Analyte Testing Device with Integrated Sample Retention and Biometric Identification
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Solution Overview
Problem
Current analyte testing devices face challenges in retaining a split fluid sample for confirmation testing and ensuring the chain of custody, as they often require multiple handling steps, risk contamination, and lack the ability to positively identify the test subject or administrator within a single device.
Innovation Solution
An analyte testing device with a sample receiving member having separate collection chambers, a fluid collector with an absorbent material and spring mechanism, and a test cartridge for detecting SARS-CoV-2 virus antigen, allowing for simultaneous testing and retention of a split sample, while providing positive identification through fingerprint acquisition.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a fluid sample is retained for confirmation testing, then the reliability of test results is improved, but the risk of contamination, loss, or mislabeling increases
Solution Approach 1:
The device divides the fluid sample into two separate portions: a primary sample for initial testing and a split sample for confirmation testing. Each sample is collected and stored in separate, sealed containers within the same device, eliminating the need to transfer samples between containers and reducing contamination risk while maintaining reliability through independent sample retention.
Solution Approach 2:
The split sample container is nested within the testing device housing, secured in a designated compartment that remains sealed throughout the testing process. This nested structure allows the sample to be retained in a protected, contamination-free environment while being readily accessible for confirmation testing when needed.
2Adaptability or versatility
If multiple handling steps are required for sample transfer, then testing flexibility is improved, but the complexity of operation and contamination risk increase
Solution Approach 1:
The device combines sample collection, sample retention, and analyte testing functions into a single integrated unit. The fluid collector, split sample container, and test cartridge are all part of one device, allowing the user to complete the entire testing process without transferring samples between separate containers or locations, thereby simplifying operation while maintaining testing flexibility.
Solution Approach 2:
The device serves multiple functions simultaneously: it collects the fluid sample, retains a split sample for confirmation, and performs the analyte test. This multi-functionality eliminates the need for separate collection containers and transfer steps, reducing operational complexity while preserving the ability to conduct both initial and confirmation testing.
3Reliability
If chain of custody requirements are implemented, then the reliability of test results is improved, but the device complexity and identification requirements increase
Solution Approach 1:
The device includes a fingerprint acquisition pad that captures the test subject's biometric information at the time of sample collection. This preliminary identification action establishes the chain of custody immediately, linking the sample to the individual without requiring complex subsequent verification steps or additional identification mechanisms during the testing process.
Solution Approach 2:
The device creates a biometric copy (fingerprint) of the test subject's identification and stores it within the device's memory or on a removable storage medium. This copied identification data serves as reliable proof of chain of custody without requiring the physical presence or additional complex identification procedures, simplifying the overall system while maintaining reliability.
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 device enables rapid, effective screening and retention of analytes, reduces contamination risks, and ensures accurate identification of the test subject, enhancing the reliability of test results and chain of custody.
Implementation Method 1
an absorbent material attached to a piston-like member operatively associated with a spring such that compression of the absorbent material results in compression of the spring, and when compression is released, the spring assists return of the absorbent material to the uncompressed state
Implementation Method 2
when compression is released, the spring assists return of the absorbent material to the uncompressed state
Implementation Method 3
an absorbent material to absorb an oropharyngeal lavage liquid
Implementation Method 4
absorbent material
Data Source
AI summary
A method of detecting SARS-CoV-2 virus antigen present in oropharyngeal lavage comprises: abstaining from food and drink for a first period of time before collecting the oropharyngeal lavage; pouring a non-alcoholic mouth rinse into the oral cavity, and swishing and gargling the non-alcoholic mouth rinse for a second period of time; inserting an absorbent end of a fluid collector comprising an absorbent material into the oral cavity to collect the oropharyngeal lavage from the oral cavity; removing the absorbent end of the fluid collector from the oral cavity; inserting the fluid collector into the sample receiving member of an analyte testing device for testing a fluid sample, with the absorbent end facing downward; and after a third period of time, reading a first indicator on a first test strip in the device to determine whether SARS-CoV-2 virus antigen is detected in the oropharyngeal lavage.