Oral Fluid PrEP Adherence Detection Device
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Solution Overview
Problem
Current methods for monitoring adherence to pre-exposure prophylaxis (PrEP) treatments, such as PrEP with tenofovir (TFV), are inadequate due to invasive collection procedures, delayed reporting, and lack of affordable, real-time, point-of-care (POC) tests that provide quantitative results, making it difficult to assess recent drug use and adherence effectively.
Innovation Solution
Development of compounds and immunogenic compositions for detecting TFV metabolites in biological samples using lateral flow immunoassays and other POC devices, which include antibodies that specifically bind to TFV or its derivatives, enabling rapid and quantitative assessment of adherence during clinical visits.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If plasma, dried blood spot, or hair analysis methods are used to monitor PrEP adherence, then adherence information can be obtained, but the collection procedures are invasive and may not be acceptable to patients
Solution Approach 1:
The patent uses a disposable oral fluid collection device that requires no invasive procedures. The device is single-use, pre-packaged, and designed for immediate testing, eliminating the need for repeated invasive sample collection while maintaining adherence monitoring capability through oral fluid analysis.
Solution Approach 2:
The oral fluid collection device is designed for self-collection by patients without requiring healthcare provider intervention. The simple spit-based collection method allows patients to independently provide samples, making the process non-invasive and acceptable to patients while still obtaining reliable adherence information.
2Measurement precision
If plasma, dried blood spot, or hair analysis methods are used to monitor PrEP adherence, then adherence data can be obtained, but there are delays in reporting that prevent implementation of timely interventions
Solution Approach 1:
The oral fluid collection device is pre-prepared with all necessary reagents and controls in a ready-to-use format. The device performs multiple functions (sample collection, processing, and detection) in a single integrated system that provides immediate results, eliminating the time delays associated with sending samples to external laboratories for analysis.
Solution Approach 2:
The patent combines sample collection, sample processing, and adherence determination into a single integrated point-of-care device. This merging of functions allows the entire adherence assessment to be completed during the clinical visit, providing immediate feedback without the delays of separate collection and analysis steps.
3Measurement precision
If plasma, dried blood spot, or hair analysis methods are used to monitor PrEP adherence, then adherence information can be obtained, but these methods provide adherence information that may not reflect recent PrEP use
Solution Approach 1:
The patent changes the biological matrix from plasma or hair to oral fluid, which has a shorter detection window that reflects recent drug use. The device also changes the detection target to the parent drug tenofovir rather than metabolites, providing information about recent dosing behavior that is more relevant for immediate adherence counseling.
4Productivity
If a POC test is developed to provide real-time adherence monitoring, then timely interventions can be implemented, but the test must be affordable and feasible for use in typical HIV clinics
Solution Approach 1:
The patent employs a disposable, single-use oral fluid collection device with integrated reagents and detection components. This approach eliminates the need for expensive, complex laboratory equipment and centralized processing, making the test affordable for routine use in HIV clinics while providing immediate adherence results.
Solution Approach 2:
The device is designed for self-collection and self-testing, eliminating the need for trained laboratory personnel and complex processing infrastructure. This simplicity reduces operational costs and makes the test feasible for implementation in resource-limited HIV clinic settings while maintaining real-time monitoring capability.
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
The solution provides a rapid, affordable, and less interruptive POC test for monitoring PrEP adherence, allowing for timely interventions and improving adherence rates by offering quantitative, real-time results in clinical settings.
Implementation Method 1
antibodies that specifically bind to TFV or its derivatives
Data Source
AI summary
The invention provides novel compounds, reagents, systems, and methods for detecting a metabolite related to a NRTI in a biological sample, and uses thereof in monitoring adherence to pre-exposure prophylaxis. Such reagents comprise NRTI derivatives, analogs, NRTI derivatives conjugates, along with antibodies directed to same, which are useful for antibody-based methods, such as a lateral flow immunoassay and other point of care devices.