JP2009300433A5 - - Google Patents

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JP2009300433A5
JP2009300433A5 JP2009118440A JP2009118440A JP2009300433A5 JP 2009300433 A5 JP2009300433 A5 JP 2009300433A5 JP 2009118440 A JP2009118440 A JP 2009118440A JP 2009118440 A JP2009118440 A JP 2009118440A JP 2009300433 A5 JP2009300433 A5 JP 2009300433A5
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holding tank
analysis chip
rotation
reagent
liquid
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抗原または抗体が結合した担体を収容可能な反応室を有する反応室ユニットに、回転を繰り返して検体及び複数の試薬を送液し、免疫学的分析を行うための分析チップであって、
(1)遠心力の作用により、検体としての懸濁液中の不溶性成分を分離液から分離して沈降可能であり、また重力の作用により前記分離液を分取し、次いで遠心力の作用により反応室ユニットに移送可能である、不溶性成分分離部と、
(2)2以上の槽および槽間を連結する流路を備え、遠心力および重力の作用により、試薬を前記流路を介して順次および/または同時に隣接する槽間を送液し、前記反応室ユニットまで送液可能である、多段送液部と
を有する分析チップ。
An analysis chip for performing immunological analysis by repeatedly rotating and feeding a sample and a plurality of reagents to a reaction chamber unit having a reaction chamber capable of accommodating a carrier bound with an antigen or an antibody,
(1) The insoluble component in the suspension as a specimen can be separated from the separated solution by the action of centrifugal force and settled, and the separated solution is separated by the action of gravity, and then the action of the centrifugal force. An insoluble component separator that can be transferred to the reaction chamber unit;
(2) Two or more tanks and a flow path connecting the tanks are provided, and by the action of centrifugal force and gravity, the reagent is sequentially and / or simultaneously sent between adjacent tanks through the flow path, and the reaction An analysis chip having a multistage liquid feeding unit capable of feeding liquid to a chamber unit.
前記回転の繰り返しは、第1回転速度による回転と、前記第1回転速度による回転速度よりも遅い回転速度または回転停止である第2回転速度による回転の繰り返しである、請求項1に記載の分析チップ。   2. The analysis according to claim 1, wherein the repetition of the rotation is a repetition of a rotation at a first rotation speed and a rotation at a rotation speed slower than the rotation speed by the first rotation speed or a second rotation speed that is a rotation stop. Chip. 前記多段送液部は、
前記分析チップの回転停止時に試薬を導入可能な第1の貯液槽と、
前記第1の貯液槽の回転の外周側に位置する第1の保持槽と、
前記第1の保持槽の重力方向に位置する第2の保持槽と、
前記第1の貯液槽と前記第1の保持槽との間を連通する流路Aと、
該第1の保持槽から重力方向に延伸し、前記第1の保持槽と前記第2の保持槽とを連通する流路Bとを含み、
前記第1の保持槽、前記流路B、および前記第2の保持槽を1つの送液ユニットとして、2以上の送液ユニットが連結して配置されており、
隣接する送液ユニット間の連結が、上段の前記送液ユニットの前記第2の保持槽から回転の外周側に延伸し、下段の前記送液ユニットの前記第1の保持槽に連通する流路Cによるものであり、
最下段の前記送液ユニットの前記第2の保持槽と前記反応室ユニットとの間を連通し、前記最下段の送液ユニットの第2の保持槽から、回転軸を基準として外周方向に延伸して反応室ユニットに接続する流路Dをさらに備える、
請求項1または2に記載の分析チップ。
The multistage liquid feeding section is
A first reservoir capable of introducing a reagent when rotation of the analysis chip is stopped;
A first holding tank located on the outer peripheral side of the rotation of the first liquid storage tank;
A second holding tank located in the direction of gravity of the first holding tank;
A flow path A communicating between the first liquid storage tank and the first holding tank;
A flow path B extending from the first holding tank in the direction of gravity and communicating with the first holding tank and the second holding tank;
The first holding tank, the flow path B, and the second holding tank are used as one liquid feeding unit, and two or more liquid feeding units are connected and arranged,
A connection between adjacent liquid-feeding units extends from the second holding tank of the upper liquid-feeding unit to the outer peripheral side of the rotation and communicates with the first holding tank of the lower liquid-feeding unit. By C,
The second holding tank and the reaction chamber unit of the lowermost liquid-feeding unit communicate with each other, and extend from the second holding tank of the lowermost liquid-feeding unit in the outer circumferential direction with reference to the rotation axis. And further comprising a flow path D connected to the reaction chamber unit,
The analysis chip according to claim 1 or 2 .
前記第1の保持槽は前記分析チップの第1の回転速度における回転時に、試薬を前記第1の保持槽内に保持可能な槽であり、
前記流路Bは、前記分析チップの前記第1の回転速度よりも低速の第2の回転速度における回転時または回転停止時において、遠心力および重力の作用を利用して前記第1の保持槽内の試薬を通液し前記第2の保持槽に移動させることが可能な流路であり、
前記第2の保持槽は、前記分析チップの前記第2の回転速度における回転時または回転停止時において、試薬を前記第2の保持槽内に保持可能である請求項に記載の分析チップ。
The first holding tank is a tank capable of holding a reagent in the first holding tank when rotating at the first rotation speed of the analysis chip.
The flow path B uses the action of centrifugal force and gravity at the time of rotation at the second rotation speed that is lower than the first rotation speed of the analysis chip or when the rotation is stopped. A flow path through which the reagent inside can be passed and moved to the second holding tank,
The analysis chip according to claim 3 , wherein the second holding tank is capable of holding a reagent in the second holding tank when the analysis chip is rotated or stopped at the second rotation speed.
前記流路Bは、流路途中で回転の外周側に屈曲している請求項またはに記載の分析チップ。 The analysis chip according to claim 3 or 4 , wherein the flow path B is bent toward the outer periphery of the rotation in the middle of the flow path. 複数の前記送液ユニットのうちの少なくとも1つの前記送液ユニットは、
前記第2の保持槽の内周側に位置する第2の貯液槽と、
前記第2の保持槽、前記第1の貯液槽または前記第1の保持槽と、前記第2の貯液槽とを連通する流路Eとをさらに有する請求項のいずれか一項に記載の分析チップ。
At least one of the plurality of liquid feeding units is the liquid feeding unit,
A second liquid storage tank located on the inner peripheral side of the second holding tank;
The second holding tank, the the first storage tank or the first holding tank, any one of claims 3-5, further comprising a flow passage E that communicates with the second storage tank The analysis chip according to item.
前記分析チップに含まれる前記第2の貯液槽の少なくとも2つに、異なる試薬が予め貯液されている請求項のいずれか一項に記載の分析チップ。 The analysis chip according to any one of claims 3 to 6 , wherein different reagents are stored in advance in at least two of the second storage tanks included in the analysis chip. 前記不溶性成分分離部は、
懸濁液保持槽、分離液保持槽、不溶性成分保持槽、および分離液送液路を有し、
前記懸濁液保持槽、前記分離液保持槽、前記不溶性成分保持槽は回転時の内周側からこの順に配置され、
前記懸濁液保持槽と前記不溶性成分保持槽とが接続され、
前記不溶性成分保持槽と前記分離液保持槽とが狭隘部により接続され、
前記不溶性成分保持槽において、前記懸濁液保持槽との接続部が、前記狭隘部より外周側に位置し、
前記分離液送液路は前記分離液保持槽から重力方向に延伸し前記反応室ユニットに連通する、
請求項1〜のいずれか一項に記載の分析チップ。
The insoluble component separation part is
A suspension holding tank, a separation liquid holding tank, an insoluble component holding tank, and a separation liquid feeding path;
The suspension holding tank, the separation liquid holding tank, and the insoluble component holding tank are arranged in this order from the inner peripheral side during rotation,
The suspension holding tank and the insoluble component holding tank are connected,
The insoluble component holding tank and the separation liquid holding tank are connected by a narrow portion,
In the insoluble component holding tank, the connection part with the suspension holding tank is located on the outer peripheral side from the narrow part,
The separation liquid feeding path extends in the direction of gravity from the separation liquid holding tank and communicates with the reaction chamber unit.
The analysis chip according to any one of claims 1 to 7 .
前記不溶性成分保持槽における前記懸濁液保持槽との接続部が、前記不溶性成分保持槽の外周側壁面に位置する請求項に記載の分析チップ。 The analysis chip according to claim 8 , wherein a connection portion of the insoluble component holding tank with the suspension holding tank is located on an outer peripheral side wall surface of the insoluble component holding tank. 前記分離液送液路が、重力方向かつ外周側に延伸する請求項またはに記載の分析チップ。 The analysis chip according to claim 8 or 9 , wherein the separation liquid supply path extends in the direction of gravity and on the outer peripheral side. 前記懸濁液保持槽と前記不溶性成分保持槽とが、懸濁液導入路により連結されている、請求項10のいずれか一項に記載の分析チップ。 The analysis chip according to any one of claims 8 to 10 , wherein the suspension holding tank and the insoluble component holding tank are connected by a suspension introduction path. 前記懸濁液保持槽、前記懸濁液導入路もしくは前記不溶性成分保持槽に接続した、オーバーフロー流路をさらに有し、前記オーバーフロー流路が、前記懸濁液導入路もしくは前記不溶性成分保持槽との接続部から一度内周側に延伸した後、外周側に折り返した構造である請求項11に記載の分析チップ。 An overflow channel connected to the suspension holding tank, the suspension introduction path or the insoluble component holding tank is further provided, and the overflow channel is connected to the suspension introduction path or the insoluble component holding tank. The analysis chip according to claim 11 , wherein the analysis chip has a structure in which the connection portion is once extended to the inner peripheral side and then folded back to the outer peripheral side. 前記不溶性成分分離部は、前記分析チップの回転中に試薬を保持し、回転停止時に重力の作用により前記分離液保持槽に試薬を排出する試薬保持槽を有する請求項12のいずれか一項に記載の分析チップ。 The insoluble component separation unit, the analyzing and holding the reagent during rotation of the chip, any one of claims 8 to 12, by the action of gravity when rotation is stopped with the reagent holding tank for discharging the reagent to the separation liquid holding tank The analysis chip according to item. 試薬保持槽に接続されており、前記分析チップの回転時に送液する試薬を貯液するための試薬貯液槽を有する請求項13に記載の分析チップ。 The analysis chip according to claim 13 , further comprising a reagent storage tank connected to a reagent holding tank and configured to store a reagent to be fed when the analysis chip is rotated. 前記分離液送液路にプレフィルター部が設けられている、請求項14のいずれか一項に記載の分析チップ。 The analysis chip according to any one of claims 8 to 14 , wherein a prefilter part is provided in the separation liquid feeding path. 前記不溶性成分分離部の前記試薬貯液槽、および前記多段送液部の前記第2の貯液槽のうちから選ばれる1または2以上の槽は、チップ本体から着脱可能な試薬リザーバユニットに設けられる請求項15のいずれか一項に記載の分析チップ。 One or more tanks selected from the reagent storage tank of the insoluble component separation part and the second storage tank of the multistage liquid supply part are provided in a reagent reservoir unit that is removable from the chip body. The analysis chip according to any one of claims 6 to 15 . 前記試薬リザーバユニットは、前記チップ本体の回転内周側に着脱可能に設けられる請求項16に記載の分析チップ。 The analysis chip according to claim 16 , wherein the reagent reservoir unit is detachably provided on a rotation inner peripheral side of the chip body. 前記試薬リザーバユニットに設けられた前記槽に貯液された試薬が、前記分析チップの回転時に前記チップ本体の各槽に移動することを特徴とする請求項16または17に記載の分析チップ。 Analysis chip according to claim 16 or 17 wherein the reagent liquid storage reagent in the reservoir provided in the reservoir unit, characterized in that to move the respective tanks of the chip body upon rotation of the analysis chip. 前記不溶性成分分離部および前記多段送液部の少なくとも一部が、互いに対向する2つの主面寄りに互いに離間して設けられていることを特徴とする請求項1〜18のいずれか一項に記載の分析チップ。 19. At least a part of the insoluble component separation part and the multistage liquid feeding part are provided apart from each other near two main surfaces facing each other, according to any one of claims 1 to 18. The analysis chip described. 前記反応室ユニットの少なくとも一部が、前記2つの主面以外の面寄りに設けられていることを特徴とする請求項19に記載の分析チップ。 The analysis chip according to claim 19 , wherein at least a part of the reaction chamber unit is provided near a surface other than the two main surfaces. 請求項1〜20のいずれか一項に記載の分析チップを、前記分析チップ外の回転軸に対して回転を繰り返すことにより、検体および試薬を前記分析チップの前記反応室に送液して、前記反応室内の被検物質量を測定することを特徴とする分析方法。 The analysis chip according to any one of claims 1 to 20 is repeatedly rotated with respect to a rotation axis outside the analysis chip, thereby sending a sample and a reagent to the reaction chamber of the analysis chip, An analysis method comprising measuring the amount of a test substance in the reaction chamber. (1)請求項1〜20のいずれか一項に記載の分析チップに、検体である懸濁液を導入し、前記分析チップを回転させる際に生じる遠心力を用いて不溶性成分を沈降させた後、回転停止して重力を用いて分離液を分取し、
(2)前記分析チップを回転させる際に生じる遠心力および重力を用いて、試薬を前記多段送液ユニットに送液し、
(3)前記分離液および試薬を、回転により生じる遠心力を用いて抗原または抗体が結合した担体に接触させる
ことを特徴とする、請求項21に記載の分析方法。
(1) Suspension which is a sample is introduced into the analysis chip according to any one of claims 1 to 20 , and insoluble components are precipitated using centrifugal force generated when the analysis chip is rotated. After that, stop the rotation and use gravity to separate the separated liquid,
(2) Using the centrifugal force and gravity generated when the analysis chip is rotated, the reagent is fed to the multistage liquid feeding unit,
(3) The analysis method according to claim 21 , wherein the separation liquid and the reagent are brought into contact with a carrier to which an antigen or an antibody is bound using a centrifugal force generated by rotation.
前記検体が血液であり、前記不溶性成分が血球成分であり、前記分離液が血清または血漿である、請求項22に記載の分析方法。 The analysis method according to claim 22 , wherein the specimen is blood, the insoluble component is a blood cell component, and the separation liquid is serum or plasma.
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