DK2760998T3 - Indretninger med tørrede reagenser til rekonstitution som kalibrerings- og/eller kvalitetskontrolløsninger, og fremgangsmåder til fremstilling og anvendelse deraf - Google Patents

Indretninger med tørrede reagenser til rekonstitution som kalibrerings- og/eller kvalitetskontrolløsninger, og fremgangsmåder til fremstilling og anvendelse deraf Download PDF

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DK2760998T3
DK2760998T3 DK12852286.9T DK12852286T DK2760998T3 DK 2760998 T3 DK2760998 T3 DK 2760998T3 DK 12852286 T DK12852286 T DK 12852286T DK 2760998 T3 DK2760998 T3 DK 2760998T3
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lyophilized reagent
cavity
activatable
predetermined amount
lyophilized
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DK12852286.9T
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Jennifer A Samproni
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Siemens Healthcare Diagnostics Inc
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    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/48—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving transferase
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    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/54—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving glucose or galactose
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
    • Y—GENERAL 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
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/102499—Blood gas standard or control
    • Y—GENERAL 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
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/20—Oxygen containing
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    • Y—GENERAL 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
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/20—Oxygen containing
    • Y10T436/207497—Molecular oxygen
    • Y—GENERAL 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
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/25—Chemistry: analytical and immunological testing including sample preparation
    • Y10T436/2525—Stabilizing or preserving
    • Y—GENERAL 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
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/25—Chemistry: analytical and immunological testing including sample preparation
    • Y10T436/2575—Volumetric liquid transfer

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Claims (18)

1. Anvendelse af en sammensætning, omfattende: en forudbestemt mængde af mindst ét lyofiliseret reagens, hvor den forudbestemte mængde af mindst ét lyofiliseret reagens omfatter natriumbikarbonat, i en fremgangsmåde til overvågning af ydeevnen af blodgas-, elektrolyt-og/eller metabolit-instrumentering, hvor det lyofiliserede reagens rekonstitueres med et hjælpestof i en matrix med lav pH-værdi in situ for at opnå en enkelt enhed af kalibrerings- og kvalitetskontrolløsning, som omfatter kuldioxid.
2. Anvendelse ifølge krav 1, hvor det lyofiliserede reagens omfatter mindst én af et salt, et protein og en katalysator.
3. Anvendelse ifølge krav 1, hvor det lyofiliserede reagens omfatter mindst én af kalciumchlorid, lithiumchlorid, natriumcitrat, natriumsulfit, natriumsulfat, glucoseoxidase, glucosedehydrogenase, hexokinase, glucosedehydrogena-se, hexokinase, lactatoxidase, hæmoglobin, kobolt og kombinationer deraf.
4. Anvendelse ifølge krav 1, hvor den rekonstituerede kalibrerings- og/eller kvalitetskontrolløsning omfatter en analyt, en metabolit og/eller en gas.
5. Anvendelse ifølge krav 1, hvor det lyofiliserede reagens er forefindes i form af en vulst eller halvkugle.
6. Anvendelse ifølge krav 5, hvor det lyofiliserede reagens er forefindes i et i det væsentlige lufttæt miljø indtil anvendelse deraf.
7. Indretning til overvågning af ydeevnen af blodgas-, elektrolyt- og/eller metabolit-instrumentering, omfattende: mindst ét hulrum med en deri anbragt forudbestemt mængde af mindst ét lyofiliseret reagens, hvor den forudbestemte mængde af mindst ét lyofiliseret reagens omfatter natriumbikarbonat; mindst ét aktiverbart hulrum i fluidisk kommunikation med det mindst ét hulrum med et deri anbragt lyofiliseret reagens, hvor det mindst ét aktiverbare hulrum har en deri anbragt forudbestemt mængde af hjælpestof, hvor hjælpestoffet omfatter vand, og hvor hjælpestoffet efter aktivering af det aktiverbare hulrum bevæger sig fra det mindst ét aktiverbare hulrum ind i det mindst ét hulrum med lyofiliseret reagens anbragt deri, hvor hjælpestoffet omfatter en matrix med lav pH-værdi og rekonstituerer det lyofiliserede reagens in situ for at opnå en enkelt enhed af kalibrerings- og kvalitetskontrolløsning, som omfatter kuldioxid; og hvor mindst en del af indretningen er forseglet for at bevare det lyofiliserede reagens i et i det væsentlige lufttæt miljø indtil anvendelse deraf.
8. Indretning ifølge krav 7, hvor det lyofiliserede reagens omfatter mindst én af et salt, et protein og en katalysator.
9. Indretning ifølge krav 7, hvor det lyofiliserede reagens omfatter mindst én af kalciumchlorid, lithiumchlorid, natriumcitrat, natriumsulfit, natriumsulfat, glucoseoxidase, glucosedehydrogenase, hexokinase, glucosedehydrogena-se, hexokinase, lactatoxidase, hæmoglobin, kobolt og kombinationer deraf.
10. Indretning ifølge krav 7, hvor den rekonstituerede kalibrerings- og/eller kvalitetskontrolløsning omfatter en analyt, en metabolit og/eller en gas.
11. Indretning ifølge krav 7, hvor det lyofiliserede reagens er forefindes i form af en vulst eller halvkugle.
12. Indretning ifølge krav 7, yderligere omfattende en sensor i fluidisk kommunikation med det mindst ét hulrum.
13. Indretning ifølge krav 7, yderligere omfattende et andet hulrum, som har en deri anbragt forudbestemt mængde af et andet lyofiliseret reagens, hvor den forudbestemte mængde af et andet lyofiliseret reagens omfatter natri umbikarbonat, og eventuelt mindst én af et salt, et protein og en katalysator, og hvor den forudbestemte mængde af et andet lyofiliseret reagens er i flui-disk kommunikation med det mindst ét aktiverbare hulrum, som har en forudbestemt mængde af hjælpestof anbragt deri, hvor hjælpestoffet efter aktivering af det aktiverbare hulrum bevæger sig fra det mindst ét aktiverbare hulrum ind i det andet hulrum med det andet lyofiliserede reagens anbragt deri, hvor hjælpestoffet rekonstituerer det andet lyofiliserede reagens in situ for at opnå en enkelt enhed af kalibrerings- og kvalitetskontrolløsning.
14. Indretning ifølge krav 13, hvor de lyofiliserede reagenser, som forefindes i det første og andet hulrum, er ens eller forskellige.
15. Indretning ifølge krav 7, yderligere omfattende: et andet hulrum med en deri anbragt forudbestemt mængde af mindst ét andet lyofiliseret reagens, hvor den forudbestemte mængde af det andet lyofiliseret reagens omfatter natriumbikarbonat, og eventuelt mindst én af et salt, et protein og en katalysator; et andet aktiverbart hulrum i fluidisk kommunikation med det andet hulrum med et andet deri anbragt lyofiliseret reagens, hvor det andet aktiverbare hulrum har en deri anbragt forudbestemt mængde af hjælpestof, hvor hjælpestoffet efter aktivering af det andet aktiverbare hulrum bevæger sig fra det andet aktiverbare hulrum ind i det andet hulrum med det andet lyofiliserede reagens anbragt deri, hvor hjælpestoffet rekonstituerer det andet lyofiliserede reagens in situ for at opnå en anden kalibrerings- og kvalitetskontrolløsning.
16. Indretning ifølge krav 15, hvor de hjælpestoffer, som forefindes i det første og andet hulrum, er ens eller forskellige.
17. Indretning ifølge et af kravene 13 og 15, yderligere omfattende en sensor i fluidisk kommunikation med det første og andet hulrum.
18. Fremgangsmåde til overvågning af ydeevnen af blodgas-, elektrolyt-og/eller metabolit-instrumentering, hvor fremgangsmåden omfatter følgende trin: anbringe indretningen ifølge et hvilket som helst af kravene 7 - 17 i mindst ét af et blodgas-, elektrolyt- og/eller metabolit-instrumentet; og aktivere indretningen til kalibrering og/eller kvalitetskontrol af blodgas-, elektrolyt- og/eller metabolit-instrumentet.
DK12852286.9T 2011-11-22 2012-11-19 Indretninger med tørrede reagenser til rekonstitution som kalibrerings- og/eller kvalitetskontrolløsninger, og fremgangsmåder til fremstilling og anvendelse deraf DK2760998T3 (da)

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US201161562677P 2011-11-22 2011-11-22
US201161577959P 2011-12-20 2011-12-20
PCT/US2012/065844 WO2013078130A1 (en) 2011-11-22 2012-11-19 Devices containing dried reagents for reconstitution as calibration and/or quality control solutions, and methods of production and use thereof

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CA2856382A1 (en) 2013-05-30
CA2856382C (en) 2020-07-14
US20140308690A1 (en) 2014-10-16
EP2760998B1 (en) 2017-02-01
JP6226872B2 (ja) 2017-11-08
CN103917643B (zh) 2020-06-05
WO2013078130A1 (en) 2013-05-30
EP2760998A1 (en) 2014-08-06
IN2014DN03246A (da) 2015-05-22
JP2014533839A (ja) 2014-12-15
EP2760998A4 (en) 2015-05-13
CN103917643A (zh) 2014-07-09

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