Biological Specimen Sample Preparation Apparatus for Self-Use

This invention is an apparatus with an integrated module based on a cap/tube configuration for biological specimen self-collection. A biofluidic sample, such as blood, is collected and inserted in the sample container of the sample prep module (SPM). Once inserted, the whole blood is dispensed in the chamber for a protein-based biomarker assay where the biofluid is subsequently mixed with a buffer and magnetic beads. A magnet is placed beside the tube at the base to retain cells of interest and any unwanted material is flushed out and absorbed on a pad within the central chamber of the top container. Cell lysis buffer is then released by a second piercing opening the lateral chambers of the top container and hand agitation ensures homogenization and complete lysis. The final step is the screwing the tube onto the membrane housing a detection for vertical or lateral flow immunoassays.

Background: 
There is an unmet need for the development of a safe and simple operation for biofluid specimen preparation for any home-based molecular diagnostics. This need for safe operations for preparing is relevant to any mobile self-tests by individuals in environments that can include low resource settings, at home, in military theater conditions or other operational missions such as space. To alleviate this lack of effective preparation systems, this invention provides an efficient, point-of-care testing apparatus design and has the potential of adapting into other needed workflow processing protocol steps such as adjustment of incubation time, additional washing steps, and more.

Applications: 

• Biological specimen self-collection
• Sampling diagnostic system for biological fluids (blood, saliva, urine, etc.)
• Cerebrospinal fluid diagnostic system

Advantages: 

• Less time-consuming
• Inexpensive
• Ability to integrate other workflow processing protocol steps onto the sample preparation devices