Systems and methods for measuring liver enzyme levels in blood
Inventors
Pei, Jianhong • Bedard, Joseph • Wusimanjiang, Yiliyasi • Florindi, Anthony • Young, Chung Chang
Assignees
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Publication Number
US-12252728-B2
Publication Date
2025-03-18
Expiration Date
Abstract
A disposable test cartridge to determine the concentration of one or more liver enzymes in a blood sample includes a cartridge body having a plurality of chambers where at least one of the chambers contains a reactant mixture that reacts when catalyzed by one of the liver enzymes ALT, AST, ALP, or GGT in a blood sample forming a reaction solution, a removable cartridge cover connected to the cartridge body, and a test strip module connected to the cartridge body. The test strip module containing at least one analyte test strip configured for receiving a portion of the reaction solution and electrochemically measuring at least one analyte that is a reaction product in the reaction solution.
Core Innovation
The invention relates to a disposable test cartridge for use in a point-of-care analyzer to determine the concentration of one or more liver enzymes in a blood sample. The cartridge includes a cartridge body with a plurality of chambers, where each chamber has an opening at a top of the cartridge body. At least one chamber contains a reactant mixture capable of undergoing a chemical reaction when combined with a blood sample to form a reaction solution containing at least one reaction product.
The reactant mixture contains chemicals specific for being catalyzed by one of the liver enzymes alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or gamma-glutamyl transferase (GGT) in the blood sample. A removable cartridge cover is connected to the cartridge body and covers the plurality of chambers. The removable cartridge cover has a capillary-receiving aperture and a removable capillary element removably insertable into the cartridge cover, the capillary element configured for obtaining a blood sample.
A test strip module is directly connected to the cartridge body and contains at least one analyte test strip configured for receiving a portion of the reaction solution and measuring at least one analyte, where the at least one analyte is the at least one reaction product. The partial content further describes electrochemical measurement of reaction-product analytes from liver enzyme-catalyzed reactions in cartridge-stored, enzyme-specific reactant mixtures.
Claims Coverage
The independent claim set includes 1, 23, and 26, covering a disposable test cartridge, a disposable cartridge kit, and a method for electrochemically determining enzyme concentration. Across these claims, the coverage emphasizes chamber-stored reactant mixtures, capillary blood collection via a removable cartridge cover, and electrochemical measurement of reaction-product analytes on analyte test strips.
Disposable test cartridge with chamber-stored reactant mixtures
A disposable test cartridge for use in a point-of-care analyzer having a cartridge body with a plurality of chambers, each chamber having an opening at a top, and at least one chamber containing a reactant mixture capable of undergoing a chemical reaction when combined with a blood sample to form a reaction solution containing at least one reaction product, where the reactant mixture contains chemicals specific for being catalyzed by ALT, AST, ALP, or GGT.
Removable cartridge cover with capillary sampling aperture and removable capillary element
A removable cartridge cover connected to the cartridge body and covering the plurality of chambers, where the removable cartridge cover has a capillary-receiving aperture and a removable capillary element removably insertable into the cartridge cover, the capillary element configured for obtaining a blood sample.
Test strip module measuring reaction-product analytes
A test strip module directly connected to the cartridge body and containing at least one analyte test strip configured for receiving a portion of the reaction solution and measuring at least one analyte, where the at least one analyte is the at least one reaction product.
Disposable cartridge kit including disposable test cartridge, pipette tip, and analyzer-ready sampling
A disposable cartridge kit for use in a point-of-care analyzer comprising a disposable test cartridge with the plurality of chambers and enzyme-specific reactant mixtures, a removable cartridge cover with capillary-receiving aperture and removable capillary element for obtaining a blood sample, a disposable pipette tip disposed in one of the plurality of chambers, and a test strip module directly connected to the cartridge body containing at least one analyte test strip configured to receive a portion of the reaction solution and measure at least one analyte that is the at least one reaction product.
Method of electrochemically determining liver enzyme concentration using point-of-care analyzer and disposable cartridge
A method of electrochemically determining the concentration of one or more liver enzymes in a blood sample using a point-of-care analyzer, comprising providing a point-of-care analyzer; obtaining a disposable test cartridge with a cartridge body of chambers containing reactant mixture specific for being catalyzed by ALT, AST, ALP, or GGT; using a removable cartridge cover with a capillary-receiving aperture and removable capillary element configured for obtaining a blood sample; using a disposable pipette tip disposed in one of the plurality of chambers; and using a test strip module containing at least one analyte test strip configured for receiving a portion of the reaction solution and measuring at least one analyte that is the at least one reaction product.
Overall, the independent claims cover a disposable cartridge system and kit for point-of-care determination of ALT, AST, ALP, and/or GGT in blood. The system relies on chamber-stored reactant mixtures forming reaction products, capillary blood collection via a removable cartridge cover, and direct test-strip measurement of reaction-product analytes using the point-of-care analyzer, with an electrochemical determination method explicitly claimed.
Stated Advantages
Documented Applications
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