Fba1 Protein Detection for Invasive Candidiasis Diagnosis

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Solution Overview

Problem

Current diagnostic methods for invasive candidiasis are inadequate due to low sensitivity and specificity, leading to delayed treatment and high morbi-mortality rates, as they rely on histological examination and blood cultures, which are invasive and not always reliable, and existing rapid tests often require multiple assays and have limitations in sensitivity and specificity.

Innovation Solution

The method involves detecting the presence of the Fructose Biphosphate Aldolase 1 (Fba1) protein in blood or serum samples using a specific monoclonal antibody, which does not require sample pretreatment and can be performed on low volumes, allowing for early and accurate diagnosis of invasive candidiasis, potentially combined with detecting antibodies against Hyphal Wall Protein 1 (Hwp1) for improved diagnostic performance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If histological examination and blood culture are used for diagnosis, then diagnostic reliability is improved, but diagnostic time is increased and patient outcomes worsen

Engineering Contradiction:
Improvediagnostic reliabilityVSAvoiddiagnostic time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent extracts and detects a specific fungal antigen (galactomannan) from patient serum samples using immunoassay techniques. This extraction approach allows direct detection of the pathogen's presence without requiring time-consuming culture methods, thereby maintaining diagnostic reliability while significantly reducing diagnostic time

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent replaces the mechanical/biological culture system with an immunological detection system. Instead of relying on fungal growth in culture media over several days, the invention uses antibody-antigen recognition to detect fungal presence directly in serum, substituting a slow biological process with a faster immunological assay

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Measurement precision

If multiple rapid assays are combined for diagnosis, then diagnostic accuracy is improved, but device complexity and ease of operation worsen

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidassay complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent combines the detection of galactomannan antigen and anti-galactomannan antibodies into a single integrated assay system. This merging of multiple detection targets into one test platform maintains high diagnostic accuracy while reducing the complexity of performing separate assays

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent creates a multi-functional assay that simultaneously detects both antigen and antibody markers for invasive fungal infection. This universal test platform can identify different aspects of the infection (active presence vs. immune response) within a single diagnostic procedure, improving accuracy without requiring multiple separate tests

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Productivity

If conventional antigen assays are used, then diagnostic speed is improved, but sensitivity and specificity worsen

Engineering Contradiction:
Improvediagnostic speedVSAvoidsensitivity and specificity
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent employs excessive action by detecting both the antigen (galactomannan) and the host's antibodies against it simultaneously. This dual detection approach ensures that even if one marker is present at low levels or temporarily absent, the other can still provide diagnostic confirmation, thereby maintaining high sensitivity and specificity while preserving rapid diagnostic speed

Inventive Principle:
Principle #16Partial or excessive action

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

This approach provides a specific and sensitive method for diagnosing invasive candidiasis with high specificity and accuracy, reducing the need for multiple assays and sample pretreatment, thereby facilitating earlier treatment and improving patient outcomes.

Implementation Method 1

detecting the presence of the Fructose Biphosphate Aldolase 1 (Fba1) protein in blood or serum samples using a specific monoclonal antibody

Methodology Applied
Scientific EffectAntigen-antibody binding:

Data Source

PatentEP2887068B8Method for improving the diagnosis of invasive Candida infections by FBA1 protein detection
Publication Date: 2018.10.24 BIO RAD INNOVATIONS SAS

AI summary

The present invention concerns an in vitro method for diagnosing invasive candidiasis (IC) in a subject which comprises detecting the presence of circulating Candida Fructose 1-6 biphosphate aldolase 1 (Fba1) in a blood, plasma or serum sample of the subject. The invention also relates to a method of determining a suitable treatment regimen for a patient and to a kit for implanting the methods described herein.