Methods of correcting a luminescence value, and methods of determining a corrected analyte concentration

• US 20050148003A1
• Filed: 12/02/2004
• Published: 07/07/2005
• Est. Priority Date: 11/26/2003
• Status: Abandoned Application

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Palmer, Phyllis J., Keith, Steven
• Application Number:
  US11/002,157
• Publication Number:
  US 20050148003A1
• Time in Patent Office: Days
• US Class Current: 435/6
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: G01N 2021/7786 Fluorescence
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• CPC Class Codes: G01N 21/7703 using reagent-clad optical fibres or optical waveguides using measurement of total internal reflection or attenuated total reflection G01N21/552; optical fibres or waveguides per se G02B
• CPC Class Codes: G01N 2201/1211 for temperature
• CPC Class Codes: G01N 33/542 with steric inhibition or signal modification, e.g. fluorescent quenching
• CPC Class Codes: G01N 33/54373 involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings

Abstract

The invention is directed to methods of correcting a luminescence value, and methods of determining a corrected analyte concentration, by use of a device capable of providing a signal when a binding protein binds to at least one analyte, and a thermometer. The invention is also directed to systems which include such a device, and a processor for correcting measured luminescence of a reporter group based on a measured temperature. The invention is further directed to apparatuses that include a memory for storing luminescence information and temperature information, and a processor for correcting luminescence information. The invention is further directed to computer programs for executing the methods of the invention, and machine-readable storage medium on which programs are recorded.

Claims

1. A device comprising

at least one binding protein having at least one reporter group attached thereto;

and

a thermometer.

2. The device of claim 1, wherein the at least one reporter group comprises a luminescent label.

3. The device of claim 1, wherein the thermometer is selected from the group consisting of a thermocouple and an infrared device.

4. The device of claim 1, wherein the reporter group is capable of providing a signal when the at least one binding protein binds to at least one analyte.

5. The device of claim 4, wherein the at least one analyte comprises at least one analyte selected from the group consisting of amino acids, peptides, polypeptides, proteins, carbohydrates, lipids, nucleotides, oligonucleotides, polynucleotides, glycoproteins or proteoglycans, lipoproteins, lipopolysaccharides, drugs, drug metabolites, small organic molecules, inorganic molecules, natural polymers and synthetic polymers.

6. The device of claim 4, wherein the at least one analyte comprises at least one analyte selected from the group consisting of glucose, galactose, lactate, fatty acids, c-reactive protein, carbohydrates and anti-inflammatory mediators.

7. A device comprising

an optical sensor capable of measuring at least one analyte in a biological sample in proximity to the optical sensor;

and

a thermometer capable of measuring a temperature of said biological sample in proximity to the optical sensor.

8. A device comprising

at least one binding protein having at least one reporter group attached thereto;

wherein the at least one reporter group is capable of detecting a temperature of a biological sample in proximity to the at least one binding protein.

9. A method comprising

acquiring luminescence information of at least one reporter group;

acquiring temperature information of a biological sample; and

determining a corrected luminescence value based on the temperature information;

wherein the corrected luminescence value is indicative of a concentration of at least one analyte in the sample.

10. The method of claim 9, further comprising

determining a concentration of the at least one analyte based on the corrected luminescence value.

11. The method of claim 9, wherein the luminescence information comprises information from at least one binding protein having the at least one reporter group attached thereto, wherein the at least one reporter group luminesces when said at least one binding protein binds to the at least one analyte.

12. The method of claim 11, wherein the temperature information comprises information regarding the temperature of at least a portion of the biological sample in proximity to the at least one binding protein.

13. The method of claim 9, wherein the at least one analyte comprises at least one analyte selected from the group consisting of amino acids, peptides, polypeptides, proteins, carbohydrates, lipids, nucleotides, oligonucleotides, polynucleotides, glycoproteins or proteoglycans, lipoproteins, lipopolysaccharides, drugs, drug metabolites, small organic molecules, inorganic molecules, natural polymers and synthetic polymers.

14. The method of claim 9, wherein the at least one analyte comprises at least one analyte selected from the group consisting of glucose, galactose, lactate, fatty acids, c-reactive protein, carbohydrates and anti-inflammatory mediators.

15. The method of claim 9, wherein corrected luminescence is a function of at least one variable selected from the group consisting of

luminescence L(T) of the reporter group at temperature (T);

temperature (T); and

room temperature (T_R).

16. The method of claim 15, wherein corrected luminescence is determined using the following formula:

L_RT=L(T)/[1+SQ1*(T−

T_R)²+SQ2*(T−

T_R)]

wherein L_RT is luminescence at room temperature, L(T) is luminescence of the reporter group at a temperature (T), T_R is room temperature, SQ1 is a coefficient relating to the magnitude of the quadratic relationship between temperature and luminescence, and SQ2 is a coefficient relating to the magnitude of the linear relationship between temperature and luminescence.

17. The method of claim 15, wherein corrected luminescence is corrected fluorescence.

18. The method of claim 9, wherein corrected luminescence is a function of at least one variable selected from the group consisting of

luminescence (L(T)) of the reporter group at temperature (T);

temperature (T);

temperature sensitivity (S1) around a skin or body temperature region (T_S); and

sensitivity (S2) in a region between room temperature (T_R) and skin temperature (T_S).

19. The method of claim 18, wherein corrected luminescence is determined by a method comprising using the following formula:

L_RT=L(T)/[1+S1*(T−

T_S)]/[1+S2*(T_S−

T_R)]

wherein L_RT is luminescence at room temperature.

20. The method of claim 18, wherein corrected luminescence is corrected fluorescence.

21. The method of claim 18, wherein corrected luminescence is determined by a method comprising using the following formula:

L_RT=L(T)*FC/[1+S1*(T−

T_S)]

wherein L_RT is luminescence at room temperature, and FC is a correction factor which accounts for the change in luminescence due to the difference in the nominal temperature of skin of a mammal for which the analyte concentration is being determined, an internal body temperature of the mammal, and room temperature.

30. A program, adapted to cause a computer to execute the method of claim 9.

31. A computer-readable storage medium, on which is recorded a program adapted to cause a computer to execute the method of claim 9.

22. A method comprising

using temperature information from a biological sample in proximity to at least one binding protein, said protein having at least one reporter group attached thereto, to correct an initially determined concentration of at least one analyte in the biological sample;

wherein the initially-determined concentration of the at least one analyte is determined by the at least one reporter group providing a signal when the at least one binding protein binds to the at least one analyte.

23. A method of correcting fluorescence information comprising:

measuring fluorescence of a reporter group at multiple temperatures;

determining a temperature-to-signal relationship; and

determining at least one correction factor.

24. A system comprising

at least one binding protein having at least one reporter group attached thereto;

a fluorometer;

a thermometer; and

a processor.

25. The system of claim 24, wherein

said at least one binding protein is capable of generating a signal upon binding of at least one analyte to the at least one binding protein;

the fluorometer is capable of measuring the signal;

the thermometer is capable of measuring temperature of a biological sample in proximity to the at least one binding protein; and

the processor is capable of correcting a measured luminescence based on the measured temperature.

26. A system comprising

a sensor capable of detecting concentration of at least one analyte in a biological sample and capable of measuring temperature of the biological sample;

and

a processor.

27. The system of claim 26, wherein the processor is adapted to be capable of providing a corrected analyte concentration based on the measured temperature.

28. An apparatus comprising

a memory for storing luminescence information of a reporter group and temperature information;

and

a processor for correcting luminescence information based on temperature information.

29. The apparatus of claim 28, wherein the processor determines a corrected luminescence as a function of at least one variable selected from the group consisting of:

luminescence (L(T)) of a reporter group at temperature (T);

temperature (T);

room temperature (T_R);

skin temperature (T_S);

temperature sensitivity (S1) around a skin or body temperature region; and

sensitivity (S2) at a region between room temperature (T_R) and skin temperature (T_S).

32. A machine-readable medium including instructions, execution of which by a machine determines a corrected luminescence value, the machine-readable instructions comprising:

a code segment for determining the corrected luminescence value as a function of at least one variable selected from the group consisting of;

luminescence (L(T)) of a reporter group at temperature (T);

temperature (T);

room temperature (T_R);

skin temperature (T_S);

temperature sensitivity (S1) around a skin or body temperature region; and

sensitivity (S2) at a region between room temperature (T_R) and skin temperature (T_S).

33. A computer data signal embodied in a transmission medium, comprising:

a computer-readable program code, said program code comprising a code segment for determining the corrected luminescence value as a function of at least one variable selected from the group consisting of;

luminescence (L(T)) of a reporter group at temperature (T);

temperature (T);

room temperature (T_R);

skin temperature (T_S);

temperature sensitivity (S1) around a skin or body temperature region; and

sensitivity (S2) at a region between room temperature (T_R) and skin temperature (T_S).