Standardized Biological Sample Collection Device
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Solution Overview
Problem
High-throughput biological sample collection faces challenges such as variability in collection devices and tubes, requiring complex in-lab management and automation, and often necessitates thermal stability during shipment, which can be compromised by sample matrices inhibiting nucleic acid extraction.
Innovation Solution
A device and method for collecting and analyzing biological samples using a standardized tube with a collection assembly that includes a primary cap, secondary cap, and sampling member, allowing for direct sample lysis and elimination of traditional extraction steps, enabling home collection, rapid sample organization, and secure digital tracking of patient information.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If traditional sample collection devices and tubes with varying sizes and specifications are used, then sample collection can be performed, but in-lab sample management and automation complexity increases
Solution Approach 1:
The patent implements a universal sample collection device where the tube body, collection assembly, and caps form a standardized system that can be used across different laboratories and applications. The tube body with standardized dimensions (e.g., 1.5-2.0 mL volume, specific outer diameter) and the collection assembly with universal cap interfaces enable the same device to serve multiple purposes: sample collection, storage, shipping, and automated processing, eliminating the need for different laboratories to manage multiple device specifications
Solution Approach 2:
The collection device is divided into distinct functional segments: a tube body for sample containment, a collection assembly with sampling member for sample acquisition, a primary cap for sealing, and an optional secondary cap for additional protection. This segmentation allows each component to be optimized for its specific function while maintaining standardized interfaces, facilitating modular assembly and simplifying inventory management across laboratories
2Adaptability or versatility
If samples are collected at a first location and analyzed at a second location, then testing can be performed, but thermal stability of samples during shipment must be maintained
Solution Approach 1:
The collection assembly includes a sampling member (swab or applicator) that is pre-positioned within the tube body in a sterile, ready-to-use state. The primary cap is pre-threaded onto the tube body with threading specifications designed to achieve immediate sealing upon engagement. This preliminary preparation ensures that when the sample is collected and the cap is secured, the sample is immediately protected and ready for shipment without requiring additional stabilization steps
Solution Approach 2:
The collection device is designed as a disposable, single-use system where the entire assembly (tube body, collection assembly, and caps) is intended for one-time use. This eliminates the need for complex sterilization and thermal stability maintenance protocols required for reusable devices, as each new device provides fresh, sterile conditions that naturally protect sample integrity during shipping and storage
3Ease of operation
If sample matrices inhibit nucleic acid extraction, then sample collection can be performed, but reliable nucleic acid analysis is prevented
Solution Approach 1:
The collection assembly acts as an intermediary between the sample source and the tube body, providing a controlled interface for sample transfer. The sampling member (swab or applicator) within the collection assembly is designed to minimize contamination and ensure consistent sample deposition into the tube body. This intermediary structure helps prevent matrix inhibitors from interfering with subsequent nucleic acid extraction by providing a clean, controlled transfer pathway
4Adaptability or versatility
If multiple different containers and sampling devices are used by different laboratories, then various sample collection needs can be met, but automation complexity increases
Solution Approach 1:
The standardized tube body and collection assembly design with specific dimensional specifications (e.g., tube outer diameter, cap threading parameters, collection assembly interface dimensions) enables universal compatibility across different laboratories and automated systems. This universality allows automated sample processing equipment to handle all samples using the same device platform, regardless of which laboratory collected the sample, thereby reducing automation complexity while maintaining the ability to meet various sample collection needs
Data Source
AI summary
The present disclosure provides a device for collecting a biological sample. The device may include a tube, a primary cap which engages an open end of the tube, and a secondary cap which engages the primary cap. The device may include a collection member, which may include a swab. Methods of collecting and analyzing samples are also disclosed.