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Disease Diagnostic System Patent Application: Lab-On-A-Device

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Researchers from the Charles R. Drew University of Medicine and Science have filed a patent application for a new diagnostic system (USPTO 20190291110).

The system is an integrated lab-on-a-device designed, developed, and tested in compatibility with a mechanical fixture for sample-to-answer biological analysis of infectious diseases.

“Infectious diseases have been sources of large-scale epidemics and pandemics resulting in millions of casualties worldwide. Detection of these biological agents normally involves several lab processes including sample preparation, nucleic acid separation and amplification, and diagnostic analysis. These steps, either performed manually or automated by high-throughput machinery, are tedious, expensive, and highly susceptible to cross-contamination.”[1]

The disease diagnostic system is described as a chip body containing a mixing chamber configured to receive a biological sample. The mixing chamber is comprised of magnetic beads and a cell lysis buffer and is configured to receive energy to facilitate mixing in the mixing chamber to form a solution.

A first pump formed in the chip body is coupled to the mixing chamber and configured to pump the solution out of the mixing chamber; a main channel formed in the chip body and coupled to the mixing chamber is configured to receive the solution pumped from the mixing chamber; and a separation area formed in the main channel receives a magnet that traps the magnetic beads and ribonucleic acid (RNA) and/or deoxyribonucleic acid (DNA) molecules in the solution bound to the magnetic beads on a surface of the separation area.

A waste chamber is coupled to the main channel downstream from the separation area receives solution comprising unbound RNA and/or DNA molecules.

A first valve is positioned between the main channel and the waste chamber configured to control flow of the solution comprising the unbound RNA and/or DNA molecules through the main channel to the waste chamber. An amplification chamber is coupled to the main channel downstream from the separation area, the amplification chamber configured to receive the bound RNA and/or DNA molecules for analysis; and a second valve positioned between the main channel and the amplification chamber is configured to control flow of the bound RNA and/or DNA molecules through the main channel to the amplification chamber. A second pump formed in the chip body and coupled to the main channel is coupled to a cavity holding a wash buffer solution; and a third coupled to a cavity holding amplification solution; wherein: with the first and second valves in a first configuration that allows flow through the main channel to the waste chamber and blocks flow to the amplification chamber, and with the bound RNA and/or DNA molecules trapped in the separation area, activation of the second pump pumps the wash buffer solution and the solution comprising the unbound RNA and/or DNA molecules through the main channel into the waste chamber; and with the first and second valves in a second configuration that allows flow through the main channel to the amplification chamber and blocks flow to the waste chamber, and with the bound RNA and/or DNA molecules released from the separation area, actuation of the third pump pumps the amplification solution and the bound RNA and/or DNA molecules through the main channel into the amplification chamber.

1. Liu, Benjamin; McGhee, Eva; Liu, Robin; Nava, Miguel. Disease Diagnostic System And Method. Filed March 20, 2019 and posted September 26, 2019.

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