Cell-free biosensors to detect creatinine, creatine, and sarcosine
Inventors
Styczynski, Mark • Chilton, Elizabeth Hutson • Heckard, Emily
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12566184-B2
Publication Date
2026-03-03
Expiration Date
Abstract
An exemplary embodiment of the present disclosure provides a biosensor that can facilitate detection of the molecules creatinine, creatine and/or sarcosine in a minimal-equipment, portable, and low-cost fashion. Some aspects of the disclosure relate to methods and systems to enable quantitative measurement of certain biomarkers at the point of care without expensive instrumentation.
Core Innovation
The patent and claims describe cell-free visual biosensors and methods for generating a color-based diagnostic tool to measure an unknown amount of an analyte, such as creatinine, creatine, or sarcosine, in a biological sample. The diagnostic tool employs distinct-color reference points corresponding to different analyte amounts, wherein a desired amount of regulator, a saturating amount of analyte, and a reaction time are selected so that the sample color corresponds to a reference point associated with an approximately equal analyte amount.
To address matrix effects and inter-sample variability in biological samples including serum, the methods utilize a SouR-regulated reporter producing a colorimetric gene product, addition of a small molecule to displace interfering molecules from assay components, or stabilization of the reporter using a stabilizing compound. The resulting approach provides a low-cost, equipment-light diagnostic platform suitable for point-of-care use.
Claims Coverage
The independent claims are claims 1, 5, and 10, covering three inventive features directed to reference-color matching for analyte estimation in biological samples and serum.
Color-based diagnostic tool using a cell-free extract
Independent claim 1 covers determining a desired amount of a reporter regulator comprising SouR, a saturating amount of analyte, and a desired reaction time to generate a colorimetric gene product using a cell-free extract, wherein the generated color corresponds to a reference point associated with an analyte amount about equal to the unknown amount in the biological sample.
Visible-color generation in serum using small-molecule displacement
Independent claim 5 covers generating a range of visible colors in serum samples by adding a small molecule that displaces an interfering molecule from a regulator, a reporter, or a molecule acted on by the reporter, using a desired amount of SouR, a saturating amount of analyte, and a desired reaction time configured to reduce or eliminate inter-sample variability.
Visible-color generation in serum using a stabilized reporter
Independent claim 10 covers generating visible colors in serum samples by providing a desired amount of a reporter comprising one or more plasmids, a saturating amount of analyte, and a desired reaction time, and stabilizing the reporter with a stabilizing compound, configured to reduce or eliminate inter-sample variability.
Together, the independent claims cover reference-color matching to estimate unknown analyte amounts in biological samples or serum through cell-free extract systems, small-molecule displacement of interfering molecules, and reporter stabilization to address inter-sample variability.
Stated Advantages
The methods and sample-specific parallel calibration are configured to reduce or eliminate inter-sample variability and matrix effects.
The approach is described as low-cost and equipment-light.
The approach is described as suitable for point-of-care use, including lyophilized formats.
Stabilizing compounds are described as stabilizing the colored signal against decay.
Documented Applications
Color-based measurement of an analyte in biological samples using a cell-free extract and color-coded reference points.
Measurement of creatinine, creatine, or sarcosine in blood, serum, plasma, urine, saliva, tears, mucus, lymph, interstitial fluid, cerebrospinal fluid, pus, breast milk, or amniotic fluid.
Point-of-care diagnostics, including use in lyophilized formats.
Interested in licensing this patent?