M359693 五、新型說明： 【新型所屬之技術領域】 本創作係關於一種檢測試片，特別是一種有關於適用於流體檢測的試 片。 【先前技術】 以流體檢測試片進行生化檢測與免疫檢測的習知技術中，流體檢測試片 在其基板或底材上設計有流道或微流道結構及表面親疏水性處理，而因流道 周圍並非吸水材質，且待測流體多為含有如蛋白質或是醣類等黏滯度高之組 成物，所以當待測流體流過後，會在流道上殘留，使得待測流體無法完全反 應，如此一來’不僅造成待測流體的浪費，更可能造成最終測試結果的誤差。 此外，習知技術的流體檢測試片在流體傳送方面，可設計有微流道結 構，並係利用微流道結構產生的毛細現象，將流體經過流道被動傳送至反應 偵測區域；另一種方式則是在注入待測流體時即利用加壓或真空負壓等方 式，給予流體一驅動力，又或於流道中設置一個或以上之微閥門 (micro-actuator or valve)等設計，使得流體可主動並依序通過流道，到達反應 偵測區域。但是無論是上述任一種方式，待測流體注入流道後常常產生或捲 入大小不一的氣泡使得流道阻塞，造成實際測量上之誤差，甚至致使測試失 敗，而微閥門(micro-actuator or valve)增設又增加整體設計困難度與試片成 本0 又，習知技術的檢測試片在製作上多使用模鑄、射出成型或壓印(imprint) 的方式在基板上做出流道或微流道結構，所以必須使用聚乙烯(pE)、聚氯乙 烯(PVC)或聚丙烯(PP)等價格較高之塑膠聚合物作為材質且模具耗損較快， 進而造成試片之總體成本的提高。 此外，由於進行的反應不同，亦須有不同的反應物或試劑。習知技術的 檢測試片往往設計成只具有單—試劑或反應物，故只適用於單—反應及單一M359693 V. New description: [New technical field] This creation is about a test strip, especially a test piece suitable for fluid detection. [Prior Art] In the conventional technique of performing biochemical detection and immunodetection using a fluid detecting test piece, the fluid detecting test piece is designed with a flow path or a micro flow path structure and a surface hydrophobicity treatment on the substrate or the substrate, and the flow detection process The water around the road is not a water-absorbent material, and the fluid to be tested mostly contains a highly viscous composition such as protein or sugar. Therefore, when the fluid to be tested flows, it will remain on the flow path, so that the fluid to be tested cannot be completely reacted. As a result, it not only causes waste of the fluid to be tested, but is more likely to cause errors in the final test results. In addition, the fluid detecting test piece of the prior art can be designed with a micro-flow channel structure in fluid transfer, and utilizes the capillary phenomenon generated by the micro-flow path structure to passively transfer the fluid through the flow path to the reaction detecting area; The method is to give a driving force to the fluid by using a pressurized or vacuum negative pressure when injecting the fluid to be tested, or to design one or more micro-actuator or valve in the flow channel to make the fluid It can actively and sequentially pass through the flow path to reach the reaction detection area. However, in either of the above manners, the fluid to be tested is often injected or entangled into the flow passages to cause the flow passage to block, causing an error in the actual measurement, and even causing the test to fail, and the micro-actuator or valve Addition increases the overall design difficulty and the cost of the test piece. 0. The test piece of the prior art is used to make a flow path or a micro flow on the substrate by means of die casting, injection molding or imprinting. Because of the structure of the track, it is necessary to use a higher-priced plastic polymer such as polyethylene (pE), polyvinyl chloride (PVC) or polypropylene (PP) as the material and the mold is depleted faster, thereby causing an increase in the overall cost of the test piece. In addition, different reactants or reagents are required due to the different reactions carried out. The test strips of the prior art are often designed to have only a single reagent or reactant, so it is only suitable for single-reaction and single
M359693 【新型内容】 為克服上述缺點，本創作提供—種二合—流體檢測試片，可同時用於生 化檢測與免疫制。主要包含—基板，基板自其上表_下麟供生化檢測 的第-流道與供免疫檢_第二流道，且第—流道與第二流道各自包含依序 連接之第-流體區、第二流體區與第三流體區，第—流體區係供流體之注 入二合—流體檢測試片的特徵在於，在第—流道與第二流道的第二流體區 與第二流體區之底部各自形成有硝化纖維層，$肖化纖維層包含有巾空網狀構 型，其中第二流體區係供流體之傳送，第三流體區係供流體之反應。又，第 二流體區的视纖維層平均厚度不大於第三鍾區硝化纖維層厚度。在確化 纖維層之中空網狀翻中形成有反應物。此外，基板具有縱向轴線，使第一 流道與第二流道的第三流體區同時位於縱向軸線上。 因此，本創作之主要目的，係提供一種二合一流體檢測試片，可同時對 單一樣本進行生化及免疫檢測。 本創作之另一目的，係提供一種二合一流體檢測試片，因具有可吸收液 體的硝化纖維層，故可避免流道之液體殘留。 本創作之另一目的，係七供一種二^^一流體檢測試片，其具有可吸收液 體的硝化纖維層；由於單位體積的硝化纖維吸收液體量係為定值，故可經由 設定基板上硝化纖維層的體積，而提供待測流體的定量檢測。 本創作之又一目的，係供一種二洽^一流體檢測試片，具有中空網狀構 型的硝化纖維層，由於流體流經中空網狀構型時，流體中的氣泡會被破壞， 故可消彌較大的氣泡，避免微流道技術中氣泡阻塞流道的狀況發生，進而影 響定量分析結果。 M359693 【實施方式】M359693 [New Content] In order to overcome the above shortcomings, this creation provides a two-in-one fluid test strip that can be used for both biochemical detection and immunization. Mainly comprising a substrate, the substrate is from the upper surface of the upper table for the biochemical detection of the first flow channel and the immunological detection _ second flow channel, and the first flow channel and the second flow channel respectively comprise the first fluid connected in sequence a zone, a second fluid zone and a third fluid zone, a fluid-injection fluid-injection test piece characterized by a second fluid zone and a second zone in the first flow channel and the second flow channel The bottom of the fluid zone is each formed with a layer of nitrocellulose, and the layer of the Shored fiber comprises a hollow web configuration, wherein the second fluid zone is for fluid transfer and the third fluid zone is for fluid reaction. Further, the average thickness of the fiber layer of the second fluid zone is not greater than the thickness of the nitration fiber layer of the third zone. A reactant is formed in the hollow mesh transition of the confirmed fiber layer. Furthermore, the substrate has a longitudinal axis such that the first flow channel and the third fluid zone of the second flow channel are simultaneously located on the longitudinal axis. Therefore, the main purpose of this creation is to provide a two-in-one fluid test strip that can simultaneously perform biochemical and immunological tests on a single sample. Another object of the present invention is to provide a two-in-one fluid detecting test piece which has a nitrocellulose layer which can absorb liquid, thereby avoiding liquid residue in the flow path. Another purpose of the present invention is to provide a fluid detecting test piece having a liquid nitrating fiber layer; since the liquid volume per unit volume of nitrocellulose is constant, it can be nitrated via a setting substrate. The volume of the fibrous layer provides a quantitative detection of the fluid to be tested. Another object of the present invention is to provide a two-way fluid detection test piece having a hollow network structure of nitrocellulose layer. When the fluid flows through the hollow network configuration, the bubbles in the fluid are destroyed, so Eliminate larger bubbles and avoid the occurrence of bubbles blocking the flow path in the micro-channel technology, which in turn affects the quantitative analysis results. M359693 [Embodiment]
_ 補充 ~1—~^ 取/月/。日雙正 由於本創作係揭露一種二合一流體檢測試片，其中所利用物理、化學原 理及溶液塗佈技術，6為_技術領域具有通常知識者所能明瞭，故以=文 中之說明’不再作完整描述。同時’以下文中所對照之圖式，係表達與本創 作特徵有關之示;t，並未亦不需要依據實際情形完整賴，合先救明。 請參考第1目，為本創作所提出之較佳實施例，為一種二合—流體檢測 . °式片，可同時用於生化檢測與免疫檢測。二合一流體檢測試片丨主要包含有 • 基板10及支撐件19。基板10自其上表φ觸向下凹設供生化檢測的第— 流道11與供免疫檢_第二流道12。第—流道u包含依序連接之第一流體 區m、第二流體區112與第三流體區113 ^第二流道12則包含有依序連接 之第一流體區12卜第二流體區122及第三流體區123。第一流道丨丨的第一 流體區111與第二流道12的第一流體區121互相連通，供流體之注入。當 流體在注入互相通連的第一流體區m與121後，分別經由第一流道U與 第二流道12的第二流體區U2與122的傳送，各自到達第一流道u與第二 流道12的第三流體區113與123 ;而流往第一流道u的流體，流至其第三 流體區113時，流體中的待測成份會在此處進行生化反應，產生訊號以供偵 測。同樣地，流向第二流道12的流體，在流至其第三流體區123時，流體 中的待測成份則會在此處進行反應，產生訊號以供偵測。在較佳的實施狀態 中’基板10為生物相容(biocompatible)。 請繼續參考第2圖，為本創作的二合一流體檢測試片俯視圖。為了便於 偵測，在二合一流體檢測試片1上的第一流道U的第三流體區113與第二 "it·道12的弟二流體區123在設置上是位於基板1〇的同一縱向軸線μ上。 如此來，配合债測的债測器只要在同一縱向轴線14上移動即可偵測到第 流道11的第二流體區113與第二流道12的第三流體區123所發出之反應 訊號。 M359693 ，年/，曰雙正 補无 請繼續參考第3圖，為第1圖中第一流道11沿AA連'圖。在_ 第一流道11的第二流體區112與第三流體區113之底部，分別形成有中空 網狀構型的硝化纖維層1121與1131。其中，第一流道11的第二流體區112 的硝化纖維層1121平均厚度Da小於第一流道11的第三流體區113硝，化纖 維層1131厚度Db。又在硝化纖維層1121與1131的中空網狀構型中，包含 有反應物。此外’由於琐化纖維層1121與1131具有多孔性的中空網狀结構， 所以可以吸收由第一流體區ill流入的流體，且流體中的待測成份與存在於 硝化纖維層1131中的反應物進行反應。_ Supplement ~1—~^ Take / month /. Due to the discovery of a two-in-one fluid test strip, the physics, chemical principles and solution coating techniques used by the authors are well known to those who have the usual knowledge in the field of technology. A full description is given. At the same time, the drawings referred to in the following texts express the indications related to the characteristics of this creation; t, and do not need to be completely based on the actual situation. Please refer to the first item, which is a preferred embodiment of the present invention, which is a two-in-one fluid detection type film, which can be used for both biochemical detection and immunoassay. The two-in-one fluid detecting test piece 丨 mainly includes a substrate 10 and a support member 19. The substrate 10 is recessed from the upper surface φ to the first flow path 11 for biochemical detection and the second flow path 12 for the immunoassay. The first flow channel u includes a first fluid zone m, a second fluid zone 112 and a third fluid zone 113. The second flow channel 12 includes a first fluid zone 12 and a second fluid zone sequentially connected. 122 and a third fluid zone 123. The first fluid zone 111 of the first flow channel and the first fluid zone 121 of the second flow channel 12 communicate with each other for fluid injection. When the fluids are injected into the first fluid regions m and 121 that are connected to each other, respectively, through the first flow path U and the second fluid regions U2 and 122 of the second flow channel 12, respectively, the first flow path u and the second flow are respectively reached. The third fluid zone 113 and 123 of the channel 12; and the fluid flowing to the first channel u to the third fluid zone 113, the component to be tested in the fluid will biochemically react here to generate a signal for detection Measurement. Similarly, the fluid flowing to the second flow path 12, when flowing to its third fluid zone 123, the component to be tested in the fluid will react there to generate a signal for detection. In a preferred embodiment, the substrate 10 is biocompatible. Please continue to refer to Figure 2 for a top view of the two-in-one fluid test strip. For the convenience of detection, the third fluid region 113 of the first flow path U on the two-in-one fluid detecting test piece 1 and the second fluid region 123 of the second "it channel 12 are disposed on the same substrate 1 The longitudinal axis μ is on. In this way, the debt detector that cooperates with the debt measurement can detect the reaction of the second fluid region 113 of the first flow channel 11 and the third fluid region 123 of the second flow channel 12 as long as it moves on the same longitudinal axis 14. Signal. M359693, year/, 曰双正 补无 Please continue to refer to Figure 3, which is the first flow path 11 in Figure 1 along the AA. At the bottom of the second fluid zone 112 and the third fluid zone 113 of the first flow path 11, nitrocellulose layers 1121 and 1131 of a hollow network configuration are respectively formed. The average thickness Da of the nitrocellulose layer 1121 of the second fluid region 112 of the first flow channel 11 is smaller than the third fluid region 113 of the first flow channel 11 and the thickness Db of the chemical fiber layer 1131. Further, in the hollow network configuration of the nitrocellulose layers 1121 and 1131, a reactant is contained. In addition, since the trivial fiber layers 1121 and 1131 have a porous hollow network structure, the fluid flowing in from the first fluid region ill can be absorbed, and the components to be tested in the fluid and the reactants present in the nitrocellulose layer 1131 can be absorbed. Carry out the reaction.
請繼續參考第4圖，為第1圖中第二流道12沿BB連線的剖面圖。第 一流道12亦與第一流道11相同’在其第二流體區122、及第三流體區123 的底部分別形成有中空網狀構型的硝化纖維層1221及123b又在硝化纖維 層1221與1231的中空網狀構型中，與上述第一流道中的硝化纖維層1121 及1131相同，均包含有反應物，且亦因具有多孔性的中空網狀結構，所以 可以吸收由第一流體區121流入的流體，且流體中的待測成份與存在於硝化 纖維層1231中的反應物進行反應。Please refer to FIG. 4 again, which is a cross-sectional view of the second flow path 12 along the BB line in FIG. 1 . The first flow path 12 is also the same as the first flow path 11'. The nitrocellulose layers 1221 and 123b having a hollow network configuration are formed at the bottoms of the second fluid region 122 and the third fluid region 123, respectively, and the nitrocellulose layer 1221 is The hollow mesh configuration of 1231 is the same as the nitrocellulose layers 1121 and 1131 in the first flow path, and includes a reactant, and also has a porous hollow network structure, so that it can be absorbed by the first fluid region 121. The fluid that flows in, and the component to be tested in the fluid reacts with the reactants present in the nitrocellulose layer 1231.
由於第一流道11與第二流道12因具有可吸收液體的硝化纖維層u21、 1131、1221及1231，故可避免流體殘留於第一流道n與第二流道12之中。 此外’當流體流經具有中空網狀構型的硝化纖維層H21、1131、1221及1231 時，流體中的氣泡會被破壞，故可避免氣泡阻塞第一流道n與第二流道12。 此外’為了降低流道與流體之間的毛細作用所造成的影響，本創作所提 出之第一流道與第二流道並非習知技術所謂的微流道，在設計上，第.丨圖所 示，第一流道11的第二流體區112寬度Wa、第一流道η的第三流體區113 寬度Wb、第二流道12的第二流體區122寬度Wc，以及第二流道12的第 三流體區123寬度Wd，則是均以至少〇.3mm為佳。 在製作上，硝化纖維層1121、1131、1221及1231的形成方式如下所述。 將由確化纖維粉末(nitrocellulose powder)製成的硝化纖維溶液洗注(casting) M359693 f卿曰I量 於第"^道y的第二流體區112與第三流體區113的底部以及第二流道12 的第:流體區122及第三流體區123的底部。經乾燥後，於第—流道u的 第一流體區112底部則會形成硝化纖維層1121，第一流道u的第三流體區 113的底部則形成確化纖維層lm，第二流道12的第二流舰122的底部 則形成确化纖維層122卜而於第二流道12的第三趟區123的底部則形成 靖化纖維層1231。為達較佳的洗注效果，第-流道11及第二流道I2之表 面粗糙度(Ra值)以介於3微米至5〇微米之間為佳。 由於單位體積的$肖化纖維吸收液體量係為定值，故可由欲吸收之待測流 體的體積推算出對應_化纖維溶液的體積，之後再行組，藉此可固定檢 測所需液體之體積量，並適用於微量檢測。 反應物形成於硝化纖維層1121、1131、1221及1231中的方式則如下所 述。待硝化纖維層112卜U3卜1221及1231分別乾燥成形後，將含有反應 物的反應溶液注入，經過風乾或是冷;東乾燦(ly〇philizati〇n)後，反應物則會 以粉末狀的形式留存在硝化纖維層1121、1131、1221及1231之中。反應物 形成於其中的方式除可以先形成硝化纖維層之後再注入反應物後的順序形 成方式外，亦可將含有反應物的反應溶液，加入由硝化纖維粉末 (nitrocellulose powder)製成的蝴化纖維溶液中，再澆注㈣sting)於第一流道 11的第二流體區112與第三流體區113的底部以及第二流道12的第二流體 區122、第二流體區123的底部’經過風乾或冷凍乾燥程序，同時將硝化纖 維溶液形成硝化纖維層1121、1131、1221及1231，以及將反應物形成粉末 狀留存在硝化纖維層1121、1131、1221及1231之中。 如上所述’第一流道U係供生化檢測，而第二流道12係供免疫檢測。 由於生化與免疫檢測所需進行之反應有所差異，故形成於第一流道U的硝 化纖維層1121與1131中的反應物，與形成於第二流道12的硝化纖維層1221 與1231中的反應物亦有所不同。 此外’在較佳的實施狀態中，第二流道12上可增設第四流體區(未圖 沒年/月/< M359693 示)_，其底部亦形成有硝I纖維層，藉以吸收多餘之流體。並且，如第4圖 所不’第一流運12的第二流體區122石肖化纖維層1221的厚度α與第三流 體區123硝化纖維層1231的厚度Dd相同。 /、 >· 以上所述僅為本創作較佳實施例而已，並非用以限定本 ^同時以上的描述對於熟之本技術領域之專門人士應可明瞭與實=二 峨_，包含於下 【圖式簡單說明】 第1圖，為本創作較佳實施例二合一流體檢測試片 發 不葱圖。 弟2圖，為本創作較佳實施例二合一流體檢測試片之俯視圖 第3圖，為本創作較佳實施例二合一流體檢測試片第〜 圖 道剖面之示意 圖 第4圖，為本創作較佳實施例二合一流體檢測試片第二流道气 之示意 【主要元件符號說明】 二合一流體檢測試片 基板10 支撐件19 上表面100 第一流道11 第二流道12 縱向軸線14 苐一流體區111、121 第二流體區112、122Since the first flow path 11 and the second flow path 12 have the liquid-absorbent nitrocellulose layers u21, 1131, 1221, and 1231, fluid can be prevented from remaining in the first flow path n and the second flow path 12. Further, when the fluid flows through the nitrocellulose layers H21, 1131, 1221, and 1231 having a hollow network configuration, the bubbles in the fluid are destroyed, so that the bubbles can be prevented from blocking the first flow path n and the second flow path 12. In addition, in order to reduce the influence of capillary action between the flow path and the fluid, the first flow path and the second flow path proposed by the present invention are not so-called micro flow paths of the prior art, and in design, The width W of the second fluid region 112 of the first flow path 11 , the width Wb of the third fluid region 113 of the first flow channel η, the width Wc of the second fluid region 122 of the second flow channel 12, and the second flow channel 12 The width Wd of the three-fluid region 123 is preferably at least 〇3 mm. In the production, the manner in which the nitrocellulose layers 1121, 1131, 1221, and 1231 are formed is as follows. Casting a nitrocellulose solution made of a nitrocellulose powder to the bottom of the second fluid zone 112 and the third fluid zone 113 and the second flow of the second fluid zone 112 The first of the channel 12: the fluid zone 122 and the bottom of the third fluid zone 123. After drying, a nitrocellulose layer 1121 is formed at the bottom of the first fluid region 112 of the first flow channel u, and a bottom portion of the third fluid region 113 of the first flow channel u forms a definitive fiber layer lm, and the second flow channel 12 The bottom of the second flow ship 122 forms a layer of the corrugated fiber 122, and the bottom of the third crotch area 123 of the second flow path 12 forms a layer of the jinghua fiber 1231. For better washing effect, the surface roughness (Ra value) of the first flow path 11 and the second flow path I2 is preferably between 3 μm and 5 μm. Since the amount of liquid absorbed by the Schulzed fiber per unit volume is constant, the volume of the corresponding _ fiber solution can be deduced from the volume of the fluid to be absorbed, and then the group can be set, thereby fixing the liquid required for detection. Volumetric and suitable for microtests. The manner in which the reactants are formed in the nitrocellulose layers 1121, 1131, 1221, and 1231 is as follows. After the nitrocellulose layer 112, U3, 1221 and 1231 are respectively dried and formed, the reaction solution containing the reactant is injected, and air-dried or cooled; after the lyophilic philizati〇n, the reactant is in the form of a powder. The form remains in the nitrocellulose layers 1121, 1131, 1221, and 1231. The method in which the reactants are formed may be formed by a method in which the nitrocellulose layer is first formed and then the reactants are injected, and the reaction solution containing the reactants may be added to the nitrocellulose powder. In the fiber solution, re-casting (d) is applied to the bottom of the second fluid zone 112 and the third fluid zone 113 of the first flow channel 11 and the second fluid zone 122 of the second flow channel 12 and the bottom of the second fluid zone 123 to be air-dried. Alternatively, the nitrocellulose solution is formed into a nitrocellulose layer 1121, 1131, 1221, and 1231, and the reactants are powdered and left in the nitrocellulose layers 1121, 1131, 1221, and 1231. As described above, the first flow path U is for biochemical detection, and the second flow path 12 is for immunodetection. The reactants in the nitrocellulose layers 1121 and 1131 formed in the first flow path U and the nitrocellulose layers 1221 and 1231 formed in the second flow path 12 are different in the reaction required for biochemical and immunological detection. The reactants are also different. In addition, in a preferred embodiment, a fourth fluid zone (not shown in the year/month/< M359693) may be added to the second flow channel 12, and a nitric acid fiber layer is formed at the bottom thereof to absorb excess Fluid. Further, as shown in Fig. 4, the thickness α of the second fluid region 122 of the first fluid transport layer 12 is the same as the thickness Dd of the third fluid region 123 nitrocellulose layer 1231. The above description is only for the preferred embodiment of the present invention, and is not intended to limit the scope of the present invention. The above description should be made clear to the skilled person in the technical field. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a view showing a two-in-one fluid detecting test piece according to a preferred embodiment of the present invention. Figure 2 is a top view of a two-in-one fluid detecting test piece according to a preferred embodiment of the present invention. Fig. 4 is a schematic view of the second embodiment of the fluid detecting test piece of the preferred embodiment. DESCRIPTION OF THE PREFERRED EMBODIMENT Two-in-one fluid detecting test piece Second flow path gas [Main component symbol description] Two-in-one fluid detecting test piece substrate 10 Supporting member 19 Upper surface 100 First flow path 11 Second flow path 12 Longitudinal axis 14 苐a fluid zone 111, 121 a second fluid zone 112, 122
M359693 第三流體區113、123 ' 硝化纖維層 1121、1131、1221、1231 硝化纖維層1121平均厚度Da 硝化纖維層1131厚度Db 硝化纖維層1221平均厚度Dc 硝化纖維層1231厚度Dd . 第二流體區112的寬度Wa 第三流體區113的寬度Wb 第二流體區122的寬度Wc ® 第三流體區123的寬度WdM359693 Third fluid zone 113, 123 'Nitrocellulose layer 1121, 1131, 1221, 1231 nitrocellulose layer 1121 average thickness Da nitrocellulose layer 1131 thickness Db nitrocellulose layer 1221 average thickness Dc nitrocellulose layer 1231 thickness Dd. Second fluid zone Width of 112 Wa The width Wb of the third fluid zone 113 The width of the second fluid zone 122 Wc ® The width Wd of the third fluid zone 123