JP2019120508A - 試験器具および試験方法 - Google Patents
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Abstract
Description
<試験器具>
図1〜図6は本発明の実施形態の一例を示す図であり、図中、同一の符号を付した部分は同一物を表わす。なお、各図において一部の構成を適宜省略して、図面を簡略化する。そして、部材の大きさ、形状、厚みなどを適宜誇張して表現する。
<生体分子の検出試験方法>
図2および図3を参照して、本実施形態の試験器具10を使用した生体分子の検出試験方法について説明する。なお図3(B)および図3(C)は、連結部19B付近の拡大図である。
<変形例>
11 培養手段
13 試験片
15 分離手段
17 開放手段
17B 針状部材
19 ケース
19A 試験片収容部
19B 連結部
19C 溶液収容部
23 流路
25 蓋
27 採取手段
27A 採取部
31 金属板
50 恒温培養器
131 サンプルパッド
133 コンジュゲートパッド
135 メンブレンフィルター
137 吸収パッド
191 判定窓
193 蒸散窓
S1 培養溶液
S2 検体液
V 脆弱構造
また、本発明は、検体の採取手段と、前記採取手段を密封した状態で前記検体を培養可能な培養手段と、前記培養手段内の検体液を吸収可能な試験片と、前記試験片と前記検体液とを非接触状態で分離可能な分離手段と、前記分離手段の少なくとも一部を開放することにより前記検体液が前記試験片に到達する流路を形成可能な開放手段と、前記試験片の少なくとも前記分離手段側の一部と、前記培養手段の少なくとも一部と、前記分離手段とを一体的に封止するケースと、を備え、前記ケースは、前記試験片を収容する試験片収容部と、前記培養手段を構成する溶液収容部と、前記分離手段を収容する前記開放手段を兼ねており、且つ、前記試験片収容部と前記溶液収容部を連結する連結部と、を有し、前記試験片収容部と前記溶液収容部が、互いに離れた位置に露出されることで、該試験片収容部と該溶液収容部のそれぞれが、利用者の手によって把持可能となっており、前記試験片収容部と前記溶液収容部を相対変位させることで、前記開放手段が操作されることを特徴とする試験器具である。
また、本発明は、検体の培養手段と試験片とが一体型のケースにて保持された試験器具を用いて生体分子を検出する試験方法であって、前記ケースは、前記試験片を収容する試験片収容部と、前記培養手段を構成する溶液収容部と、分離手段を収容する開放手段を兼ねており、前記培養手段と前記試験片とを分離した状態で採取手段によって前記検体を採取し、該採取手段を密閉した状態で前記検体を前記培養手段において培養するステップと、前記ケースによる前記採取手段と培養後の検体液の封止状態を維持したまま、互いに離れた位置に露出される前記試験片収容部と前記溶液収容部とを利用者の手によって把持し、該試験片収容部と該溶液収容部を相対変位させることで、前記開放手段を操作して前記培養手段と前記試験片との分離を解除し、培養後の検体液を外部に露出させることなく前記試験片に吸収させるステップと、前記試験片を目視により判定するステップと、を有することを特徴とする試験方法である。
Claims (8)
- 密封状態で検体を培養可能な培養手段と、
前記培養手段によって培養された検体液を吸収可能な試験片と、
前記試験片と前記検体液とを非接触状態で分離可能な分離手段と、
前記分離手段の少なくとも一部を開放することにより前記検体液が前記試験片に到達する流路を形成可能な開放手段と、
前記試験片の少なくとも前記分離手段側の一部と、前記培養手段の少なくとも一部と、前記分離手段とを一体的に封止するケースと、を備えた、
ことを特徴とする試験器具。 - 前記開放手段の少なくとも一部は前記ケースに収容される、
ことを特徴とする請求項1に記載の試験器具。 - 前記試験片は判定領域を有し、前記ケースは少なくとも該判定領域を外部から視認可能に構成されている、
ことを特徴とする請求項1または請求項2に記載の試験器具。 - 前記ケースは、前記試験片と、前記培養手段と、前記分離手段とを密封する、
ことを特徴とする請求項1から請求項3のいずれか一項に記載の試験器具。 - 前記開放手段は、封止を維持した状態で変形可能な前記ケースの一部であり、該開放手段に外力を加えて変形させることで前記分離手段を開放する、
ことを特徴とする請求項1から請求項4のいずれか一項に記載の試験器具。 - 前記分離手段は、前記培養手段の前記試験片側の流路の端部を封止する封止部材であり、
前記流路と前記封止部材は前記開放手段の内部に収容され、該開放手段の変形により前記封止部材が前記流路から離脱することで前記流路と前記試験片の収容領域とが連通可能に構成されている、
ことを特徴とする請求項5に記載の試験器具。 - 前記検体の採取手段を備え、
前記培養手段は、前記採取手段を密封状態で収容して前記検体を培養可能である、
ことを特徴とする請求項1から請求項6のいずれか一項に記載の試験器具。 - 検体の培養手段と試験片とが一体的型のケースにて保持された試験器具を用いて生体分子を検出する試験方法であって、
前記培養手段と前記試験片とを分離した状態で前記検体を採取し、密閉状態で前記培養手段において培養するステップと、
前記ケースによる封止状態を維持したまま前記培養手段と前記試験片との分離を解除し、培養後の検体液を外部に露出させることなく前記試験片に吸収させるステップと、
前記試験片を目視により判定するステップと、
を有することを特徴とする試験方法。
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JP2017253140A JP6652262B2 (ja) | 2017-12-28 | 2017-12-28 | 試験器具および試験方法 |
CN201880084732.XA CN111527408B (zh) | 2017-12-28 | 2018-12-21 | 试验器具以及试验方法 |
US16/955,446 US11857971B2 (en) | 2017-12-28 | 2018-12-21 | Test device and test method |
EP18893370.9A EP3726216B1 (en) | 2017-12-28 | 2018-12-21 | Test device and test method |
PCT/JP2018/047153 WO2019131475A1 (ja) | 2017-12-28 | 2018-12-21 | 試験器具および試験方法 |
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JP6652262B2 JP6652262B2 (ja) | 2020-02-19 |
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EP (1) | EP3726216B1 (ja) |
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2018
- 2018-12-21 EP EP18893370.9A patent/EP3726216B1/en active Active
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US5620657A (en) * | 1989-11-27 | 1997-04-15 | Behringwerke Ag | Device and method for completing a fluidic circuit |
JPH08503556A (ja) * | 1993-09-16 | 1996-04-16 | エフ.ホフマン − ラ ロシュ アーゲー | 分析装置 |
JP2001513897A (ja) * | 1997-03-05 | 2001-09-04 | ポイント・オブ・ケア・テクノロジーズ・インコーポレイテッド | 流体試料の収集および試験装置 |
JP2001116739A (ja) * | 1999-08-06 | 2001-04-27 | Sekisui Chem Co Ltd | 検査用器具 |
JP2006029817A (ja) * | 2004-07-12 | 2006-02-02 | Fujirebio Inc | 試験用具 |
JP2012230025A (ja) * | 2011-04-27 | 2012-11-22 | Fujikura Kasei Co Ltd | 検査器具 |
WO2017104143A1 (ja) * | 2015-12-18 | 2017-06-22 | 富士フイルム株式会社 | イムノクロマトグラフキット |
Also Published As
Publication number | Publication date |
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US11857971B2 (en) | 2024-01-02 |
JP6652262B2 (ja) | 2020-02-19 |
CN111527408A (zh) | 2020-08-11 |
EP3726216B1 (en) | 2024-08-14 |
US20200346217A1 (en) | 2020-11-05 |
EP3726216A4 (en) | 2021-09-15 |
WO2019131475A1 (ja) | 2019-07-04 |
EP3726216A1 (en) | 2020-10-21 |
CN111527408B (zh) | 2024-07-16 |
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