EP1563441A2 - Procede de realisation d'un controle qualite destine a un processus d'analyse et dispositif destine a la mise en oeuvre du procede - Google Patents

Procede de realisation d'un controle qualite destine a un processus d'analyse et dispositif destine a la mise en oeuvre du procede

Info

Publication number
EP1563441A2
EP1563441A2 EP03769436A EP03769436A EP1563441A2 EP 1563441 A2 EP1563441 A2 EP 1563441A2 EP 03769436 A EP03769436 A EP 03769436A EP 03769436 A EP03769436 A EP 03769436A EP 1563441 A2 EP1563441 A2 EP 1563441A2
Authority
EP
European Patent Office
Prior art keywords
processes
analysis
database
stored
sub
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP03769436A
Other languages
German (de)
English (en)
Inventor
Klaus Abraham-Fuchs
Michael Moritz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Siemens AG
Siemens Corp
Original Assignee
Siemens AG
Siemens Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Siemens AG, Siemens Corp filed Critical Siemens AG
Publication of EP1563441A2 publication Critical patent/EP1563441A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H15/00—ICT specially adapted for medical reports, e.g. generation or transmission thereof
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/60—ICT specially adapted for the handling or processing of medical references relating to pathologies

Definitions

  • the invention relates to a method for performing a quality control for an analysis process, which runs in an analysis device and consists of a chain of sub-processes, and a device for performing the method. It relates in particular to quality assurance for biochemical analysis devices, in particular for medical diagnostics and in particular using one of the technologies comprising biochips, “lab-on-the-chip ⁇ and ⁇ TAS (“ Totally Integrated Analysis System 1 ”using the microtechnology gie) as well as the quality assurance of the manufacturing process of disposable sensors and other consumables used in the analyzer such as reagent cartridges, sensors with a limited lifespan and maintenance-intensive components.
  • a disposable sensor filled with blood is inserted into the evaluation device, which then drives a pump in the disposable sensor, which pushes the blood over a membrane of the disposable sensor that separates the red blood cells and conveys it into a chamber of the disposable sensor, where the blood contained, for example, react in high concentration to antigens indicating disease with specific, color-marked antibodies to form a complex.
  • the mixture containing the complexes is pressed by the pump onto a prism of the disposable sensor, on which further antibodies are attached. are arranged that capture and fix the complexes.
  • a laser of the evaluation device scans the prism and excites the color-marked connections to light up, and a detector of the evaluation device captures the fluorescent light, the intensity of the fluorescent light being a measure of the concentration of antigens.
  • An object of the invention is to provide an improved method for performing a quality control for an analysis process, so that, inter alia, the aforementioned disadvantages are reduced.
  • a method for performing a quality control for an analysis process which belongs to a group of related analysis processes that can be executed in at least one analysis device and each comprises a chain of sub-processes, includes the following features: - Basic chemical and / or physical basic sub-processes are stored in a first database for the group,
  • At least part of the chain of the analysis process is simulated by specifying one of the basic subprocesses for each subprocess of the part of the chain by means of at least one control parameter and at least one associated threshold value,
  • measured values are determined for the control parameters and for the
  • the measured values are compared with the associated threshold values.
  • the analysis task is solved by a sequence of sub-processes, each sub-process being a chemical reaction, for example a bond between two molecules, a physical reaction, e.g. Heating, transport process or mixing, or a physical measurement process. If even one subprocess is not carried out properly, this will generally have the consequence that the analysis result is faulty, which is selectively detected with the method for each of the quality-relevant subprocesses.
  • the invention provides a generic quality control system using electronic databases,
  • FIG. 1 shows a structure and flow diagram for a method for performing a quality control for a biochemical analysis process
  • FIG. 2 shows an analysis device, comprising an evaluation device and disposable sensors that can be inserted into the evaluation device, for carrying out the method.
  • FIG. 1 shows, as an exemplary embodiment of the invention, a structure and the sequence of a method for performing a quality control for a biochemical analysis process running in an analysis device and consisting of a chain of sub-processes.
  • a first database 110 for quality control in which all possible basic sub-processes of a group of related analysis processes are parameterized in an abstract manner by means of process variables and each of the basic sub-processes for quality control can be characterized by at least one control parameter and, associated with the control parameter, by at least one threshold value.
  • the basic sub-processes describe basic chemical and / or physical sub-processes of the group, whereby these basic sub-processes can occur several times in variations in the entire analysis process.
  • the following table shows examples of basic subprocesses A to F of the group with conceivable process variables associated with the individual basic subprocesses. Furthermore, at least one control parameter is provided for the respective basic subprocesses A to F in the form of a placeholder K (X), which should not fall below a lower threshold value min (X) and / or an upper one for the purposes of quality control Threshold value max (X) should not exceed, where X is a placeholder for one of the basic subprocesses A to F.
  • a second database 120 is generated in a first step 150 of FIG. 1, which compiles the actual analysis process of the analysis device from the basic sub-processes and describes them sufficiently completely.
  • a suitable graphical user interface is used for this, which uses methods known from the prior art, such as drag and-drop, drop-down lists, ticking list elements with a mouse click, etc.
  • the chain of subprocesses is created by dragging and dropping icons of the basic subprocesses and the definition of the process variables and control parameters is supported by selection from dropdown lists.
  • the analysis device comprises an appropriately prepared computer work station or is designed to be connectable to such.
  • the analysis process can be simulated at a central computer workstation with a corresponding graphical user interface, and the resulting database can be loaded into a memory of the analysis device provided for this purpose as part of a manufacturing process of the analysis device, wherein the memory can also be a memory of disposable sensors of the analysis device which can be inserted into a basic device of the analysis device for executing the analysis process.
  • the memory can also be a memory of disposable sensors of the analysis device which can be inserted into a basic device of the analysis device for executing the analysis process.
  • the analysis process of the analysis device is thus described in the form of the second database 120, which all subprocesses El to Dl in their chronological order and associated characterizing features of the sub-processes.
  • the second database 120 does not actually have to contain all the actually occurring subprocesses of the analysis process, but only those that are actually quality-relevant for a result of the analysis process.
  • observation signals are determined by measurement, which are stored in a further database, for example a third database 130, and the corresponding control parameters K (E1) to K (C2) are assigned.
  • the measured observation signals can also be assigned directly to the corresponding control parameters K (E1) to K (C2) of the second database 120 via a measured value interface.
  • One of the observation signals can be a measured value from a sensor or detector mounted in the analysis device, for example a temperature sensor, a light barrier or a photomultiplier, or it can be a value derived from one or more measured values.
  • a threshold value is not met, error messages are automatically generated and reported to the analysis device.
  • the measured values for all sub-processes are documented in the third database 130 and the achievement of the prescribed threshold values is evaluated, for example in the form that corresponding error flags are set.
  • the following table shows an example of this, in which mixing in accordance with regulations in sub-process Dl is indicated by a "no" * as an error flag, since the measured value of 7.9 is below the lower threshold value min (Dl).
  • the exceeding and / or falling below the threshold values can also be stored in the third database 130 in the form of a percentage deviation. Furthermore, the analysis process can be stopped immediately with a corresponding error message on the analysis device if one of the threshold values min (El) to min (C2) of one of the control parameters K (E1) to K (C2) is not observed.
  • a time profile of the measured values for the control parameters is stored in the third database 130 in the form of quality protocols over successive analysis processes, for example with several different disposable sensors.
  • identifiers of disposable sensors, identifiers of batches of disposable sensors and / or identifiers of the individual analysis processes are also stored in the third database 130.
  • the third database 130 in which the measured values for the control parameters K (E1) to K (C2) of many analysis processes are stored over a predefinable period of time, can be evaluated using statistical methods.
  • this serves for the automatic generation of indications of quality-relevant events, for example in order to use the scatter range of measured values for at least one of the control parameters K (E1) to K (C2) over many analysis processes or from a course observation of Measured values for the control parameters in the sense of a trend to draw conclusions on the analysis device, for example for necessary maintenance work.
  • the control parameters K (E1) to K (C2) over many analysis processes or from a course observation of Measured values for the control parameters in the sense of a trend to draw conclusions on the analysis device, for example for necessary maintenance work.
  • FIG. 2 shows, as an exemplary embodiment of the invention for carrying out the method for quality control, an analysis device which comprises an evaluation device 210 as a basic device and thumb-sized disposable sensors 220 provided as subunits of the analysis device for insertion into the evaluation device 210, for example filled with blood ,
  • each of the disposable sensors 220 comprises a memory chip 225 which, among other things, carries information for the evaluation device 210, which special program is running and how the evaluation is to be carried out.
  • the first database 110 can either be stored in the analysis device or at a computer workstation 230.
  • the evaluation device 210 is designed to be connectable to a computer workstation 230 via an electrotechnical data connection, for example the Internet 250.
  • the evaluation device 210 can also comprise a correspondingly prepared computer work station.
  • the compilation of the analysis system-specific process description from the basic sub-processes of the first database 110 takes place on the computer workstation 230.
  • the finished process description is then transferred from the computer workstation 230 to an electronic data memory in the analysis device and stored there as a second database 120.
  • the electronic data storage can also be based on memory chip 225 attached to disposable sensor 220.
  • the measured values determined are also saved in the aforementioned data memory in the context of the third database 130.
  • the measurement values saved in the third database 130 in the form of the quality control protocols are evaluated automatically either in the analysis device or preferably at a further computer workstation 240 which has access to the databases 120 and 130 via an electrical data connection, for example the Internet 250. Warning messages are generated automatically and sent to the user and / or the manufacturer of the evaluation device 210 or the disposable sensors 220 if quality defects are detected.

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Primary Health Care (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Data Mining & Analysis (AREA)
  • Databases & Information Systems (AREA)
  • Pathology (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

L'invention concerne un procédé de réalisation d'un contrôle qualité destiné à un processus d'analyse appartenant à un groupe de processus d'analyses similaires, pouvant être réalisés dans au moins un appareil d'analyse, et comportant respectivement une chaîne de processus partiels. Le procédé selon l'invention consiste à enregistrer des processus partiels de base, chimiques et/ou physiques, dans une première base de données, pour le groupe ; à reproduire au moins une partie de la chaîne du processus d'analyse par spécification d'un des processus partiels de base, pour chaque processus partiel de la partie de la chaîne, à l'aide d'au moins un paramètre de contrôle et d'une valeur seuil correspondante ; à déterminer des valeurs de mesure des paramètres de contrôle, pour au moins un cycle du processus d'analyse ; et, à comparer les valeurs de mesure aux valeurs seuil correspondantes du contrôle qualité.
EP03769436A 2002-11-18 2003-10-22 Procede de realisation d'un controle qualite destine a un processus d'analyse et dispositif destine a la mise en oeuvre du procede Withdrawn EP1563441A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10253700 2002-11-18
DE10253700A DE10253700B4 (de) 2002-11-18 2002-11-18 Verfahren zum Durchführen einer Qualitätskontrolle für einen Analyseprozess und Verwendung des Verfahrens
PCT/EP2003/011712 WO2004046993A2 (fr) 2002-11-18 2003-10-22 Procede de realisation d'un controle qualite destine a un processus d'analyse et dispositif destine a la mise en oeuvre du procede

Publications (1)

Publication Number Publication Date
EP1563441A2 true EP1563441A2 (fr) 2005-08-17

Family

ID=32240131

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03769436A Withdrawn EP1563441A2 (fr) 2002-11-18 2003-10-22 Procede de realisation d'un controle qualite destine a un processus d'analyse et dispositif destine a la mise en oeuvre du procede

Country Status (7)

Country Link
US (1) US7359806B2 (fr)
EP (1) EP1563441A2 (fr)
JP (1) JP2006506717A (fr)
CN (1) CN1711548A (fr)
AU (1) AU2003278124A1 (fr)
DE (1) DE10253700B4 (fr)
WO (1) WO2004046993A2 (fr)

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JP5021486B2 (ja) * 2004-11-10 2012-09-05 ユィロス・パテント・アクチボラグ 液体検出および信頼度判定
SE0402731D0 (sv) * 2004-11-10 2004-11-10 Gyros Ab Liquid detection and confidence determination
CN101408550B (zh) * 2007-06-15 2015-02-25 奥索临床诊断有限公司 临床诊断分析仪性能估测仪
US8140300B2 (en) * 2008-05-15 2012-03-20 Becton, Dickinson And Company High throughput flow cytometer operation with data quality assessment and control
US8214159B2 (en) * 2008-12-04 2012-07-03 Siemens Medical Solutions Usa, Inc. Apparatus and method for automated quality control
WO2011140084A1 (fr) * 2010-05-03 2011-11-10 Bio-Rad Laboratories, Inc. Système et procédé de mise en place d'inserts à mise à jour automatique pour produits
BR112014012003B1 (pt) * 2011-11-18 2021-04-27 Fio Corporation Sistema de controle de qualidade, método e meio legível por computador para o uso com bens de consumo, usuários e dispositivos de teste de diagnóstico biológico/ambiental
CN104484558B (zh) * 2014-12-08 2018-04-24 深圳华大基因科技服务有限公司 生物信息项目的分析报告自动生成方法及系统

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Also Published As

Publication number Publication date
AU2003278124A1 (en) 2004-06-15
JP2006506717A (ja) 2006-02-23
US7359806B2 (en) 2008-04-15
WO2004046993A3 (fr) 2004-07-29
DE10253700A1 (de) 2004-06-03
CN1711548A (zh) 2005-12-21
DE10253700B4 (de) 2005-11-17
US20060167830A1 (en) 2006-07-27
WO2004046993A9 (fr) 2005-06-23
WO2004046993A2 (fr) 2004-06-03

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