ES2193123T3 - Procedimiento para controlar la idoneidad para el uso de elementos de analisis. - Google Patents

Procedimiento para controlar la idoneidad para el uso de elementos de analisis.

Info

Publication number
ES2193123T3
ES2193123T3 ES01119090T ES01119090T ES2193123T3 ES 2193123 T3 ES2193123 T3 ES 2193123T3 ES 01119090 T ES01119090 T ES 01119090T ES 01119090 T ES01119090 T ES 01119090T ES 2193123 T3 ES2193123 T3 ES 2193123T3
Authority
ES
Spain
Prior art keywords
control
quotient
value
test
test strip
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.)
Expired - Lifetime
Application number
ES01119090T
Other languages
English (en)
Inventor
Otto Gaa
Gertrud Albrecht
Dieter Loch-Leroux
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.)
F Hoffmann La Roche AG
Original Assignee
F Hoffmann La Roche AG
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 F Hoffmann La Roche AG filed Critical F Hoffmann La Roche AG
Application granted granted Critical
Publication of ES2193123T3 publication Critical patent/ES2193123T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/10Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/11Automated chemical analysis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Microbiology (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Investigating Or Analyzing Non-Biological Materials By The Use Of Chemical Means (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
  • Analysing Materials By The Use Of Radiation (AREA)

Abstract

Procedimiento para controlar la idoneidad para el uso de elementos de análisis (1), en el que se controla si un valor de control (L2), medido para por lo menos un parámetro de control de un elemento de análisis controlado (1), está situado dentro de un margen de tolerancia, caracterizado porque a) en una primera etapa se determina, en una medición de valores de referencia, un primer valor de referencia patrón (W1) en un medio de control de referencia (4), que pone a disposición un valor de referencia normalizado para el parámetro de control, b) en una segunda etapa se determina como valor de referencia de control (L1) el parámetro de control de un primer elemento de análisis, c) en una tercera etapa se forma el cociente entre el valor de referencia de control (L1) y el primer valor de referencia patrón (W1) y se establece como primer cociente de referencia (Q1) para elementos de análisis posteriormente medidos, d) en una cuarta etapa, para el control de un segundo elemento de análisis que se ha de controlar, se determina el parámetro de control del elemento de análisis como valor de control (L2), e) en una quinta etapa se forma como cociente de control (Q2) el cociente entre el valor de control (L2) y el primer valor de referencia patrón (W1), f) en una sexta etapa se determina la desviación (o) entre el cociente de control (Q2) y el primer cociente de referencia (Q1), y g) se rechaza el segundo elemento de análisis controlado, cuando la desviación (o) está situada fuera de un margen de tolerancia previamente establecido.
ES01119090T 2000-09-01 2001-08-08 Procedimiento para controlar la idoneidad para el uso de elementos de analisis. Expired - Lifetime ES2193123T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE10043556 2000-09-01

Publications (1)

Publication Number Publication Date
ES2193123T3 true ES2193123T3 (es) 2003-11-01

Family

ID=7654945

Family Applications (1)

Application Number Title Priority Date Filing Date
ES01119090T Expired - Lifetime ES2193123T3 (es) 2000-09-01 2001-08-08 Procedimiento para controlar la idoneidad para el uso de elementos de analisis.

Country Status (6)

Country Link
US (3) US20020164805A1 (es)
EP (1) EP1189064B1 (es)
JP (1) JP3423939B2 (es)
AT (1) ATE235059T1 (es)
DE (2) DE10138661A1 (es)
ES (1) ES2193123T3 (es)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040014106A1 (en) * 2002-05-14 2004-01-22 Nanosphere, Inc. Electrical detection of DNA hybridization and specific binding events
DE10353445B4 (de) 2003-11-15 2017-03-02 Roche Diabetes Care Gmbh Spenderbehältnis und Vorratsbehältnis für analytische Verbrauchsmittel
NL2000206C2 (nl) 2006-08-31 2008-03-03 Robert Veeger Afgifte-inrichting voor het afgeven van een vloeibare substantie.
EP1982644B1 (en) * 2007-04-21 2016-03-09 Roche Diagnostics GmbH Analytical system for detecting an analyte in a body fluid and disposable integrated puncturing and analyzing element
CN103163093B (zh) * 2013-03-19 2014-11-19 中国人民解放军军事医学科学院卫生学环境医学研究所 基于超细纤维担载的多通道重金属联合检测圆盘
HUE058133T2 (hu) 2018-11-07 2022-07-28 Hoffmann La Roche Eljárások és eszközök analitikai mérés elvégzéséhez

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS59779B2 (ja) * 1977-01-20 1984-01-09 株式会社京都第一科学 尿等の分析方法
US4436812A (en) * 1980-10-29 1984-03-13 Fuji Electric Co., Ltd. Process of calibrating a blood sugar analyzing apparatus
EP0167783B1 (de) * 1984-06-28 1988-10-19 ZELLER PLASTIK Koehn, Gräbner & Co. Verschliessvorrichtung für die Entnahmeöffnung eines Behälters und zugehöriger Behälter
US5279294A (en) * 1985-04-08 1994-01-18 Cascade Medical, Inc. Medical diagnostic system
JPH0629852B2 (ja) * 1985-08-26 1994-04-20 富士写真フイルム株式会社 偏倚乾式分析要素を用いた液体試料中の被検物質の定量分析方法
JPH076917B2 (ja) * 1986-09-01 1995-01-30 富士写真フイルム株式会社 乾式分析方法における検量線の補正方法
DE3715938A1 (de) * 1987-05-13 1988-11-24 Boehringer Mannheim Gmbh Behaelter fuer teststreifen
US5258308A (en) * 1989-07-21 1993-11-02 Freeman Mary J Method, kit and apparatus for verifying calibration and linearity of vertical photometers
JP3058680B2 (ja) * 1990-11-30 2000-07-04 株式会社トプコン 眼底像処理装置
US5174963A (en) * 1991-01-07 1992-12-29 United Medical Manufacturing Company Blood glucose reflectance meter including a null prompting means and a device for providing a constant brightness light
DE59408870D1 (de) * 1993-04-23 1999-12-09 Roche Diagnostics Gmbh System zur Bevorratung und Zurverfügungstellung von Testelementen
JP3488925B2 (ja) * 1994-09-08 2004-01-19 ライフスキヤン・インコーポレーテツド 条片上標準を備えた分析物検出用の光学読取式条片
US6103536A (en) * 1997-05-02 2000-08-15 Silver Lake Research Corporation Internally referenced competitive assays
DE19854316A1 (de) 1998-04-24 1999-10-28 Roche Diagnostics Gmbh Vorratsbehältnis für analytische Hilfsmittel
DE19902601A1 (de) 1999-01-23 2000-07-27 Roche Diagnostics Gmbh Verfahren und Vorrichtung zum Entnehmen analytischer Verbrauchsmittel aus einem Vorratsbehältnis

Also Published As

Publication number Publication date
DE10138661A1 (de) 2002-05-02
US20080138906A1 (en) 2008-06-12
EP1189064A1 (de) 2002-03-20
JP3423939B2 (ja) 2003-07-07
JP2002131315A (ja) 2002-05-09
US20020164805A1 (en) 2002-11-07
US7736904B2 (en) 2010-06-15
ATE235059T1 (de) 2003-04-15
EP1189064B1 (de) 2003-03-19
DE50100121D1 (de) 2003-04-24
US20050009190A1 (en) 2005-01-13

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