Methods of determining an analyte concentration in a body fluid sample, as well as analytical devices and systems for use therein

Patent metadata

Field	Value
Publication number	US-10274430-B2
Application number	US-201615145840-A
Country	US
Kind code	B2
Filing date	May 4, 2016
Priority date	Nov 28, 2013
Publication date	Apr 30, 2019
Grant date	Apr 30, 2019

Abstract

Methods, analytical devices and analytical systems are provided for determining at least one analyte concentration in a body fluid sample. The methods, which may be incorporated into the devices and systems, can include the following steps: applying a body fluid to a test carrier; illuminating the test carrier by at least one light source, where the at least one light source is modulated by using at least two modulation frequencies; receiving light remitted by the test carrier by using at least one detector; determining an analyte concentration by evaluating at least one detector signal generated by the detector, where the detector signal is demodulated with the at least two modulation frequencies to generate at least two demodulated detector signals, each demodulated signal corresponding to one of the modulation frequencies; and detecting a fault by comparing the at least two demodulated detector signals.

First claim

The invention claimed is:

1. A method of determining at least one analyte concentration in a body fluid sample, the method comprising the steps of:
a). applying the body fluid sample to a test carrier;
b). illuminating the test carrier with at least one light source, the at least one first light source comprising at least one first light source being modulated by at least two modulation frequencies and at least one second light source being modulated by at least two modulation frequencies being different from the at least two modulation frequencies by which the first light source is modulated, wherein the at least one light source is modulated by using at least two different modulation frequencies;
c). receiving light remitted by the test carrier with at least one detector;
d). determining an analyte concentration by evaluating at least one detector signal generated by the at least one detector, wherein the at least one detector signal is demodulated with the at least two different modulation frequencies to generate at least two demodulated detector signals, each demodulated detector signal corresponding to one of the at least two modulation frequencies; and
e). detecting a fault by comparing the at least two demodulated detector signals.

2. The method of claim 1 , wherein step e) is an online fault detection performed permanently or repeatedly.

3. The method of claim 1 , wherein the at least one light source is modulated by using at least three modulation frequencies.

4. The method of claim 1 , wherein step e) further comprises detecting faulty demodulated detector signals.

5. The method of claim 4 , wherein step e) further comprises rejecting faulty demodulated detector signals and using only non-faulty demodulated detector signals for determining the at least one analyte concentration in the body fluid sample.

6. The method of claim 5 , wherein at least one faulty demodulated detector signal is used for determining the at least one analyte concentration, and wherein a degree of faultiness is taken into account.

7. The method of claim 1 , wherein the at least one light source comprises at least one first light source being modulated by at least two modulation frequencies and at least one second light source being modulated by at least two modulation frequencies being different from the at least two modulation frequencies by which the first light source is modulated.

8. The method of claim 7 , wherein at least two demodulated detector signals are generated for the modulation frequencies by which the first light source is modulated, and wherein at least two demodulated detector signals are generated for the modulation frequencies by which the second light source is modulated.

9. The method of claim 8 , wherein step e) is performed both for the at least two demodulated detector signals for the at least two different modulation frequencies by which the first light source is modulated and for the at least two demodulated detector signals for the modulation frequencies by which the second light source is modulated.

10. The method of claim 1 , wherein step e) is performed at least once before step a).

11. The method of claim 10 , further comprising the step of:
determining at least one dry empty value by evaluating the at least one detector signal generated by the at least one detector before applying the body fluid sample to the test carrier.

12. The method of claim 1 , further comprising the step of:
verifying at least one position of the test carrier, wherein the verifying step comprises the steps of:
i) inserting the test carrier into an analytical device;
ii) illuminating the test carrier by the at least one light source;
iii) receiving light remitted by the test carrier by using the at least one detector; and
iv) determining at least one position of the test carrier within the analytical device by evaluating at least one detector signal generated by the at least one detector, wherein the at least one position comprises at least one of a location or an orientation of the test carrier.

13. The method of claim 1 , further comprising the step of:
detecting at least one ambient light fault, wherein the ambient light fault detecting step comprises the steps of:
I. receiving ambient light by using the at least one detector;
II. evaluating at least one detector signal generated by the at least one detector; and
III. performing an ambient light fault detection by comparing the at least one detector signal generated by the at least one detector with the at least two different modulation frequencies.

14. The method of claim 1 , wherein the demodulation comprises independently multiplying the at least one detector signal with the at least two different modulation frequencies and filtering the results by using low pass filters.

15. The method of claim 14 , wherein the demodulation, before multiplying the at least one detector signal with the at least two different modulation frequencies, comprises filtering the at least one detector signal by using at least one band pass filter.

16. The method of claim 1 , further comprising at least one of the following steps:
inserting the test carrier into an analytical device;
initiating the fault detecting; and
acquiring a dry empty value.

17. An analytical device for determining at least one analyte concentration in a body fluid, the analytical device comprising:
at least one receptacle for receiving at least one test carrier, wherein at least one body fluid sample is applicable to the at least one test carrier;
at least one light source configured for illuminating the at least one test carrier, the at least one light source comprising at least one first light source configured to be modulated by at least two modulation frequencies and at least one second light source configured to be modulated by at least two modulation frequencies being different from the at least two modulation frequencies by which the first light source is modulated;
at least one detector configured for receiving light remitted by the at least one test carrier;
at least one evaluation unit configured for determining the at least one analyte concentration by evaluating at least one detector signal generated by the at least one detector;
at least one modulation device configured for modulating the at least one light source by using at least two different modulation frequencies;
at least one demodulation device configured for the demodulating the at least one detector signal with the at least two modulation frequencies to generate at least two demodulated detector signals, each demodulated detector signal corresponding to one of the at least two different modulation frequencies; and
at least one fault detection device configured for performing a fault detection based on a comparison of the at least two demodulated detector signals.

18. An analytical system for determining at least one analyte concentration in a body fluid sample, the analytical system comprising:
the analytical device of claim 17 ; and
at least one test carrier.

Assignees

• Roche Diabetes Care Inc

Inventors

• Albrecht Gertrud
• Baumann Edgar
• Genthner-Riegler Markus
• Kalveram Stefan
• Niesporek Christian
• Schwenker Kai-Oliver
• Serr Markus
• Wehowski Frederic
• Wettengel Klaus

Classifications

• G01N21/75 Primary

  Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated (systems in which material is burnt in a flame or plasma G01N21/72, G01N21/73) · CPC title

• G01N21/8483 Primary

  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 title

• G01N2021/7786

  Fluorescence · CPC title

• G01N33/4875

  Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method (test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B) · CPC title

• G01N2201/0697

  Pulsed lasers · CPC title