Methods for detecting an analyte and performing a failsafe step in a body fluid using optical and impedance measurements

• US 10,180,420 B2
• Filed: 12/09/2015
• Issued: 01/15/2019
• Est. Priority Date: 06/10/2013
• Status: Active Grant

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Bauer-Espindola, Klaus Andreas, Horn, Carina, Marquant, Michael, Nortmeyer, Christine, Unkrig, Volker
• Primary Examiner(s): Gitomer, Ralph J
• Application Number:
  US14/963,576
• Publication Number:
  US 20160091482A1
• Time in Patent Office: 1,133 Days
• Field of Search: None
• CPC Class Codes: G01N 2021/7786 Fluorescence
• 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 21/78 producing a change of colour
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 27/02 by investigating impedance
• CPC Class Codes: G01N 27/12 of a solid body in dependence upon absorption of a fluid; of a solid body in dependence upon reaction with a fluid , for detecting components in the fluid
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/492 Determining multiple analytes

Abstract

A method for detecting at least one analyte in a body fluid is disclosed comprising performing an optical measurement, wherein at least one test chemical is contacts the body fluid. The test chemical is an optical test chemical adapted to perform at least one detection reaction, wherein at least one optically detectable property is changed due to the detection reaction to provide at least one optical measurement value. At least one impedance measurement is generated wherein at least one alternating electrical signal is applied to the body fluid via the impedance measurement electrodes and at least one answer signal is recorded, and at least one impedance measurement value is generated. At least one evaluation step is performed wherein at least one evaluation algorithm is used, and the optical measurement value and the impedance measurement value are used for determining a concentration of the analyte in the body fluid.

Claims

1. A method for detecting at least one analyte in a body fluid, the method comprising the following steps:

a) performing an optical measurement, wherein at least one test chemical is contacted with the body fluid, wherein the test chemical is an optical test chemical and is adapted to perform at least one detection reaction in the presence of the analyte, wherein at least one optically detectable property of at least one of the body fluid and the test chemical is changed due to the detection reaction, wherein at least, one optical measurement value is generated;

b) performing at least one impedance measurement, wherein at least two impedance measurement electrodes are used, wherein at least one alternating electrical signal is applied to the body fluid via the impedance measurement electrodes land wherein at least one answer signal is recorded, wherein at least one impedance measurement value is generated;

c) performing at least one evaluation step, wherein, in the evaluation step the optical measurement value and the impedance measurement value are used for detecting the analyte in the body fluid; and

d) performing at least one failsafe step, wherein, in the failsafe step, only the impedance measurement value is used, the failsafe step comprising comparing one or both of a degree of filling of a capillary element and a degree of wetting of a test chemical with at least one threshold value.

2. The method according to claim 1 and further comprising performing a failsafe step comprising comparing at least one or both of an environmental parameter and a sample parameter to a threshold value.

3. The method according to claim 1, wherein in step c), detection of the analyte is performed as a detection of the concentration of the analyte in the body fluid and the concentration of the analyte in the body fluid is a corrected concentration which is corrected for at least one interferent concentration in the body fluid.

4. The method according to claim 1, wherein step c) comprises the following substeps:

c.1) determining an estimated value of the concentration of the analyte in the body fluid by using the optical measurement value and

c.2) determining a corrected value of the concentration of the analyte in the body fluid by using the estimated value and correcting the estimated value by using the impedance measurement value.

5. The method according to claim 4 wherein step c) comprises using a first evaluation algorithm, and further comprises using at least one correction algorithm using the impedance measurement.

6. The method according to claim 1, wherein a single test element is used for both method step a) and method step b).

7. The method according to claim 1, wherein at least one impedance measurement electrode of the at least two impedance measurement electrodes comprises a metal selected from the group consisting of:

aluminum, molybdenum, tungsten, tantalum, niobium, zirconium, titanium, ruthenium, rhodium, iridium, palladium, platinum, silver, and gold.

8. The method according to claim 1, wherein at least one impedance measurement electrode of the at least two impedance measurement electrodes comprises aluminum.

9. The method according to claim 1, wherein step d) comprises using the impedance measurement value to determine the wetting of at least, one of the impedance measurement electrodes, the test chemical and a capillary element.

10. The method according to claim 1 and further comprising performing a failsafe step comprising comparing the temperature of a surrounding environment to a threshold value.

11. The method according, to claim 1 and further comprising performing a failsafe step comprising, comparing a sample temperature to a threshold value.

12. The method of claim 1, wherein the at least two impedance measurement electrodes provide the at least one impedance measurement value used for determining the concentration of the analyte in the body fluid and the at least two impedance measurement electrodes further are used for providing at least one wetting information, wherein the wetting information comprises at least one item of information regarding a wetting of at least one of the test element, a capillary element of the test element, the test chemical and the impedance measurement electrodes with the body fluid.

13. A method for, detecting the concentration of at least one, analyte in a body fluid, the method comprising:

a) performing an optical measurement, wherein at least one test chemical is contacted with the body fluid, wherein the test chemical is an optical test chemical and is adapted to, perform at least one detection reaction in the presence of the analyte, wherein at least one optically detectable property of at least one of the body fluid and the test chemical is changed due to the detection reaction, wherein at least one optical measurement value is generated;

b) performing at least one impedance measurement, wherein at least two impedance measurement electrodes are used, wherein at least one alternating electrical signal is applied to the body fluid via the impedance measurement electrodes and wherein at least one answer signal is recorded, wherein at least one impedance measurement value is generated;

c) performing at least one evaluation step, wherein, in the evaluation step the optical measurement value and the impedance measurement value are used for determining a concentration of the analyte in the body fluid; and

d) performing at least one failsafe step, wherein, in the failsafe step, only the impedance measurement value is used, the failsafe step comprising comparing one or both of a degree of filling of a capillary element and a degree of wetting of a test chemical with at least one threshold value.

14. The method according to claim 13 wherein step c) comprises using the optical measurement value to determine an estimated concentration and correcting the estimated concentration from the optical measurement value to optical for at least one interferent concentration.

15. The method according to claim 14 which comprises correcting the estimated concentration for hematocrit concentration.