instant invention and a carrier; and methods for inhibiting, treating, and/or preventing pertussis and/or a B. pertussis infection in a subject in need thereof are provided, comprising administering an anti-TcfA antibody of the instant invention to the subject.
Core Innovation
The patent provides an isolated antibody or an antigen binding fragment thereof that is immunologically specific for tracheal colonization factor A (TcfA). The antibody or fragment comprises all six complementarity determining regions from 14D12, 23F8, 18B2, 20F4, 14G11, 13E11, 10B1, 7E11, or 3E6, and the disclosure includes antibody fragments as antigen binding fragments that retain immunological specificity for TcfA.
The disclosed antibodies and fragments are provided in connection with diagnostic immunoassays, including lateral flow immunoassay test strips. In the lateral flow immunoassay, a test site includes one or more anti-TcfA antibodies, and a conjugation pad includes one or more anti-TcfA antibodies conjugated to a detectable agent, with conjugated antibodies that specifically bind defined linear TcfA amino-acid ranges.
The disclosure further states therapeutic and prophylactic use of anti-TcfA antibodies to inhibit Bordetella pertussis infection and/or colonization. The patent describes detection support that includes specificity against non-pertussis nasopharyngeal bacteria and detection across multiple Bordetella pertussis strains and TcfA isoforms, with documented testing using baboon nasopharyngeal washes and limited human nasopharyngeal swab testing with RT-PCR concordance.
Claims Coverage
The claim set centers on one isolated anti-TcfA antibody or antigen-binding fragment defined by all six CDRs from specified clones, with additional independent or dependent features addressing sequence-defined fragments, lateral flow test-strip architecture, defined TcfA epitope binding ranges, and nasopharyngeal sample types.
Isolated anti-TcfA antibody defined by CDR content from specified clones
An isolated antibody or an antigen binding fragment thereof immunologically specific for tracheal colonization factor A (TcfA), wherein said antibody or fragment comprises all six complementarity determining regions from 14D12, 23F8, 18B2, 20F4, 14G11, 13E11, 10B1, 7E11, or 3E6.
Antibody fragment defined by heavy-chain and light-chain sequence sets
An antibody fragment wherein said fragment comprises specified heavy chain and light chain sequences (SEQ ID NOs) in alternative sequence sets (a through i).
Lateral flow immunoassay test strip with test-site and conjugation-pad anti-TcfA antibodies
A lateral flow immunoassay test strip that includes a test site with one or more anti-TcfA antibodies and a conjugation pad with one or more anti-TcfA antibodies conjugated to a detectable agent.
Conjugated antibody binding defined TcfA amino-acid ranges
An immunoassay wherein the conjugated antibody specifically binds amino acids 139-150 or 151-156 of TcfA.
Conjugated antibody binding to TcfA amino acids 289-324
An immunoassay wherein the conjugated antibody specifically binds amino acids 289-324 of TcfA.
Nasopharyngeal swab, aspirate, or wash sample in the immunoassay method
A method wherein the biological sample is a nasopharyngeal swab, aspirate, or wash.
Overall, the claims define an isolated anti-TcfA antibody or antigen-binding fragment by CDR content from specified clones and further specify fragment sequences, lateral flow assay components, TcfA epitope binding ranges, and nasopharyngeal sample types.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Rapid point-of-care lateral flow immunoassays using nasopharyngeal swab/aspirate/wash specimens, with RT-PCR concordance reported for limited human testing.
Inhibition of Bordetella pertussis infection and/or colonization using anti-TcfA antibodies for therapeutic and prophylactic use.
Detection across multiple Bordetella pertussis strains and both TcfA isoforms (secreted and cell-associated) as described in the disclosure.
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