Blood biomarkers for appendicitis and diagnostics methods using biomarkers
Inventors
Chawla, Lakhmir S. • McCaffrey, Timothy A.
Assignees
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Publication Number
US-11371096-B2
Publication Date
2022-06-28
Expiration Date
Abstract
The invention relates to methods and kits for diagnosing and/or treating appendicitis in a subject, comprising performing one or more assays configured to detect one or more biomarkers on a body fluid sample obtained from the subject to provide one or more assay result(s) and correlating the assay result(s) to the occurrence or nonoccurrence of appendicitis in the subject or likelihood of the future outcome to the subject.
Core Innovation
The invention relates to biomarker-based diagnosis and treatment of appendicitis. It performs an assay for measuring a level or a concentration of Defensin alpha 3 protein in a body fluid sample obtained from a human patient presenting with symptoms that mimic appendicitis, and the measured Defensin alpha 3 level or concentration is used to support clinical decision making for diagnosing appendicitis.
A key aspect is comparing the patient’s measured Defensin alpha 3 level or concentration with a threshold derived from a control population. The threshold is defined as the level or concentration of Defensin alpha 3 protein in a body fluid sample obtained from control human subjects having symptoms that mimic appendicitis and not having appendicitis, and the body fluid for the patient is the same as the body fluid obtained from the control population.
Diagnosis is made when the level of Defensin alpha 3 in the patient’s body fluid sample is decreased as compared to the threshold. The invention further provides treating the diagnosed patient, wherein the treatment comprises performing an appendectomy, and the disclosed body fluid sample types include blood, serum, plasma, and urine.
Claims Coverage
The document includes one independent claim directed to diagnosing and treating appendicitis using a Defensin alpha 3 protein assay and a control-population threshold, with treatment by appendectomy. Additional dependent claims add quantified diagnostic performance and specify allowable sample selection.
Defensin alpha 3 protein assay and threshold-based diagnosis
Performing an assay for measuring a level or a concentration of Defensin alpha 3 protein in a body fluid sample obtained from a human patient presenting with symptoms that mimic appendicitis; comparing the level or concentration of Defensin alpha 3 protein with a threshold defined from a control population having symptoms that mimic appendicitis and not having appendicitis using the same body fluid type; diagnosing the patient with appendicitis when the level is decreased as compared to the threshold.
Appendectomy as treatment following Defensin alpha 3 diagnosis
Treating the diagnosed patient wherein the treatment comprises performing an appendectomy.
Same body fluid selection for patient and control population
Selecting the body fluid sample for the patient from the same category used to obtain the control population body fluid samples.
Overall claim coverage centers on Defensin alpha 3 protein level measurement in a body fluid sample, control-population threshold comparison with the same body fluid type, diagnosing appendicitis when Defensin alpha 3 is decreased, and subsequent treatment by appendectomy.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Diagnosing appendicitis in a human patient presenting with symptoms that mimic appendicitis, followed by performing an appendectomy.
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