Systems and methods for sample preparation for enzymatic A1C detection and quantification
Inventors
Hughes, Gary • Werner, Brittney
Assignees
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Publication Number
US-11634745-B2
Publication Date
2023-04-25
Expiration Date
Abstract
A system for preparing a sample containing hemoglobin HbA1c for measurement by an electrochemical sensor includes a lysing formulary, the lysing formulary including a zwitterionic surfactant. The system further includes a oxidizing formulary, the oxidizing formulary including a cationic surfactant and a isothiazoline derivative and a protease formulary, the protease formulary including a molecule including an azole.
Core Innovation
The invention relates to an electrochemical HbA1c assay sample-preparation system that prepares a sample containing hemoglobin HbA1c for measurement by an electrochemical sensor. The system includes coordinated sample preparation stages that include a lysing mixture, an oxidizing mixture, and a protease mixture.
The lysing mixture includes a zwitterionic surfactant to lyse whole blood, and the oxidizing mixture includes a cationic surfactant and an isothiazoline derivative to oxidize hemoglobin. The protease mixture includes a molecule including an azole, where hemoglobin glycated species are digested with a protease, and the azole is used to enhance the protease digestion by promoting a relaxed hemoglobin state.
The system further includes a sampler/mixer device configured to dose a sample area of a test strip, with the lysing mixture located in the sampler/mixer device. The document describes an electrochemical strip concept in which a mixed sample is dosed to interdigitated electrodes, and dried oxidizing and protease reagents are provided for the assay.
Claims Coverage
The partial content provides one independent claim directed to a sample-preparation system for preparing a hemoglobin HbA1c sample for electrochemical sensing, followed by dependent claims that refine the protease/azole composition and the test strip/sampler/mixer arrangement. The inventive features are concentrated in the coordinated lysing/oxidizing/protease mixture composition and the sampler/mixer dosing to a test strip.
Coordinated lysing/oxidizing/protease mixtures for HbA1c electrochemical sensing
A system for preparing a sample containing hemoglobin HbA1c for measurement by an electrochemical sensor, comprising a lysing mixture including a zwitterionic surfactant, an oxidizing mixture including a cationic surfactant and an isothiazoline derivative, and a protease mixture including a molecule including an azole.
Sampler/mixer dosing to a test strip sample area
The system includes a sampler/mixer device, wherein the lysing mixture is located in the sampler/mixer device, and the sampler/mixer device is configured to dose a sample area of a test strip.
Specific surfactants and dilution for the lysing and oxidizing mixtures
The zwitterionic surfactant is n-Tetradecyl-N,N-dimethyl-3-ammonio-1-propanesulfonate (Zwittergent 3-14®) and the cationic surfactant is 1-Dodecyl pyridinium chloride, and the isothiazoline derivative is 1,2 Benzisothiazol-3(2H)-one and at a 1:5 dilution.
Imidazole-defined azole in the protease mixture
The azole compound is imidazole.
Imidazole concentration and pH constraints enhancing protease mixture function
The system is configured such that the protease mixture includes imidazole at a concentration between 0.5 M and 2 M at a pH between 6 and 8.
Neutral Proteinase in the protease mixture
The protease mixture includes Neutral Proteinase.
Oxidizing and protease mixtures placed in the test strip
The system includes a test strip in which the oxidizing mixture and the protease mixture are placed.
Sampler/mixer device separate from the test strip
The system is configured so that the sampler/mixer device is separate from the test strip.
Overall, the claim set covers a HbA1c sample-preparation system that uses a zwitterionic lysing mixture, a cationic/isothiazoline oxidizing mixture, and an azole-containing protease mixture, with a sampler/mixer dosing a test-strip sample area. Dependent claims further specify the azole as imidazole with concentration and pH ranges, specify Neutral Proteinase, and constrain how mixtures are positioned relative to the test strip and whether the sampler/mixer device is separate.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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