CB-CAP Assays for Pre-Lupus Diagnostic Scoring
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Solution Overview
Problem
Diagnosing Systemic Lupus Erythematosus (SLE) remains a clinical challenge due to non-specific symptoms and the lack of sensitive and specific diagnostic tests, leading to underdiagnosis or overdiagnosis, which can result in increased morbidity and mortality, as well as unnecessary exposure to toxic medications.
Innovation Solution
A method and system utilizing cell-bound complement activation product (CB-CAP) assays to classify patients as having pre-Lupus or Lupus by comparing levels of CB-CAPs such as E-C4d, R-C4d, T-C4d, B-C4d, M-C4d, and G-C4d in blood samples with control levels, generating a score to determine the risk of developing Lupus, and providing a report on the classification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional blood tests and clinical criteria are used for Lupus diagnosis, then the diagnostic process is simple and widely accessible, but the diagnosis lacks sensitivity and specificity leading to underdiagnosis or overdiagnosis
Solution Approach 1:
The diagnostic approach is segmented into multiple independent CB-CAP assays targeting different complement activation products (C3d, C4d, C5b-9) bound to different cell types. This segmentation allows each assay to contribute independently to the overall diagnostic score, improving precision while maintaining manageable complexity through modular testing
Solution Approach 2:
The CB-CAP assay platform serves multiple diagnostic functions: it detects complement activation, identifies specific immune pathways involved, and provides a quantitative risk score. This multi-functionality improves diagnostic accuracy without requiring separate specialized tests for each aspect
2Measurement precision
If multiple different physicians are involved over an extended period for accurate Lupus diagnosis, then diagnostic accuracy improves, but the time to diagnosis increases significantly
Solution Approach 1:
The CB-CAP assays are performed as preliminary diagnostic tests early in the clinical workflow, providing risk stratification before full diagnostic workup. This preliminary action identifies high-risk patients who need urgent specialized evaluation, reducing overall diagnostic time while maintaining accuracy
Solution Approach 2:
The quantitative CB-CAP risk score provides immediate feedback to clinicians about disease likelihood, guiding subsequent diagnostic decisions. This feedback mechanism reduces the need for prolonged evaluation by multiple physicians by providing clear directional guidance early in the process
3Ease of operation
If non-specific symptoms are overlooked or overemphasized in Lupus diagnosis, then the diagnostic process remains simple, but underdiagnosis or overdiagnosis occurs increasing morbidity and mortality
Solution Approach 1:
The CB-CAP assays serve as an intermediary objective measure between non-specific clinical symptoms and definitive diagnosis. This intermediary provides quantifiable evidence that mediates the diagnostic decision, reducing reliance on subjective interpretation of symptoms while maintaining process simplicity
Solution Approach 2:
The diagnostic approach transitions from qualitative assessment of non-specific symptoms to quantitative measurement of CB-CAP levels. This parameter change from subjective to objective metrics improves reliability while the automated scoring system maintains ease of operation
Data Source
AI summary
Cell-bound complement activation product (CB-CAP) profiling and scoring serve as diagnostic biomarkers for patients to determine whether a patient who has not met at least four American College of Rheumatology (or similar e.g. SLICC) criteria for a definite Lupus diagnosis should be classified as exhibiting a pre-existing condition that this document refers to as pre-Lupus. This document also describes methods for determining whether a patient who has been determined to exhibit pre-Lupus has progressed to exhibiting definite Lupus.