JP7083345B2 - 全血分離装置 - Google Patents
全血分離装置 Download PDFInfo
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- G01N33/487—Physical analysis of biological material of liquid biological material
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- G01N33/491—Blood by separating the blood components
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- B01L2300/00—Additional constructional details
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- B01L2300/047—Additional chamber, reservoir
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- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
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- B01L2300/00—Additional constructional details
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- B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
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- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/08—Geometry, shape and general structure
- B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
- B01L2300/0838—Capillaries
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- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/12—Specific details about materials
- B01L2300/123—Flexible; Elastomeric
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- 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
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2400/00—Moving or stopping fluids
- B01L2400/04—Moving fluids with specific forces or mechanical means
- B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
- B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2400/00—Moving or stopping fluids
- B01L2400/04—Moving fluids with specific forces or mechanical means
- B01L2400/0475—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
- B01L2400/0481—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure squeezing of channels or chambers
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2400/00—Moving or stopping fluids
- B01L2400/06—Valves, specific forms thereof
- B01L2400/0677—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
- B01L2400/0683—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers mechanically breaking a wall or membrane within a channel or chamber
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Description
[0081] Quidel社のFDA承認済みSOFIA(登録商標)のライム病FIA検査装置を使用した血清血漿検査方法と比較して、記載されている指先穿刺全血による全血分離装置の使用を評価するために、研究が実施された。この前向き研究は、米国全体にわたってライム病流行地に位置する11の現場においてライム病の疑いがあってライム病の症状を呈する529人の被験者から採取された適合血液検体(指先穿刺及び血清/血漿)試料を使用して実施された。全血試料採取及びライム病免疫学的測定は、11の臨床現場の各々においてCLIA認定免除の担当者によって即座に実施された。このことは、訓練を受けていない担当者の手で使用しやすいことを実証している。CLIA認定免除の検査場とは異なる中央規準研究所において、既承認のライム病IgM・IgGアッセイ及びウェスタンブロットのライム病IgM・IgGアッセイが実施された。SOFIA(登録商標)によるライム病IgM・IgGアッセイを使用した指先穿刺全血による全血分離装置と血漿血清非分離装置との比較の一次結果が表1及び表2に示されている。条件間で統計的差異(p>0.05)は見られない、つまり、全血分離装置では血漿及び血清を用いた検査と同様の成績が得られることを示している。
Claims (20)
- リザーバを備える容器と、
試料装置であって、
流体試料を受容するための流入チャンバであって、毛細管を備える流入チャンバと、
混合チャンバと、
前記流入チャンバと前記混合チャンバとを分離し、処理試薬を含むパッドであって、前記流入チャンバの前記毛細管からの試料の流れを直接受容するパッドと、
前記混合チャンバに隣接する流出口と、
前記リザーバが前記混合チャンバと流体連通するように前記試料装置を前記容器に密閉接続するためのインターフェースと、を備える試料装置と、を備えるキット。 - 前記毛細管は、一定量の流体試料を採取するように選択された長さを有する、請求項1に記載のキット。
- 前記試料装置はさらに、前記混合チャンバと前記流出口との間にフィルタをさらに備える、請求項1に記載のキット。
- 前記リザーバ内に緩衝液をさらに備える、請求項1に記載のキット。
- 前記処理試薬は赤血球凝集物質である、請求項1に記載のキット。
- 試料装置であって、
流入チャンバであって、液体試料を受容するためのパッドを備えた流入チャンバと、
流出口を有する混合チャンバと、を備える試料装置と、
容器であって、
溶液を収容するように構成された又は溶液を収容するリザーバと、
前記リザーバが前記混合チャンバと流体連通するように前記試料装置を前記容器に密閉接続するためのインターフェースと、を備える容器と、
を備える、キット。 - 前記液体試料を採取するための採取装置をさらに備える、請求項6に記載のキット。
- 前記採取装置は、毛細管と、前記毛細管と流体連通した球形部と、を備える、請求項7に記載のキット。
- 前記パッドは処理試薬を含む、請求項6に記載のキット。
- 前記処理試薬は赤血球凝集物質である、請求項9に記載のキット。
- 容器であって、
溶液を収容している又は収容するように構成されたリザーバと、
混合チャンバと、
前記混合チャンバから前記リザーバを分離する障壁と、を備える容器と、
試料装置であって、
液体試料を受容するための流入チャンバと、
チャネルと、
前記流入チャンバと前記チャネルとの間に配置される、パッドと、を備える試料装置と、
ディスペンサであって、
流出口と、
前記混合チャンバが前記流出口と流体連通するように前記ディスペンサを前記容器に密閉接続するためのインターフェースであって、前記ディスペンサが前記容器に接続されたときに前記試料装置を付勢し前記障壁を通過させる、インターフェースと、を備えるディスペンサと、
を備える、キット。 - 前記ディスペンサはさらに、前記ディスペンサが前記容器に接続されたときに前記混合チャンバと前記流出口との間に存在するフィルタを備える、請求項11に記載のキット。
- 前記フィルタは、前記ディスペンサの対向する開口部間に位置決めされる、請求項12に記載のキット。
- 前記容器は、前記混合チャンバ内の前記試料装置の少なくとも一部を固定するために少なくとも1つの突起部を備える、請求項11に記載のキット。
- 前記ディスペンサは、前記ディスペンサが前記容器に接続されたときに前記試料装置の少なくとも一部を付勢し前記少なくとも1つの突起部を通過させるように構成される、請求項14に記載のキット。
- 前記容器は、複数の突起部を備えることにより、前記複数の突起部間及び前記混合チャンバ内で前記試料装置の少なくとも一部を固定する、請求項11に記載のキット。
- 前記パッドは処理試薬を含む、請求項11に記載のキット。
- 前記処理試薬は赤血球凝集物質である、請求項17に記載のキット。
- 試薬を備えるリザーバを有するディスペンサをさらに備える、請求項1に記載のキット。
- 試薬を備えるリザーバを有するディスペンサをさらに備える、請求項6に記載のキット。
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201662423062P | 2016-11-16 | 2016-11-16 | |
US62/423,062 | 2016-11-16 | ||
US201762464331P | 2017-02-27 | 2017-02-27 | |
US62/464,331 | 2017-02-27 | ||
PCT/US2017/061963 WO2018094012A1 (en) | 2016-11-16 | 2017-11-16 | Device for whole blood separation |
Publications (2)
Publication Number | Publication Date |
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JP2019537723A JP2019537723A (ja) | 2019-12-26 |
JP7083345B2 true JP7083345B2 (ja) | 2022-06-10 |
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JP2019524980A Active JP7083345B2 (ja) | 2016-11-16 | 2017-11-16 | 全血分離装置 |
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US (3) | US10908145B2 (ja) |
EP (1) | EP3541515A1 (ja) |
JP (1) | JP7083345B2 (ja) |
CN (1) | CN110461473B (ja) |
WO (1) | WO2018094012A1 (ja) |
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EP3541515A1 (en) | 2016-11-16 | 2019-09-25 | Quidel Corporation | Device for whole blood separation |
US11325117B2 (en) | 2017-07-27 | 2022-05-10 | Biomerieux, Inc. | Centrifugally separating samples in a container having a seal and containing a plunger for opening the seal |
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CN110201548A (zh) * | 2019-04-23 | 2019-09-06 | 江苏科华医疗器械科技有限公司 | 一种快速末梢血浆采集器及其使用方法 |
CA3149447A1 (en) * | 2019-08-30 | 2021-03-04 | Alexandre ZOUGMAN | Detergent-free simultaneous multiomics sample preparation method using novel new vesicle design |
WO2021076846A1 (en) * | 2019-10-18 | 2021-04-22 | Tasso, Inc. | Plasma separation devices and related methods |
US20210215715A1 (en) | 2020-01-10 | 2021-07-15 | Quidel Corporation | Test strip with structured substrate for multiplex lateral flow assay for disease diagnostics |
EP4080218A4 (en) * | 2020-04-20 | 2024-02-28 | Leobio Co Ltd | DEVICE AND METHOD FOR MEASURING GLYCATED HEMOGLOBIN |
WO2021216983A1 (en) | 2020-04-24 | 2021-10-28 | Quidel Corporation | Immunoassays for detection of immunoglobulins against sars cov-2 and methods of use |
CA3181809A1 (en) * | 2020-06-29 | 2022-01-06 | Aaron Kauffmann | Devices and methods for plasma separation and metering |
JP2022052672A (ja) * | 2020-09-23 | 2022-04-04 | 株式会社Provigate | 液体試料処理装置 |
US11618017B2 (en) * | 2021-07-01 | 2023-04-04 | Porex Corporation | Squeezable sample preparation device |
CN115112463A (zh) * | 2022-06-15 | 2022-09-27 | 安徽九陆生物科技有限公司 | 一种微量血液过滤装置及其在血液营养元素检测中的应用 |
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2017
- 2017-11-16 EP EP17808288.9A patent/EP3541515A1/en active Pending
- 2017-11-16 CN CN201780083563.3A patent/CN110461473B/zh active Active
- 2017-11-16 JP JP2019524980A patent/JP7083345B2/ja active Active
- 2017-11-16 WO PCT/US2017/061963 patent/WO2018094012A1/en active Search and Examination
- 2017-11-16 US US15/815,480 patent/US10908145B2/en active Active
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2020
- 2020-12-30 US US17/138,466 patent/US11650200B2/en active Active
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JP2011515171A (ja) | 2008-03-28 | 2011-05-19 | オリオン ディアグノスティカ オサケ ユキチュア | サンプリングおよび分注装置 |
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CN110461473A (zh) | 2019-11-15 |
US20210116438A1 (en) | 2021-04-22 |
US11650200B2 (en) | 2023-05-16 |
WO2018094012A1 (en) | 2018-05-24 |
JP2019537723A (ja) | 2019-12-26 |
US20180136194A1 (en) | 2018-05-17 |
EP3541515A1 (en) | 2019-09-25 |
US20230243809A1 (en) | 2023-08-03 |
US10908145B2 (en) | 2021-02-02 |
CN110461473B (zh) | 2021-11-05 |
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