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

The invention relates to a point-of-care diagnostic instrument architecture that includes an enclosure having an interior portion and an opening providing access to the interior portion. Inside the enclosure, a fixed support bracket and a moving support bracket are arranged such that the moving support bracket is moveable relative to the fixed support bracket and the opening. Within the interior portion adjacent to the opening, a first imaging system collects images from a first imaging area, and a second imaging system collects images from a second imaging area with non-overlapping relation to the first imaging area.

A rotary connector and a pneumatic connector are arranged within the interior portion between the first imaging system and the second imaging system, and a drive system on the fixed support bracket positions the moving support bracket relative to the fixed support bracket. The described instrument architecture is integrated with a single-use integrated diagnostic cartridge for nucleic-acid amplification and detection, including nucleic-acid amplification and reaction imaging using fluorescent detection. The enclosure and interior systems support cartridge handling and process-related subsystems that include a pneumatic subsystem for pressurized fluid delivery, a thermal subsystem with a cartridge heater and a chemistry heater zone, and a heat-staking assembly to seal fluidic channels and prevent amplicon contamination as described.

The invention describes optical components and imaging arrangements for label/reaction imaging, including a fluorophore excitation/emission optical path and a longpass filter configured to select an emission band. A label imaging assembly and a distal reaction imaging assembly provide spatial separation between label-based imaging and reaction well imaging. The imaging arrangement supports label-based sample-volume checking and cartridge ejection prior to assay steps.

Claims Coverage

Three independent claim themes are explicitly provided across the input items. The main inventive features are an enclosure with fixed and moving support brackets, two non-overlapping imaging systems, connectors arranged between the imaging areas, and a drive system that positions the moving support bracket relative to the fixed support bracket, together with label/reaction imaging arrangements for diagnostic cartridge workflows.

The independent claims cover a diagnostic instrument enclosure that combines two non-overlapping imaging systems with fixed and moveable support brackets, includes a rotary and pneumatic connector arrangement between the imaging systems, and uses a drive system mounted on the fixed support bracket to position the moving support bracket, with the enclosure opening providing access between the fixed and moving brackets. The remaining inventive coverage includes label and reaction imaging assemblies that separate label-based imaging from reaction well imaging.

Stated Advantages

Documented Applications