Test method and test device for analysing a body fluid

Patent metadata

Field	Value
Publication number	US-2016349187-A1
Application number	US-201615235154-A
Country	US
Kind code	A1
Filing date	Aug 12, 2016
Priority date	Feb 18, 2009
Publication date	Dec 1, 2016
Grant date	—

Abstract

There is provided a test method for analysing a body fluid in which a test tape is used in a test device to successively provide analytical test fields stored on the test tape, wherein body fluid is applied by a user to the test field provided at a time and the said test field is photometrically scanned using a measuring unit of the device to record measurement signals. To increase the measurement reliability, it is proposed that a control value is determined from a time-dependent and/or wavelength-dependent change in the measurement signals and that the measurement signals are processed as valid or discarded as erroneous depending on the control value.

First claim

The invention claimed is:

1 . A method of detecting reagent layer failure on a test tape having a plurality of test fields, the method comprising the steps of:
providing a test field of the test tape to initiate a test, wherein the test tape is in a test device having a measuring unit comprising at least one radiation source to generate at least one wavelength of light and a photodiode for reflection-photometric signal detection of the at least one wavelength of light; photometrically scanning the test field with the measuring unit and detecting relative remission measurement signals over a duration of a waiting time prior to applying a body fluid sample to the test field; calculating a control value based upon a measurement signal difference between relative remissions detected at a beginning and at an end of the waiting time; and detecting a reagent layer failure and discarding the test if the control value is above zero and below a preset threshold.

2 . The method of claim 2 , wherein the reagent layer failure results from environmental reagent layer deterioration due to at least one of heat, humidity and sunlight.

3 . A method of detecting a test field shifting error on a test tape having a plurality of test fields, the method comprising the steps of:
applying a body fluid sample to a test field of the test tape to initiate a test, wherein the test tape is in a test device having a measuring unit comprising at least one radiation source to generate at least one wavelength of light and a photodiode for reflection-photometric signal detection of the at least one wavelength of light; photometrically scanning the test field with the measuring unit and detecting relative remission measurement signals over a duration of a measurement interval; calculating a control value based upon a measurement signal difference between a relative remission measurement signal detected at a beginning of the measurement interval and a relative remission measurement signal detected at an end of the measurement interval; and detecting a test field shifting error and discarding the test if the control value is about zero.

4 . The method of claim 3 , wherein the test tape further includes dark edge strips located adjacent to at least two sides of each of the plurality of test fields.

5 . A device for analyzing an analyte in a body fluid sample, the device comprising:
a measuring unit having at least one radiation source to generate at least one wavelength of light; a photodiode for reflection-photometric signal detection of the at least one wavelength of light; a control device programmed to execute the method of claim 1 ; and a test tape having a plurality of analytical test fields each in a dedicated section of the test tape, wherein the analytical test fields can be successively provided for application of the body fluid sample by means of tape transport and can be scanned using the measuring unit to detect relative remission measurement signals from the at least one wavelength over a duration of a measurement interval.

6 . A device for analyzing an analyte in a body fluid sample, the device comprising:
a measuring unit having at least one radiation source to generate at least one wavelength of light; a photodiode for reflection-photometric signal detection of the at least one wavelength of light; a control device programmed to execute the method of claim 3 ; and
a test tape having a plurality of analytical test fields each in a dedicated section of the test tape, wherein the analytical test fields can be successively provided for application of the body fluid sample by means of tape transport and can be scanned using the measuring unit to detect relative remission measurement signals from the at least one wavelength over a duration of a measurement interval.

Assignees

• Roche Diabetes Care Inc

Inventors

• Miltner Karl
• Lorenz Robert
• Porsch Ulrich
• Knapp Clemens

Classifications

• G01N2021/8494

  Measuring or storing parameters of the band · CPC title

• G01N2035/0491

  Position sensing, encoding; closed-loop control · CPC title

• G01N35/00009

  provided with a sample supporting tape, e.g. with absorbent zones · CPC title

• A61B5/14532 Primary

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

• A61B2562/0295

  Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 · CPC title