ES2761654T3 - Procedimiento para vincular resultados de pruebas diagnósticas rápidas de punto de atención con procedimientos basados en laboratorio - Google Patents
Procedimiento para vincular resultados de pruebas diagnósticas rápidas de punto de atención con procedimientos basados en laboratorio Download PDFInfo
- Publication number
- ES2761654T3 ES2761654T3 ES17165677T ES17165677T ES2761654T3 ES 2761654 T3 ES2761654 T3 ES 2761654T3 ES 17165677 T ES17165677 T ES 17165677T ES 17165677 T ES17165677 T ES 17165677T ES 2761654 T3 ES2761654 T3 ES 2761654T3
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- Prior art keywords
- sample
- poc
- test
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- laboratory
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Links
- 238000000034 method Methods 0.000 title claims abstract description 52
- 238000002405 diagnostic procedure Methods 0.000 title description 2
- 238000012360 testing method Methods 0.000 claims abstract description 142
- 238000012545 processing Methods 0.000 claims abstract description 40
- 239000003153 chemical reaction reagent Substances 0.000 claims abstract description 38
- 238000003018 immunoassay Methods 0.000 claims abstract description 22
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 20
- 238000009533 lab test Methods 0.000 claims abstract description 19
- 239000003599 detergent Substances 0.000 claims abstract description 18
- 244000005700 microbiome Species 0.000 claims abstract description 11
- 239000007983 Tris buffer Substances 0.000 claims abstract description 10
- 239000011780 sodium chloride Substances 0.000 claims abstract description 10
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims abstract description 10
- 230000009089 cytolysis Effects 0.000 claims abstract description 8
- 239000000523 sample Substances 0.000 claims description 115
- 239000003085 diluting agent Substances 0.000 claims description 44
- 230000006641 stabilisation Effects 0.000 claims description 44
- 238000011105 stabilization Methods 0.000 claims description 44
- 238000003752 polymerase chain reaction Methods 0.000 claims description 27
- 108020004707 nucleic acids Proteins 0.000 claims description 10
- 102000039446 nucleic acids Human genes 0.000 claims description 10
- 150000007523 nucleic acids Chemical class 0.000 claims description 10
- 230000007613 environmental effect Effects 0.000 claims description 8
- 239000012472 biological sample Substances 0.000 claims description 7
- 239000000872 buffer Substances 0.000 claims description 6
- 150000003839 salts Chemical class 0.000 claims description 6
- 238000011330 nucleic acid test Methods 0.000 claims description 5
- 230000000087 stabilizing effect Effects 0.000 claims description 3
- 238000007826 nucleic acid assay Methods 0.000 claims description 2
- 238000003757 reverse transcription PCR Methods 0.000 description 18
- 108020000999 Viral RNA Proteins 0.000 description 16
- 238000002123 RNA extraction Methods 0.000 description 14
- 206010022000 influenza Diseases 0.000 description 12
- 208000037797 influenza A Diseases 0.000 description 12
- 239000011543 agarose gel Substances 0.000 description 11
- 238000003860 storage Methods 0.000 description 11
- 239000006163 transport media Substances 0.000 description 9
- 230000003612 virological effect Effects 0.000 description 7
- 239000012895 dilution Substances 0.000 description 6
- 238000010790 dilution Methods 0.000 description 6
- 208000037798 influenza B Diseases 0.000 description 6
- 239000013614 RNA sample Substances 0.000 description 5
- 239000011159 matrix material Substances 0.000 description 5
- 108090000623 proteins and genes Proteins 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- 241000712431 Influenza A virus Species 0.000 description 4
- 238000012956 testing procedure Methods 0.000 description 4
- 238000004458 analytical method Methods 0.000 description 3
- 238000003556 assay Methods 0.000 description 3
- 230000015556 catabolic process Effects 0.000 description 3
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- 238000002156 mixing Methods 0.000 description 3
- 108010061100 Nucleoproteins Proteins 0.000 description 2
- 238000003149 assay kit Methods 0.000 description 2
- 238000012790 confirmation Methods 0.000 description 2
- 238000010166 immunofluorescence Methods 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000012898 sample dilution Substances 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 238000012546 transfer Methods 0.000 description 2
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 1
- 102000010029 Homer Scaffolding Proteins Human genes 0.000 description 1
- 108010077223 Homer Scaffolding Proteins Proteins 0.000 description 1
- 208000002979 Influenza in Birds Diseases 0.000 description 1
- 102000011931 Nucleoproteins Human genes 0.000 description 1
- 238000012408 PCR amplification Methods 0.000 description 1
- 238000010222 PCR analysis Methods 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 239000000427 antigen Substances 0.000 description 1
- 102000036639 antigens Human genes 0.000 description 1
- 108091007433 antigens Proteins 0.000 description 1
- 206010064097 avian influenza Diseases 0.000 description 1
- 238000004113 cell culture Methods 0.000 description 1
- 238000012512 characterization method Methods 0.000 description 1
- 239000002738 chelating agent Substances 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000012228 culture supernatant Substances 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
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- 239000002532 enzyme inhibitor Substances 0.000 description 1
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- ZJYYHGLJYGJLLN-UHFFFAOYSA-N guanidinium thiocyanate Chemical compound SC#N.NC(N)=N ZJYYHGLJYGJLLN-UHFFFAOYSA-N 0.000 description 1
- 230000003100 immobilizing effect Effects 0.000 description 1
- 238000011065 in-situ storage Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000012139 lysis buffer Substances 0.000 description 1
- 230000001404 mediated effect Effects 0.000 description 1
- 102000044158 nucleic acid binding protein Human genes 0.000 description 1
- 108700020942 nucleic acid binding protein Proteins 0.000 description 1
- 238000012123 point-of-care testing Methods 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000007430 reference method Methods 0.000 description 1
- 230000000241 respiratory effect Effects 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 238000012549 training Methods 0.000 description 1
Classifications
-
- 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
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
- G01N33/56983—Viruses
-
- 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
- C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
- C12Q1/6806—Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay
-
- 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
- C12Q1/70—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Analytical Chemistry (AREA)
- Molecular Biology (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Physics & Mathematics (AREA)
- Virology (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Urology & Nephrology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Tropical Medicine & Parasitology (AREA)
- Cell Biology (AREA)
- Food Science & Technology (AREA)
- Medicinal Chemistry (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Sampling And Sample Adjustment (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US36607610P | 2010-07-20 | 2010-07-20 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2761654T3 true ES2761654T3 (es) | 2020-05-20 |
Family
ID=45497436
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES17165677T Active ES2761654T3 (es) | 2010-07-20 | 2011-07-20 | Procedimiento para vincular resultados de pruebas diagnósticas rápidas de punto de atención con procedimientos basados en laboratorio |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US9945855B2 (enExample) |
| EP (2) | EP2596121A4 (enExample) |
| JP (1) | JP5911861B2 (enExample) |
| CN (2) | CN103069002A (enExample) |
| AU (1) | AU2011282214B2 (enExample) |
| CA (1) | CA2805486C (enExample) |
| ES (1) | ES2761654T3 (enExample) |
| WO (1) | WO2012012527A2 (enExample) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013039931A1 (en) * | 2011-09-13 | 2013-03-21 | Monk Akarshala Design Private Limited | Learning facility management in a modular learning system |
| AU2013246418B2 (en) | 2012-04-13 | 2017-02-23 | Becton, Dickinson And Company | Reflex testing of samples using residual materials from a prior test |
| WO2015019195A2 (en) * | 2013-08-07 | 2015-02-12 | Xagenic Inc. | Systems, devices, and methods for deploying onboard reagents in a diagnostic device |
| WO2020049569A2 (en) | 2018-09-05 | 2020-03-12 | Hero Scientific Ltd. | Testing for particulates |
| GB201703383D0 (en) | 2017-03-02 | 2017-04-19 | Gargle Tech Ltd | Testing for particulates |
| CA3086538A1 (en) | 2017-12-15 | 2019-06-20 | Evanostics Llc | Optical reader for analyte testing |
| US11864868B2 (en) * | 2018-12-12 | 2024-01-09 | Morgan State University | Modular, portable and rapidly deployable system for health assessment |
| US12066383B2 (en) | 2018-12-18 | 2024-08-20 | Aspida Dx Inc. | Optical analyte detection |
| US12449336B2 (en) | 2020-03-11 | 2025-10-21 | Hero Scientific Ltd. | Testing devices |
| CA3202405A1 (en) | 2021-01-06 | 2022-07-14 | Zvi Feldman | Filtration sampling devices |
Family Cites Families (36)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BE791340A (fr) * | 1972-01-06 | 1973-03-01 | Becton Dickinson Co | Nouveaux procede et appareil de prelevement de culture et d'identification de micro-organismes des humeurs |
| US4666850A (en) | 1983-10-28 | 1987-05-19 | Becton, Dickinson And Company | Microbial pathogen detecting system and process |
| US4693972A (en) * | 1984-01-16 | 1987-09-15 | Becton, Dickinson And Company | Composition and method for rapid detection of microorganisms in clinical samples |
| US4618576A (en) * | 1984-02-27 | 1986-10-21 | Becton Dickinson And Company | Diagnostic test for Streptococcus A |
| US5091316A (en) * | 1988-06-09 | 1992-02-25 | Becton, Dickinson And Company | Biological sample collection and transport device |
| US5084005A (en) * | 1988-07-13 | 1992-01-28 | Becton, Dickinson And Company | Swab for collection of biological samples |
| US5700636A (en) * | 1990-10-19 | 1997-12-23 | Becton Dickinson And Company | Methods for selectively detecting microorganisms associated with vaginal infections in complex biological samples |
| US5747265A (en) | 1992-10-30 | 1998-05-05 | T Cell Diagnostics, Inc. | Method for measuring the amount of a cell-associated molecule |
| US6514461B1 (en) * | 1997-02-14 | 2003-02-04 | Escreen, Inc. | System for automatically testing a fluid specimen |
| US6267722B1 (en) * | 1998-02-03 | 2001-07-31 | Adeza Biomedical Corporation | Point of care diagnostic systems |
| US6394952B1 (en) * | 1998-02-03 | 2002-05-28 | Adeza Biomedical Corporation | Point of care diagnostic systems |
| JP5192631B2 (ja) * | 2000-11-08 | 2013-05-08 | ベクトン・ディキンソン・アンド・カンパニー | 生物学的試料を収集し安定化させるための方法および装置 |
| US6602718B1 (en) * | 2000-11-08 | 2003-08-05 | Becton, Dickinson And Company | Method and device for collecting and stabilizing a biological sample |
| US20040176705A1 (en) * | 2003-03-04 | 2004-09-09 | Stevens Timothy A. | Cartridge having an integrated collection element for point of care system |
| US7662562B2 (en) * | 2004-08-10 | 2010-02-16 | Becton, Dickinson And Company | Method for rapid identification of microorganisms |
| JP2006084351A (ja) * | 2004-09-16 | 2006-03-30 | Denka Seiken Co Ltd | 検体浮遊液組成物、キット及び検査方法 |
| US20060246423A1 (en) * | 2005-02-10 | 2006-11-02 | Adelson Martin E | Method and kit for the collection and maintenance of the detectability of a plurality of microbiological species in a single gynecological sample |
| US20060286557A1 (en) * | 2005-06-15 | 2006-12-21 | Basehore Lee S | Combined lysis and PCR buffer |
| GB0601302D0 (en) * | 2006-01-23 | 2006-03-01 | Semikhodskii Andrei | Diagnostic methods and apparatus |
| WO2007098184A2 (en) | 2006-02-21 | 2007-08-30 | Nanogen, Inc. | Methods and compositions for analyte detection |
| US8097419B2 (en) * | 2006-09-12 | 2012-01-17 | Longhorn Vaccines & Diagnostics Llc | Compositions and method for rapid, real-time detection of influenza A virus (H1N1) swine 2009 |
| US8080645B2 (en) * | 2007-10-01 | 2011-12-20 | Longhorn Vaccines & Diagnostics Llc | Biological specimen collection/transport compositions and methods |
| US20090098527A1 (en) * | 2006-09-12 | 2009-04-16 | Fischer Gerald W | Biological organism identification product and methods |
| US7989185B2 (en) * | 2006-11-29 | 2011-08-02 | The Board Of Trustees Of The Leland Stanford Junior University | Rapid, informative diagnostic assay for influenza viruses including H5N1 |
| JP5431644B2 (ja) * | 2006-12-28 | 2014-03-05 | シスメックス株式会社 | 呼吸器感染症の検査方法 |
| EP2118634A2 (en) | 2007-02-05 | 2009-11-18 | Andrew Homer Nathaniel | Drug detection kit and method |
| US7748283B2 (en) * | 2007-02-16 | 2010-07-06 | Whatman, Inc. | Controlled transfer biological sample collection devices and methods of using such devices |
| TW200844441A (en) * | 2007-05-11 | 2008-11-16 | Animal Health Res Inst Council Of Agriculture | Method of testing foot–and- mouth disease (FMD) by using immunochromatographic |
| DK2535428T3 (en) * | 2007-10-01 | 2015-11-23 | Longhorn Vaccines & Diagnostics Llc | Biological prøvesamlings- and transport system, and methods of using |
| EP2247753B1 (en) * | 2008-02-01 | 2014-06-25 | Siemens Healthcare Diagnostics Inc. | Urine transport medium |
| US8802370B2 (en) | 2008-05-23 | 2014-08-12 | Strand Diagnostics, Llc | Method and apparatus to minimize diagnostic and other errors due to transposition of biological specimens among subjects |
| WO2010064628A1 (ja) * | 2008-12-05 | 2010-06-10 | オリンパス株式会社 | 核酸含有試料の調製方法、試料調製用溶液、及び核酸の解析方法 |
| USD655424S1 (en) * | 2009-11-18 | 2012-03-06 | Becton, Dickinson And Company | Cassette for a medical device |
| US20120003710A1 (en) * | 2010-02-19 | 2012-01-05 | Barbara Dawn Leinweber | Isolation of Biomolecules from Biological Samples |
| EP2739731A1 (en) * | 2011-08-04 | 2014-06-11 | The Regents of The University of California | Saliva collection, processing, stabilization, and storage method |
| US8603769B2 (en) * | 2011-10-07 | 2013-12-10 | Becton, Dickinson And Company | Method for direct and rapid identification of microorganisms and antimicrobial susceptibility testing from positive blood cultures |
-
2011
- 2011-07-20 ES ES17165677T patent/ES2761654T3/es active Active
- 2011-07-20 CN CN201180039453XA patent/CN103069002A/zh active Pending
- 2011-07-20 AU AU2011282214A patent/AU2011282214B2/en active Active
- 2011-07-20 EP EP11810337.3A patent/EP2596121A4/en not_active Ceased
- 2011-07-20 JP JP2013520836A patent/JP5911861B2/ja active Active
- 2011-07-20 CA CA2805486A patent/CA2805486C/en active Active
- 2011-07-20 CN CN201710902140.1A patent/CN107663553A/zh active Pending
- 2011-07-20 US US13/810,948 patent/US9945855B2/en active Active
- 2011-07-20 WO PCT/US2011/044674 patent/WO2012012527A2/en not_active Ceased
- 2011-07-20 EP EP17165677.0A patent/EP3257948B1/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| US9945855B2 (en) | 2018-04-17 |
| JP2013533487A (ja) | 2013-08-22 |
| US20130216998A1 (en) | 2013-08-22 |
| AU2011282214B2 (en) | 2015-07-23 |
| WO2012012527A8 (en) | 2013-03-14 |
| CA2805486C (en) | 2018-03-06 |
| AU2011282214A1 (en) | 2013-02-07 |
| EP3257948A1 (en) | 2017-12-20 |
| CN103069002A (zh) | 2013-04-24 |
| EP3257948B1 (en) | 2019-10-02 |
| JP5911861B2 (ja) | 2016-04-27 |
| EP2596121A2 (en) | 2013-05-29 |
| CA2805486A1 (en) | 2012-01-26 |
| WO2012012527A3 (en) | 2012-07-05 |
| WO2012012527A2 (en) | 2012-01-26 |
| EP2596121A4 (en) | 2013-12-18 |
| CN107663553A (zh) | 2018-02-06 |
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