Test method and test device for analysing a body fluid

Patent metadata

Field	Value
Publication number	US-9439587-B2
Application number	US-201514703312-A
Country	US
Kind code	B2
Filing date	May 4, 2015
Priority date	Feb 18, 2009
Publication date	Sep 13, 2016
Grant date	Sep 13, 2016

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.

First claim

The invention claimed is:

1. A method of analyzing a body fluid for blood sugar determination in which a test tape in the form of a tape cassette is used in a test device to successively provide a plurality of analytical test fields stored on the test tape by means of tape transport, the method comprising the steps of:
determining a test field control value from a dry blank value measurement of a test field prior to applying the body fluid thereto;
determining usability of the test field by comparing the test field control value to a preset lot control value, wherein the preset lot control value is determined during a batchwise production of the tape cassette by measuring test fields and calibration fields on a test tape material and then storing the preset lot control value on a storage medium that is applied to the tape cassette, and wherein the test field is usable if the test field control value does not deviate by more than a specified tolerance from the preset lot control value;
applying the body fluid to the test field at a time;
photometrically scanning over a duration of a measurement interval the test field via a measuring unit of the test device to detect measurement signals for blood sugar determination; and
providing the blood sugar determination if the test field is usable.

2. The method of claim 1 , wherein a first test field or the entire test tape is not usable when the test field control value of the first test field deviates by more than a specific tolerance from the lot control value.

3. The method of claim 1 , wherein a calibration measurement is carried out by detecting a white calibration field on the test tape that is assigned to the respective test field by means of the measuring unit, and wherein the test field control value is determined as a relative value from the dry blank value measurement and the calibration measurement.

4. The method of claim 1 , wherein the storage medium is an RFID-chip and the lot control value is stored in the RFID-chip.

Assignees

• Roche Diabetes Care Inc

Inventors

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

Classifications

• A61B2560/0223

  of calibration, e.g. protocols for calibrating sensors · CPC title

• G01N2035/0491

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

• A61B5/14532 Primary

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

• A61B5/1455

  using optical sensors, e.g. spectral photometrical oximeters · CPC title

• G01N2201/062

  LED's · CPC title