Methods and devices for photometrically determining sample application on test elements

Patent metadata

Field	Value
Publication number	US-9869679-B2
Application number	US-201514639602-A
Country	US
Kind code	B2
Filing date	Mar 5, 2015
Priority date	Sep 5, 2012
Publication date	Jan 16, 2018
Grant date	Jan 16, 2018

Abstract

Methods are provided for photometrically determining/detecting sample application to an analytical test element for use with a blood glucose measuring device, where the method includes obtaining a sequence of reflectance readings from the test element with the measuring device, including a blank value prior to sample application, and then monitoring changes of the reflectance readings from the test element with respect to a sample application condition defined by a limit for a reflectance decrease or a reflectance threshold. The methods also can include adjusting the sample application condition in accordance with a drift correction and can include determining an analyte concentration in the body fluid sample. In addition, photometric blood glucose measuring devices are provided that incorporate the methods disclosed herein.

First claim

The invention claimed is:

1. A method of photometrically determining whether a body fluid sample has been applied to an analytical test element, the method comprising the steps of:
obtaining a sequence of reflectance readings from the analytical test element with a photometric blood glucose measuring device, wherein the sequence of reflectance readings starts with a blank reading;
monitoring changes in the sequence of reflectance readings in a sample recognition cycle with respect to a sample application condition;
adjusting the sample application condition with a drift correction calculated from the sequence of reflectance readings including the blank reading, wherein the sample application condition is defined by a limit for a reflectance decrease or a reflectance threshold, wherein a value for the drift correction is provided to adjust the sample application condition without aborting the sample recognition cycle;
determining whether the sequence of reflectance readings fulfills the adjusted sample application condition; and
on condition that the adjusted sample application condition is fulfilled, confirming that the body fluid sample has been applied to the analytical test element.

2. The method of claim 1 , wherein the adjusted sample application condition is fulfilled when a difference between the blank reading and an actual reflectance reading in the sequence of reflectance readings is higher than a given reflectance decrease.

3. The method of claim 2 , wherein the value for the drift correction is added to a predefined signal decrease to obtain the given reflectance decrease.

4. The method of claim 1 , wherein the adjusted sample application condition is fulfilled when an actual reflectance reading in the sequence of reflectance readings is less than a given reflectance threshold.

5. The method of claim 4 , wherein the value for the drift correction is subtracted from a predefined signal threshold to obtain the given reflectance threshold.

6. The method of claim 1 further comprising the step of calculating the value for the drift correction from the blank reading and one or more actual reflectance readings in the sequence of reflectance readings before the adjusted sample application condition is fulfilled.

7. The method of claim 1 , wherein a mean actual reflectance is calculated as a mean value from a predetermined number of last reflectance readings in the sequence of reflectance readings and is subtracted from a blankreading value for the blank reading to obtain the value for the drift correction.

8. The method of claim 1 further comprising the step of determining an analyte concentration in the body fluid sample using at least one reflectance reading in the sequence of reflectance readings after the adjusted sample application condition is fulfilled.

9. The method of claim 1 further comprising the step of defining a limit for the value for the drift correction and terminating the method if the limit is exceeded.

10. The method of claim 1 , wherein a drift of the reflectance readings in the sequence of reflectance readings is caused by ambient measurement conditions selected from the group consisting of humidity, temperature and UV radiation.

11. The method of claim 1 , wherein the adjusted sample application condition is fulfilled when a drop in reflectance of the analytical test element occurs faster than a drift of the sequence of reflectance readings.

12. A blood glucose measuring device that photometrically determines whether a body fluid sample has been applied to an analytical test element, the device comprising:
a receiving unit configured to receive the analytical test element;
a photometric detector configured to take a sequence of reflectance readings from the analytical test element, wherein the sequence of reflectance readings starts with a blank reading;
a signal processor configured to monitor a change in the sequence of reflectance readings in a sample recognition cycle with respect to a sample application condition;
an arithmetic unit configured to calculate a drift correction from the sequence of reflectance readings and to adjust the sample application condition in accordance with the drift correction, wherein the sample application condition is defined by a limit for a reflectance decrease or a reflectance threshold, and wherein a value for the drift correction is provided for adjusting the sample application condition without aborting the sample recognition cycle and further for confirming the body fluid sample has been applied to the analytical test element before an analyte measurement is started by a further reflectance reading after the adjusted sample application condition is fulfilled.

13. The blood glucose measuring device of claim 12 , wherein the analytical test element comprises a reagent configured to react with an analyte in the body fluid sample application and alter a reflectance of a test field of the analytical test element.

14. The blood glucose measuring device of claim 12 , wherein the analytical test element is a disposable test strip, and the receiving unit is formed as a strip grip to position the analytical test strip with respect to the photometric detector.

15. The method of claim 1 , wherein the drift correction is calculated after the sequence of reflectance readings includes a predetermined quantity of actual reflectance readings.

Assignees

• Roche Diabetes Care Inc

Inventors

• Albrecht Gertrud
• Gaa Otto
• Lorenz Robert
• Rueckert Frank

Classifications

• 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

• G01N33/66 Primary

  involving blood sugars, e.g. galactose · CPC title

• Y10T436/144444

  Glucose · CPC title

• G01N21/55

  Specular reflectivity · CPC title