Device and Method for Automatic Calibration Verification of an Analyzer

• US 20100161267A1
• Filed: 12/15/2009
• Published: 06/24/2010
• Est. Priority Date: 12/19/2008
• Status: Abandoned Application

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Bartel, Arnold, Engel, Bernhard
• Application Number:
  US12/638,139
• Publication Number:
  US 20100161267A1
• Time in Patent Office: Days
• US Class Current: 702/100
• CPC Class Codes: G01N 2035/00851 process control parameters
• CPC Class Codes: G01N 33/492 Determining multiple analytes
• CPC Class Codes: G01N 35/00623 of instruments
• CPC Class Codes: G01N 35/00732 Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: G01N 35/1002 Reagent dispensers

Abstract

A method and a device for carrying out calibration verification (CV process) of an analyzer for determining different measurement parameters in body fluids is provided. The device according to the invention comprises the following components: a cartridge with a plurality of containers, which can be connected to an intake system of an analyzer, each of which contains a measurement fluid with known measurement parameter values; a storage unit assigned to the cartridge for storing the measurement parameter values of the measurement fluids and data relevant for the CV process of the analyzer to be verified; a docking or intake area at or in the analyzer for receiving the cartridge with a data path for reading the storage unit; an evaluation unit typically housed in the analyzer for evaluating the values measured by the analyzer; and an output unit for printing an evaluation protocol.

Claims

1. A method for carrying out a verification of the calibration (calibration verification, CV) of a measurement system of an analyzer for determining different measurement parameters in body fluids, comprising the steps of:

inserting into or docking onto the analyzer a cartridge containing a plurality of identical sets of at least five different measurement fluids with known different measurement parameter values, which are distributed over the total measurement range of the measurement parameters which can be measured by the measurement system, in particular including measurement parameter values at the upper and lower limits of the measurement ranges,

reading in the measurement parameter values stored in a storage unit assigned to the cartridge, and other data and information relevant for the CV process of the analyzer to be verified,

selecting measurement fluids to be measured according to the data stored in the storage unit,

feeding the measurement fluids into the measurement system by the analyzer and measuring them by the analyzer,

automatic evaluation of the measurement results by an evaluation unit assigned to the analyzer, taking into account the stored data, and

output of an evaluation protocol on an output device.

2. The method according to claim 1, wherein at least three identical sets of at least five different measurement fluids each are used.

3. The method according to claim 1, wherein the selection of the measurement fluids to be measured is restricted to the measurement parameters activated in the analyzer.

4. The method according to claim 1, wherein the evaluation protocol comprises a written and/or a graphical presentation, in which the measured values of the individual measurement parameters (actual values) and/or statistical variables derived therefrom are compared with stored target values, taking into account permissible limits.

5. The method according to claim 1, wherein the analyzer, depending on the results of the evaluation protocol, automatically initiates suitable or necessary measures for maintaining the measuring operation.

6. The method according to claim 5, wherein individual measurement parameters or groups of measurement parameters of the parameter panel are disabled.

7. A device for carrying out a calibration verification process (CV process) on an analyzer for determining different measurement parameters in body fluids, which comprises

a cartridge with a plurality of sets of containers, which can be connected to an intake system of an analyzer, each set of containers comprising at least five different measurement fluids with known different measurement parameter values, which are distributed over the total measurement range of the measurement parameters which can be measured by the measurement system, in particular including measurement parameter values at the upper and lower ends of the measurement ranges;

a storage unit assigned to the cartridge for storing the measurement parameter values of the measurement fluids and data and information relevant for the CV process of the analyzer to be verified;

a docking or intake area at or in the analyzer for receiving the cartridge with a data path for reading the storage unit;

an evaluation unit for evaluating the values measured by the analyzer; and

an output unit for printing an evaluation protocol.

8. The device according to claim 7, wherein the cartridge houses at least three sets of containers with at least five different measurement fluids.

9. The device according to claim 7, wherein the storage unit is realized as a data chip, which is attached to the cartridge.

10. The device according to claim 7, wherein the storage unit is realized as a data storage medium, which is contained in the package of the cartridge.

11. The device according to claim 7, wherein the evaluation unit and/or the output unit are parts of the analyzer.