using a fusion polypeptide; Chagas' disease; kits

Inventors

Houghton, Raymond L. • Reed, Steven G. • Raychaudhuri, Syamal

Assignees

InBios International Inc • Access to Advanced Health Institute

Abstract

Compositions comprising fusion polypeptides of T. cruzi epitopes are provided, together with methods for the use of such compositions in the diagnosis of T. cruzi infection and in screening blood supplies. Diagnostic kits comprising such compositions are also provided.

Core Innovation

The disclosure relates to Chagas' disease diagnostics for Trypanosoma cruzi using multi-epitope fusion polypeptides and component peptides. Fusion polypeptides include constructs based on TcF and peptide components such as SAPA, Pep30, Pep36, KMP-11, and a peptide 1 and modified peptide 1 family, with specific fusion polypeptide amino acid sequences identified by SEQ ID NOs 8, 15, 17, 19, and 20.

The invention further provides fusion polypeptides defined by exact amino acid sequence selection and by sequence variants based on identity thresholds of at least 90%, 95%, or 98% identity to SEQ ID NOs 8, 15, 17, 19, or 20. The diagnostic concept relies on antibody-fusion polypeptide complex formation and subsequent detection using a detection reagent that binds to the complex.

The disclosure also describes diagnostic kits and compositions that include the fusion polypeptides together with detection reagents and optional components such as physiologically acceptable carriers and immunostimulants. Detection reagents can include reporter groups, with embodiments enumerating enzymes, substrates, cofactors, inhibitors, dyes, radionuclides, luminescent groups, fluorescent groups, and biotin.

Claims Coverage

The document includes multiple independent claim sets directed to defined fusion polypeptides by sequence identity and selection, methods for detecting T. cruzi infection using antibody-fusion polypeptide complex formation and binding detection, and diagnostic kits and compositions that include the fusion polypeptides with detection reagents and optional carrier and immunostimulant components. Across the independent claims, the coverage centers on the fusion polypeptide sequence definitions plus the two-step contacting and binding-detection scheme, with kit embodiments adding detection reagent and optional reporter group selection.

Overall, the claim coverage is anchored in specific multi-epitope fusion polypeptide sequences and sequence-identity variants, coupled to a detection workflow that forms an antibody-fusion polypeptide complex and then uses a detection reagent that binds to the complex. The coverage also extends to diagnostic kits containing the SEQ ID NO: 19 fusion polypeptide and detection reagent, and compositions that further include physiologically acceptable carriers and immunostimulants.

Stated Advantages

Documented Applications