Serum Biomarker Detection Kit for Ectopic Pregnancy Diagnosis
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Solution Overview
Problem
Current methods for diagnosing ectopic pregnancy are hindered by the lack of reliable serum biomarkers, complexity of serum proteomes, and high patient-to-patient variability, leading to inaccurate and invasive diagnostic tests.
Innovation Solution
Development of a diagnostic reagent kit that includes ligands or polynucleotides binding to specific gene expression products or proteins associated with ectopic pregnancy, allowing for the measurement and comparison of biomarker levels in biological fluids to differentiate between ectopic and intrauterine pregnancies.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If extensive fractionation is used to analyze serum complexity and detect low-abundance proteins, then measurement precision is improved, but device complexity and productivity deteriorate
Solution Approach 1:
The patent extracts and removes the most abundant proteins from serum samples using immunodepletion technology, concentrating the low-abundance proteins of interest. This extraction approach eliminates the need for extensive fractionation while improving detection sensitivity for rare biomarkers, directly resolving the contradiction between measurement precision and device complexity
Solution Approach 2:
The invention applies targeted immunodepletion that selectively removes specific abundant proteins (albumin, immunoglobulins, etc.) while preserving the low-abundance biomarkers. This localized quality change in the serum proteome allows direct analysis without comprehensive fractionation, improving both precision and simplifying the analytical process
2Reliability
If a large number of patient samples are analyzed to account for patient-to-patient heterogeneity, then reliability is improved, but productivity deteriorates
Solution Approach 1:
The patent develops a universal immunodepletion protocol and biomarker panel that can be applied across diverse patient populations regardless of individual variability. This universal approach maintains reliability by consistently identifying the same biomarker signature across patients while improving productivity through standardized processing
Solution Approach 2:
The invention changes the analytical parameters by focusing on a specific set of biomarkers with characteristic expression patterns that remain consistent across patients. This parameter change allows reliable diagnosis with fewer samples while maintaining accuracy despite patient heterogeneity
3Measurement precision
If trans-vaginal ultrasound and serial β-hCG detections are used for diagnosis, then measurement precision is improved, but ease of operation deteriorates due to invasive procedures
Solution Approach 1:
The patent extracts biomarker information directly from serum samples, eliminating the need for invasive trans-vaginal ultrasound procedures. The immunodepletion technique isolates specific biomarkers that provide diagnostic precision comparable to or better than traditional methods while being completely non-invasive
Solution Approach 2:
The invention uses serum biomarkers as intermediary molecules that carry diagnostic information without requiring direct visualization or invasive sampling. These biomarkers serve as mediators between the ectopic pregnancy condition and the diagnostic test, providing accurate results through simple blood draws
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables accurate and less invasive early detection of ectopic pregnancy by identifying characteristic biomarker signatures in biological fluids, improving diagnostic precision and reducing morbidity and mortality.
Implementation Method 1
one or more ligands, wherein each ligand binds to a different gene expression product or protein selected from Table 2 and/or from FIG. 7
Implementation Method 2
one or more polynucleotides or oligonucleotides, wherein each polynucleotide or oligonucleotide hybridizes to a different gene, gene fragment, gene transcript or expression product encoding the biomarkers
Data Source
AI summary
Methods and compositions are provided for diagnosing ectopic pregnancy in a mammalian subject by detecting changes in expression of the selected genes, gene fragments or transcripts or expression products, or changes in the expression levels of one or more of proteins or peptide fragments, identified in Table 2 and FIGS. 8 and 9 herein. A selected gene, gene transcript or protein/peptide expression product, or profiles or signatures formed by combinations of same, detected in a biological fluid, preferably sera, of a subject, enables comparison of the corresponding genes, proteins or profiles from that of a reference or control having a normal intrauterine pregnancy. Detection of characteristic changes in the gene profile or protein expression signature of the subject is correlated with a diagnosis of ectopic pregnancy. Various compositions for use in such diagnosis include PCR primer-probe sets or ligands, labeled or immobilized, which are capable of detecting the changes in expression or translation of these targets.