Devices, systems, and methods for performing optical and electrochemical assays
Inventors
Low, Michael L. • Bass, Barry • Gershtein, Sergey
Assignees
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Publication Number
US-12292403-B2
Publication Date
2025-05-06
Expiration Date
Abstract
This present invention relates generally to devices, systems, and methods for performing optical and electrochemical assays and, more particularly, to devices and systems having universal channel circuitry configured to perform optical and electrochemical assays, and methods of performing the optical and electrochemical assays using the universal channel circuitry. The universal channel circuitry is circuitry that has electronic switching capabilities such that any contact pin, and thus any sensor contact pad in a testing device, can be connected to one or more channels capable of taking on one or more measurement modes or configurations (e.g., an amperometric measurement mode or a current drive mode).
Core Innovation
The invention provides a point-of-care diagnostic system and method for performing assays on a biological sample in an analyzer using universal channel circuitry. First and second test cartridges are inserted into corresponding cartridge ports of the analyzer, and the analyzer uses a multi-terminal connector and one or more processors with memory storing executable instructions to configure measurement circuitry based on which cartridge is inserted and identified by an operating state signal.
The processor receives an operating state signal indicative of the inserted cartridge, assigns universal channels to cartridge contacts and corresponding pins, and switches one or more switches of the circuitry into appropriate drive and measurement modes. When the first test cartridge is inserted, the first channel is assigned to the light emitter and the second channel is assigned to the light detector, and the processor performs an optical analytical test using the first channel and the second channel.
When the second test cartridge is inserted, the processor assigns the first channel to the amperometric electrode and the second channel to the reference electrode, switches the first channel to an amperometric measurement mode and the second channel to a reference measurement mode, and then performs an electrochemical analytical test using the first channel and the second channel. The disclosed cartridge identification and validation logic includes receiving operating-state signals and using lookup tables and databases to identify cartridge and sensor types, including barcode-derived operating state values.
Claims Coverage
The independent claim set covers analyzer-controlled assay workflow with universal channel circuitry that dynamically assigns measurement channels to cartridge contacts based on an operating state signal, enabling optical analytical tests with a light emitter/light detector and electrochemical analytical tests with an amperometric electrode/reference electrode. Dependent claims further refine cartridge type identification and sensor validation, barcode-based operating state signals, and sample-prep hardware such as a blood-cell-retaining filter.
Universal channel circuitry for dynamic cartridge contact assignment
The analyzer comprises universal channel circuitry including a first channel and a second channel, and the processor assigns the channels to cartridge contacts via corresponding pins based on the inserted cartridge.
Operating-state signal-based cartridge-dependent switching
The processor receives an operating state signal indicative of the inserted cartridge and switches circuitry into a current driver mode and a current measurement mode for optical testing or into an amperometric measurement mode and a reference measurement mode for electrochemical testing.
Optical analytical test using assigned light emitter/light detector channels
When the first test cartridge is inserted, the processor assigns the first channel to the light emitter via the first contact and corresponding first pin and assigns the second channel to the light detector via the second contact and corresponding second pin, then performs an optical analytical test using the first channel and the second channel.
Electrochemical analytical test using assigned amperometric/reference channels
When the second test cartridge is inserted, the processor assigns the first channel to the amperometric electrode via the third contact and corresponding third pin and assigns the second channel to the reference electrode via the fourth contact and corresponding fourth pin, then performs an electrochemical analytical test using the first channel and the second channel.
Barcode-derived operating state signal
The operating state signal received from the first or second test cartridge includes a value read from a barcode on the respective cartridge.
Lookup table/database-based cartridge type identification and sensor validation
The method determines, from operating state signals, the first cartridge type via a lookup table and database, and confirms that the first test cartridge contains an optical sensor with the light emitter connected to the first contact and the light detector connected to the second contact.
Blood-cell-retaining filter allowing plasma passage
The first test cartridge includes a filter that retains blood cells from a biological sample while allowing plasma to pass from a sample receiving chamber to a conduit.
Overall, the claim set emphasizes universal channel circuitry reconfigured by switches into optical versus electrochemical modes based on operating state signals from inserted cartridges, including mapping contacts to channels and performing the corresponding optical or electrochemical analytical test. Dependent claims further specify barcode-based operating state values, cartridge type identification and sensor validation via lookup tables and databases, and an optional blood-cell-retaining filter with plasma passage.
Stated Advantages
Documented Applications
Performs optical analytical tests and electrochemical analytical tests on a biological sample in a point-of-care diagnostic system by inserting first and second test cartridges into cartridge ports of an analyzer.
Supports workflows where an optical analytical test is performed, where an optical analytical test and an electrochemical analytical test are performed together on one cartridge, and where optical versus electrochemical testing is performed across different cartridges.
Uses cartridge identification and validation logic based on operating-state signals, including barcode-derived values, to identify cartridge and sensor type for selecting measurement configuration.
Includes sample preparation hardware in a test cartridge using a blood-cell-retaining filter that retains blood cells while allowing plasma to pass for downstream assay processing.
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