TWI737135B

TWI737135B - Slide sets, machine and method for optical blood coagulation test

Info

Publication number: TWI737135B
Application number: TW109102296A
Authority: TW
Inventors: 王友仁; 陳庠菁; 李汪洋
Original assignee: 微采視像科技股份有限公司; 國立成功大學
Priority date: 2020-01-21
Filing date: 2020-01-21
Publication date: 2021-08-21
Also published as: TW202129276A; CN113219184A

Abstract

The invention provides an optical blood coagulation testing specimen pairs including a detecting area, an agent area and a capillary element, wherein the agent area is separated from the detecting area, and the agent area and the detecting area are connected with a guiding path of the capillary element. By controlling the connection between the detecting area and the agent area, a blood sample is ensured to be mixed with an agent thoroughly and rapidly before being detected, thereby enhancing the accuracy of the detection.

Description

光學式凝血檢測試片組、光學式凝血檢測機及光學式凝血檢測方法 Optical coagulation test strips, optical coagulation detector and optical coagulation test Measuring method

本發明是有關於一種凝血檢測試片及其應用，特別是一種光學式凝血檢測試片組、適用之光學式凝血檢測機及凝血檢測方法。 The invention relates to a coagulation detection test strip and its application, in particular to an optical coagulation detection test strip group, a suitable optical coagulation detection machine and a coagulation detection method.

凝血(coagulation)係血液由液態轉變成凝膠狀的過程，以快速止血並阻絕傷口與外界的接觸。傷口形成後，凝血作用快速發生，引發一系列的反應而刺激血小板釋出凝血酶原(prothrombin)。凝血酶原接著被活化成凝血酶(thrombin)。凝血酶將溶於血漿中的纖維蛋白原(fibrinogen)轉變成不溶於水的纖維蛋白(fibrin)。上述纖維蛋白聚合成網狀結構以扭結血液中的其他細胞與血小板以形成血塊(blood clot)，因此使傷口附近的血液轉變成凝膠狀。 Coagulation is the process by which blood changes from liquid to gel to quickly stop bleeding and prevent the wound from contacting the outside world. After the wound is formed, coagulation occurs rapidly, triggering a series of reactions to stimulate the platelet to release prothrombin (prothrombin). Prothrombin is then activated to thrombin. Thrombin converts fibrinogen, which is dissolved in plasma, into fibrin, which is insoluble in water. The above-mentioned fibrin polymerizes into a network structure to kink other cells and platelets in the blood to form a blood clot, thereby turning the blood near the wound into a gel.

然而，病毒的感染、基因疾病、器官的病變或是藥物的使用，都可能影響凝血而導致傷口流血不止或是形成血栓。凝血檢測可用以協助診斷疾病、評估手術的風險或監控抗凝血藥物的使用。常用的凝血檢測包含凝血酶原時間(prothrombin time，PT)，其係血液接觸到凝血試劑至凝血酶原活化而造成血液樣本形成結塊(clotting)所需的時間。 However, viral infections, genetic diseases, organ diseases, or drug use may affect blood coagulation and cause wounds to bleed continuously or form thrombus. Coagulation tests can be used to help diagnose diseases, assess the risk of surgery, or monitor the use of anticoagulant drugs. Commonly used blood coagulation tests include prothrombin time (PT), which is the time required for blood to contact a coagulation reagent to activate prothrombin and cause clotting of the blood sample.

反應檢測的精確與否取決於反應起始與結束時間點之判斷。以PT測量為例，反應起始之時間點在血液樣本與試劑反應之時，而結束之時間點在血液樣本凝固之時，其中後者的判斷之精確性取決於血液樣本是否與凝血試劑快速而充分地混合。然而為了運送與保存，市售的凝血試劑多半呈粉狀而非容易混勻的液體狀，因此需要一種方法可使血液樣本與凝血試劑可快速而充分混合，且凝血檢測進行時不受未混勻之血液樣本或凝血試劑之干擾。 The accuracy of the reaction detection depends on the judgment of the start and end time points of the reaction. Taking the PT measurement as an example, the reaction start time is when the blood sample reacts with the reagent, and the end time point is when the blood sample is coagulated. The accuracy of the latter judgment depends on whether the blood sample reacts quickly with the coagulation reagent. Mix thoroughly. However, for transportation and storage, most of the coagulation reagents on the market are in powder form rather than liquid that is easy to mix. Therefore, a method is needed to allow the blood sample and the coagulation reagent to be quickly and fully mixed, and the coagulation test is not unmixed. Interference of homogeneous blood samples or coagulation reagents.

有鑑於此，實有必要提供一種光學式凝血檢測試片組，以改善凝血檢測之精確度。 In view of this, it is necessary to provide an optical coagulation test strip set to improve the accuracy of coagulation detection.

因此，本發明之一態樣是在提供一種光學式凝血檢測試片組，藉由控制檢測區與試劑區連通與否，確使流入檢測區的血液樣本已與凝血試劑充分混合，進而顯著改善凝血檢測之準確性。 Therefore, one aspect of the present invention is to provide an optical coagulation test strip set. By controlling whether the detection area and the reagent area are connected or not, it is ensured that the blood sample flowing into the detection area is fully mixed with the coagulation reagent, thereby significantly improving Accuracy of coagulation test.

本發明之另一態樣是在提供一種光學式凝血檢測機，其係適用於上述光學式凝血檢測試片組。 Another aspect of the present invention is to provide an optical coagulation detection machine, which is suitable for the above-mentioned optical coagulation detection test strip set.

本發明之又一態樣是在提供一種光學式凝血檢測方法，可令血液與凝血試劑充分混合後再進行檢測，經實驗證實上述光學式凝血檢測方法可使檢測結果更為精確。 Another aspect of the present invention is to provide an optical coagulation detection method, which can fully mix blood and coagulation reagents before performing the detection. Experiments have proved that the optical coagulation detection method can make the detection result more accurate.

根據本發明之上述態樣，提供一種光學式凝血檢測試片組，可包含檢測區、試劑區及毛細單元，其中試劑區與檢測區相間隔，且試劑區具有試劑，而毛細單元可形成連通上述檢測區與上述試劑區的引道。在一實施例中，上述引道包含吸入端與相反於前述吸入端的導出端，其中吸入端連通試劑區，導出端連通檢測區，上述吸入端的截面可小於上述導出端的另一截面。 According to the above aspect of the present invention, there is provided an optical coagulation detection test strip set, which may include a detection area, a reagent area, and a capillary unit, wherein the reagent area is spaced from the detection area, and the reagent area has reagents, and the capillary units can be connected The approach path between the detection zone and the reagent zone. In one embodiment, the above-mentioned approach path includes a suction end and a discharge end opposite to the above-mentioned suction end, wherein the suction end communicates with the reagent area and the outlet end communicates with the detection area. The section of the suction end may be smaller than the other section of the outlet end.

在本發明的一實施例中，上述光學式凝血檢測試片組包含基材、與基材間隔第一間隙的第一上片，以及與基材間隔第二間隙的第二上片，其中基材與第一上片相配合界定出上述檢測區，基材與第二上片界定出上述試劑區，且第一間隙小於第二間隙。 In an embodiment of the present invention, the optical coagulation detection test strip set includes a substrate, a first top sheet separated from the substrate by a first gap, and a second top sheet separated from the substrate by a second gap, wherein the substrate The material and the first top sheet cooperate to define the detection zone, the substrate and the second top sheet define the reagent zone, and the first gap is smaller than the second gap.

根據上述實施例，上述第二間隙與上述第一間隙的差值不小於50微米。 According to the above embodiment, the difference between the second gap and the first gap is not less than 50 microns.

在本發明的又一實施例中，上述第二間隙不大於1毫米。 In another embodiment of the present invention, the above-mentioned second gap is not greater than 1 mm.

根據上述實施例，上述毛細單元包含折疊形成引道的摺疊片材。 According to the above-mentioned embodiment, the above-mentioned capillary unit includes a folded sheet that is folded to form an approach path.

在本發明的另一實施例中，毛細單元是以透明親水性材料所製成。 In another embodiment of the present invention, the capillary unit is made of transparent hydrophilic material.

根據本發明之另一態樣，提供一種光學式凝血檢測機，適用於上述光學式凝血檢測試片組，其中光學式凝血檢測機可包含發光部件、感光部件及阻斷閥。上述發光部件可對應檢測區設置，且能朝檢測區射出光線。上述感光部件可用以接收上述發光部件所射出的光線。上述阻斷閥可對應毛細單元設置，且可在導通位置及阻斷位置間移動。當阻斷閥在上述導通位置時，上述引道連通試劑區及檢測區。當阻斷閥在上述阻斷位置時，阻斷閥壓抵上述毛細單元，導致檢測區與試劑區不連通。 According to another aspect of the present invention, an optical coagulation detection machine is provided, which is suitable for the above optical coagulation detection test strip set, wherein the optical coagulation detection machine may include a light-emitting component, a photosensitive component, and a blocking valve. The above-mentioned light-emitting components can be arranged corresponding to the detection area, and can emit light toward the detection area. The photosensitive member can be used to receive the light emitted by the light-emitting member. The above blocking valve can be set corresponding to the capillary unit, and can move between the on position and the blocking position. When the blocking valve is in the above-mentioned conducting position, the above-mentioned approach path connects the reagent area and the detection area. When the blocking valve is in the blocking position, the blocking valve is pressed against the capillary unit, causing the detection area to be disconnected from the reagent area.

在本發明的一實施例中，上述光學式凝血檢測機可進一步包含對應上述試劑區設置的震動單元，其中震動單元能使試劑區產生持續時間不大於7秒的震動。 In an embodiment of the present invention, the optical coagulation detector may further include a vibration unit corresponding to the reagent area, wherein the vibration unit can cause the reagent area to vibrate with a duration of not more than 7 seconds.

根據本發明之又一態樣，提供一種光學式凝血檢測方法，包含準備上述光學式凝血檢測試片組及上述光學式凝血檢測機，並將光學式凝血檢測試片組置於光學式凝血檢測機中，再將阻斷閥由導通位置移動至阻斷位置。接著，將血液樣本送入試劑區，使血液樣本與試劑區內的試劑反應而形成反應樣本。再來，將阻斷閥由阻斷位置移動至導通位置，使反應樣本經毛細單元由試劑區流向檢測區。接下來，以感光部件接收發光部件朝向檢測區發出的光線，以檢測反應樣本。 According to another aspect of the present invention, there is provided an optical coagulation detection method, including preparing the optical coagulation detection test strip set and the optical coagulation detection machine, and placing the optical coagulation detection test strip set in the optical coagulation detection In the machine, move the blocking valve from the on position to the blocking position. Then, the blood sample is sent to the reagent area, and the blood sample reacts with the reagent in the reagent area to form a reaction sample. Next, move the blocking valve from the blocking position to the pilot The open position allows the reaction sample to flow from the reagent area to the detection area through the capillary unit. Next, the photosensitive member receives the light emitted from the light-emitting member toward the detection area to detect the reaction sample.

根據本發明之上述態樣，提供又一種光學式凝血檢測試片組，可包含第一試片與第二試片，其中第一試片包含可透光的檢測區，第二試片包含具有試劑的試劑區。上述第二試片能相對上述第一試片在反應位置與檢測位置間移動。當第二試片在反應位置時，試劑區與檢測區不連通；當第二試片在檢測位置時，試劑區與檢測區相連通。 According to the above aspect of the present invention, there is provided yet another optical coagulation detection test strip set, which can include a first test strip and a second test strip, wherein the first test strip includes a light-permeable detection area, and the second test strip includes Reagent area for reagents. The second test strip can move between the reaction position and the detection position relative to the first test strip. When the second test strip is in the reaction position, the reagent area is not connected to the detection area; when the second test strip is in the detection position, the reagent area is connected to the detection area.

在本發明的一實施例中，上述第一試片可進一步包含第一基板及與第一基板間隔第一間隙的第一上片，第一基板與第一上片相配合界定出前述檢測區，而第二試片更包含第二基板，及與第二基板間隔第二間隙的第二上片，而第二基板與第二上片相配合界定出試劑區，且第一間隙小於第二間隙。 In an embodiment of the present invention, the above-mentioned first test piece may further include a first substrate and a first top piece separated from the first substrate by a first gap, and the first substrate and the first top piece cooperate to define the aforementioned detection area , And the second test strip further includes a second substrate, and a second upper sheet separated from the second substrate by a second gap, and the second substrate and the second upper sheet cooperate to define a reagent area, and the first gap is smaller than the second gap.

在本發明的一實施例中，第二間隙與第一間隙的差值不小於50微米。 In an embodiment of the present invention, the difference between the second gap and the first gap is not less than 50 microns.

在本發明的另一實施例中，第二間隙不大於1毫米。 In another embodiment of the present invention, the second gap is not greater than 1 mm.

根據上述實施例，上述光學式凝血檢測試片組可進一步包含形成引道的毛細單元，當上述第二試片在反應位置時，引道的一端連通檢測區或試劑區，而當第二試片在檢測位置時，引道的兩端分別連通檢測區與試劑區。 According to the above embodiment, the optical coagulation detection test strip set may further include a capillary unit forming an approach path, and when the second test strip is in the reaction position When set, one end of the approach path is connected to the detection area or the reagent area, and when the second test strip is in the detection position, the two ends of the approach path are respectively connected to the detection area and the reagent area.

在本發明的再一實施例中，上述引道具有連通試劑區的入口端及相反於入口端的出口端，其中出口端的截面大於入口端的截面。 In still another embodiment of the present invention, the above-mentioned approach path has an inlet end connected to the reagent zone and an outlet end opposite to the inlet end, wherein the cross section of the outlet end is larger than the cross section of the inlet end.

在本發明的又一實施例中，上述毛細單元可包含折疊形成引道的摺疊片材。 In another embodiment of the present invention, the above-mentioned capillary unit may include a folded sheet that is folded to form an approach path.

在本發明的再一實施例中，上述第一試片與毛細單元是由透明親水性聚合物所製成。 In another embodiment of the present invention, the first test piece and the capillary unit are made of transparent hydrophilic polymer.

根據本發明之另一態樣，提供一種光學式凝血檢測機，適用於上述光學式凝血檢測試片組，其中光學式凝血檢測機包含發光部件、感光部件及震動單元。上述發光部件能朝檢測區射出光線。上述感光部件可用以接收發光部件所射出的光線。上述震動單元能使試劑區產生持續時間不大於7秒的震動。 According to another aspect of the present invention, there is provided an optical coagulation detection machine suitable for the above-mentioned optical coagulation detection test strip set, wherein the optical coagulation detection machine includes a light-emitting component, a photosensitive component and a vibration unit. The light-emitting component can emit light toward the detection area. The above-mentioned photosensitive member can be used to receive the light emitted by the light-emitting member. The above-mentioned vibration unit can cause the reagent area to generate vibration with a duration of not more than 7 seconds.

根據本發明之又一態樣，提供一種光學式凝血檢測方法，包含準備上述光學式凝血檢測試片組及上述光學式凝血檢測機，並將光學式凝血檢測試片組置於光學式凝血檢測機，使第二試片位於反應位置並位於震動單元的相對上方，而發光部件所發出的光線可以照射至檢測區。接著，將血液樣本送入試劑區，且以震動單元使試劑區產生持續時間不大於7秒的震動，從而使血液樣本與試劑區內的試劑反應而形成反應樣本。再來，將第二試片由反應位置移動至檢測位置，使與試劑反應後的反應樣本流向檢測區。接下來，以感光部件接收發光部件朝檢測區發出的光線，以檢測反應樣本。 According to another aspect of the present invention, there is provided an optical coagulation detection method, including preparing the optical coagulation detection test strip set and the optical coagulation detection machine, and placing the optical coagulation detection test strip set in the optical coagulation detection The second test piece is located at the reaction position and relatively above the vibration unit, and the light emitted by the light-emitting component can be irradiated to the detection area. Then, send the blood sample into the reagent area, and use the vibration unit to make the reagent area vibrate with a duration of no more than 7 seconds, so that the blood sample and the reagent in the reagent area React to form a reaction sample. Then, the second test strip is moved from the reaction position to the detection position, so that the reaction sample after reacting with the reagent flows to the detection area. Next, the photosensitive member receives the light emitted from the light-emitting member toward the detection area to detect the reaction sample.

應用本發明之光學式凝血檢測試片組，可藉由區分試劑區與檢測區而使得進行檢測的血液樣本已與凝血試劑充分混合成反應樣本，進而提高凝血檢測的精確度。 By using the optical coagulation test strip set of the present invention, the reagent area and the detection area can be distinguished so that the blood sample to be tested has been fully mixed with the coagulation reagent to form a reaction sample, thereby improving the accuracy of coagulation detection.

100,600:光學式凝血檢測試片組 100,600: optical coagulation test strip group

110,610:第一試片 110,610: first test piece

111,611:檢測區 111,611: detection area

112,612:第一基板 112,612: first substrate

113,613:第一上片 113,613: the first film

115,125,615,625:支撐件 115, 125, 615, 625: support

119:上表面 119: upper surface

120,620:第二試片 120,620: second test piece

121,621:試劑區 121,621: reagent area

122,622:第二基板 122,622: second substrate

123,623:第二上片 123,623: second film

129,629:試劑 129,629: Reagents

130,630:毛細單元 130,630: capillary unit

131,631:引道 131,631: Approach

132:吸入端 132: suction side

133‧‧‧導出端 133‧‧‧Export

134,634‧‧‧摺疊片材 134,634‧‧‧folded sheet

135‧‧‧第一部分 135‧‧‧Part One

136‧‧‧第二部分 136‧‧‧Part Two

137‧‧‧毛細管 137‧‧‧Capillary tube

138,638‧‧‧摺線 138,638‧‧‧Polyline

200,700‧‧‧光學式凝血檢測機 200,700‧‧‧Optical coagulation detector

201,701‧‧‧承載平台 201,701‧‧‧Carrier Platform

202,702‧‧‧上蓋 202,702‧‧‧Top cover

203,703‧‧‧***口 203,703‧‧‧Insertion port

210,710‧‧‧發光部件 210,710‧‧‧Light-emitting parts

220,720‧‧‧感光部件 220,720‧‧‧Photosensitive parts

230‧‧‧阻斷閥 230‧‧‧Block valve

231‧‧‧下表面 231‧‧‧lower surface

240,730‧‧‧震動單元 240,730‧‧‧Vibration unit

632‧‧‧入口端 632‧‧‧Entrance

633‧‧‧出口端 633‧‧‧Exit port

705‧‧‧固定件 705‧‧‧Fixture

707‧‧‧位移件 707‧‧‧Displacement piece

801,803,805,807,809‧‧‧步驟 801,803,805,807,809‧‧‧Step

1301,1303,1305,1307,1309‧‧‧步驟 1301,1303,1305,1307,1309‧‧‧Step

1410,1430,1450,1470,1510,1530,1550,1570‧‧‧折線 1410,1430,1450,1470,1510,1530,1550,1570‧‧‧Broken line

1411,1413,1431,1433,1511,1513,1531,1533‧‧‧點 1411,1413,1431,1433,1511,1513,1531,1533‧‧‧points

H₁,Y₁‧‧‧第一間隙 H ₁ ,Y ₁ ‧‧‧First gap

H₂,Y₂‧‧‧第二間隙 H ₂ ,Y ₂ ‧‧‧Second gap

A-A’,C-C’‧‧‧軸 A-A’,C-C’‧‧‧axis

R₁,R₂‧‧‧半徑 R ₁ ,R ₂ ‧‧‧radius

從以下結合所附圖式所做的詳細描述，可對本揭露之態樣有更佳的了解。需注意的是，根據業界的標準實務，各特徵並未依比例繪示。事實上，為了使討論更為清楚，各特徵的尺寸都可任意地增加或減少。 From the following detailed description in conjunction with the accompanying drawings, a better understanding of the aspect of the present disclosure can be obtained. It should be noted that, according to industry standard practice, each feature is not drawn to scale. In fact, in order to make the discussion clearer, the size of each feature can be increased or decreased arbitrarily.

〔圖1〕係顯示根據本發明一實施例之光學式凝血檢測試片組的示意圖。 [Fig. 1] is a schematic diagram showing an optical coagulation test strip group according to an embodiment of the present invention.

〔圖2〕係顯示根據本發明一實施例之光學式凝血檢測試片組的分解圖。 [Fig. 2] is an exploded view showing an optical coagulation test strip group according to an embodiment of the present invention.

〔圖3〕係顯示根據本發明一實施例之光學式凝血檢測試片組的剖面圖。 [Figure 3] shows a cross-sectional view of an optical coagulation test strip group according to an embodiment of the present invention.

〔圖4A〕至〔圖4B〕係顯示根據本發明一實施例之毛細單元展開(圖4A)與折疊(圖4B)之上視圖。 [FIG. 4A] to [FIG. 4B] are top views showing unfolded (FIG. 4A) and folded (FIG. 4B) capillary units according to an embodiment of the present invention.

〔圖5A〕至〔圖5B〕係分別顯示根據本發明一實施例之毛細單元。 [FIG. 5A] to [FIG. 5B] respectively show a capillary unit according to an embodiment of the present invention.

〔圖6〕係顯示根據本發明一實施例之光學式凝血檢測試片組設置於光學式凝血檢測機之示意圖。 [Fig. 6] is a schematic diagram showing the optical coagulation test strip set in an optical coagulation test machine according to an embodiment of the present invention.

〔圖7A〕與〔圖7B〕係顯示根據本發明一實施例之光學式凝血檢測機之阻斷閥分別在阻斷位置(圖7A)與導通位置(圖7B)時之剖面圖。 [FIG. 7A] and [FIG. 7B] are cross-sectional views of the blocking valve of the optical coagulation detector according to an embodiment of the present invention in the blocking position (FIG. 7A) and the conducting position (FIG. 7B), respectively.

〔圖8〕係顯示根據本發明一實施例之光學式凝血檢測方法。 [Figure 8] shows an optical coagulation detection method according to an embodiment of the present invention.

〔圖9A〕至〔圖9B〕係顯示根據本發明一實施例之光學式凝血檢測試片組試劑區與檢測區不連通(圖9A)或連通(圖9B)的示意圖。 [FIG. 9A] to [FIG. 9B] are schematic diagrams showing that the reagent area and the detection area of the optical coagulation test strip set according to an embodiment of the present invention are not connected (FIG. 9A) or connected (FIG. 9B).

〔圖10A〕與〔圖10B〕係顯示根據本發明一實施例之光學式凝血檢測試片組試劑區與檢測區不連通(圖10A)或連通(圖10B)的剖面圖。 [FIG. 10A] and [FIG. 10B] are cross-sectional views showing that the reagent area and the detection area of the optical coagulation test strip set according to an embodiment of the present invention are not connected (FIG. 10A) or connected (FIG. 10B).

〔圖11A〕至〔圖11B〕係顯示根據本發明不同實施例之光學式凝血檢測試片組試劑區與檢測區不連通(圖11A)或連通(圖11B)的示意圖。 [FIG. 11A] to [FIG. 11B] are schematic diagrams showing that the reagent area and the detection area of the optical coagulation test strip set according to different embodiments of the present invention are not connected (FIG. 11A) or connected (FIG. 11B).

〔圖12A〕與〔圖12B〕係顯示根據本發明一實施例之光學式凝血檢測機與光學式凝血檢測試片組設置於光學式凝血檢測機時，試劑區與檢測區不連通(圖12A)或連通(圖12B)的示意圖。 [FIG. 12A] and [FIG. 12B] show that when the optical coagulation detection machine and the optical coagulation detection test strip group are set in the optical coagulation detection machine according to an embodiment of the present invention, the reagent area and the detection area are not connected (Figure 12A) ) Or connection (Figure 12B).

〔圖13〕係顯示根據本發明一實施例之光學式凝血檢測方法。 [Figure 13] shows an optical coagulation detection method according to an embodiment of the present invention.

〔圖14A〕與〔圖14B〕係顯示根據本發明一實施例之凝血檢測結果(圖14A)並根據結果進行一階微分(圖 14B)。 [Figure 14A] and [Figure 14B] show the results of a coagulation test according to an embodiment of the present invention (Figure 14A) and perform first-order differentiation based on the results (Figure 14A). 14B).

〔圖15A〕與〔圖15B〕係顯示根據本發明一實施例之凝血檢測結果(圖15A)並根據結果進行一階微分(圖15B)。 [FIG. 15A] and [FIG. 15B] show the coagulation test results (FIG. 15A) according to an embodiment of the present invention and perform first-order differentiation based on the results (FIG. 15B).

本發明所提到的單數形式“一”、“一個”和“所述”包括複數引用，除非上下文另有明確規定。數值範圍(如10%~11%的A)若無特定說明皆包含上、下限值(即10%≦A≦11%)；數值範圍若未界定下限值(如低於0.2%的B，或0.2%以下的B)，則皆指其下限值可能為0(即0%≦B≦0.2%)。上述用語是用以說明及理解本發明，而非用以限制本發明。 The singular forms "a", "an" and "the" mentioned in the present invention include plural references unless the context clearly dictates otherwise. The numerical range (such as 10%~11% of A) includes the upper and lower limits (ie 10%≦A≦11%) unless otherwise specified; if the numerical range does not define the lower limit (such as less than 0.2% of B) , Or less than 0.2% of B), it means that its lower limit may be 0 (ie 0%≦B≦0.2%). The above terms are used to describe and understand the present invention, but not to limit the present invention.

本發明提供一種光學式凝血檢測試片組、其適用之光學式凝血檢測試機及其檢測方法，其分隔試劑與血液樣本進行混合之試劑區及光學檢測血液樣本之檢測區，並以毛細單元形成之引道連通兩區，再藉由控制引道或控制試劑區與檢測區之相對位置使試劑區與檢測區連通或不連通，以確保血液樣本與試劑充分在試劑區混合成反應樣本後才進行檢測，而反應樣本中不包含未混合均勻之試劑乾粉，從而可提高檢測的準確性。 The present invention provides an optical coagulation detection test strip set, an optical coagulation detection test machine and a detection method applicable thereto, which separate the reagent area for mixing reagents and blood samples and the detection area for optical detection of blood samples, and use capillary units The formed approach path connects the two areas, and then the reagent area and the detection area are connected or disconnected by controlling the approach path or the relative position of the reagent area and the detection area to ensure that the blood sample and the reagent are fully mixed in the reagent area to form a reaction sample. The test is performed, and the reaction sample does not contain unmixed reagent dry powder, which can improve the accuracy of the test.

上述血液樣本包含紅血球及血漿，可例如全血或減除白血球之血品。上述試劑可為凝血試劑，可包含但不限於氯化鈣、活化劑(如：鞣花酸、矽藻土、玻璃珠或高嶺土等物質)、磷脂及安定劑。在一實施例中，凝血試劑的劑型係凍乾粉。在一實施例中，凝血試劑的劑型係液體。 The above blood sample contains red blood cells and plasma, such as whole blood or a blood product depleted of white blood cells. The above-mentioned reagent may be a blood coagulation reagent, which may include, but is not limited to, calcium chloride, activators (such as ellagic acid, diatomaceous earth, glass beads, or kaolin), phospholipids, and stabilizers. In one embodiment, the dosage form of the coagulation reagent is a lyophilized powder. In one embodiment, the dosage form of the coagulation reagent is liquid.

如圖1與圖2所示，本發明一實施例之光學式凝血檢測試片組100包含第一試片110、第二試片120與毛細單元130。上述第一試片110可包含第一基板112及第一上片113，其中第一基板112與第一上片113間隔第一間隙H₁且共同界定檢測區111，且第一基板112與第一上片113之間可進一步包含兩個支撐件115設置於檢測區111之兩側。第二試片120可包含第二基板122及第二上片123，其中第二基板122與第二上片123間隔第二間隙H₂且共同界定試劑區121，試劑區121具有試劑129，且第二基板122與第二上片123之間可進一步兩個支撐件125設置於試劑區121之兩側。圖2為簡潔說明，故省略支撐件。在實際應用時，第一基板112及第二基板122可例如一體成型之基材(圖未繪示)。 As shown in FIGS. 1 and 2, the optical coagulation detection test strip group 100 according to an embodiment of the present invention includes a first test strip 110, a second test strip 120 and a capillary unit 130. Said first test strip 110 may include a first substrate 112 and the first topsheet 113, wherein the first substrate 112 and the first interval of the first topsheet 113 and together define a gap H ₁ detection zone 111, and the first substrate 112 and the second An upper piece 113 may further include two supporting members 115 disposed on both sides of the detection area 111. The second test strip 120 may include a second substrate 122 and a second top sheet 123, wherein the second substrate 122 and the second top sheet 123 are separated by a second gap H ₂ and jointly define a reagent area 121, the reagent area 121 has a reagent 129, and Two supporting members 125 can be further arranged on both sides of the reagent area 121 between the second substrate 122 and the second upper sheet 123. Figure 2 is a concise description, so the support is omitted. In practical applications, the first substrate 112 and the second substrate 122 may be, for example, an integrally formed substrate (not shown in the figure).

值得注意的是，支撐件115(125)之態樣不限。在圖1所示之實施例中，支撐件115與支撐件125各有兩個且分別位於檢測區111及試劑區121之二側。在另一實施例中，支撐件115(125)可為圓柱且對應設置於檢測區 111(試劑區121)之四個角(圖未繪示)。在又一實施例中，支撐件115(125)可環設於檢測區111(試劑區121)但留有毛細單元之穿設孔(圖未繪示)。在實際應用時，支撐件115(125)可例如由凝固之黏著劑固化後形成。 It should be noted that the configuration of the support 115 (125) is not limited. In the embodiment shown in FIG. 1, there are two supporting members 115 and two supporting members 125 and they are respectively located on two sides of the detection area 111 and the reagent area 121. In another embodiment, the support 115 (125) may be cylindrical and correspondingly disposed in the detection area The four corners of 111 (reagent area 121) (not shown in the figure). In another embodiment, the support 115 (125) can be arranged around the detection area 111 (reagent area 121) but with capillary unit perforation holes (not shown in the figure). In practical applications, the support 115 (125) may be formed by curing a solidified adhesive, for example.

上述毛細單元130可形成引道131，其中引道131包含連通檢測區111之導出端133以及連通試劑區121之吸入端132，吸入端132之截面小於導出端133之截面(顯示於圖2)。在一實施例中，毛細單元130包含摺疊片材134，其中摺疊片材134經折疊後形成引道131。 The capillary unit 130 can form an approach path 131, wherein the approach path 131 includes a lead-out end 133 connected to the detection area 111 and a suction end 132 connected to the reagent area 121. The cross-section of the suction end 132 is smaller than the cross-section of the lead-out end 133 (shown in Figure 2) . In an embodiment, the capillary unit 130 includes a folded sheet 134, wherein the folded sheet 134 is folded to form an approach path 131.

請參閱圖3，其係圖1沿軸A-A’之剖面圖，其中鏈線表示摺疊片材134對折形成的摺線138。如圖3所示，第二間隙H₂大於第一間隙H₁，在一實施例中，第二間隙H₂與第一間隙H₁的差值不小於50微米。在一實施例中，第二間隙H₂不大於1毫米。在一實施例中，第二間隙H₂可例如500微米，第一間隙H₁可例如420微米。由於第二間隙H₂大於第一間隙H₁，由摺疊片材134形成之引道131在吸入端132與導出端133形成高度差，因此可引導血液樣本由吸入端132流向導出端133。 Please refer to FIG. 3, which is a cross-sectional view of FIG. 1 along the axis AA′, in which the chain line represents the folding line 138 formed by folding the folded sheet 134 in half. 3, a second gap larger than the first gap H ₂ H _1, in one embodiment, the second gap and the first gap difference H ₂ H ₁ is not less than 50 microns. In an embodiment, the second gap H _{2 is} not greater than 1 mm. In an embodiment, the second gap H ₂ may be, for example, 500 micrometers, and the first gap H ₁ may be, for example, 420 micrometers. Since the second gap H _{2 is} larger than the first gap H ₁ , the suction end 132 and the discharge end 133 of the guide path 131 formed by the folded sheet 134 form a height difference, so that the blood sample can be guided to flow from the suction end 132 to the discharge end 133.

請參閱圖4A及4B，其係據本發明一實施例之毛細單元130展開(圖4A)與沿圖4A中摺線138折疊(圖4B)之上視圖。如圖4A及圖4B所示，展開的摺疊片材134沿摺線138對折後形成第一部分135與第二部分136(圖4A)，而引道131形成於第一部分135與第二部分136之間(圖4B)。如圖4A所示，展開的摺疊片材134在導出端133向兩側延伸而形成T字型，並在對折後形成如圖4B所示之L型，使吸入端132之截面長度W₂小於導出端133之截面長度W₁。 Please refer to FIGS. 4A and 4B, which are top views of the capillary unit 130 unfolded (FIG. 4A) and folded along the fold line 138 in FIG. 4A (FIG. 4B) according to an embodiment of the present invention. As shown in FIGS. 4A and 4B, the unfolded folded sheet 134 is folded in half along the fold line 138 to form a first part 135 and a second part 136 (FIG. 4A), and an approach path 131 is formed between the first part 135 and the second part 136 (Figure 4B). As shown in FIG. 4A, the unfolded folded sheet 134 extends to both sides at the lead-out end 133 to form a T-shape, and after being folded in half, it forms an L-shape as shown in FIG. 4B, so that the sectional length W _{2 of the} suction end 132 is smaller than The cross-sectional length W _{1 of the} leading-out end 133.

需說明的是，毛細現象係液體分子間的內聚力及液體與固體間的附著力共同作用之結果。一般而言，液體與固體的接觸表面積越大且/或固體與固體間的縫隙越小，附著力越大，而越容易對液體產生拉力。以上述實施例為例，由於第一間隙H₁小於第二間隙H₂，在引道131的吸入端132與導出端133形成高度差，且吸入端132之截面小於導出端133之截面，因此血液樣本傾向由吸入端132流向導出端133。另外，在部分實施例中的毛細單元130因為具有特殊的形狀，如圖4B所示之L型，因此可影響血液樣本的流動而產生微小的漩渦，從而協助試劑129與血液樣本的混合。 It should be noted that the capillary phenomenon is the result of the cohesion between liquid molecules and the adhesion between liquid and solid. Generally speaking, the larger the contact surface area between the liquid and the solid and/or the smaller the gap between the solid and the solid, the greater the adhesion force, and the easier it is to generate tension on the liquid. Taking the above embodiment as an example, since the first gap H _{1 is} smaller than the second gap H ₂ , a height difference is formed between the suction end 132 and the discharge end 133 of the approach path 131, and the cross section of the suction end 132 is smaller than the cross section of the discharge end 133, so The blood sample tends to flow from the suction end 132 to the discharge end 133. In addition, because the capillary unit 130 in some embodiments has a special shape, such as the L shape shown in FIG. 4B, it can affect the flow of the blood sample and generate tiny vortices, thereby assisting the mixing of the reagent 129 with the blood sample.

需說明的是，毛細單元130之態樣不限，惟吸入端132之截面長度W₂小於導出端133之截面長度W₁。請參閱圖5A及圖5B，其分別係根據本發明一實施例之毛細單元130。在一實施例中，毛細單元130之摺疊片材134為梯形，經對折後形成引道131，如圖5A所示。在另一實施例中，摺疊片材134為扇形，經反覆折疊後形成多個引道 131(圖未繪示)。在又一實施例中，毛細單元130包含多個等向排列之毛細管137，其中引道131形成於毛細管137中，如圖5B所示。上述毛細管137在導出端133之半徑R₂大於在吸入端132之半徑R₁。 It should be noted that the configuration of the capillary unit 130 is not limited, but the cross-sectional length W _{2 of the} suction end 132 is smaller than the cross-sectional length W _{1 of the} discharge end 133. Please refer to FIG. 5A and FIG. 5B, which are respectively the capillary unit 130 according to an embodiment of the present invention. In one embodiment, the folded sheet 134 of the capillary unit 130 has a trapezoidal shape and is folded in half to form an approach path 131, as shown in FIG. 5A. In another embodiment, the folded sheet 134 is fan-shaped, and after repeated folding, a plurality of guide channels 131 are formed (not shown in the figure). In another embodiment, the capillary unit 130 includes a plurality of capillary tubes 137 in an equidirectional arrangement, wherein the guide channel 131 is formed in the capillary tube 137, as shown in FIG. 5B. _{The radius R 2 of} the capillary tube 137 at the outlet end 133 is larger than the radius R ₁ at the suction end 132.

第一試片110、第二試片120及毛細單元130之製作材料不限。在一實施例中，毛細單元130之製作材料是親水性材料，以增加對血液樣本之附著力。親水性材料可為聚對苯二甲酸乙二醇酯(polyethylene terephthalate，PET)、聚乙烯醇(polyvinyl alcohol，PVA)、聚乙烯吡咯烷酮(poly vinyl pyrrolidone，PVP)或聚乙二醇(poly(ethylene oxide)，PEO)。在一較佳實施例中，上述親水性材料為透明的材料，其中透光度大於60%，或大於80%。在另一實施例中，第一上片113及第一基板112對應檢測區111的區域之製作材料為上述透明的材料。 The materials of the first test strip 110, the second test strip 120 and the capillary unit 130 are not limited. In one embodiment, the material of the capillary unit 130 is a hydrophilic material to increase adhesion to the blood sample. The hydrophilic material can be polyethylene terephthalate (PET), polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP) or polyethylene glycol (poly(ethylene glycol)). oxide), PEO). In a preferred embodiment, the above-mentioned hydrophilic material is a transparent material, wherein the light transmittance is greater than 60%, or greater than 80%. In another embodiment, the first top sheet 113 and the first substrate 112 corresponding to the detection area 111 are made of the above-mentioned transparent material.

本發明亦提供一種光學式凝血檢測機以配合上述凝血檢測機200使用。請參閱圖6，其係光學式凝血檢測試片組100設置於光學式凝血檢測機200之示意圖。如圖6所示，光學式凝血檢測機200可包含承載平台201，以承載或固定上述光學式凝血檢測試片組100。此外，光學式凝血檢測機200可進一步包含上蓋202，其中上蓋202設置於承載平台201之上，且上蓋202具有***口203以接受第一試片110之***，上蓋202至少覆蓋檢測區以避免外在光線干擾檢測。在另一實施例中，承載平台201可更進一步包含試片槽(圖未繪示)以進一步固定凝血檢測試片組100。 The present invention also provides an optical coagulation detector for use with the above-mentioned coagulation detector 200. Please refer to FIG. 6, which is a schematic diagram of the optical coagulation detection test strip group 100 being set in the optical coagulation detection machine 200. As shown in FIG. 6, the optical coagulation detection machine 200 may include a carrying platform 201 to carry or fix the above-mentioned optical coagulation detection test strip group 100. In addition, the optical coagulation detector 200 may further include an upper cover 202, wherein the upper cover 202 is disposed on the carrying platform 201, and the upper cover 202 has an insertion port 203 for receiving the first test. With the insertion of the sheet 110, the upper cover 202 at least covers the detection area to prevent external light from interfering with the detection. In another embodiment, the carrying platform 201 may further include a test strip slot (not shown in the figure) to further fix the coagulation test strip group 100.

如圖7A至7B係顯示根據本發明一實施例之光學式凝血檢測機200之阻斷閥230分別在阻斷位置(圖7A)與導通位置(圖7B)時之剖面圖。如圖7A所示，光學式凝血檢測機200包含發光部件210、感光部件220及阻斷閥230。在本實施例中，發光部件210位於承載平台201之頂部而相對設置於檢測區111之下，感光部件220對應發光部件210設置於上蓋202之底部。在另一實施例中，發光部件210設置於上蓋202之底部而感光部件220位於承載平台201之頂部，兩者相對檢測區111設置(圖未繪示)。 FIGS. 7A to 7B show cross-sectional views of the blocking valve 230 of the optical coagulation detector 200 according to an embodiment of the present invention in the blocking position (FIG. 7A) and the conducting position (FIG. 7B ), respectively. As shown in FIG. 7A, the optical coagulation detector 200 includes a light-emitting component 210, a photosensitive component 220 and a blocking valve 230. In this embodiment, the light-emitting component 210 is located on the top of the supporting platform 201 and relatively disposed under the detection area 111, and the photosensitive component 220 is disposed at the bottom of the upper cover 202 corresponding to the light-emitting component 210. In another embodiment, the light emitting component 210 is disposed at the bottom of the upper cover 202 and the photosensitive component 220 is disposed on the top of the supporting platform 201, and the two are disposed opposite to the detection area 111 (not shown in the figure).

值得注意的是，圖7A至7B並不限制發光部件210與感光部件220之位置，但發光部件210發出之光線所形成之光路需穿過檢測區111再由感光部件220接收，其中光線可藉由多個反射鏡或是折射鏡進行反射或折射以滿足上述光路的條件(圖未繪示)。 It is worth noting that FIGS. 7A to 7B do not limit the positions of the light emitting component 210 and the photosensitive component 220, but the light path formed by the light emitted by the light emitting component 210 needs to pass through the detection area 111 and then be received by the photosensitive component 220, where the light can be The reflection or refraction is performed by multiple mirrors or refracting mirrors to meet the above-mentioned optical path conditions (not shown in the figure).

在上述實施例中，阻斷閥230對應毛細單元130設置，以壓抵或釋放毛細單元130之引道131。詳細而言，請見圖7A及圖7B。如圖7A及圖7B所示，阻斷閥230位於上蓋202之底部，可相對於毛細單元130移動。阻斷閥230具有下表面231，當下表面231與第一基板112之上表面 119相距不大於摺疊片材134之第一部分135與第二部分136厚度之和時，阻斷閥230位於阻斷位置，此時由於阻斷閥230壓抵毛細單元130，檢測區111與試劑區121不連通，如圖7A所示。當下表面231與上表面119相距大於摺疊片材134之第一部分135與第二部分136厚度之和時，阻斷閥230位於導通位置，此時引道131連通試劑區121及檢測區111，如圖7B所示。在實務上，阻斷閥230可由馬達控制而移動。 In the above embodiment, the blocking valve 230 is provided corresponding to the capillary unit 130 to press or release the approach path 131 of the capillary unit 130. In detail, please see Figure 7A and Figure 7B. As shown in FIGS. 7A and 7B, the blocking valve 230 is located at the bottom of the upper cover 202 and can move relative to the capillary unit 130. The blocking valve 230 has a lower surface 231. When the lower surface 231 is connected to the upper surface of the first substrate 112 When the distance between 119 is not greater than the sum of the thickness of the first part 135 and the second part 136 of the folded sheet 134, the blocking valve 230 is in the blocking position. At this time, since the blocking valve 230 is pressed against the capillary unit 130, the detection zone 111 and the reagent zone 121 is not connected, as shown in Figure 7A. When the distance between the lower surface 231 and the upper surface 119 is greater than the sum of the thickness of the first portion 135 and the second portion 136 of the folded sheet 134, the blocking valve 230 is in the conducting position, and the guide channel 131 connects the reagent area 121 and the detection area 111, such as Shown in Figure 7B. In practice, the blocking valve 230 can be moved by motor control.

如圖7A及圖7B所示，光學式凝血檢測機200可進一步包含對應試劑區121而設置於承載平台201頂部的震動單元240，其中震動單元240能使試劑區121產生持續的震動，震動時間小於或等於7秒。 As shown in FIGS. 7A and 7B, the optical coagulation detector 200 may further include a vibration unit 240 corresponding to the reagent area 121 and disposed on the top of the carrier platform 201, wherein the vibration unit 240 can cause the reagent area 121 to vibrate continuously. Less than or equal to 7 seconds.

請參閱圖8並同時參閱圖2、圖7A及圖7B，其係根據本發明一實施例之光學式凝血檢測方法。如步驟801所示，將上述光學式凝血檢測試片組100置於上述光學式凝血檢測機200。接著，如步驟803所示，將阻斷閥230由圖7B所示的導通位置移動到圖7A所示的阻斷位置，再進行步驟805，將血液樣本送入試劑區121，使血液樣本與試劑129反應而形成反應樣本。接續地，如步驟807所示，將阻斷閥230由圖7A所示的阻斷位置移動至圖7B所示的導通位置，使試劑區121與檢測區111連通，因此反應樣本可由試劑區121經毛細單元130流向檢測區111。然後，如步驟809所示，以光學檢測反應樣本的透光率，並計算凝血時間。此外，在步驟805至步驟807之間可進一步包含利用震動單元240使試劑區121產生持續但不大於7秒的震動以進一步混合試劑129與血液樣本。在此實施例中，由於檢測區111與試劑區121不直接相通，而是以引道131間接相連接，因此可藉由阻斷閥230控制檢測區111與試劑區121的連通或不連通，確使血液樣本與試劑129充分混合後才由引道導入檢測區111，從而改善檢測的精確度。 Please refer to FIG. 8 together with FIG. 2, FIG. 7A and FIG. 7B, which is an optical coagulation detection method according to an embodiment of the present invention. As shown in step 801, the above-mentioned optical coagulation detection test strip group 100 is placed in the above-mentioned optical coagulation detection machine 200. Next, as shown in step 803, move the blocking valve 230 from the conducting position shown in FIG. 7B to the blocking position shown in FIG. The reagent 129 reacts to form a reaction sample. Subsequently, as shown in step 807, the blocking valve 230 is moved from the blocking position shown in FIG. 7A to the conducting position shown in FIG. It flows to the detection area 111 through the capillary unit 130. Then, follow the steps As shown in step 809, the light transmittance of the reaction sample is optically detected, and the clotting time is calculated. In addition, the step 805 to step 807 may further include using the vibration unit 240 to cause the reagent area 121 to vibrate continuously but not more than 7 seconds to further mix the reagent 129 and the blood sample. In this embodiment, since the detection area 111 and the reagent area 121 are not directly connected, but indirectly connected by the approach path 131, the blocking valve 230 can be used to control the connection or disconnection of the detection area 111 and the reagent area 121, Make sure that the blood sample and the reagent 129 are fully mixed before being introduced into the detection area 111 from the approach path, thereby improving the accuracy of detection.

除了藉由阻斷閥230壓抵毛細單元130，檢測區111與試劑區121之連通或不連通亦可決定與檢測區111與試劑區121之相對位置。請參閱圖9A與圖9B，係顯示根據本發明一實施例之光學式凝血檢測試片組600之試劑區621與檢測區611不連通(圖9A)或連通(圖9B)的示意圖。如圖9A及圖9B所示，光學式凝血檢測試片組600包含第一試片610及第二試片620，其中第一試片610包含可透光的檢測區611，第二試片620包含具有試劑629的試劑區621，檢測區611與試劑區621可透過毛細單元630之引道631相連通。在一實施例中，毛細單元630包含摺疊片材634，而引道631可例如摺疊片材634經折疊後形成。詳細而言，第一試片610更進一步包含第一基板612及與第一基板612間隔第一間隙Y₁的第一上片613，並由第一基板612與第一上片613相配合以界定出檢測區611，第二試片 620更進一步包含第二基板622及與第二基板622間隔第二間隙Y₂的第二上片623，並由第二基板622與第二上片623相配合以界定出試劑區621。在一實施例中，第一基板612與第一上片613之間及第二基板622與第二上片623之間可分別包含但不限於多個支撐件615與支撐件625以使第一上片613與第一基板612之間及第二上片623與第二基板622之間分別間隔第一間隙Y₁與第二間隙Y₂。在此實施例中，第二試片620能相對第一試片610在反應位置(圖9A)與檢測位置(圖9B)間移動。當第二試片620在反應位置時，試劑區621與檢測區611不連通，當第二試片620在檢測位置時，試劑區621與檢測區611相連通。 In addition to pressing the capillary unit 130 by the blocking valve 230, the connection or disconnection between the detection area 111 and the reagent area 121 can also determine the relative position of the detection area 111 and the reagent area 121. Please refer to FIGS. 9A and 9B, which are schematic diagrams showing that the reagent area 621 and the detection area 611 of the optical coagulation test strip set 600 according to an embodiment of the present invention are not connected (FIG. 9A) or connected (FIG. 9B ). As shown in FIGS. 9A and 9B, the optical coagulation detection test strip group 600 includes a first test strip 610 and a second test strip 620, wherein the first test strip 610 includes a light-permeable detection area 611, and the second test strip 620 It includes a reagent area 621 with a reagent 629, and the detection area 611 and the reagent area 621 can communicate with the passage 631 of the capillary unit 630. In an embodiment, the capillary unit 630 includes a folded sheet 634, and the approach path 631 may be formed by folding the folded sheet 634, for example. Specifically, the first test strip 610 further includes a first substrate 612 and the first substrate 612 and the first gap interval of the first topsheet 613 Y _1, by the first substrate 612 and the first topsheet 613 cooperate to defining a detection zone 611, 620 further comprises second test strip 622 and the second substrate and the second substrate 622 spaced a second gap of the second topsheet 623 Y _2, and by a second substrate 622 and the second topsheet 623 Cooperate to define a reagent area 621. In one embodiment, between the first substrate 612 and the first top sheet 613 and between the second substrate 622 and the second top sheet 623, a plurality of supporting members 615 and supporting members 625 may be included, but not limited to, to make the first _{A first gap Y 1} and a second gap Y ₂ are spaced between the upper sheet 613 and the first substrate 612 and between the second upper sheet 623 and the second substrate 622, respectively. In this embodiment, the second test strip 620 can move relative to the first test strip 610 between the reaction position (FIG. 9A) and the detection position (FIG. 9B ). When the second test strip 620 is in the reaction position, the reagent area 621 is not connected to the detection area 611, and when the second test strip 620 is in the detection position, the reagent area 621 is connected to the detection area 611.

在上述實施例中，第一間隙Y₁小於第二間隙Y₂。在一實施例中，第二間隙Y₂與第一間隙Y₁的差值不小於50微米。在一實施例中，第二間隙Y₂不大於1毫米。在一實施例中，第二間隙Y₂係800微米，而第一間隙Y1係200微米。 In the above embodiment, the first gap Y _{1 is} smaller than the second gap Y ₂ . In an embodiment, _{the difference between the second gap Y 2} and the first gap Y ₁ is not less than 50 microns. In an embodiment, the second gap Y _{2 is} not greater than 1 mm. In one embodiment, the second gap Y ₂ is 800 microns, and the first gap Y1 is 200 microns.

詳細而言，請參閱圖10A及圖10B，其分別係圖9A及圖9B沿軸C-C’的剖面圖，其中鏈線表示摺疊片材634對折形成的摺線638。引道631具有入口端632及相反於入口端632之出口端633，其中入口端632可插設於試劑區621而出口端633可插設於檢測區611。當第二試片620位於反應位置時，引道631僅與試劑區621或檢測區611 任一者相連通。在一實施例中，引道631僅藉由出口端633與檢測區611相連通不與試劑區621相通(圖10A)。在另一實施例中，引道631僅與試劑區621相連通而不與檢測區611相通(圖未繪示)。當第二試片620位於檢測位置時，引道631同時與試劑區621及檢測區611相連通，如圖10B所示。 In detail, please refer to FIGS. 10A and 10B, which are cross-sectional views of FIGS. 9A and 9B along the axis C-C', respectively. The chain line represents the folding line 638 formed by folding the folded sheet 634 in half. The approach path 631 has an inlet end 632 and an outlet end 633 opposite to the inlet end 632. The inlet end 632 can be inserted into the reagent area 621 and the outlet end 633 can be inserted into the detection area 611. When the second test strip 620 is at the reaction position, the approach path 631 is only connected to the reagent area 621 or the detection area 611 Either one is connected. In one embodiment, the approach path 631 communicates with the detection area 611 only through the outlet end 633 but does not communicate with the reagent area 621 (FIG. 10A ). In another embodiment, the approach path 631 only communicates with the reagent area 621 and does not communicate with the detection area 611 (not shown in the figure). When the second test strip 620 is located at the detection position, the approach path 631 communicates with the reagent area 621 and the detection area 611 at the same time, as shown in FIG. 10B.

特別說明的是，第一試片610與第二試片620之態樣不限，除了如圖9A及圖9B所示，亦可如圖11A及圖11B所示，其係顯示根據本發明不同實施例之光學式凝血檢測試片組600試劑區621與檢測區611不連通(圖11A)或連通(圖11B)的示意圖。在本實施例中，第一試片610之第一基板612、第一上片613及支撐件615係一體成形，從而相配合以界定出檢測區611，第二試片620之第二基板622、第二上片623及支撐件625係一體成形，從而相配合以界定出試劑區621。如圖11A所示，毛細單元630之出口端633與檢測區611不連通，因此在試劑區621的血液樣本無法流入檢測區611。如圖11B所示，檢測區611與試劑區621藉由毛細單元630相連通，因此在試劑區621的血液樣本可被導入檢測區611。 In particular, the configuration of the first test strip 610 and the second test strip 620 is not limited. In addition to those shown in FIGS. 9A and 9B, they can also be shown in FIGS. A schematic diagram of the optical coagulation test strip set 600 of the embodiment in which the reagent area 621 and the detection area 611 are not connected (FIG. 11A) or connected (FIG. 11B ). In this embodiment, the first substrate 612 of the first test strip 610, the first top sheet 613, and the support 615 are integrally formed so as to cooperate to define the detection area 611, and the second substrate 622 of the second test strip 620 , The second top piece 623 and the supporting member 625 are integrally formed so as to cooperate to define the reagent area 621. As shown in FIG. 11A, the outlet end 633 of the capillary unit 630 is not connected to the detection area 611, so the blood sample in the reagent area 621 cannot flow into the detection area 611. As shown in FIG. 11B, the detection area 611 and the reagent area 621 are connected by the capillary unit 630, so the blood sample in the reagent area 621 can be introduced into the detection area 611.

在本實施例中，毛細單元630之態樣不限，但出口端633的截面大於入口端632的另一截面。毛細單元630之樣態可例如圖4B、圖5A或圖5B所繪示之毛細單元130。 In this embodiment, the shape of the capillary unit 630 is not limited, but the cross section of the outlet end 633 is larger than the other cross section of the inlet end 632. The capillary unit 630 can be, for example, the capillary unit 130 shown in FIG. 4B, FIG. 5A or FIG. 5B.

在一實施例中，第二試片620之製作材料不限，但第一基板612、第一上片613對應檢測區611之部分及毛細單元630是由上述透明親水性聚合物所製成。 In one embodiment, the material of the second test piece 620 is not limited, but the first substrate 612, the portion of the first top piece 613 corresponding to the detection area 611, and the capillary unit 630 are made of the above-mentioned transparent hydrophilic polymer.

請見圖12A及圖12B，其係顯示根據本發明不同實施例之光學式凝血檢測試片組600設置於光學式凝血檢測機700時，試劑區621與檢測區611不連通(圖12A)或連通(圖12B)的示意圖。如圖12A所示，光學式凝血檢測機700可包含承載平台701、上蓋702、發光部件710、感光部件720及震動單元730，其中上蓋702設置於承載平台701之上而至少覆蓋檢測區611，且上蓋702包含***口703以容置上述光學式凝血檢測試片組600之第一試片610。前述發光部件710與感光部件720之設置位置不限，但發光部件710所射出的光線之光路需經過檢測區611而為感光部件720接收，可例如圖12A及圖12B，其中發光部件710對應檢測區611設置於承載平台701之頂部，而感光部件720對應發光部件710設置於上蓋702之底部。在一實施例中，發光部件710設置於上蓋702而感光部件720設置於承載平台701(圖未繪示)。此外，在承載平台701上，第二試片620於反應位置之試劑區621之下方設有上述震動單元730，以使試劑區621產生持續時間不大於7秒的震動。 Please refer to Figures 12A and 12B, which show that when the optical coagulation test strip set 600 according to different embodiments of the present invention is set in the optical coagulation detector 700, the reagent area 621 and the detection area 611 are not connected (Figure 12A) or Schematic diagram of connectivity (Figure 12B). As shown in FIG. 12A, the optical coagulation detector 700 may include a carrying platform 701, an upper cover 702, a light-emitting component 710, a photosensitive component 720, and a vibration unit 730, wherein the upper cover 702 is disposed on the carrying platform 701 so as to cover at least the detection area 611, The upper cover 702 includes an insertion port 703 to accommodate the first test strip 610 of the optical coagulation test strip group 600 described above. The position of the light-emitting component 710 and the photosensitive component 720 is not limited, but the light path of the light emitted by the light-emitting component 710 needs to pass through the detection area 611 to be received by the photosensitive component 720. For example, as shown in FIGS. 12A and 12B, the light-emitting component 710 detects correspondingly. The area 611 is disposed on the top of the supporting platform 701, and the photosensitive component 720 is disposed on the bottom of the upper cover 702 corresponding to the light emitting component 710. In one embodiment, the light-emitting component 710 is disposed on the upper cover 702 and the photosensitive component 720 is disposed on the supporting platform 701 (not shown in the figure). In addition, on the supporting platform 701, the second test strip 620 is provided with the above-mentioned vibration unit 730 below the reagent area 621 of the reaction position, so that the reagent area 621 generates vibration with a duration of not more than 7 seconds.

在上述實施例中，第二試片620可相對第一試片610在反應位置(圖12A)與檢測位置(圖12B)之間移動，以使檢測區611與試劑區621不連通(圖12A)或連通(圖12B)。詳細而言，第二試片620相對第一試片610之移動方式不限，可為第二試片620相對承載平台701之移動，或是將第二試片620固定於承載平台701並由承載平台701之移動帶動第二試片620之移動。前者可例如在承載平台701上設置滑軌以及可在滑軌上移動的滑動台(圖未繪示)，其中滑動台可用以固定第二試片620並使第二試片620在反應位置與檢測位置間移動。後者如圖12A所示，承載平台701可包含固定件705與位移件707，其中固定件705承載第一試片610，而位移件707承載第二試片620。當第二試片620從反應位置移向檢測位置時，位移件707向固定件705移動，直到第二試片620位於使檢測區611與試劑區621連通的檢測位置(圖12B)。位移件707向固定件705移動的方式不限，可例如以滑軌連接位移件707並使位移件707在滑軌上滑動，或以伸縮桿連接位移件707而以伸縮桿之伸縮帶動位移件707之移動(圖未繪示)。 In the above embodiment, the second test strip 620 can move relative to the first test strip 610 between the reaction position (FIG. 12A) and the detection position (FIG. 12B), so that the detection area 611 and the reagent area 621 are not connected (FIG. 12A) ) Or connected (Figure 12B). In detail, the movement of the second test strip 620 relative to the first test strip 610 is not limited, and it can be the movement of the second test strip 620 relative to the carrier platform 701, or the second test strip 620 is fixed on the carrier platform 701 and The movement of the carrier platform 701 drives the movement of the second test piece 620. For the former, a sliding rail and a sliding table (not shown in the figure) movable on the sliding rail can be provided on the carrying platform 701, wherein the sliding table can be used to fix the second test piece 620 and make the second test piece 620 in the reaction position and Movement between detection positions. The latter is shown in FIG. 12A, the carrying platform 701 may include a fixing part 705 and a displacement part 707, wherein the fixing part 705 carries the first test piece 610 and the displacement part 707 carries the second test piece 620. When the second test strip 620 moves from the reaction position to the detection position, the displacement member 707 moves to the fixing member 705 until the second test strip 620 is located at the detection position connecting the detection area 611 and the reagent area 621 (FIG. 12B ). The manner in which the displacement member 707 moves to the fixed member 705 is not limited. For example, a slide rail is used to connect the displacement member 707 and slide the displacement member 707 on the slide rail, or a telescopic rod is connected to the displacement member 707 and the displacement member is driven by the extension of the telescopic rod. Movement of 707 (not shown in the figure).

請參閱圖13，並同時參閱圖9A、圖9B、圖12A及圖12B，其係根據本發明一實施例之光學式凝血檢測方法。如步驟1301所示，將光學式凝血檢測試片組600置於光學式凝血檢測機700中，其中第一試片610容置於***口 703內，以使發光部件710所發出的光線可以照射至檢測區611。接著，如步驟1303所示，使第二試片620位於反應位置且試劑區621位於震動單元730上。然後，如步驟1305所示，將血液樣本送入試劑區621，並用震動單元730使試劑區621產生持續時間不大於7秒的震動，以使血液樣本與試劑區621內的試劑629反應而形成反應樣本，再如步驟1307所示，將第二試片620由反應位置移動至檢測位置，使反應樣本流向檢測區611。接下來，如步驟1309所示，以光學檢測反應樣本的透光率，並計算凝血時間。 Please refer to FIG. 13 together with FIG. 9A, FIG. 9B, FIG. 12A, and FIG. 12B, which is an optical coagulation detection method according to an embodiment of the present invention. As shown in step 1301, the optical coagulation detection test strip group 600 is placed in the optical coagulation detection machine 700, wherein the first test strip 610 is accommodated in the insertion port 703, so that the light emitted by the light-emitting component 710 can irradiate the detection area 611. Then, as shown in step 1303, the second test strip 620 is positioned at the reaction position and the reagent area 621 is positioned on the vibration unit 730. Then, as shown in step 1305, the blood sample is sent into the reagent area 621, and the vibration unit 730 is used to make the reagent area 621 vibrate with a duration of not more than 7 seconds, so that the blood sample reacts with the reagent 629 in the reagent area 621 to form For the reaction sample, as shown in step 1307, the second test strip 620 is moved from the reaction position to the detection position, so that the reaction sample flows to the detection area 611. Next, as shown in step 1309, the light transmittance of the reaction sample is optically detected, and the clotting time is calculated.

以下利用數個實施例以說明本發明之應用，然其並非用以限定本發明，本發明技術領域中具有通常知識者，在不脫離本發明之精神和範圍內，當可作各種之更動與潤飾。 Several embodiments are used below to illustrate the application of the present invention, but they are not used to limit the present invention. Those with ordinary knowledge in the technical field of the present invention can make various modifications and changes without departing from the spirit and scope of the present invention. Retouch.

凝血酶原時間(prothrombin time，PT)係表示血液樣本接觸凝血試劑後，凝血酶原轉化成凝血酶並使血液樣本凝固所需的時間，由於血液樣本凝固的過程中血液樣本之透光度會發生改變，因此可藉由血液樣本之透光度的變化推算PT。在本實施例中，以訊號電壓之變化表徵血液樣本的透光度。請參閱圖14A與圖14B，其中圖14A中，橫軸表示時間，縱軸表示訊號電壓，折線1410及折線1430分別表示未使用或使用本發明提供之光學式凝血檢測試片組之凝血結果，點1411、點1413分別為折線1410在第0 秒至第20秒區間之間的相對較小值與相對較大值，點1431、點1433分別為折線1430在第10秒至第30秒區間之間的相對較小值與相對較大值；圖14B中，橫軸表示時間，縱軸表示訊號電壓對時間的進行一階微分之結果(dV/dt)，折線1450及折線1470分別為圖4A中折線1410及折線1430之變化率。需注意的是，在此實施例中，不論是否使用本發明提供之光學式凝血檢測試片組，血液樣本在加入至試劑區至檢測進行前，皆無經過震動處理。此外，圖14A大於0.145V之訊號電壓表示檢測前的透光度，故省略而未繪示。 Prothrombin time (PT) refers to the time required for the conversion of prothrombin to thrombin and clotting of the blood sample after the blood sample comes into contact with the coagulation reagent. Because the light transmittance of the blood sample during the clotting process of the blood sample will change The change occurs, so the PT can be estimated from the change in the light transmittance of the blood sample. In this embodiment, the change in signal voltage is used to characterize the light transmittance of the blood sample. Please refer to FIGS. 14A and 14B. In FIG. 14A, the horizontal axis represents time, and the vertical axis represents signal voltage. Broken line 1410 and broken line 1430 respectively represent the coagulation results of the optical coagulation test strip provided by the present invention or not used. The point 1411 and the point 1413 are respectively the broken line 1410 in the 0th The relatively small value and the relatively large value between the second to the 20th second interval, points 1431 and 1433 are respectively the relatively small value and the relatively large value of the broken line 1430 between the 10th second to the 30th second interval; In FIG. 14B, the horizontal axis represents time, and the vertical axis represents the result of first-order differentiation of the signal voltage with respect to time (dV/dt). The broken line 1450 and the broken line 1470 are the rate of change of the broken line 1410 and the broken line 1430 in FIG. 4A, respectively. It should be noted that in this embodiment, no matter whether the optical coagulation test strip provided by the present invention is used or not, the blood sample is not subjected to vibration processing before being added to the reagent area until the test is performed. In addition, the signal voltage greater than 0.145V in FIG. 14A represents the light transmittance before detection, so it is omitted and not shown.

如圖14A所示，訊號電壓的變化可分為三個階段。第一階段中訊號電壓驟降，如折線1410由第0秒至點1411對應的時間點所示，或如折線1430由第10秒至點1413對應的時間點所示。第一階段中，由於與試劑混合的血液樣本進入檢測區，血液樣本中紅血球等細胞阻擋光線的通過，使檢測區透光度急遽下降，導致訊號電壓驟降。需說明的是，第二階段中，訊號電壓上升，直到血液開始凝固(如折線1410中點1411至點1413所示，或如折線1430中點1431至點1433所示)，這是因為原先散佈於血液中的紅血球受到纖維蛋白原(fibrinogen)或試劑中離子的影響，凝聚成錢串狀(rouleaux)，從而使光線得以從錢串狀紅血球間穿過，造成的透光率上升。 As shown in Figure 14A, the change in signal voltage can be divided into three stages. In the first stage, the signal voltage drops sharply, as shown by the time point corresponding to the broken line 1410 from the 0th second to the point 1411, or as shown by the time point corresponding to the broken line 1430 from the 10th second to the point 1413. In the first stage, as the blood sample mixed with the reagent enters the detection area, cells such as red blood cells in the blood sample block the passage of light, causing a sharp drop in the light transmittance of the detection area, resulting in a sharp drop in signal voltage. It should be noted that in the second stage, the signal voltage rises until the blood starts to coagulate (as shown from the point 1411 to the point 1413 of the broken line 1410, or as shown from the point 1431 to the point 1433 of the broken line 1430). This is because the original spread The red blood cells in the blood are affected by fibrinogen or the ions in the reagent and condense into rouleaux, so that light can pass between the red blood cells in the rouleaux, resulting in an increase in light transmittance.

第三階段中，訊號電壓下降在第三階段中，在血液樣本與凝血試劑的作用下，血液樣本中的凝血酶原開始作用，使得纖維蛋白原形成具有網狀結構的纖維蛋白，造成凝聚的錢串狀紅血球再度分散在網狀結構上，導致血液樣本的透光率再度下降，直到血液樣本完全凝固。 In the third stage, the signal voltage drops. In the third stage, under the action of the blood sample and the coagulation reagent, the prothrombin in the blood sample starts to act, causing fibrinogen to form fibrin with a network structure, resulting in agglomeration The money string-shaped red blood cells are dispersed on the mesh structure again, causing the light transmittance of the blood sample to decrease again until the blood sample is completely coagulated.

如前所述，PT量測始於血液樣本與凝血試劑的接觸，而終於血液樣本的結塊形成，也就是凝血酶原開始作用的時間點。凝血酶原開始作用時，訊號電壓下降率具有相對較大之絕對值。如圖14B所示，折線1470在約第27秒有相對較小值(相對較大絕對值)，而此時間點即PT量測結束的時間點。 As mentioned earlier, the PT measurement begins with the contact of the blood sample with the coagulation reagent, and finally the formation of agglomerates in the blood sample, which is the time point when prothrombin starts to act. When prothrombin starts to work, the signal voltage drop rate has a relatively large absolute value. As shown in FIG. 14B, the broken line 1470 has a relatively small value (relatively large absolute value) at about the 27th second, and this time point is the time point when the PT measurement ends.

承上，如要精確計算PT，電壓訊號需要能清楚表徵血液凝固的過程。如圖14A所示，如未使用本發明之光學式凝血檢測試片組進行凝血測試，則在血液開始凝固(如點1413所示)之時間點後，折線1410緩慢下降，且變化率無顯著差異，但如使用本發明之光學式凝血檢測試片組進行凝血測試，血液開始凝固(如點1433所示)之時間點後，折線1430下降程度劇烈且有顯著的斜率變化。如圖14B所示，折線1430經一階微分後(折線1470)，在約第27秒有較清楚而容易辨別的相對較小值。據此，應用本發明之光學式凝血檢測試片組將可獲得清晰度更好的凝血檢測訊號，從而增加PT量測之精確度。 In addition, for accurate calculation of PT, the voltage signal needs to be able to clearly characterize the process of blood coagulation. As shown in Figure 14A, if the optical coagulation test strip set of the present invention is not used for the coagulation test, after the time point when the blood begins to coagulate (as indicated by point 1413), the broken line 1410 slowly drops, and the rate of change is not significant However, if the optical coagulation test strip set of the present invention is used for coagulation test, after the time point when the blood starts to coagulate (as indicated by point 1433), the broken line 1430 drops drastically and has a significant slope change. As shown in FIG. 14B, after the first-order differentiation of the broken line 1430 (the broken line 1470), there is a relatively small value that is clearer and easier to distinguish at about the 27th second. Accordingly, the application of the optical coagulation detection test strip set of the present invention can obtain a clearer coagulation detection signal, thereby increasing the accuracy of PT measurement.

為了使血液樣本與試劑混合的更加均勻，可在使用本發明之光學式凝血檢測試片組進行凝血檢測時，在放入血液樣本後進一步以馬達提供震源而使得試劑區發生震動，從而將血液樣本與試劑混合均勻，其結果請見圖15A與圖15B。 In order to make the blood sample and the reagent mix more uniformly, when the optical coagulation test strip set of the present invention is used for coagulation detection, after the blood sample is placed, a motor is further used to provide a vibration source to cause the reagent area to vibrate, thereby reducing the blood The sample and reagent are mixed evenly, and the results are shown in Figure 15A and Figure 15B.

請參閱圖15A與圖15B，其中圖15A中，橫軸表示時間，縱軸表示訊號電壓，折線1510及折線1530分別表示沒有或有進行震動處理，點1511、點1513分別為折線1510在第10秒至第30秒區間之間的相對較小值與相對較大值，點1531、點1533分別為折線1530在第10秒至第30秒區間之間的相對較小值與相對較大值；圖15B中，橫軸表示時間，縱軸表示訊號電壓對時間的進行一階微分之結果(dV/dt)，折線1550及折線1570分別為圖5A中折線1510及折線1530之變化率。 Please refer to Figures 15A and 15B. In Figure 15A, the horizontal axis represents time and the vertical axis represents signal voltage. The broken line 1510 and the broken line 1530 respectively represent no or no vibration processing. Points 1511 and 1513 are broken lines 1510 in the 10th. The relatively small value and the relatively large value between the second to the 30th second interval, points 1531 and 1533 are respectively the relatively small value and the relatively large value of the broken line 1530 between the 10th second to the 30th second interval; In FIG. 15B, the horizontal axis represents time, and the vertical axis represents the result (dV/dt) of the first-order differentiation of the signal voltage with respect to time. The broken line 1550 and the broken line 1570 are the rate of change of the broken line 1510 and the broken line 1530 in FIG. 5A, respectively.

如圖15A所示，在血液凝固開始(如點1513及點1533所示)後，相對於未經震動處理前(如折線1510所示)，經震動處理後(如折線1530所示)的訊號電壓下降幅度較大。從圖15B可知，相較於折線1550，折線1570具有較清楚的而容易辨別的極小值。因此，應用本發明之光學式凝血檢測試片組並以震動加以混合試劑與血液樣本，將可獲得更明顯而清晰的訊號，從而使凝血檢測之結果更為精準。 As shown in Figure 15A, after the blood coagulation starts (as shown at points 1513 and 1533), compared to the signal after the shock treatment (as shown by the broken line 1530) before the vibration treatment (as shown by the broken line 1510) The voltage drop is relatively large. It can be seen from FIG. 15B that, compared with the broken line 1550, the broken line 1570 has a clearer and easily distinguishable minimum value. Therefore, by applying the optical coagulation test strip set of the present invention and mixing the reagent and the blood sample with vibration, a more obvious and clear signal can be obtained, so that the result of the coagulation test is more accurate.

由圖15A與圖15B可知，在使用本發明之光學式凝血檢測試片組時輔以震動處理，可改善訊號品質。然而，由於本發明之光學式凝血檢測試片組是以毛細單元連通試劑區與檢測區，震動處理的時間不能超過正常人的PT(約11至13.5秒)，以免血液樣本黏滯於引道中而無法順利導入檢測區。為找出較佳的震動時間，將血液樣本以不同的時間進行震動，其結果如表1所示，其中圖號○代表血液順利流進檢測區，圖號X代表血液沒有順利流進檢測區。當震動時間分別為1秒、3秒、5秒與7秒時，血液樣本可順利流入檢測區且改善訊號品質(圖未繪示)，但如果震動時間達9秒，則血液無法順利流入檢測區。因此，震動時間不大於7秒。 It can be seen from FIGS. 15A and 15B that when the optical coagulation test strip set of the present invention is used, vibration processing can be supplemented to improve the signal quality. However, because the optical coagulation test strip set of the present invention is connected with the reagent area and the detection area by a capillary unit, the vibration processing time cannot exceed the PT of a normal person (about 11 to 13.5 seconds), so as to prevent the blood sample from sticking in the approach channel It cannot be imported into the detection area smoothly. In order to find a better vibration time, the blood samples were shaken at different times. The results are shown in Table 1. The figure number ○ represents the smooth flow of blood into the detection area, and the figure number X represents that the blood does not flow into the detection area smoothly. . When the vibration time is 1 second, 3 seconds, 5 seconds, and 7 seconds, the blood sample can smoothly flow into the detection area and improve the signal quality (not shown in the figure), but if the vibration time is 9 seconds, the blood cannot flow into the detection smoothly Area. Therefore, the vibration time is not more than 7 seconds.

表1

Table 1

綜言之，本發明雖以特定的結構與特定的檢測方法作為例示，說明本發明之光學式凝血檢測試片組、含此之設備及其檢測方法，惟本發明所屬技術領域中任何具有通常知識者可知，本發明並不限於此，在不脫離本發明之精神和範圍內，本發明亦可使用其他結構或其他檢測方法進行。 In summary, although the present invention takes a specific structure and a specific detection method as an example to illustrate the optical coagulation test strip set of the present invention, the equipment containing the test strip, and the detection method thereof, any technical field of the present invention has common Those skilled in the art know that the present invention is not limited to this, and the present invention can also be carried out using other structures or other detection methods without departing from the spirit and scope of the present invention.

雖然本發明已以數個實施例揭露如上，然其並非用以限定本發明，在本發明所屬技術領域中任何具有通常知識者，在不脫離本發明之精神和範圍內，當可作各種之更動與潤飾，因此本發明之保護範圍當視後附之申請專利範圍所界定者為準。 Although the present invention has been disclosed in several embodiments as above, it is not intended to limit the present invention. Anyone with ordinary knowledge in the technical field to which the present invention belongs can make various modifications without departing from the spirit and scope of the present invention. Modifications and modifications, therefore, the scope of protection of the present invention shall be subject to those defined by the attached patent application scope.

100:光學式凝血檢測試片組 100: Optical coagulation test strip group

110:第一試片 110: The first test piece

111:檢測區 111: detection area

112:第一基板 112: first substrate

113:第一上片 113: The first film

115,125:支撐件 115, 125: support

120:第二試片 120: second test piece

121:試劑區 121: Reagent area

122:第二基板 122: second substrate

123:第二上片 123: Second Top

130:毛細單元 130: capillary unit

131:引道 131: Approach

134:摺疊片材 134: Folded sheet

H1:第一間隙 H1: The first gap

H2:第二間隙 H2: second gap

A-A’:軸 A-A’: axis

Claims

一種光學式凝血檢測試片組，包含：一檢測區；一試劑區，與該檢測區相間隔且該試劑區具有一試劑；一毛細單元，形成連通該檢測區與該試劑區的一引道，其中該引道包含連通該試劑區的一吸入端以及相反於該吸入端而連通該檢測區的一導出端，該吸入端的一截面小於該導出端的另一截面；一基材；一與該基材間隔一第一間隙的第一上片，以及一與該基材間隔一第二間隙的第二上片，其中該基材與該第一上片相配合界定出該檢測區，該基材與該第二上片界定出該試劑區，且該第一間隙小於該第二間隙。 An optical coagulation detection test strip group, comprising: a detection area; a reagent area spaced from the detection area and the reagent area has a reagent; a capillary unit forming an approach path connecting the detection area and the reagent area , Wherein the approach path includes a suction end connected to the reagent zone and a discharge end connected to the detection zone opposite to the suction end, a cross section of the suction end is smaller than another cross section of the discharge end; a substrate; The substrate is separated by a first upper sheet with a first gap, and a second upper sheet is separated from the substrate by a second gap, wherein the substrate and the first upper sheet cooperate to define the detection area, the substrate The reagent area is defined by the material and the second top sheet, and the first gap is smaller than the second gap.

如請求項1所述之光學式凝血檢測試片組，其中該第二間隙與該第一間隙的一差值不小於50微米。 The optical coagulation test strip set according to claim 1, wherein a difference between the second gap and the first gap is not less than 50 microns.

如請求項1所述之光學式凝血檢測試片組，其中該第二間隙不大於1毫米。 The optical coagulation test strip set according to claim 1, wherein the second gap is not greater than 1 mm.

如請求項1至3任一項所述之光學式凝血檢測試片組，其中該毛細單元包含折疊形成該引道的一摺疊片材。 The optical coagulation test strip set according to any one of claims 1 to 3, wherein the capillary unit includes a folded sheet folded to form the approach path.

如請求項4所述之光學式凝血檢測試片組，其中該毛細單元是以透明親水性材料所製成。 The optical coagulation test strip set according to claim 4, wherein the capillary unit is made of transparent hydrophilic material.

一種光學式凝血檢測機，適用於如請求項1 所述之光學式凝血檢測試片組，其中該光學式凝血檢測機包含：一發光部件，對應該檢測區設置，且能朝該檢測區射出一光線；一感光部件，用以接收該發光部件所射出的該光線；以及一阻斷閥，對應該毛細單元設置，且可在一導通位置及一阻斷位置間移動，當該阻斷閥在該導通位置時，該引道連通該試劑區及該檢測區，當該阻斷閥在該阻斷位置時，該阻斷閥壓抵該毛細單元，因此該檢測區與該試劑區不連通。 An optical coagulation detection machine, suitable for such as claim 1 In the optical coagulation detection test strip set, the optical coagulation detection machine includes: a light-emitting component arranged corresponding to the detection area and capable of emitting a light toward the detection area; and a photosensitive component for receiving the light-emitting component The emitted light; and a blocking valve, which is set corresponding to the capillary unit and can be moved between a conducting position and a blocking position. When the blocking valve is in the conducting position, the guide channel communicates with the reagent area And the detection zone, when the blocking valve is in the blocking position, the blocking valve is pressed against the capillary unit, so the detection zone is not connected with the reagent zone.

如請求項6所述之光學式凝血檢測機，其中該光學式凝血檢測機更包含對應該試劑區設置的一震動單元，該震動單元能使該試劑區產生持續時間不大於7秒的一震動。 The optical coagulation detector according to claim 6, wherein the optical coagulation detector further comprises a vibration unit corresponding to the reagent area, and the vibration unit can cause the reagent area to generate a vibration with a duration of not more than 7 seconds .

一種光學式凝血檢測方法，包含：準備如請求項1所述之光學式凝血檢測試片組，及如請求項6所述之光學式凝血檢測機；將該光學式凝血檢測試片組置於該光學式凝血檢測機；該阻斷閥由該導通位置移動至該阻斷位置；將一血液樣本送入該試劑區，使該血液樣本與該試劑區內的該試劑反應而形成一反應樣本；該阻斷閥由該阻斷位置移動至該導通位置，該反應樣本經該毛細單元由該試劑區流向該檢測區；以及以該感光部件接收該發光部件朝向該檢測區發出的該光線，以檢測該反應樣本。 An optical coagulation detection method, comprising: preparing the optical coagulation detection test strip set according to claim 1 and the optical coagulation detection machine according to claim 6; placing the optical coagulation detection test strip set The optical coagulation detection machine; the blocking valve is moved from the conducting position to the blocking position; a blood sample is sent into the reagent zone, so that the blood sample reacts with the reagent in the reagent zone to form a reaction sample The blocking valve moves from the blocking position to the conducting position, and the reaction sample flows from the reagent area to the detection area through the capillary unit; and The light-sensitive component receives the light emitted from the light-emitting component toward the detection area to detect the reaction sample.

一種光學式凝血檢測試片組，包含：一第一試片，包含一第一基板及與該第一基板間隔一第一間隙的一第一上片，該第一基板與該第一上片相配合界定出可透光的一檢測區；以及一第二試片，包含一第二基板，及與該第二基板間隔一第二間隙的一第二上片，該第二基板與該第二上片相配合界定出具有一試劑的一試劑區，且該第一間隙小於該第二間隙，其中該第二試片能相對該第一試片在一反應位置與一檢測位置間移動，當該第二試片在該反應位置時，該試劑區與該檢測區不連通，當該第二試片在該檢測位置時，該試劑區與該檢測區相連通。 An optical coagulation detection test strip group, comprising: a first test strip, comprising a first substrate and a first top sheet separated from the first substrate by a first gap, the first substrate and the first top sheet Cooperate to define a detection area that can transmit light; and a second test piece, including a second substrate, and a second upper piece separated from the second substrate by a second gap, the second substrate and the first The two upper plates cooperate to define a reagent area with a reagent, and the first gap is smaller than the second gap, wherein the second test strip can move between a reaction position and a detection position relative to the first test strip, When the second test strip is in the reaction position, the reagent area is not connected to the detection area, and when the second test strip is in the detection position, the reagent area is connected to the detection area.

如請求項9所述之光學式凝血檢測試片組，其中該第二間隙與該第一間隙的一差值不小於50微米。 The optical coagulation test strip set according to claim 9, wherein a difference between the second gap and the first gap is not less than 50 microns.

如請求項9所述之光學式凝血檢測試片組，其中該第二間隙不大於1毫米。 The optical coagulation test strip set according to claim 9, wherein the second gap is not greater than 1 mm.

如請求項9至11中任一請求項所述之光學式凝血檢測試片組，更包含形成一引道的一毛細單元，當該第二試片在該反應位置時，該引道的一端連通該檢測區或該試劑區，而當該第二試片在該檢測位置時，該引道的兩端分別連通該檢測區與該試劑區。 The optical coagulation test strip set according to any one of claims 9 to 11 further includes a capillary unit forming an approach path. When the second test strip is at the reaction position, one end of the approach path The detection area or the reagent area is connected, and when the second test strip is at the detection position, the two ends of the approach path are respectively connected to the detection area and the reagent area.

如請求項12所述之光學式凝血檢測試片組，其中該引道具有連通該試劑區的一入口端及相反於該入口端的一出口端，該出口端的一截面大於該入口端的另一截面。 The optical coagulation test strip set of claim 12, wherein the approach path has an entrance end connected to the reagent area and opposite to the entrance An outlet end of the end, a cross section of the outlet end is larger than another cross section of the inlet end.

如請求項12所述之光學式凝血檢測試片組，其中該毛細單元包含折疊形成該引道的一摺疊片材。 The optical coagulation test strip set according to claim 12, wherein the capillary unit includes a folded sheet that is folded to form the approach path.

如請求項14所述之光學式凝血檢測試片組，其中該第一試片與該毛細單元是由透明親水性聚合物所製成。 The optical coagulation test strip set according to claim 14, wherein the first test strip and the capillary unit are made of transparent hydrophilic polymer.

一種光學式凝血檢測機，適用於如請求項9所述之光學式凝血檢測試片組，其中該光學式凝血檢測機包含：一發光部件，能朝該檢測區射出一光線；一感光部件，用以接收該發光部件所射出的該光線；以及一震動單元，使該試劑區產生持續時間不大於7秒的一震動。 An optical coagulation detection machine suitable for the optical coagulation detection test strip set according to claim 9, wherein the optical coagulation detection machine includes: a light-emitting component capable of emitting a light toward the detection area; a photosensitive component, Used to receive the light emitted by the light-emitting component; and a vibration unit to cause the reagent area to generate a vibration with a duration of not more than 7 seconds.

一種光學式凝血檢測方法，包含：準備如請求項9至15任一請求項所述之光學式凝血檢測試片組，及如請求項16所述之光學式凝血檢測機；將該光學式凝血檢測試片組置於該光學式凝血檢測機，使該第二試片位於該反應位置並位於該震動單元上，而該發光部件所發出的該光線可以照射至該檢測區；將一血液樣本送入該試劑區，且以該震動單元使該試劑區產生持續時間不大於7秒的震動，從而使該血液樣本與該試劑區內的該試劑反應而形成一反應樣本；將該第二試片由該反應位置移動至該檢測位置，使與該試劑反應後的該反應樣本流向該檢測區；以及以該感光部件接收該發光部件朝該檢測區發出的該光線，以檢測該反應樣本。 An optical coagulation detection method, comprising: preparing the optical coagulation detection test strip set according to any one of claims 9 to 15 and the optical coagulation detection machine according to claim 16; the optical coagulation The detection test strip group is placed in the optical coagulation detection machine, so that the second test strip is located at the reaction position and on the vibration unit, and the light emitted by the light-emitting component can irradiate the detection area; a blood sample Send into the reagent area, and use the vibration unit to make the reagent area vibrate with a duration of no more than 7 seconds, so that the blood sample reacts with the reagent in the reagent area to form a reaction sample; Moving the second test strip from the reaction position to the detection position so that the reaction sample after reacting with the reagent flows to the detection area; and the photosensitive member receives the light emitted from the light-emitting member toward the detection area to Test the reaction sample.