Oral Fluid Collection Kit for Seroprotection Testing
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Solution Overview
Problem
Current methods for estimating immunization coverage in developing countries face challenges due to inaccurate administrative data, limited precision in coverage surveys, and the impracticality of serum-based serosurveys, which require centrifugation and temperature-controlled storage, especially in field settings.
Innovation Solution
A serological sampling system that includes a collection kit with a swab and a detection device for oral fluid, allowing for the collection and analysis of antibodies without centrifugation, enabling point-of-care testing and providing a rapid, reliable, and affordable method to assess seroprotection levels.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If serum-based serosurveys are used to estimate immunization coverage, then measurement precision is improved, but device complexity and ease of operation deteriorate due to requirements for centrifugation and temperature-controlled storage
Solution Approach 1:
The patent changes the physical state and composition parameters by using oral fluid instead of serum, and employs lyophilized reagents that can be reconstituted with the collected oral fluid, eliminating the need for centrifugation and temperature-controlled storage while maintaining seroprotection detection capability
Solution Approach 2:
The patent extracts the essential detection function from the complex serum processing workflow by using oral fluid samples that can be directly tested without centrifugation, separating the detection capability from the complex sample preparation requirements
2Ease of operation
If oral fluid collection is used instead of serum, then ease of operation is improved, but measurement precision may deteriorate due to lower antibody concentration
Solution Approach 1:
The patent applies preliminary action by pre-freezing the oral fluid sample before testing, which concentrates the antibodies and enhances detection sensitivity, thereby maintaining measurement precision while preserving the ease of oral fluid collection
Solution Approach 2:
The patent changes the temperature parameter by freezing the oral fluid sample, which concentrates the antibodies and improves detection sensitivity, thereby maintaining measurement precision while preserving the ease of collection
3Measurement precision
If centrifugation is required to obtain serum, then measurement precision is improved, but loss of time and productivity deteriorate
Solution Approach 1:
The patent extracts the detection function from the serum-specific workflow by using oral fluid samples that can be directly tested without centrifugation, eliminating the time-consuming separation step while maintaining adequate detection precision through the freezing concentration method
4Reliability
If temperature-controlled storage is implemented for serum samples, then reliability is improved, but ease of operation and productivity worsen in field settings
Solution Approach 1:
The patent changes the storage parameter by using lyophilized reagents and frozen oral fluid samples that are stable without temperature control during collection, enabling field testing while maintaining sample reliability through the stability of the frozen state and lyophilized formulation
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 system allows for objective monitoring of immunization services, identifying populations in need of immunization and estimating seroprotection levels without detailed medical records, facilitating the assessment of vaccine efficacy and coverage.
Implementation Method 1
an absorbent swab material configured to collect oral fluid containing antibodies from gums of a patient
Implementation Method 2
an extraction solution in the tubular body, the extraction solution formulated to remove collected antibodies from the absorbent swab material
Implementation Method 3
compressing the absorbent swab material between the lower surface of the primary interior volume and the at least one additional surface of the plunger
Data Source
AI summary
Seroprotection analysis systems, kits, and techniques are described for testing oral fluid for the presence of protective levels of antibodies of interest. In one aspect, the presence of protective levels of target antibodies indicates a test subject has achieved a target seroprotection level, such as but not limited to a target seroprotection level following vaccination. A collection kit can include a swab that enables collection of oral fluid containing antibodies from both dentulous and edentulous individuals, a container that can be pre-filled with an extraction solution, and a nozzle that can be coupled to the container to form a fluid-tight device. A user can use the nozzle to seal the swab in the container and to compress the swab within the container. After or during compression, the solution can be dispensed from the fluid-tight device, such as by inverting the fluid-tight device to flush the swab with the buffer solution and to transfer the fluid to a detection device through a channel in the nozzle. The detection system can be an assay reader device.