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US 2026/0147004 A1Published application
Device, method, and apparatus for biological testing with a mobile device
OwnerEmmanuel Mpockinventor
Life of this patent
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Abstract
A method and system for performing assays for hemoglobin HbA1c, employing a smart phone that interacts with a disposable test strip coated with dry chemistry in physically and chemically segregated reactive zones. In the given regions of the strip, the chemistry interacts with the sample resulting in the conversion of the analyte, such as glycated hemoglobin, into a complexed substrate which can be quantified optically. The phone takes measurements of various parameters during the process of the test reactions, displays relevant instructions and the assay results.
Claims17
A method for measuring the concentration of HbA1c in a blood sample, comprising the steps of:
- (i) providing a blood sample;
- (ii) providing a test strip having a plurality of microchannels disposed therein, wherein said microchannels link at least a sample well with a one or more reaction wells, wherein (a) the reaction well or the microchannels comprise at least one lysing agent;
- and wherein (b) the test strip is adapted to comprise or interact with one or a plurality of magnets placed on, within or adjacent to the test strip, providing a magnetic field that extends functionally into one or more of the microchannels, sample well and/or reaction well;
- (iii) providing magnetic beads wherein boronic acid derivatives are attached to said magnetic beads;
- wherein said beads are located within the test strip in one or more of the microchannels, sample well and/or reaction well, and localized to a desired location by the use of the magnetic fields;
- (iv) placing a whole or pre-lysed blood sample into the sample well of the test strip such that the sample is drawn into the microchannels by capillary action;
- wherein unlysed red blood cells in the sample are lysed by the lysing agent, releasing haemoglobin including HbA1c at a first location (Location 1);
- (v) taking an optical reading (reading 1) at Location 1;
- (vi) causing the sample to travel through the microchannel towards a second location (Location 2) wherein said magnetic beads with boronic acid derivatives attached thereto contact the sample and whereby the boronic acid derivatives interact with HbA1c in said sample to form a stable boronic acid-HbA1c complex, thereby immobilizing the HbA1c on the magnetic beads;
- (vii) optionally, taking an optical reading (reading 2) at Location 2;
- (viii) while maintaining the magnetic beads at Location 2 by use of the magnets, causing the remainder of the sample to travel through the microchannel towards a third location and taking an optical reading (reading 3) at this location (Location 3);
- (iv) comparing at least reading 1 with reading 3 to provide direct test data;
- (v) analyzing said test data using the CPU of a smart phone executing a programme that calculates the HbA1c concentration as a percentage of total hemoglobin, and
- (vi) displaying the resultant data on a screen of the smart phone.
11 more elements
A method for quantifying a analyte of interest contained in a sample comprising:
- placing a sample of lysed or unlysed blood, serum, urine, saliva, biological material, food or an environmental extract into a sample well in a test strip whence the sample is drawn into a microchannel by capillary action to a first location (Location 1) where the analyte of interest reacts with a chemiluminescent or fluorescent tag to form a complex, thereby emitting a signal for which a reading is taken (reading 1 at Location 1);
- causing the sample to travel through the microchannel wherein the analyte of interest can be bound to a second species to form a complex that is bound to magnetic particles conjugated with antibody or ligand to immobilize and concentrate the signal (reading 2 at Location 2);
- causing the sample, now depleted of the analyte of interest, to further travel through the microchannels to a third read zone where a reading can be taken (reading 3 at Location 3);
- wherein the total signal, the bound signal and the depleted signal can be measured directly.
1 more element
Dependencies are inferred from the claim text.