TW202403281A - Biochip detection device - Google Patents
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Abstract
Description
本發明係有關於一種生物晶片檢測裝置,特別是有關於一種可同時檢測多種不同檢測試體以及提高檢測結果的精準度之技術領域。The present invention relates to a biological chip detection device, and in particular to a technical field that can simultaneously detect a variety of different detection specimens and improve the accuracy of detection results.
免疫層析技術已經在現今醫療體系上扮演相當重要的角色,可用以定性或定量量測各種生物指標的變化,以提供檢驗人員或醫療人員進行疾病診斷或藥物治療等資訊的參考。Immunochromatography technology has played a very important role in today's medical system. It can be used to qualitatively or quantitatively measure changes in various biological indicators to provide laboratory personnel or medical personnel with information for disease diagnosis or drug treatment.
目前市面上絕大多數的檢測試片係以定性設計方式讓檢測者以目測方式來得知檢驗的結果,雖然可同時檢測多種不同的檢測項目,但是呈色劑要流動至多個待測液的反應區時,呈色劑是以單一方向的側向流動,再依序流動至每一反應區與待測液進行反應,此方式會造成呈色劑流動至每一反應區的容量會由多漸少,因為呈色劑分布地的不均勻,使得待測液所接收的呈色劑不同而產生檢驗誤差,甚至發生檢驗不準確的問題。因此,如何藉由創新的檢測裝置設計,能夠同時檢測多種不同檢測項目,又可提高檢測的準確度是亟待解決的問題。The vast majority of test strips currently on the market are qualitatively designed to allow the examiner to obtain the test results through visual inspection. Although a variety of different test items can be tested at the same time, the coloring agent needs to flow to the reactions of multiple liquids to be tested. zone, the colorant flows sideways in a single direction, and then flows to each reaction zone sequentially to react with the liquid to be tested. This method will cause the capacity of the colorant to flow to each reaction zone to gradually change. Rarely, due to the uneven distribution of the coloring agent, the liquid to be tested receives different coloring agents, resulting in inspection errors, or even inaccuracies in inspection. Therefore, how to use innovative detection device designs to simultaneously detect a variety of different detection items and improve detection accuracy is an urgent problem to be solved.
另外,由於檢測試體是從人體或動物取下,除了液體的部分以外,有時候檢測試體還含有組織的一些碎屑,這些碎屑可能會影響測試結果。In addition, since the test specimen is taken from the human body or animal, in addition to the liquid part, sometimes the test specimen also contains some tissue debris, which may affect the test results.
有鑑於此,本發明的目的在於提供一種可同時檢測多個不同檢測試體,僅需以微量的待測液就可與呈色劑進行反應,不僅能降低採檢的困難度與大幅增加檢測樣品,又利用呈色劑的周邊擴散流動方式,均勻地同時與所有待測液進行結合與反應,可有效提高檢測結果的精準度。In view of this, the object of the present invention is to provide a method that can detect multiple different test specimens at the same time. Only a trace amount of the test liquid can be reacted with the coloring agent, which can not only reduce the difficulty of inspection and greatly increase the detection time. The sample also utilizes the peripheral diffusion flow of the chromogen to evenly combine and react with all the liquids to be tested at the same time, which can effectively improve the accuracy of the test results.
本發明的生物晶片檢測裝置的一實施例包括一底座以及一反應模組。反應模組設置底座上,反應模組包括由下至上層疊的一反應膜、一擴散膜、一過濾膜以及一上蓋,反應膜鄰近底座,擴散膜具有至少一吸液開孔與位於吸液開孔周邊的一吸液區域,上蓋設置於底座且包括一第一操作區以及鄰接於第一操作區的一第二操作區,上蓋的第一操作區具有複數個供滴入一待測液的滴入孔,第二操作區具有供滴入一呈色劑的一反應開孔。過濾膜係設置於對應於上蓋的第一操作區的位置,且反應膜以及擴散膜可在對應於上蓋的第一操作區與第二操作區之間的位置移動。An embodiment of the biochip detection device of the present invention includes a base and a reaction module. The reaction module is set on a base. The reaction module includes a reaction membrane, a diffusion membrane, a filter membrane and an upper cover stacked from bottom to top. The reaction membrane is adjacent to the base. The diffusion membrane has at least one liquid suction opening and is located in the liquid suction opening. There is a liquid suction area around the hole. The upper cover is arranged on the base and includes a first operating area and a second operating area adjacent to the first operating area. The first operating area of the upper cover has a plurality of openings for dripping a liquid to be tested. The dropping hole, the second operating area has a reaction opening for dripping a coloring agent. The filter membrane is arranged at a position corresponding to the first operating area of the upper cover, and the reaction membrane and the diffusion membrane are movable between the positions corresponding to the first operating area and the second operating area of the upper cover.
在另一實施例中,反應膜包括一本體以及連接於本體的一拉桿,擴散膜設置於本體。In another embodiment, the reaction membrane includes a body and a tie rod connected to the body, and the diffusion membrane is disposed on the body.
在另一實施例中,反應膜的本體尺寸與擴散膜的尺寸相等,反應膜抵接吸液開孔與局部吸液區域。In another embodiment, the body size of the reaction membrane is equal to the size of the diffusion membrane, and the reaction membrane contacts the liquid absorption opening and the local liquid absorption area.
在另一實施例中,底座靠近上蓋的一側設有一圍繞底座邊緣的突緣,反應膜的本體設置於突緣圍繞的區域內,突緣的一側形成一限位槽,反應膜的拉桿延伸通過限位槽且露出於底座及上蓋。In another embodiment, a flange surrounding the edge of the base is provided on one side of the base close to the upper cover. The body of the reaction membrane is disposed in the area surrounded by the flange. A limiting groove is formed on one side of the flange. The pull rod of the reaction membrane Extends through the limiting groove and is exposed on the base and upper cover.
在另一實施例中,反應開孔的孔徑大於吸液開孔的孔徑,且當擴散膜移動至對應於第二操作區的位置時,吸液區域部分裸露於反應開孔。In another embodiment, the pore diameter of the reaction opening is larger than the pore diameter of the liquid-absorbing opening, and when the diffusion membrane moves to a position corresponding to the second operating area, the liquid-absorbing area is partially exposed to the reaction opening.
在另一實施例中,每個滴入孔的孔壁呈圓錐狀。In another embodiment, the wall of each drip hole is conical.
在另一實施例中,上蓋設有一凹部,設置於第一操作區,過濾膜設置且定位於凹部內。In another embodiment, the upper cover is provided with a recess, which is disposed in the first operating area, and the filter membrane is disposed and positioned in the recess.
在另一實施例中,該等滴入孔以第一操作區的中心位置向外呈間隔環繞設置。In another embodiment, the drip holes are arranged at intervals outward from the center of the first operating area.
在另一實施例中,反應模組包括兩個反應膜、兩個擴散膜及兩個過濾膜,上蓋包括兩個第一操作區以及兩個第二操作區,兩個第一操作區係相鄰設置,每個反應膜及擴散膜分別於對應於一個第一操作區及一個第二操作區之間的位置移動。In another embodiment, the reaction module includes two reaction membranes, two diffusion membranes and two filtration membranes. The upper cover includes two first operating areas and two second operating areas. The two first operating areas are in phase. They are arranged adjacent to each other, and each reaction membrane and diffusion membrane respectively move between positions corresponding to a first operating area and a second operating area.
在另一實施例中,每一滴入孔係供一待測液滴入並滲透經過濾膜、吸液開孔至反應膜形成一待測區域,反應膜從第一操作區移動至第二操作區,反應開孔與吸液開孔係供一呈色劑滴入至圍繞待測區域的中心位置,藉由吸液區域將呈色劑吸附朝向周圍擴散流動至待測區域以彼此形成反應,並取得最終檢測結果。In another embodiment, each drop-in hole is for a liquid to be tested to be dropped into and penetrate through the filter membrane, and the liquid suction hole is opened to the reaction membrane to form an area to be tested, and the reaction membrane moves from the first operating area to the second In the operating area, the reaction opening and the suction opening allow a colorant to be dropped into the center around the area to be measured. The colorant is adsorbed by the liquid suction area and diffuses towards the surrounding area to form a reaction with each other. , and obtain the final test results.
在另一實施例中,呈色劑包含反應抗體與膠體金,且待測液之容量介於0.1微克至0.2微克。In another embodiment, the coloring agent includes a reactive antibody and colloidal gold, and the capacity of the test solution is between 0.1 microgram and 0.2 microgram.
本發明的生物晶片檢測裝置能夠同時檢測多種檢測試體,僅需微量的待測液就可與呈色劑進行反應,不僅能降低採檢的困難度與大幅增加檢測樣品,又利用呈色劑的周邊擴散流動方式,均勻地同時與所有待測液進行結合與反應,此外更利用清洗液提升檢測結果的精確性,整體可有效提高檢測結果的精準度。另外本發明的生物晶片檢測裝置還包括設置在過濾膜,能夠將檢測試體中的組織碎屑或異物等濾除,而且本發明的反應膜可以移動,在要滴入呈色劑之前,可先將反應膜從第一操作區移動至第二操作區,以便於從反應開孔滴入呈色劑,避免影響最後測試結果的顯色。The biological chip detection device of the present invention can detect multiple detection specimens at the same time. It only requires a trace amount of the liquid to be tested to react with the coloring agent. It can not only reduce the difficulty of inspection and greatly increase the number of detection samples, but also utilize the coloring agent. The peripheral diffusion flow method evenly combines and reacts with all the liquids to be tested at the same time. In addition, the cleaning liquid is used to improve the accuracy of the test results, which can effectively improve the accuracy of the test results as a whole. In addition, the biological chip detection device of the present invention also includes a filter membrane, which can filter out tissue debris or foreign matter in the test subject. Moreover, the reaction membrane of the present invention is movable and can be moved before dripping the coloring agent. First, move the reaction membrane from the first operating area to the second operating area so that the coloring agent can be dripped from the reaction opening to avoid affecting the color development of the final test result.
請參閱圖1、圖2、圖3,其為本發明的生物晶片檢測裝置的一實施例。本發明的生物晶片檢測裝置是應用於免疫層析技術。本實施例的生物晶片檢測裝置包括一底座10以及一反應模組20。反應模組20設置在底座10上。Please refer to FIG. 1, FIG. 2, and FIG. 3, which is an embodiment of the biochip detection device of the present invention. The biological chip detection device of the present invention is applied to immunochromatography technology. The biological chip detection device of this embodiment includes a
反應模組20包括由下至上層疊的一反應膜21、一擴散膜22、一過濾膜24以及一上蓋23。反應膜21鄰近底座10。反應膜21可以為硝化纖維膜(nitro-cellulose membrane)、PVDF膜〔polyvinylidone (PVDF) membrane〕、尼龍膜(nylon membrane)等,係用以吸附待測液40中的所欲檢測的蛋白質。擴散膜22具有至少一吸液開孔221與位於吸液開孔221周邊的一吸液區域222,上蓋23藉由卡合柱A及設置於底座10的卡合孔B而卡合於底座10,且底座10在靠近上蓋23的表面設有一突緣11,使得當上蓋23卡合於底座10時,上蓋23與底座10之間形成一容置空間,反應膜21及擴散膜22都設置於凹部235內的容置空間中。The reaction module 20 includes a
上蓋23呈矩形且包括一第一操作區231及一第二操作區232,第二操作區232鄰接於第一操作區231。上蓋23在第一操作區231形成多個滴入孔233,上蓋23在第二操作區232形成一個反應開孔234。滴入孔233以第一操作區231的中心位置向外呈間隔環繞設置,反應開孔234呈正方形。反應開孔234的尺寸大於吸液開孔221的孔徑。The
本實施例的反應膜21包括一本體211以及連接於本體211的一拉桿212,擴散膜22設置於本體211。底座10的突緣11的一側形成一限位槽12,拉桿212從本體211延伸而穿過限位槽12而露出於底座10及上蓋23。使用者拉動拉桿212,可以使反應膜21及擴散膜22在上蓋23與底座10之間且於第一操作區231及第二操作區232之間移動。過濾膜24能夠過濾待測液40中的生物體組織碎屑,避免生物體組織碎屑影響檢測結果。The
上蓋23在第一操作區231設有一凹部235,過濾膜24設置且定位於凹部235內,凹部235對應於上蓋23的第一操作區231的多個滴入孔233。The
如圖3所示,當反應膜21移動至第一操作區231時,滴入孔233與吸液開孔221形成相連通。待測液40由滴入孔233滴入後,待測液40能夠經由過濾膜24濾除組織碎屑後通過吸液開孔221進入反應膜21。上蓋23的材質為透明,有助於檢測者直視觀看檢測的反應過程與狀態。反應膜21的尺寸與擴散膜22的尺寸大體上相等,反應膜21抵接於吸液開孔221與吸液區域222,反應膜21只要能涵蓋吸液開孔221的範圍,確保欲滴入的液體(例如待測液、呈色劑及清洗液等)能夠落入反應膜21即可。本實施例的擴散膜22具有一個吸液開孔221,吸液開孔221呈圓形。As shown in FIG. 3 , when the
如圖3所示,每個滴入孔233的孔壁呈圓錐狀,且靠近反應膜21側的孔徑小於遠離反應膜21側的孔徑,如在待測液40進入滴入孔233後,滴入孔233藉由圓錐狀的孔壁使待測液40聚集在特定的位置避免溢流,靜待待測液40在反應膜21逐漸擴散。待測液40自滴入孔233滴入後,待測液40會滲透通過過濾膜24後經反應開孔234、吸液開孔221至反應膜21以形成一待測區域。As shown in FIG. 3 , the hole wall of each dripping
然後,如圖4及圖5所示,拉動反應膜21的拉桿212使反應膜21及擴散膜22從第一操作區231移動至第二操作區232,使反應膜21的本體211上形成的待測區域對應於反應開孔234。如圖6所示,滴入孔233之側邊可以分別具有不同的一滴注標記,例如數字編號、圖案或是英文字母等滴注標記,本實施例是在滴入孔233旁標註數字1、2、3、4、5、6、7。滴注標記係對應待測液40的一檢測資料,檢測資料包含受測者資料、檢體及檢測項目等相關資料,如此一來,檢測者可藉由滴注標記清楚辨識每一個所對應的檢測資料,能有效防止檢測者的作業疏失。每一滴入孔233係供一待測液40滴入,待測液40可以為體液或血液,在此以七個滴入孔233為例說明,每一個滴入孔233所滴入的待測液40皆不同,屬於不同的檢測資料,其中受測者資料與檢體不同,但是檢測項目可為相同,也可為不相同,可根據檢測需求作適當的調整。Then, as shown in Figures 4 and 5, the pull rod 212 of the
然後如圖6所示,從反應開孔234將呈色劑50滴入。呈色劑50經由吸液開孔221滴入至多個待測區域所圍繞的中心位置,藉由吸液區域222將呈色劑50吸附朝向周圍擴散流動至多個待測區域以彼此形成反應。其中,吸液區域222位於吸液開孔221的周圍,因此呈色劑50受到吸液區域222的毛細作用,呈色劑50以自由角度均勻且同時朝向多個待測區域流動直至吸液區域222,使得所有的待測區域能均勻接收到呈色劑50,讓呈色劑50與待測液40產生結合與反應。值得注意的是,待測液40之容量介於0.1微克至0.2微克,本發明僅需要微量的待測液40即可進行後續的檢測反應,相較於習知檢測試片所需要的待測液容量高達1毫克以上才能檢測,本發明確實能降低採檢的困難度與大幅增加檢測樣品之功效。Then, as shown in FIG. 6 , the coloring agent 50 is dropped into the
呈色劑50包含反應抗體與膠體金兩者混合而成,其中,膠體金與反應抗體事先結合並保留反應抗體能與所欲檢測的蛋白質結合的區域。膠體金在生物醫學個研究領域中,特別是醫學檢驗中得到日益廣泛的應用。膠體金實質上是蛋白質等高分子被吸附到膠體金顆粒表面的包被過程,也就是膠體金顆粒表面的負電荷與蛋白質,例如葡萄球菌A蛋白、免疫球蛋白、毒素、醣蛋白、酶、抗生素、激素等非共價的正電荷基團因靜電吸附而形成牢固結合。由於毛細作用,呈色劑50沿著吸附體吸液區域222方向移動,當移動至有待測區域時,呈色劑50中所欲檢測的蛋白質會與待測液40中的反應抗體產生抗體與抗原的專一性結合反應,而呈現不同的顏色。The coloring agent 50 includes a mixture of reactive antibodies and colloidal gold, wherein the colloidal gold is previously combined with the reactive antibodies and retains a region where the reactive antibodies can bind to the protein to be detected. Colloidal gold is increasingly widely used in biomedical research fields, especially in medical testing. Colloidal gold is essentially a coating process in which macromolecules such as proteins are adsorbed to the surface of colloidal gold particles, that is, the negative charge on the surface of colloidal gold particles interacts with proteins, such as staphylococcal protein A, immunoglobulins, toxins, glycoproteins, enzymes, Non-covalent positively charged groups such as antibiotics and hormones form strong bonds due to electrostatic adsorption. Due to capillary action, the coloring agent 50 moves along the direction of the absorption area 222 of the adsorbent. When it moves to the area to be measured, the protein to be detected in the coloring agent 50 will generate antibodies with the reactive antibodies in the liquid to be measured 40 The specific binding reaction with the antigen gives rise to different colors.
請參閱圖7,其表示本發明的生物晶片檢測裝置的另一實施例。本實施例具有與前一實施例部分相同的結構,因此相同的元件給予相同的符號並省略其說明。本實施例與前一實施例的差異在於本實施例包括兩個反應膜21、兩個擴散膜22以及兩個過濾膜24。上蓋23包括兩個第一操作區231以及兩個第二操作區232,兩個第一操作區231係相鄰設置,兩個過濾膜24分別於對應於兩個第一操作區231。兩側反應膜21的拉桿212朝相反方向延伸,藉此使兩個反應膜21承載擴散膜22朝相反方向移動。Please refer to FIG. 7 , which shows another embodiment of the biological chip detection device of the present invention. This embodiment has partially the same structure as the previous embodiment, so the same elements are given the same symbols and their descriptions are omitted. The difference between this embodiment and the previous embodiment is that this embodiment includes two
本發明的生物晶片檢測裝置能夠同時檢測多種檢測試體,僅需微量的待測液就可與呈色劑進行反應,不僅能降低採檢的困難度與大幅增加檢測樣品,又利用呈色劑的周邊擴散流動方式,均勻地同時與所有待測液進行結合與反應,此外更利用清洗液提升檢測結果的精確性,整體可有效提高檢測結果的精準度。另外本發明的生物晶片檢測裝置還包括設置在過濾膜,能夠將檢測試體中的組織碎屑或異物等濾除,而且本發明的反應膜可以移動,在要滴入呈色劑之前,可先將反應膜從第一操作區移動至第二操作區,以便於從反應開孔滴入呈色劑,避免影響最後測試結果的顯色。The biological chip detection device of the present invention can detect multiple detection specimens at the same time. It only requires a trace amount of the liquid to be tested to react with the coloring agent. It can not only reduce the difficulty of inspection and greatly increase the number of detection samples, but also utilize the coloring agent. The peripheral diffusion flow method evenly combines and reacts with all the liquids to be tested at the same time. In addition, the cleaning liquid is used to improve the accuracy of the test results, which can effectively improve the accuracy of the test results as a whole. In addition, the biological chip detection device of the present invention also includes a filter membrane, which can filter out tissue debris or foreign matter in the test subject. Moreover, the reaction membrane of the present invention is movable and can be moved before dripping the coloring agent. First, move the reaction membrane from the first operating area to the second operating area so that the coloring agent can be dripped from the reaction opening to avoid affecting the color development of the final test result.
惟以上所述者,僅為本發明之較佳實施例而已,當不能以此限定本發明實施之範圍,即大凡依本發明申請專利範圍及新型說明內容所作之簡單的等效變化與修飾,皆仍屬本發明專利涵蓋之範圍內。另外,本發明的任一實施例或申請專利範圍不須達成本發明所揭露之全部目的或優點或特點。此外,摘要部分和標題僅是用來輔助專利文件搜尋之用,並非用來限制本發明之權利範圍。此外,本說明書或申請專利範圍中提及的「第一」、「第二」等用語僅用以命名元件(element)的名稱或區別不同實施例或範圍,而並非用來限制元件數量上的上限或下限。However, the above are only preferred embodiments of the present invention, and should not be used to limit the scope of the present invention. That is, simple equivalent changes and modifications may be made based on the patent scope and novel description content of the present invention. All are still within the scope of the patent of this invention. In addition, any embodiment or patentable scope of the present invention does not necessarily achieve all the purposes, advantages or features disclosed in the present invention. In addition, the abstract section and title are only used to assist in searching patent documents and are not intended to limit the scope of the invention. In addition, the terms "first" and "second" mentioned in this specification or the patent application are only used to name elements or to distinguish different embodiments or scopes, and are not used to limit the number of elements. upper or lower limit.
10:底座 11:突緣 12:限位槽 20:反應模組 21:反應膜 22:擴散膜 23:上蓋 24:過濾膜 40:待測液 50:呈色劑 211:本體 212:拉桿 221:吸液開孔 222:吸液區域 231:第一操作區 232:第二操作區 233:滴入孔 234:反應開孔 235:凹部 A:卡合柱 B:卡合孔 10: Base 11: Nose 12:Limit slot 20:Reaction module 21:Reaction membrane 22: Diffusion film 23: Upper cover 24:Filter membrane 40: Liquid to be tested 50: Coloring agent 211:Ontology 212:Tie rod 221: Liquid suction opening 222: Liquid suction area 231: First operating area 232: Second operating area 233:Drip hole 234:Reaction opening 235: concave part A:Latching post B:Latching hole
圖1是本發明的生物晶片檢測裝置的一實施例的立體圖。 圖2是圖1的生物晶片檢測裝置的分解圖。 圖3是圖1的生物晶片檢測裝置的剖視圖,其中待測液從滴入孔滴入。 圖4是圖1的生物晶片檢測裝置的的反應膜及擴散膜從第一操作區移動至第二操作區的示意圖。 圖5是圖4的生物晶片檢測裝置的反應膜及擴散膜位於第二操作區的立體圖。 圖6是圖5的生物晶片檢測裝置的呈色劑滴入反應膜後朝待測液擴散移動的示意圖。 圖7是本發明的生物晶片檢測裝置的另一實施例的示意圖。 Figure 1 is a perspective view of an embodiment of the biowafer detection device of the present invention. FIG. 2 is an exploded view of the biological chip detection device of FIG. 1 . Figure 3 is a cross-sectional view of the biological chip detection device of Figure 1, in which the liquid to be tested is dripped from the drip hole. FIG. 4 is a schematic diagram of the reaction membrane and diffusion membrane of the biowafer detection device in FIG. 1 moving from the first operating area to the second operating area. FIG. 5 is a perspective view of the reaction membrane and diffusion membrane of the biowafer detection device in FIG. 4 located in the second operating area. FIG. 6 is a schematic diagram of the chromogen of the biowafer detection device in FIG. 5 after being dropped into the reaction membrane and then diffusing and moving toward the liquid to be tested. Figure 7 is a schematic diagram of another embodiment of the biological chip detection device of the present invention.
10:底座 10: Base
11:突緣 11: Nose
12:限位槽 12:Limit slot
20:反應模組 20:Reaction module
21:反應膜 21:Reaction membrane
22:擴散膜 22: Diffusion film
24:過濾膜 24:Filter membrane
211:本體 211:Ontology
212:拉桿 212:Tie rod
221:吸液開孔 221: Liquid suction opening
222:吸液區域 222: Liquid suction area
231:第一操作區 231: First operating area
232:第二操作區 232: Second operating area
233:滴入孔 233:Drip hole
234:反應開孔 234:Reaction opening
A:卡合柱 A:Latching post
B:卡合孔 B:Latching hole
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