Biomarkers for detecting the presence of bacteria

Inventors

DiNello, Robert K. • Geisberg, Mark

Assignees

Silver Lake Research Corp

Abstract

In some aspects, provided are methods relating to the use of bacterial N-methyl-2 superfamily proteins as a biomarker for the presence of bacteria in a sample. The invention also relates to novel methods of diagnosis of the presence of bacteria in a liquid or solid sample, detection of bacterial infections in humans or animals, and use of antibodies or other specific binding molecules capable of binding to N-methyl-2 superfamily proteins.

Core Innovation

The invention relates to using bacterial N-methyl-2 superfamily proteins, including Type IV pilins and PilA, as biomarkers for rapid detection and diagnosis of bacteria. The approach is based on binding one or more N-methyl-2 superfamily conserved sequence motifs that are present on more than one species of bacteria, using antibodies, antibody fragments, aptamers, or ligands that form one or more complexes with the N-methyl-2 superfamily proteins in a sample.

Detection of the presence of complexes indicates the presence of bacteria. The conserved domain includes the amino acid sequence motif [KRHEQSTAG]-G-[FYLIVM]-[ST]-[LT]-[LIVP]-E-[LIVMFWSTAG] (SEQ ID NO. 1), which supports broad detection across bacterial species. The same N-methyl-2 superfamily proteins can also enable identification of specific bacterial subsets by using epitope or sequence differences within N-methyl-2 superfamily proteins.

The invention further documents assay implementation for detecting bacteria and bacterial contamination in different sample types using immunoassays, including lateral flow immunoassays. It describes assay formats and supports for detecting one or more complexes, including device and solid-support implementations.

Claims Coverage

The document provides three independent methods centered on detecting bacteria, detecting bacterial contamination, and identifying one or more specific bacteria via complexes formed with N-methyl-2 superfamily proteins containing a conserved motif. A further independent claim specifies allowable solid-support types used in the methods.

Across the independent claims, the core inventive concept is detecting and/or identifying bacteria by forming and detecting complexes between binding agents and N-methyl-2 superfamily proteins containing SEQ ID NO. 1 conserved domain motif, with specificity achieved by targeting proteins expressed by a subset of bacteria and not by other bacteria. The solid-support independent claim specifies particle, bead, plastic or glass surface, porous membrane, array, or chip formats used to implement the method.

Stated Advantages

Documented Applications