Methods of measuring analytes that include a test element quality measurement based upon intrinsic luminescence of a test chemical of the test element

Patent metadata

Field	Value
Publication number	US-9611504-B2
Application number	US-201414277077-A
Country	US
Kind code	B2
Filing date	May 14, 2014
Priority date	Nov 14, 2011
Publication date	Apr 4, 2017
Grant date	Apr 4, 2017

Abstract

An analytical apparatus is disclosed for detecting at least one analyte in a sample, where in an analyte measurement at least an electrical or optical property changeable by presence of the analyte at least one test chemical of a test element is recorded, and where the analytical apparatus also can perform at least one quality measurement on the at least one test chemical such as an intrinsic luminescence, which is recorded and from the intrinsic luminescence a conclusion is drawn on a quality of the test chemical and thus the test element. Methods also are disclosed for detecting at least one analyte in a sample that include a quality measurement of the at least one test chemical of the test strip.

First claim

The invention claimed is:

1. A method of measuring an analyte in a fluid sample, the method comprising the steps of:
measuring intrinsic luminescence of at least one test chemical of a test element to obtain at least one quality measurement, wherein the test element has at least one test field, the test field being an area in which at least one cohesive layer of the at least one test chemical is applied to a carrier element or is incorporated into the carrier element, wherein from at least one measured intrinsic luminescence a quality of the test chemical is related to degrading or aging of the at least one test chemical, and wherein the measuring of intrinsic luminescence of at least one test chemical is performed before a fluid sample is applied to the at least one test field of the test element; and
measuring at least one analyte in an applied fluid sample to obtain an analyte measurement result, wherein at least one electrical property or at least one optical property of the at least one test chemical changeable by presence of the analyte is recorded.

2. The method of claim 1 , wherein the at least one intrinsic luminescence is recorded at a wavelength range from about 380 nm to about 420 nm.

3. The method of claim 2 , wherein a second intrinsic luminescence is recorded at a wavelength range from about 420 nm to about 650 nm.

4. The method of claim 3 , wherein the measuring intrinsic luminescence step comprises calculating a quality index from the at least one intrinsic luminescence and the second intrinsic luminescence or calculating a linear combination of intrinsic luminescences.

5. The method of claim 1 , wherein the measuring intrinsic luminescence step comprises comparing the at least one measured intrinsic luminescence to at least one predetermined threshold and discarding the analyte measurement result if the at least one recorded intrinsic luminescence is above the at least one predetermined threshold.

6. The method of claim 1 , wherein the measuring intrinsic luminescence step comprises correcting or compensating the analyte concentration based upon the at least one measured intrinsic luminescence.

7. The method of claim 1 , wherein the at least one test chemical comprises an oxidase or a dehydrogenase.

8. The method of claim 7 , wherein the dehydrogenase is selected from the group consisting of glucose 6-phosphate dehydrogenase (EC 1.1.1.49), NAD-dependent cholesterol dehydrogenase (EC 1.1.1.62), FAD-dependent glucose dehydrogenase (EC 1.1.99.10) and PQQ-dependent glucose dehydrogenase (EC 1.1.5.2).

9. The method of claim 1 , wherein the at least one test chemical is L-amino acid dehydrogenase (E.C.1.4.1.5).

10. The method of claim 1 , wherein the at least one test chemical is an aspartate aminotransferase or an alanine aminotransferase.

Assignees

• Roche Diabetes Care Inc

Inventors

• Petrich Wolfgang
• Horn Carina
• Steinke Nelli
• Ringemann Christian
• von Ketteler Alexa Freifrau

Classifications

• C12Q1/32

  involving dehydrogenase · CPC title

• G01N2035/00673

  of reagents · CPC title

• G01N21/6428

  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 title

• A61B5/14532 Primary

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• A61B2560/0233

  Optical standards · CPC title