Bioanalysis test kit and method for analyzing such a test kit
Inventors
Stütz, Evamaria • Buchholz, Stephan • Schreiter, Matthias • Gigler, Alexander Michael
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11493483-B2
Publication Date
2022-11-08
Expiration Date
Abstract
The invention relates to a test kit which is designed for bioanalysis, in particular for an immunoassay. The test kit comprises at least one measuring sensor (M) for the quantitative detection of a substance and at least one reference sensor (R1, R2, R3) which is already supplied with the substance in a defined manner. In the method for analyzing a test kit, the measuring sensor (M) is read and a measurement value for a concentration, a substance quantity, or a mass is obtained, wherein the read value of the at least one measuring sensor (M) is scaled using the read values of the at least one reference sensor (R1, R2, R3), or a measured value which corresponds to the read value is obtained by means of a compensation curve which puts the read values of the reference sensors (R1, R2, R3) into relationship with the defined supply of the substance to the reference sensors (R1, R2, R3).
Core Innovation
The invention relates to a test kit for bioanalysis, the test kit comprising at least one measurement sensor coated with an antigen, an antibody, or the antigen and the antibody. The measurement sensor is configured to quantitatively detect a substance via binding of the substance to the antigen, the antibody, or the antigen and the antibody, so that quantitative results are obtained from the sensor readout.
To compensate for external influences during bioanalysis, at least one reference sensor is provided, the reference sensor being coated with the antigen, the antibody, or the antigen and the antibody, and having a defined concentration, amount, or mass of the substance already bound. The reference sensors and the measurement sensors are formed with acoustic resonators, and quantitative detection is carried out by scaling the measuring-sensor readout using the reference-sensor readouts or a compensation curve/compensation function.
The sensors are implemented using acoustic resonators, specifically film bulk acoustic resonators (FBARs), with independently actuated resonators functionalized for selective binding. The kit includes measurement and reference compartments, and at least one reference compartment per reference sensor is separated from the measurement sensor in a fluid-tight manner during measurement, including for field use via a valve.
Claims Coverage
The document provides one independent claim directed to a bioanalysis test kit architecture combining antigen/antibody-coated measurement sensors with antigen/antibody-coated reference sensors with defined bound substance, where both sensor types use acoustic resonators and are structurally separated by a fluid-tight reference compartment.
Antigen/antibody measurement sensor for quantitative binding detection
At least one measurement sensor coated with an antigen, an antibody, or the antigen and the antibody, configured to quantitatively detect a substance via binding of the substance to the antigen, the antibody, or the antigen and the antibody.
Reference sensor with defined bound concentration, amount, or mass
At least one reference sensor coated with the antigen, the antibody, or the antigen and the antibody, wherein a defined concentration, amount, or mass of the substance is already bound, enabling quantitative scaling using reference sensor behavior.
Acoustic resonators forming measurement and reference sensors
The at least one reference sensor, the at least one measurement sensor, or both are formed with acoustic resonators.
Fluid-tight reference compartment per reference sensor
At least one reference compartment per reference sensor, wherein the at least one reference compartment is separated from the measurement sensor in a fluid-tight manner during measurement.
Overall, the claim coverage centers on a bioanalysis test kit that pairs antigen/antibody-coated quantitative measurement sensors with antigen/antibody-coated reference sensors having defined already-bound substance, uses acoustic resonator-based sensors for both, and includes a fluid-tight reference compartment per reference sensor separated from the measurement sensor during measurement.
Stated Advantages
Inherent compensation of external influences during bioanalysis through a reference scale based on the reference sensor readouts or a compensation curve/compensation function.
Quantitative detection by scaling the measuring-sensor readout using reference-sensor readouts or a compensation curve/compensation function with a linear compensation relationship for converting frequency shifts into concentration.
Documented Applications
The test kit is configured as a pregnancy test kit, a drugs test kit, or a combined pregnancy and drugs test kit.
Interested in licensing this patent?