Swab Collection Device with Integrated Reagents and Sealing Cap
Solution Overview
Problem
Current molecular diagnostics based on PCR techniques face challenges such as the need for large sample quantities, lengthy transportation times, sample contamination or deterioration, and the risk of infection for analysts, while also requiring expertise and taking days or weeks to produce results.
Innovation Solution
A device and method for collecting biological samples using a collection vessel with integrated reagents for nucleic acid amplification, featuring a cap with a channel that seals the swab with reagents, allowing for on-site, rapid, and safe molecular testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If samples are transported to laboratory for processing and testing, then reliable test results can be obtained, but transportation process is lengthy and samples may get contaminated or deteriorated
Solution Approach 1:
The invention merges the sample collection tube with the nucleic acid extraction reagents and the PCR testing components into a single integrated microreactor system. This allows sample collection, nucleic acid extraction, and PCR amplification to occur in the same device without requiring transportation to a separate laboratory, thereby eliminating transportation time while maintaining test reliability.
Solution Approach 2:
The microreactor system is designed to perform nucleic acid extraction and PCR amplification automatically using pre-loaded reagents within the same device where the sample is collected. The system self-services the entire diagnostic process from sample collection to result generation without requiring external laboratory equipment or personnel intervention, thus eliminating transportation delays.
2Reliability
If samples are transported to laboratory for processing, then comprehensive testing can be performed, but samples may get contaminated or deteriorated during transport
Solution Approach 1:
The invention combines the sample collection environment with the nucleic acid extraction and PCR testing environment in a single sealed microreactor device. By eliminating the intermediate transportation step between collection and testing, the system removes the opportunity for sample contamination or deterioration that would occur during transport to a separate laboratory.
Solution Approach 2:
The microreactor system performs the entire diagnostic workflow self-contained within the collection device, including automated nucleic acid extraction and PCR amplification. This self-service capability ensures that samples remain isolated in a controlled environment from collection through testing, preventing contamination from external sources during transportation.
3Reliability
If traditional PCR testing is performed in laboratory, then accurate diagnosis can be achieved, but it requires expertise and professional experience
Solution Approach 1:
The invention integrates the complex laboratory-based PCR testing system into a miniaturized microreactor device that can be operated at the point of care. By combining sample collection, nucleic acid extraction, and PCR amplification into a single device with pre-loaded reagents and automated procedures, the system maintains diagnostic accuracy while eliminating the need for specialized laboratory expertise.
Solution Approach 2:
The microreactor system automatically performs nucleic acid extraction and PCR amplification using pre-programmed protocols and pre-loaded reagents. This self-service automation eliminates the need for trained laboratory personnel to manually perform complex procedures, making accurate molecular diagnostics accessible to non-experts at the point of care while maintaining diagnostic reliability.
4Reliability
If large quantity of sample is collected for testing, then reliable test results can be obtained, but it increases the risk of infection for analysts
Solution Approach 1:
The invention integrates sample collection with immediate nucleic acid extraction and PCR testing in a single sealed microreactor system. By processing the sample in-situ without transferring it to external laboratory equipment, the system maintains reliable test results while minimizing the analyst's exposure to infectious agents throughout the entire testing process.
Solution Approach 2:
The microreactor system automatically performs all processing steps including nucleic acid extraction and amplification within the sealed collection device. This self-contained approach allows testing to be performed on-site with minimal sample manipulation by the analyst, reducing the volume of hazardous samples handled and thereby reducing infection risk while maintaining test reliability.
Data Source
AI summary
The present disclosure provides devices, methods and kits for collecting a sample of a subject for nucleic acid amplification. The device may comprise: a collection vessel that can include reagents necessary for nucleic acid amplification, wherein the collection vessel may be adapted to accept at least one swab containing a sample; a cap integrated with the collection vessel and having a channel extending therethrough to permit the at least one swab to be deposited in the collection vessel, wherein the channel is closable upon rotation of the cap; and at least one cutting member that severs a longitudinal portion of a stem of the swab extending through said channel upon rotation of the cap.