Diagnostic system

Inventors

Andeshmand, Sayeed • Cauley, III, Thomas H. • Dixon, John • GLADE, David • Maamar, Hédia • McAdams, Michael John • Ng, Dzam-Si Jesse • Rolfe, David Alexander

Assignees

Talis Biomedical Corp

Abstract

Methods and systems are provided for point-of-care nucleic acid amplification and detection. One embodiment of the point-of-care molecular diagnostic system includes a cartridge and an instrument. The cartridge can accept a biological sample, such as a urine or blood sample. The cartridge, which can comprise one or more of a loading module, lysis module, purification module and amplification module, is inserted into the instrument which acts upon the cartridge to facilitate various sample processing steps that occur in order to perform a molecular diagnostic test.

Core Innovation

A method of testing a sample suspected of containing one or more target pathogens is performed using an integrated diagnostic cartridge that includes a sample port assembly, a lysis chamber, porous solid supports, a rehydration chamber with one or more dried reagents, a metering channel, and two or more assay chambers within the cartridge. The sample is advanced to the lysis chamber, mixed with at least one lysis agent to generate a lysed sample, and passed through a first porous solid support to capture nucleic acid, which is subsequently released to generate an enriched nucleic acid.

The enriched nucleic acid is introduced into the rehydration chamber containing one or more dried reagents, and after introducing the enriched nucleic acid into the metering channel, the contents are mixed to produce an analyte/reagent solution. The analyte/reagent solution is distributed to two or more assay chambers, and the analyte/reagent solution in each assay chamber is sealed from the other assay chambers and from a waste chamber.

Isothermal amplification is performed within each sealed assay chamber while simultaneously detecting amplification product. Detection of an amplification product indicates a presence, an absence, or a quantity of the one or more target pathogens in the sample suspected of containing the one or more target pathogens.

Claims Coverage

The independent claim is centered on one cartridge-based testing workflow with four inventive features: nucleic-acid capture and release on a porous solid support, rehydration with dried reagents to form an analyte/reagent solution, distribution into multiple sealed assay chambers, and isothermal amplification with simultaneous detection to determine pathogen status.

The independent claim is directed to a cartridge workflow that performs lysis, nucleic-acid capture and release using a porous solid support, formation of an analyte/reagent solution from dried reagents and enriched nucleic acid, distribution into multiple sealed assay chambers, and isothermal amplification with simultaneous detection to indicate presence, absence, or quantity of target pathogens.

Stated Advantages

Documented Applications