Systems and methods for an electrochemical total cholesterol test
Inventors
Werner, Brittney • Patwardhan, Aniruddha • Hughes, Gary
Assignees
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Publication Number
US-11808727-B2
Publication Date
2023-11-07
Expiration Date
Abstract
An electrochemical test for total cholesterol includes a test strip for an electrochemical testing testing of a blood analyte which includes a first receiving port, the first receiving port for receiving a blood sample, the first receiving port at a first end of the test strip. The test strip further includes a first electrode and a second electrode, the first and second electrodes proximate to the first receiving port. The test strip further includes a first contact and a second contact, the first and second contacts at a second end of the test strip, the first and second contacts interconnected with the first and second electrodes, respectively. The test strip further includes cholesterol oxidase, located proximate to the first and the second electrode. The test strip further includes a mediator, located proximate to the first and the second electrode, wherein the cholesterol oxidase and the mediator interact with the blood sample and the first and second electrode to generate a measurable electrical event.
Core Innovation
The invention relates to an electrochemical total cholesterol testing approach using a dry test strip for electrochemical testing of a blood analyte. The dry test strip includes a first receiving port for receiving a blood sample and a blood separation membrane placed over the first receiving port, where the blood separation membrane includes lectins. A first electrode and a second electrode are positioned proximate to the first receiving port, including a capillary tube at the first receiving port that leads to the first electrode and the second electrode.
In the capillary tube, a dried surfactant solution is located, and the dried surfactant solution is wetted by the blood sample. The test strip further includes first and second contacts at a second end of the test strip, interconnected with the first and second electrodes, respectively. Cholesterol oxidase is located proximate to the first and the second electrode, and a mediator is located proximate to the first and the second electrode so that the cholesterol oxidase and the mediator interact with the blood sample and the first and second electrode to generate a measurable electrical event.
The cholesterol oxidase is configured to react and directly transfer electrons to the mediator such that the mediator interacts with the first and second electrode. The mediator is an osmium compound. The dried surfactant solution includes Sodium Cholate, Potassium Phosphate, and BSA, located proximate to the first and second electrode.
An additional aspect of the invention provides a dry test strip and meter combination system for electrochemical testing of a blood analyte. The system includes the dry test strip with the receiving port, lectin-containing blood separation membrane, electrodes proximate to the receiving port with a capillary tube containing a dried surfactant solution, and first and second contacts. A meter receives the test strip and includes plurality of contacts to interface with the first and second contacts, and the cholesterol oxidase and mediator interact with the blood sample to produce a cholesterol level measured from a measurable electrical event detected by the meter and converted to the cholesterol level.
Claims Coverage
The partial content includes two independent claims, each focused on a dry test strip architecture and its coupling to electrochemical measurement. Both independent claims include a lectin-containing blood separation membrane, electrode positioning proximate to a receiving port with a capillary tube carrying dried surfactant, and a cholesterol oxidase plus an osmium-compound mediator that generate a measurable electrical event to yield a cholesterol level.
Dry test strip with lectin-containing blood separation membrane and capillary-wetted dried surfactant
A dry test strip for electrochemical testing of a blood analyte having a first receiving port with a blood separation membrane including lectins placed over the first receiving port, and first and second electrodes proximate to the first receiving port including a capillary tube at the first receiving port leading to the first electrode and the second electrode, wherein the capillary tube includes a dried surfactant solution wetted by the blood sample, with first and second contacts at a second end interconnected with the first and second electrodes.
Cholesterol oxidase configured for direct electron transfer to an osmium-compound mediator to generate a measurable electrical event
Cholesterol oxidase located proximate to the first and second electrode and a mediator located proximate to the first and second electrode, where the cholesterol oxidase and the mediator interact with the blood sample and the first and second electrode to generate a measurable electrical event, with the cholesterol oxidase configured to react and directly transfer electrons to the mediator, and wherein the mediator is an osmium compound.
Dry test strip and meter system converting a measurable electrical event to a cholesterol level
A dry test strip and meter combination system for electrochemical testing of a blood analyte including a meter having a test strip receiving port shaped to receive the test strip and a plurality of contacts with a first portion positioned to interface with the first and second contacts of the test strip, where cholesterol oxidase and the osmium-compound mediator interact with the blood sample and the first and second electrode to produce a cholesterol level measured on the basis of a measurable electrical event detected by the meter and converted to the cholesterol level.
Across the independent claims, the core coverage combines a lectin-containing blood separation membrane at a receiving port, electrodes proximate to the receiving port with a capillary tube holding dried surfactant wetted by blood, and cholesterol oxidase configured to directly transfer electrons to an osmium-compound mediator to generate a measurable electrical event that is used to determine a cholesterol level via a meter.
Stated Advantages
Eliminating reflectance membranes.
Reduced sample volume.
Reduced reagent/cost.
Improved precision and speed.
Documented Applications
Point-of-care/home use electrochemical total cholesterol testing using a dry test strip and, in one embodiment, a dry test strip and meter combination system.
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