Preparation of subjects for medical or veterinary examination

Inventors

MALKAR, Aditya • Brown, Lauren • van der Schee, Marc

Assignees

Owlstone Medical Ltd

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Publication Number

US-10709323-B2

Patent

Publication Date

2020-07-14

Expiration Date


Abstract

Disclosed is a method of identifying if a subject is sufficiently prepared to permit successful colonoscopic examination, the method comprising the steps of: (a) obtaining a stool sample from a subject having undergone preparation for a colonoscopic examination; (b) analysing the sample to detect the presence and/or amount of faecal matter, if any, in the stool sample; and (c) from the analysis in step (b), identifying whether the subject has been sufficiently prepared.

Core Innovation

A method is provided for identifying if a subject is sufficiently prepared to permit successful colonoscopic examination. A stool sample is obtained from a subject having undergone preparation for a colonoscopic examination, and volatile organic compounds collected or derived from the stool sample are analyzed using Field Asymmetric Ion Mobility Spectrometer analysis to detect the presence and/or amount of faecal matter, if any, in the stool sample.

From the Field Asymmetric Ion Mobility Spectrometer analysis, the subject is identified as sufficiently prepared or not sufficiently prepared for colonoscopic examination. The disclosed approach addresses the problem that visual inspection of liquid stool is insufficient, and instead uses FAIMS measurement and discrimination against predetermined threshold values based on spectral patterns, including heat map-based discrimination using prior databases.

The disclosed method is configured to support decision-making regarding colon readiness, such that the colon is considered sufficiently clear for detecting polyps, for example polyps of at least 5 mm. An example is described in which FAIMS spectra distinguish adequately versus inadequately prepared subjects, enabling early appointment decisions intended to reduce wasted resources and patient inconvenience.

Claims Coverage

The document includes one independent claim covering an FAIMS-based stool and volatile organic compound analysis to detect faecal matter and determine colonoscopic preparation status, with dependent claims narrowing to specific subject and preparation contexts and specifying measurement and decision details using instrument parameter pairs and predetermined threshold values.

FAIMS analysis of stool VOCs to detect faecal matter

A method comprising obtaining a stool sample from a subject having undergone preparation for a colonoscopic examination, analysing the sample using Field Asymmetric Ion Mobility Spectrometer analysis which detects volatile organic compounds collected or derived from the stool sample to detect the presence and/or amount of faecal matter, if any, in the stool sample, and from the analysis identifying whether the subject has been sufficiently prepared.

Laxative before obtaining the stool sample

The method of identifying if a subject is sufficiently prepared is performed including administering a laxative to the subject before obtaining the stool sample.

Human subject

The method is performed on a human subject.

Threshold-based determination using ion current intensity at DF/CV settings

The method measures ion current intensity at one or more pairs of a field dispersion field and a compensation voltage, compares each to a predetermined threshold value, and determines whether the subject is sufficiently prepared for colonoscopic examination.

Overall, the claim set covers identifying colonoscopic readiness by detecting stool-derived volatile organic compounds associated with faecal matter using FAIMS, then determining preparedness from the FAIMS analysis, optionally including a laxative pre-sampling step and/or restricting to human subjects, and optionally using ion current intensity comparisons at specified dispersion field and compensation voltage pairs to predetermined threshold values.

Stated Advantages

Enables early appointment decisions to reduce wasted resources.

Reduces patient inconvenience.

Distinguishes adequately versus inadequately prepared subjects using FAIMS spectra.

Documented Applications

Pre-colonoscopy screening to identify whether a subject is sufficiently prepared to permit successful colonoscopic examination, supporting decisions such as whether the colon is sufficiently clear to detect polyps of at least 5 mm and enabling early appointment decisions.

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