DK2395337T3 - Fremgangsmåde til kvantitativ overførsel af analytter - Google Patents

Fremgangsmåde til kvantitativ overførsel af analytter Download PDF

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DK2395337T3
DK2395337T3 DK11151118.4T DK11151118T DK2395337T3 DK 2395337 T3 DK2395337 T3 DK 2395337T3 DK 11151118 T DK11151118 T DK 11151118T DK 2395337 T3 DK2395337 T3 DK 2395337T3
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mixture
analyte
sampling device
amount
collection portion
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DK11151118.4T
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Daniele Triva
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Copan Italia Spa
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5029—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures using swabs
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
    • C12Q1/24—Methods of sampling, or inoculating or spreading a sample; Methods of physically isolating an intact microorganisms
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B2010/0216—Sampling brushes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/16—Surface properties and coatings
    • B01L2300/161—Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N2001/028—Sampling from a surface, swabbing, vaporising
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N2001/2893—Preparing calibration standards
    • 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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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Analytical Chemistry (AREA)
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  • Immunology (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
  • Wood Science & Technology (AREA)
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  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • Clinical Laboratory Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
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  • Medical Informatics (AREA)
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  • Genetics & Genomics (AREA)
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  • Hydrology & Water Resources (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Claims (15)

1. Fremgangsmåde til kvantitativ overførsel af analytter, såsom mikroorganismer, antistoffer/antigener, antimikrobielt virkende stoffer, nukleotider, antibiotika, hormoner, DNA-sekvenser, enzymer, organisk materiale, biologisk materiale eller materiale af biologisk oprindelse, jordforbedringstilskud eller selektive tilskud til dyrkningsområder eller lignende, omfattende følgende trin: forberedelse af en i det væsentlige homogen blanding af en forudbestemt begyndelsesmængde af mindst en analyt og en væske, hvorved der opnås en koncentrationsværdi eller en kendt mængde af analytten i blandingen; indføring i blandingen af mindst en opsamlingsdel (3) af en prøvetagningsindretning (1) med et bærelegeme (2), idet opsamlingsdelen (3) omfatter en første del (2a) af bærelegemet (2) og et stort antal fibre (6), der er fastgjort til og anbragt på bærelegemets (2) første del (2a) ved velourisering, for at definere en velouriseret opsamlingsdel (3) eller en velouriseret tampon, således at en del af blandingen opsamles på opsamlingsdelen (3); udtrækning af prøvetagningsindretningens (1) opsamlingsdel (3) fra blandingen, idet en forudbestemt kendt mængde af den blanding, der skal overføres, tilbageholdes på prøvetagningsdelen (3); og dehydratisering, tørring eller frysetørring af i det mindste opsamlingsdelen (3), som er forsynet med den forudbestemte mængde af den blanding, der skal overføres, for at opnå en fordoseret prøvetagningsindretning (1) med en forudbestemt mængde tørret eller frysetørret analyt på opsamlingsdelen (3).
2. Fremgangsmåde ifølge krav 1, ved hvilken trinnet til forberedelse af blandingen omfatter følgende trin: forberedelse af den forudbestemte begyndelsesmængde analyt; blanding af den forudbestemte begyndelsesmængde analyt med væsken for at opnå en blanding af den forudbestemte begyndelsesmængde analyt i væsken, og/eller følgende trin: fremstilling af en i det væsentlige homogen blanding.
3. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, ved hvilken trinnet til at opnå en kendt koncentrationsværdi af analytten i blandingen udføres ved blanding af en kendt mængde af analytten med en kendt mængde af væsken og/eller ved et trin til måling af en koncentrationsværdi for analytten i blandingen.
4. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, som endvidere omfatter et trin til måling af en mængde blanding, der effektivt tilbageholdes i opsamlingsdelen (3) under trinnet til udtrækning af prøvetagningsindretningens (1) opsamlingsdel (3) fra blandingen, og især ved hvilken måletrinnet udføres ved sammenligning af blandingens begyndelsesvægt før indsætning i opsamlingsdelen med blandingens slutvægt efter udtrækning af opsamlingsdelen (3).
5. Fremgangsmåde ifølge et hvilket som helst af kravene 1-3, som endvidere omfatter et trin til måling af en mængde blanding, der effektivt tilbageholdes i opsamlingsdelen (3) i trinnet til udtrækning af prøvetagningsindretningens (1) opsamlingsdel (3) fra blandingen, og/eller især ved hvilken trinnet til måling udføres ved sammenligning af prøvetagningsindretningens (1) vægt før indsætning i blandingen og prøvetagningsindretningens (1) vægt efter udtrækning fra blandingen.
6. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, ved hvilken tørretrinnet udføres ved tørring i en varmluftovn eller ved anvendelse af en anden kendt fremgangsmåde, der er egnet til behandling af den specifikke analyt.
7. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, som endvidere omfatter trin til indsætning af opsamlingsdelen (3) i en vakuumbeholder og frembringelse af en i det væsentlige vakuumtilstand i vakuumbeholderen under trinnet til tørring eller frysetørring eller uafhængigt af trinnet til tørring eller frysetørring.
8. Fremgangsmåde ifølge det foregående krav, ved hvilken opsamlingsdelen (3) forsegles direkte i vakuum efter dehydratiseringsprocessen.
9. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, som endvidere omfatter et trin til revitalisering eller rehydratisering af den forudbestemte mængde tørret eller frysetørret analyt på opsamlingsdelen (3), f.eks. ved hjælp af mindst én nærings- og/eller hydratiseringsopløsning, for at opnå en forudbestemt mængde rehydratiseret analyt på opsamlingsdelen (3).
10. Fremgangsmåde ifølge det foregående krav, som endvidere omfatter et trin til frigivelse af mindst 85% eller mindst 90% eller mindst 95% af den forudbestemte mængde, der skal overføres af blandingen, eller den forudbestemte mængde analyt ved hjælp af direkte podning på en skål eller fortynding i flydende terræn for at muliggøre udførelse af analyse på analytten.
11. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, ved hvilken den velouriserede opsamlingsdel (3) er konfigureret til at den modtager en i det væsentlige kendt mængde af blandingen eller til at opsamle en mængde mellem 5 og 1000 μΙ af blandingen eller mellem 10 og 500 μΙ af blandingen eller ellem 50 og 200 μΙ af blandingen eller mellem 80 og 120 μΙ af blandingen og/eller til at opsamle en mængde på mindst 0,5 μΙ pr. mm2, mindst 0,6 μΙ pr. mm2 eller mindst 0,7 μΙ pr. mm2 eller mindst 0,75 μΙ pr. mm2, og/eller ved hvilken fibrene (6) er anbragt på bærelegemets (2) første del (2a) på en i det væsentlige ordnet måde og således, at der dannes et i det væsentlige kontinuerligt lag på opsamlingsdelen (3), og/eller er anbragt på opsamlingsdelen (3), således at der defineres et stort antal kapillarmellemrum (9), som er indrettede til at absorbere blandingen ved kapillarvirkning.
12. Fremgangsmåde ifølge det foregående krav, ved hvilken fibrene (6) har en lineær tæthed eller et fibertal mellem 1,7 og 3,3 dtex og/eller en længde mellem 0,6 og 3 mm og/eller en overfladetæthed af fibrene (6) på opsamlingsdelen (3) mellem 50 og 500 fibre pr. mm2 eller mellem 100 og 200 fibre pr. mm2 og/eller er fremstillet af et i det væsentlige ikke-hydrofilt eller med hensyn til blandingen ikke-adsorberende materiale og/eller af et materiale valgt blandt: polyamid, rayon, polyester, kulfiber, alginat, et naturligt materiale, som er ikke-adsorberende med hensyn til blandingen, eller en blanding af de ovennævnte materialer.
13. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, ved hvilken trinnet til indsætning af en opsamlingsdel af blandingen udføres ved direkte nedsænkning af opsamlingsdelen i mindst én mikrobeholder eller ved hjælp af en mikrovolumenpumpe.
14. Prøvetagningsindretning (1) omfattende et bærelegeme (2) og en velouriseret opsamlingsdel (3), idet opsamlingsdelen (3) er forsynet med en mængde af en analyt, der skal overføres, kendetegnet ved, at opsamlingsdelen (3) er forsynet med en forudbestemt tørret kendt mængde af analytten, der skal overføres, hvorved der tilvejebringes en fordoseret prøvetagningsindretning.
15. Sæt til udførelse af diagnostiske eller kemiske prøver, såsom positive eller negative kontroller eller til overførsel af labile stoffer i hydratiseret fase til supplering af dyrkningsområder, omfattende i det mindste en prøvetagningsindretning (1) ifølge krav 14, i hvilken sættet yderligere omfatter midler til tørring eller frysetørring af en forudbestemt mængde blanding på en opsamlingsdel (3) i prøvetagningsindretningen (1) og/eller midler til revitalisering af en forudbestemt mængde tørret eller frysetørret analyt på prøvetagningsindretningens (1) opsamlingsdel (3).
DK11151118.4T 2010-06-09 2011-01-17 Fremgangsmåde til kvantitativ overførsel af analytter DK2395337T3 (da)

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EP (1) EP2395337B1 (da)
JP (1) JP5853319B2 (da)
KR (1) KR101790186B1 (da)
CN (1) CN102947687B (da)
AR (1) AR081583A1 (da)
AU (1) AU2011263439B2 (da)
BR (1) BR112012031294B1 (da)
CA (1) CA2728775C (da)
CL (1) CL2012003435A1 (da)
DK (1) DK2395337T3 (da)
ES (1) ES2537441T3 (da)
IT (1) IT1401447B1 (da)
NZ (1) NZ603988A (da)
RU (1) RU2559475C2 (da)
WO (1) WO2011154849A1 (da)
ZA (1) ZA201209629B (da)

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US20110306078A1 (en) 2011-12-15
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