Clinical algorithm for excluding patients identified in virtual imaging
Aspects of the invention relate to clinical triage protocols for screening a patient population using virtual imaging techniques, for example, virtual colonoscopy. Methods for increasing the specificity of a virtual imaging procedure are provided. In aspects of the invention, colonic effluents are analyzed using one or more molecular detection assays.
1 . A clinical algorithm for selecting a patient for invasive testing, the method comprising
performing a virtual colonoscopy on a patient:
collecting a colonic effluent sample from the patient;
performing a molecular assay on the colonic effluent; and
performing an invasive analysis on the patient if the patient is identified as positive for a disease in both the virtual colonoscopy and the molecular assay.
2 . The method of claim 1 , wherein the patient is human.
3 . The method of claim 1 , wherein the molecular assay is performed on the colonic effluent only if the patient is identified as positive in the virtual colonoscopy.
4 . A method for excluding patients from undergoing an invasive colonic testing, the method comprising:
performing a virtual colonoscopy on a population of subjects;
collecting a colonic effluent from each subject in the population;
identifying candidates for invasive colonic testing as those subjects that are positive for indicia of colonic disease in the virtual colonoscopy; and,
excluding candidates from the invasive colonic testing if they are negative in a molecular assay performed on their colonic effluent.
5 . A patient care algorithm comprising:
performing a virtual colonoscopy on a subject;
performing a molecular analysis on a colonic sample obtained from the subject if the virtual colonoscopy is positive
performing an invasive colonic test on the subject if the molecular analysis is positive.
6 . The method of any one of claims 1 - 5 , wherein the molecular assay is an assay capable of detecting one or more abnormal nucleic acids associated with a disease.
7 . The method of claim 6 , wherein the disease is colon cancer.