Assessment of biomarker concentration in a fluid

Inventors

Erlichster, Michael • Skafidas, Efstratios • ABEYRATHNE, Chathurika Darshani • Lee, Ting Ting • Chana, Gursharan

Assignees

MX3 Diagnostics Inc

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Publication Number

US-12123865-B2

Patent

Publication Date

2024-10-22

Expiration Date


Abstract

A method and system improving the accuracy and/or interpretability of measurements in a body fluid, such as saliva, sweat or urine involves measurement of multiple parameters in a sample with biosensors. One or more biosensors may reflect the concentration of a target biomarker, and one or more biosensors may describe a parameter of the fluid known to impact the function of the first biosensor the way the measurement of the first biosensor should be interpreted.

Core Innovation

The invention relates to a point-of-care biomarker measurement system that measures a concentration of a biomarker in body fluid using biosensors and processor-based correction. A first biosensor generates a first output proportional to the concentration of the biomarker in the body fluid, and the system uses additional body-fluid measurements to improve the accuracy and interpretability of the biomarker result. The body fluid includes saliva.

The system includes a reference dataset that describes an impact of body-fluid parameters on the first biosensor output. In one configuration, the system measures osmolarity with a second biosensor and provides the measured osmolarity as a second output. The processor applies the reference dataset to the first output and the second output to provide a corrected biomarker concentration.

In another configuration, the system uses a second biosensor to measure pH and provides the measured pH as a second output, and uses a third biosensor to measure osmolarity and provides the measured osmolarity as a third output. The reference dataset describes an impact of the second output and the third output on the first output, and the processor applies the reference dataset to the first output, the second output, and the third output to provide a corrected biomarker concentration.

Claims Coverage

The partial content includes two independent claims. The inventive features cover combining a biomarker-concentration biosensor with body-fluid osmolarity, and optionally pH, measurements, and using a reference dataset to correct the biomarker output.

Reference-dataset correction using biomarker and osmolarity outputs

A first biosensor configured to generate a first output proportional to the concentration of the biomarker in the body fluid; a second biosensor configured to measure an osmolarity of the body fluid and provide the measured osmolarity as a second output; a reference dataset describing an impact of the second output on the first output; and a processor configured to apply the reference dataset to the first output and the second output to provide a corrected biomarker concentration, wherein the body fluid is saliva.

Reference-dataset correction using biomarker, pH, and osmolarity outputs

A first biosensor configured to generate a first output proportional to the concentration of the biomarker in the body fluid; a second biosensor configured to measure a pH of the body fluid and provide the measured pH as a second output; a third biosensor configured to measure an osmolarity of the body fluid and provide the measured osmolarity as a third output; a reference dataset describing an impact of the second output and the third output on the first output; and a processor configured to apply the reference dataset to the first output, the second output and the third output to provide a corrected biomarker concentration.

Across the independent claims, the core coverage is a processor-applied reference dataset that corrects a biomarker-concentration biosensor output using measured body-fluid osmolarity, and in a broader configuration also using measured pH alongside osmolarity to produce a corrected biomarker concentration.

Stated Advantages

Improves accuracy/interpretability by providing a corrected biomarker concentration using a reference dataset and additional body-fluid measurements (pH and/or osmolarity).

Documented Applications

Point-of-care biomarker measurement in body fluid, specifically saliva, with corrected biomarker concentration based on measured osmolarity and optionally pH.

Providing user-facing output of the measured osmolarity and/or measured pH.

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