# US 10,244,970 B2 · Test method and test device for analysing a body fluid

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- Number: US 10,244,970 B2
- Document ID: US10244970B2
- Status: Granted
- Kind: B2
- Application number: 15/235,154
- Filed: 2016-08-12
- Published: 2016-12-01
- Granted: 2019-04-02
- Earliest claimed: 2009-02-18
- Assignees: Roche Diabetes Care, Inc.
- Applicants: Roche Diabetes Care, Inc.
- Inventors: Karl Miltner; Robert Lorenz; Ulrich Porsch; Clemens Knapp
- Web page: https://patentgrep.com/patent/US10244970B2

## CPC

- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/1455: using optical sensors, e.g. spectral photometrical oximeters
- 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)}
- G01N 35/00009: {provided with a sample supporting tape, e.g. with absorbent zones}
- A61B 2560/0223: of calibration, e.g. protocols for calibrating sensors
- A61B 2562/0295: Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
- G01N 2021/8488: {the band presenting reference patches}
- G01N 2021/8494: {Measuring or storing parameters of the band}
- G01N 2035/0491: {Position sensing, encoding; closed-loop control}
- G01N 2201/062: LED's
- G01N 2201/13: Standards, constitution
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

There is provided a test method for analyzing 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.

## Claims

### Claim 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 an unused 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 unused test field with the measuring unit and detecting relative remission measurement signals of the at least one wavelength of light generated by the at least one radiation source over a duration of a waiting time prior to applying a body fluid sample to the unused test field;
calculating a control value based upon a blank 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.

### Claim 2 (depends on 1)

The method of claim 1, wherein the reagent layer failure results from environmental reagent layer deterioration due to at least one of heat, humidity and sunlight.