Vesicles that incorporate reporting constructs for characterizing Botulinum neurotoxin protease activity and suitable for use in an assay are provided. The reporting constructs are a pair of recombinant hybrid proteins that act in concert. The reporting constructs are a pair of recombinant hybrid proteins that act in concert, and that include a Botulinum neurotoxin protease recognition and cleavage sequence positioned to release a fluorophore upon cleavage.

This document discusses, among other things, receiving a plurality of donor fecal samples from a plurality of donors and storing and indexing each respective donor fecal samples using at least one characteristic of the respective donor fecal sample. In an example, the donor fecal sample can be screened and processed for subsequent use in fecal bacteriotherapy to displace pathogenic or undesired organisms in the digestive track of a patient with healthy or desirable gut microbiota.

The present disclosure provides methods related to accurate detection and treatment of medical conditions related to Clostridioides difficile infection (CDI). In specific cases, the disclosure concerns accurate assessment of a symptom associated with CDI related to the presence or risk that may or may not be a pathogenic infection. Particular embodiments encompass detection of one or more specific analytes that provide information for accurate diagnosis and treatment of CDI.

The present specification discloses SNAP-25 compositions, methods of making α-SNAP-25 antibodies that bind an epitope comprising a carboxyl-terminus at the P.sub.1 residue from the BoNT/A cleavage site scissile bond from a SNAP-25 cleavage product, α-SNAP-25 antibodies that bind an epitope comprising a carboxyl-terminus at the P.sub.1 residue from the BoNT/A cleavage site scissile bond from a SNAP-25 cleavage product, methods of detecting BoNT/A activity, and methods of detecting neutralizing α-BoNT/A antibodies.

The present invention relates to engineered Clostridium difficile type IV pilin (tfp) genes, type IV pilin proteins which can serve as a diagnostic marker for identification of patients infected with C. difficile, and vaccines comprising type IV pilin proteins, antigenic fragments and variants thereof for therapeutic interventions.

The present specification discloses SNAP-25 compositions, methods of making α-SNAP-25 antibodies that bind an epitope comprising a carboxyl-terminus at the P.sub.1 residue from the BoNT/A cleavage site scissile bond from a SNAP-25 cleavage product, α-SNAP-25 antibodies that bind an epitope comprising a carboxyl-terminus at the P.sub.1 residue from the BoNT/A cleavage site scissile bond from a SNAP-25 cleavage product, methods of detecting BoNT/A activity, and methods of detecting neutralizing α-BoNT/A antibodies.

A method for prediction of the susceptibility of an at risk patient to developing or redeveloping an infection with Clostridium difficile, having the determination by immunoassay, in a stool sample from said patient, of the level of antibody IgA anti-toxin B of Clostridium difficile, and comparing this level with a reference value S determined beforehand using two populations of patients exposed to the bacterium, one population not having developed or redeveloped such an infection and the other population having developed or redeveloped such an infection, —a level lower than said reference value S signifying that the patient is a patient with a heightened risk of developing or redeveloping a Clostridium difficile infection, and —a level higher than said reference value S signifying that the patient is not a patient with a heightened risk of developing or redeveloping a Clostridium difficile infection.

This application relates to assays, devices, and methods for conducting highly sensitive assays that employ two binding agents and are useful in detecting specific targets such as antigens. These devices and methods provide the ability to detect minute amounts of the specific target with reduced risk of false positive results.

Methods for diagnosing, treating, and monitoring the treatment of Clostridium difficile infections (CDI), e.g., Clostridium difficile-Associated Diarrhea (CDAD). The methods can include detecting the presence of one or more volatile organic compounds (VOCs) in a sample from ambient air or stool sample from subjects suspected of having a CDI, e.g., CDAD.

The present application provides stable peptide-based Botulinum neurotoxin (BoNT) serotype A capture agents and methods of use as detection and diagnosis agents and in the treatment of diseases and disorders. The application further provides methods of manufacturing BoNT serotype A capture agents using iterative on-bead in situ click chemistry.