Λ 6 13 6 201824 五、發明説明（玉） 本發明之背景 (請先閱讀背面之注意事項再填寫本頁) 本發明像有關一種用以進行一免疫化學粒子之凝集反 應之裝置，該凝集反應係被設計來提供用以實施一凝集反 應且讀出其結果之一種方便的設備。 凝集反應及其程序於該技藝中一般而言偽眾所週知的 ，一典型的凝集作用包括抗原或抗體攜運細胞、徹生物。 或特殊分析所出現之粒子等之懸浮體之叢生一起（或集成 ),各該粒子之此種叢生或凝集隨後即被監視以決定是否 使用據以檢測之一分析。 經濟部屮央標準局员工消费合作社印製 用以作用免疫化學粒子試劑之一種方法包括放置液體 試劑於一載玻片上，且一般上係前後搖動或擺動該載玻Η 以促使試劑混合並形成凝集，各該方法亦已被發展以避免 為了看得見其凝集而必需搖動粒子試劑，例如，美國專利 第4, 596, 695號即掲露用以反應免疫化學粒子試 劑之一凝集反應室，該反應室包括具有第一表面之一第一 透明板及具有與第一表面間隔分離之一第二表面之一第二 板，以於各兩板間界定出一反應室，該反應室本質上於流 動可反應之免疫化學粒子試劑期間僳藉毛細作用而非一傳 送至該室内之一外部蓮動來促使免疫化學粒子試劑流動。 本發明之一目的僳在提供可簡易地適宜使用於多數個 樣本之自動化學診斷之一種裝置，本發明之另一目的係在 提供可於一單一裝置中之一單一樣本上同時進行多數個高 感度之診斷試驗，在某一方面，本發明之一種裝置中，其 凝集反應可以一最少的樣本材料快速地進行及監視，在另 本紙張尺度逍用中Κ Η家樣準（CNS)甲4規格(210X297公釐） 一 3 - 經濟部中央標準局员工消費合作社印製 201824_Be 五、發明説明（2) 一方面，本發明係指具有從一中央井部向外輻射之多數値 溝道之一種裝置，該中央井部即可以一最少量的樣本材料 使其此反應之簡易且看得見的顯著結果快速地被進行及監 視，在另一方面，本發明係指用以進行凝集反應之改進的 裝置，該反應具有蓮用一設備以控制液體體流經該於該裝 置中包含有一與毛細室呈液體交流狀態之一多孔吸收性材 料之裝置之所有液體流動比率。 本發明之概要 本發明係提供一種具有一凝集反應室以進行凝集免疫 試驗反應之裝置，在一方面中，該裝置包括一第一可濕（ 親水的）層及一平行的第二層，其中，其第一層俗具有溝 道者，故當第一層及第第二層彼此相接觸時，一凝集反應 室即被形成以藉毛細作用來傳送液體，其凝集反應室可額 外地包括鄰近於由第一及第二層所形成之反應室之入口處 之一樣本接收并部，當用以進行一試驗之一預定數量的試 劑被分散於其間（例如於一井部内）時，其反應室即具有 用以控制液體（流體）流動之設備，用以控制流經該反應 室之所有液體流動比率之設備包括利用諸如與反應室呈液 體交流狀態之一吸收性紙之一多孔吸收性材料，典型地像 位於反應室之末稍端。 在本發明之一凝集反應室中，其試劑可被陳列於乾燥 的地點或細長的區域内，亦可將試劑懸浮於水溶性聚合物 中。 本紙張尺度遑用中國國家«準(CNS)甲4規格(210x297公龙） (請先閱讀背面之注意事項再填寫本頁) 裝- 訂_ -4 - Λ 6 0 6 201824 五、發明説明（3) (請先閲讀背面之注意事項再填寫本頁) 於1 987年1 2月23日申請之名為> 凝集反應裝 置〃而申請案號為07/138, 253號之一共同申請 的美國專利申請案（其所掲露者因此而特別地併入此文中 作為參考），即指示出於尺寸上結構成非常小以適當自動 化及樣本和試劑之有效使用之一凝集反應室，典型地，此 一室之長度係從大約10公釐至大約75公釐（mm), 其溝道之深度傣從大約0. 01至大約5. 0mm;其寬 度則從大約0.1至10. 0mm,供具有四室及一樣本 接收井部之此一凝集反應裝置用之一典型的整體尺寸俗大 約37. 5mmXl2. 5mmXl. 5mm (芡 X w X h ) 〇 經濟部屮央標準局員工消t合作社印製 前述共同申請之美國專利申請案一般上亦掲露用以於 一凝集反應室中控制液體流量之一種設備，該凝集反應室 包含有溝道或形成於溝道内之諸如背脊，特別是形成於延 伸過溝道之整個寬度及至少延伸過溝道之一部份長度之背 脊之幾何結構，前述共同申請之美國專利申請案亦掲露用 以於其室内控制液體流置之另一種設備，亦即乾涸於溝道 部份内之一水溶性材料之使用，諸如一水溶性聚合物（例 如聚乙稀Utt略院酮（Ρ 〇 1 y ν i η 1 y p y r r ο 1 i d ο n e)、聚乙稀醇 、凝膠或牛的血清白朊）。 然而，當於莆助在溝道中控制液體（流體）流量之整 個比率上傜有用時，即可發現此種手段極難於被使用以致 於獲得一貫的齊一結果，例如，諸如聚乙烯吡咯烷酮（P-olyvinypyrrlidone)之一水溶性聚合物被蓮用時即發現 本紙張尺度逍用中困Η家標準(CNS)甲4規格(210X297公货) -5 - Λ 6 Β6 Γ01324 五、發明説明（4) (請先閱讀背面之注意事項再塡寫本頁) 難於獲得聚乙烯吡咯烷酮之乾燥的披覆，以致於獲得各該 溝道中之所有流動液體之一貫的穩定性，又，使用諸如紙 之一多孔性吸收媒體與使用諸如乾燥的聚乙烯吡咯烷酮（ polyvinylpyrrolidome)之披覆對各該裝置之製造的簡易 度而言像極有利的。 本發明僳指用以進行具有改良的特性之凝集反應之一 種裝置，包括用以控制經過凝集室之毎單位面積之液體流 動比率之改良設備本發明亦指諸如可隨用隨丟之薄片狀卡 片之結構成便利而可隨用隨丟的結構型態之此種裝置，各 該裝置可任意地安裝於可隨用隨丟之堅固的容器内。 圖式之簡單說明 圖1偽本發明凝集反應裝置之一具體化實施例之上視 立體圖，顯示一矩形樣本接收井部及四値反應室。 圔2偽其凝集反應裝置之一底面之一具體化實施例之 上視立體圖，顯示於其末稍端具有多孔性材料條片之一矩 形樣本接收井部及四値溝道（供反應室用）。 經濟部屮央標準局员工消费合作社印製 圖3像另一具體化實施例之一分解的上視立體圖，係 顯示出一三層結構，包括：一第一或基層；顯示一切除而 作為一圓的接收井部用之部份及一通常俗直線狀之凝集室 及一多孔性吸材料條片之一第二層；及一第三層或頂層。 圖4傜另一具髏化實施例之一分解的上視立體圖，僳 顯示一三層結構，包括：一第一或基層；顯示一切除而作 為一圓的接收井部用之部份及於其末稍端具有一延伸部份 本紙》尺度遑用中β國家標準(CNS)甲4規格(210X297公釐) -6 - Λ 6 13 6 201824 五、發明説明（5) 之一凝集室及一多孔吸收性材料之條Η;及一第三或頂層 (請先閱讀背面之注意事項再填寫本頁) 〇 圖5俱另一具體化實施例之一分解的上視立體圖，像 顯示一三層結構，包括：一第一或基層；一第二層，顯示 有一切除部份以作為圓形接收井部及位於第二靥末稍端中 之具有一整個多孔吸收性條片之一般呈直線狀之一凝集反 應室；及一第三或頂層。 圖6像另一具體化實施例之一分解的立體圔，僳顯示 一三層結構，包括一第一或基層；一第二層，顯示有一切 除部份作為一圓形的接收井部及於其末稍端具有一延伸部 份之一凝集反應室，於第二層中之反應室末稍端處則具有 一整値多孔吸收性條片；及一第三或頂層。 經濟部屮央標準局員工消費合作社印製 圖7像另一具髏化實施例之上視平面圖，僳顯示一薄 片狀結構之零件，包括：一基層；一第二層，具有一切除 部份作為圓形的接收井部及具有延伸的末稻部地帶之多數 個輻射狀凝集反應室；具有間隔的液體吸收區域（4 )及 液體吸藏區域（2 6)之一環狀結構；及與環狀結構共同 形成頂層之另一圓形層。 圖8係一概略圖，用以顯示從接收井部向外通往具有 一延伸的末稍端之一凝集室之毎單位面積之不同流動比率 之區域，且顯示其延伸的末稍端中之一群凝集粒子。 圖9係一概略圖，用以顯示從接收井部向外通往具有 一半圓形或碗形末稍端之一凝集室之毎單位面積之不同流 動比率之區域，且顯示其半圓形端中之一群凝集粒子。 本紙張尺度逍用中困國家楳準（CNS)甲4規格(210x297公龙) -7 - Λ 6 Β6 201824 五、發明説明（6) (請先閲讀背面之注意事項再填寫本頁) 圖10係一概略圖，用以顯示從接收井部向外地通往 具有一大略呈矩形形狀之一凝集室之不同的流動比率之區 域，且於增加寬度之矩形區域中顯示一凝集粒子帶。 較佳具體化實施例之詳細描述 本發明係指適於用來進行凝集反應之多種改良裝置， 本發明之一具髏化實施例像顯示於圖1中，如圖1中所示 之裝置（10)通常包括一第一表面（12)及一平行的 第二表面（14),該兩平面之一則有若干溝道（16) 形成於其間，故當兩平面被放置一起時，一室或撤室（ 經濟部屮央標準局員工消費合作社印製 1 8)即被形成，液體即藉毛細作用而流經該室或徹室（ 18)，為了擁有毛細流動，即需其溝道表面之一係可水 潮的（親水的），各該表面最好被設計成當其被組合時卽 産生多數個室或徹室（18),每一溝道（18)均於其 未稍端較理想地具有一纖維質材料而最好是紙之多孔吸收 性材料之一條片，以控制流經其溝道之所有液體流動比率 ，例如紙之前述多孔材料僳被從諸如聚乙烯吡咯烷酮（P-olyvinylpyrrolidone),聚乙嫌醇（polyvinylalcohol ),凝膠或牛的血清白朊之諸如水溶性聚合物之乾涸的披 覆之水溶性材料區分出來，被使用於本發明中之多孔性吸 水材料本身通常像非水溶性。 於其中開設有若干溝道之表面最好亦具有一樣本接收 井部（20),該井部（20)像開放予每一溝道（1 6 ),其接收井部（20)係被定位成如圖1中所示者般未 本紙張尺度逍用中國國家《準(CNS)甲4規格(210父297公龙) -8 - 201824_ill 五、發明説明（7 ) 被其第二表面（14)所覆蓋，一液體樣本可被置放於接 收井部（2 0)中，以致於藉毛細作用而傳送至其反應室 (18),若此，即可能形成具有多數値室及一大的樣本 接收井部之一裝置，以致於一單一滴之樣本即可被置放於 井部中且毛細地傳送至多數個室中，其毎一室隨後邸可以 一單一樣本來進行一不同的凝集試驗，每一溝道末稍端中 之多孔吸收性條片即有利地控制流經其溝道之所有液體流 動比率。 本發明之又一目的在提供一種裝置，偽水得足以被蓮 用於自動化儀器中且藉自動化設備予以監視各該凝集粒子 出現於每一室中之情形，若此，在其凝集裝置之另一具體 化實施例中，其底面（12)將俗不透明的而其頂面（ 14)將偽透明的以傳輸或反射光線而可於該裝置（10 )上放置一光學掃描器，若此，其不透明的底面（12) 即給予一較佳的背景，以供撿測此具體化實施例中之凝集 粒子。 經濟部中央櫺準局貝工消费合作社印製 (請先閱讀背面之注意事项再填寫本頁} 例如，當一細胞溶液被導入一室（18)之一端時， 其所包含之抗體即與細胞上之抗原相對抗且乾涸於各該溝 道（16)之内部，其溶液將經由其溝道而遷移並與抗血 清相混合，其細胞即集結一起，此將在無任何離子或混合 物步驟下發生，經溝道控制其液體流動則因凝集反應最好 發生於液體流動期間而是必要的，足夠的潛伏時間必需被 併入液匾流動期間以完成試劑之最適宜的反應。 本具體化實施例中之流經一毛細室之液體流動比率僳 本紙張尺度逍用中B 家樣準(CNS)甲4規格(210X297公釐) -9 - Λ 6 Β6 201824 五、發明説明（8) (請先閱讀背面之注意事項再填寫本頁) 藉置於凝集反應室之每一溝道（16)之末稍端中之一多 孔吸收性材料條片（2 2 )予以控制，其多孔材料最好係 一纖維質材料，尤其是諸如Whatman過濾紙之紙，在圖 1中所示之此具體化實施例中，吾人可將凝集反應室之反 應室當作是末端，而該被當作末端之反應區則正位於紙條 片（22)之起點處，被用作為流體流動控制設備之諸如 紙之多孔性材料在諸如聚乙烯吡咯烷酮（PVP)之水溶 性材料之披覆的蓮用上提供了兼具製造及實施上之優點。 經濟部+央標準局员工消费合作社印製 圔3及圖4顯示用以根據本發明進行凝集反應之一種 裝置之另一具體化實施例，這些具體化實施例具有呈黏著 關偽之一能吸藏液體之第一可濕層（1),平行地覆蓋於 第一層（1)上之一第二液體吸藏層（2),最好係非濕 的且平行地覆蓋於第二層（2)上並具有供觀察粒子用之 一窗戶或觀察區之一第三液體吸藏層（3),其第一層（ 1)傜由具有一水濕性表面之一液體吸藏材料所製成，在 此具體化實施例中，其第三層（3)係由諸如一透明的多 碩酸鹽（polycarbonate)薄膜之一透明的、非濕的液體 吸藏薄膜所製成，因此而於凝集室中亦被作為用以觀察粒 子之一窗戶或觀察區，其第二層（2)則插入並附著於第 一層（1 )及第三層（3 )之間，例如藉由分別位於第二 層（2 )之每一側之面對第一層（1 )的頂側及第三層（ 3)的底側之黏著層，其第二層（2)具有溝槽（25) ,該溝槽（25)偽切割過第二層（2)之厚度而界定出 一溝道，用以導引藉溝槽（25)分別連同第一層（1) 本紙張尺度逍用中國國家標準（CNS)甲4規格(210X297公釐) -10 - Λ 6 13 6 201824 五、發明説明（9) 及第三層（3)之結合所界定之該室以毛細作用傳送之液 體。 換句話說，當其第一，第二及第三層被呈薄片狀地結 合一起時，毎一第一及第三層之一部份係分別作為凝集室 之地板及屋頂，而由第二層（2)之溝槽（25)之各該 壁面的部份界定為該室之牆壁（9),其凝集反應室具有 一近基部地帶（6)及一末稍部地帶（7),例如圖4中 之近基部地帶（6)偽由第二層（2)之溝槽（25)之 一個一般性的矩形部份來表示，而其末稍部地帶（7)則 由其第二層（2)之溝槽（25)之三角形或延伸部份來 表示。 顯示於圖3及4中之各該具體化實施例之一均具有第 三靥（3)中之一井狀溝槽（8)及於第二層（2)中之 如同第三層（3)中之井狀溝槽（8)之相同的尺寸及結 構之一相當的第二個井狀溝槽（5),第二層（2)中之 井狀溝槽（5)偽直接位於第三層（3)中之井狀溝槽（ 8)之下方，故當所有的三層均被結合一起而成為薄Η狀 時，其第二値井狀溝槽（5)即連同井狀溝槽（8)而沿 著第一層之相當部份界定出一井部以接收液體，該井部俗 與該室之近基部地帶（6)呈液體相交流之狀態，其井部 之底面偽由第一層（1)之一相當的圓形部份所形成，該 部份可被當作傜溝槽（5)及（8)在第一層（1)表面 上之投影。 流經這些具體化實施例中之凝集室之所有液體的流動 本紙張尺度遑用中Β國家«準(CNS)肀4規格(210x297公*) (請先閱讀背面之注意事項再填寫本頁) t 丁 經濟部中央橾準局员工消t合作社印製 -11 - 經濟部中央標準局員工消t合作社印製 201824 λ6 _ 五、發明説明（1(^ 比率係藉一條多孔性吸收材料（4)予以控制，最好係以 過濾紙置於靠近該室之末稍端處以為與該室之液體交流， 該過濾紙最好傜部份地延伸入該室之末稍端（當圖3及4 之結構分別被結合一起而成薄片狀時），在一較佳具體化 實施例中，如同圖3及4中所示之第三層（3)則具有較 多孔性紙條4之尺寸稍大之溝槽（2 8),故當個別的各 層被黏著一起時，多孔性吸水材料之紙條（4)即部份地 安置於溝槽（28)内，更待別地，其紙條（4)之較小 的前面部份則位於溝槽（25)之末稍地帶（7)内而使 紙條（4)之其餘的主要部份定位於溝槽（28)内，以 免沿著紙條（4)之長度及其兩側處之徹毛細溝道之不利 地形成。 其最後的薄板狀結構可被當作像一薄且可隨用隨丟之 卡片，該卡片則具有與凝集室之末稍部地帶（7)以液體 交流之紙條（4 )。 圔5及6則顯示其他具體化實施例之一種裝置，當顯 示於這些圔中之各層均被黏著一起而形成一薄片狀之卡片 以進行凝集反應時，這些具體化實施例即具有呈附著關係 之一液體吸藏式的第一可濕層、平行地覆蓋於第一層上之 一第二液體吸藏層及平行地覆蓋於第二層上且具有用以觀 察粒子之若干視窗之最好像非可濕的第三液體吸藏層，其 第一層（1)像由具有一可水濕的表面之一液體吸藏材料 所製成，如圖3及4所示之各該具體化實施例，這些具體 化實施例亦使用一第三層（3),該第三層（3)像由諸 本紙張尺度逍用中國國家楳準（CNS)甲4規格(210x297公*) (請先閱讀背面之注意事項再塡寫本頁) 裝_ 線. -12 - Λ 6 Β6 201824 五、發明説明（ (請先閱讀背面之注意事項再填寫本頁) 如一透明的聚碩酸鹽薄膜或一非可濕的玻璃紙帶之最好偽 非可濕的一透明的液體吸藏薄膜所製成，該第三層因此又 可作為一視窗以供觀察凝集室中之粒子，其第二層像插入 且黏著於第一層（1)及第三層（3)之間，例如，藉由 第二層（2)之毎一側上分別面對著第一層（1)之頂面 及第三層（3)之底面之一黏物物將其黏著，其第二層（ 2)具有切割過其厚度之一値一般性的溝槽（25),該 溝槽（25)即界定出一溝道，用以導引藉經由溝槽（ 25)分別結合第一層（1)及第三層（3)所界定之反 應室所進行之毛細作用所傳送之液體。 經濟部屮央標準局R工消费合作杜印製 如同圔3及4中所示之具體化實施例，當其第一，第 二及第三層被結合一起而呈薄片狀時，每一第一及第三層 之一部份均分別作為凝集室之地板及屋頂，而由第二層（ 2)之溝槽（2 5)之各該壁面之部份界定為該室之各該 壁面（9),溝槽（25)之各該壁面之其他部份則界定 為圓形的接收井部（5)之壁面，其凝集室具有一近基部 地帶（6)及一末稍部地帶（7),例如圖6中所示之近 基部地帶（6)傜由第二層（2)之溝槽（25)之一般 呈矩形的部份所代表，而其末稍部地帶（7)則由第二層 (2)之溝槽（25)之三角形或延伸的部份所代表。 由圖5及圔6所示之每一具體化實施例均具有一第三 層（3)中之井部界定的溝槽（8)及與第三層（3)中 井部界定之溝槽（8)具有相同尺寸及結構之第二層（2 )中之一相當的第二値井部界定的溝槽（5),其第二層 本紙張尺度遑用中國困家標準(CNS)甲4規格(210x297公龙) -13 - Λ 6 Β6 01824 五、發明説明（ (請先閲讀背面之注意事項再填寫本頁) (2 )中井部界定的溝槽（5 )像直接定位於第三層（3 )中之井部界定的溝槽（8)之正下方，故當所有的三層 均被結合一起而呈薄片狀時，其第二井部界定溝槽（5) 即結合井部界定溝槽（8)而沿著第一層之相當部份界定 出用以接收液體之一井部，該井部可與其反應室之近基部 地帶（6)以液體相交流，其井部之底面傜由第一層（1 )之一相當的圓形部份所形成，該部份可被當作偽溝槽（ 5)及（6)之外形對第（1)層表面之投影。 經濟部屮央標準局眞工消費合作社印製 然而，在圖5及6之具體化實施例中，其第二層（2 )傜由諸如吸收性紙張之一液體吸收性材料所製成，而選 擇性地以諸如一防水墨水之一物質滲透過厚度以形成一被 滲透的區域（26)及一無滲透區域（4),其無滲透區 域（4 )像可吸收液髏的而被滲透的區域（2 6 )則為液 體吸藏式者，在這些具體化實施例中，其無滲透區域（4 )傜與其反應室之末稍部地帶（7)呈液體交流狀態而作 為用以控制流經凝集室之所有液體流動比率之設備，其第 二層（2)於被滲透的區域（26)中亦具有一溝槽（ 25)以界定出一溝道，藉以導引經溝槽（25)結合其 第一層（1)及第三層（3)所界定出之一反應室以毛細 作用所傳送之液體，此室亦具有一近基部地帶（6)及一 末稍部地帶（7),於此室中即可進行凝集反應，如由圖 5及6中所可見者，其無滲透區域（4)像位於鄰近凝集 室之末稍端處且與該室呈液體交流狀態。 又，由圖5及圖6所示之各該具髏化實施例均具有一 本紙張尺度边用中國困家樣準(CNS)甲4規格(2〗0乂297公*) -14 - Λ 6 13 6 201824 五、發明説明（d 第三層（3)中之井部界定的溝槽（8)及與第三層（3 )中井部界定之溝槽（8)具有相同尺寸及結構之第二層 (2) 中之一相當的第二個井部界定的溝槽（5),其第 二層（2)中井部界定的溝槽（5)係直接定位於第三層 (3) 中之井部界定的溝槽（8)之正下方，故當所有的 三層均被結合一起而呈薄Η狀時，其第二井部界定溝槽（ 5)即結合井部界定溝槽（8)而沿著第一層之相當部份 界定出用以接收液體之一圓形井部，該井部可與其反應室 之近基部地帶（6)以液體相交流，其井部之底面係由第 一層（1)之一相當的圓形部份所形成。 圖7顯示本發明之一較佳具體化實施例之一分解的平 面圖，此具體化實施例僳用來以最小量的液體樣本進行多 數値凝集反應，呈組合型態之此種裝置可被認為是具有待 別標示出來之從一共同的液體接收井部向外呈輻射狀之六 個凝集室之一相當薄的薄片狀之可隨用隨丢的結構，圖3 之裝置包括呈附著關偽之大略呈圓形的第一可濕但液體吸 藏層（1)、平行地覆蓋於第一層（1)上之大略呈圓形 之第二液體吸藏層（2)及平行地覆蓋於第二層（2)上 之一第三液鼸吸藏層（3),這些値別層可藉例如位於其 値別層間之一黏著物將其結合一起，在此具體化實施例中 ，其第三層（3)像由諸如一聚碌酸發（ρο 1 ycarbonate )薄膜之一圓形的透明塑膠薄膜所製成，因此而作為用以 觀察在六値輻射狀凝集室内之粒子用之窗戶或觀察區，插 入且黏著於第一及第三靥間之第二靥（2)具有一溝槽（ 本紙張尺度逍用中國國家橾準(CNS)甲4規格(210X297公釐) (請先閲讀背面之注意事項再填寫本頁) 裝< 經濟部中央標準局员工消费合作社印製 -15 - Λ 6 Β6 201824 五、發明説明（^ (請先閲讀背面之注意事項再塡寫本頁) 經濟部屮央揲準局员工消t合作社印製 25),該溝槽（25)傜呈具有交値向外延伸之輻射狀 的溝槽臂之一中央圓形部份（5)之型態，其溝槽（25 )之各該輻射狀臂界定出六個溝道，用以導引藉毛細作用 經由輻射狀溝槽臂結合第一層（1)及第三層（3)所分 別界定之各室所傳送之液體，各該凝集反應可同時於最終 之六個室内進行，該六個室中之每一個均具有一個一般性 之矩形近基部地帶（6)及一値一般性之延伸或三角形狀 之末稍部地帶（7)，在此具髏化實施例中流經每一凝集 室之所有液體流動比率僳藉由最好是過濾紙之一多孔吸收 性材料之條片（4)予以控制，傜從具有一孔（28)之 此多孔性材料之一般性的圓環（27)延伸入由輻射狀溝 槽臂所界定之各該溝道之毎一溝道之末稍部地帶（7), 其圓環（27)傜選擇性地以一種物質經由其厚度將其滲 透，以提供無滲透的液體吸收區域（4)及被滲透的液體 吸藏區域（26),從圓環（27)係選擇性吸收區域（ 4)及被滲透的液體吸藏區域（26),從圓環（27) 向内延伸的這些無滲透的紙條片（4)俗與各該室呈液髏 交流狀態且傈位於鄰近各該室之末稍端處，最好像部份地 位於末稍端内（當圖3之結構分別被結合一起而呈薄片狀 時）〇 由圖7所表示之裝置之第三層（3)具有一圓形的井 部界定之溝槽（8),而其第二層具有與第三層（3)中 之井部界定溝槽（8)相同尺寸及型態之一相當的圓形第 二井部界定溝槽（5),其第二層（2)之井部界定溝槽 本紙張尺度边用中國家標準(CNS)甲4規格(210父297公龙) -16 _ Λ 6 Β6 201824 五、發明説明（id (請先閱讀背面之注意事項再填寫本頁) (5)傜位於其組合結構中之第三層（3)之井部界定溝 槽之正下方，若此，其第二井部界定溝槽（5)即結合第 三層（3)中之井部界定溝槽（8)及第一層（1)之個 別的圓形部份而界定出用以接收液體之井部，該井部俗與 各該室中之每一室之近基部地帶（6)呈液髏交流狀態。 其結果是：一般性的圓形薄片狀結構可被當作係一相 當薄而可自由使用之卡片，且具有與凝集室之末稍部地帶 (7)呈液體交流狀態之液體吸收紙條片（4)，若此， 在本發明之所有具體化實施例中，本發明之裝置均具有用 以控制流經反應室之所有液體流動比率之設備，該設備偽 與反應室呈液體交流狀態之一多孔吸收性材料，該材料典 型地偽定位於反應室之末稍端附近且通常偽部份地延伸入 反應室之末稍端内，然而，本發明之各該裝置之蓮用（藉 以進行凝集反應）可藉一附加設備之利用而進一步地被加 強，以控制流經該裝置之反應室之液體流動，傜藉如圖4 ，6, 7及8中所示般地修改其反應室之幾何型態或反應 室之内部形狀。 經濟部屮央櫺準局員工消費合作社印製 例如，在圔4、6,及7中，第二層（2)之一般性 的溝槽（25)即於該室之近基部地帶（6)中界定出至 少大略上平行之若干壁面（9),因此而界定出寬度大約 固定不變之一第一通道，由向著該室之末稍地帶（7)之 方向觀之，其一般性的溝槽（2)即於末稍地帶（7)中 界定出若干壁面，各該壁面即彼此相間隔以界定出與近基 部地帶（6)之第一通道相較具有加大的寬度之第二通道 尺度遑用中國β家標準(CNS)甲4規格(210x297公*) -17 - A6 B6 201824 五、發明説明（ (請先W讀卄面之注意事項再填艿本页) ，明顯地；於此一室中進行之凝集反應即可有利地發生， 諸如例如帶狀物之該室之末稍地帶（7)中之凝集粒子之 一個或更多個圖案即形成，該圖案較通常産生於先前技術 之凝集室中之凝集粒子之非圖案性之凝集更易於經第三靥 (3)之窗戶予以觀察，圆8顯示出在增加室寬之地帶中 之凝集粒子之一大略呈半圓形帶狀（27)之概略性的表示， 亦即，在該室之末稍地帶（7)中之該室的延伸之 > 第二通 道〃中（此處像大約呈三角形），如同圖8中沿著該室内 之反應路徑所使用之不同長度的箭頭之概略型態所表示者 ，末稍地帶（7)中之各該壁面像彼此相間隔以沿著此第 二通道提供液臞通道之一毎單位面積之降低的液體流動比 率，在圖8中，其較短的箭頭當然是用來代表較其較長的 箭頭所代表者之路徑中的每單位面積之較小的流動比率。 •打. 經濟部屮"櫺?-局肖工消';''合作^卬製 •線 至於該室中之末稍地帶之第二路徑之三角形的型態則 係較好的，且已被發現：對此所謂a第二路徑〃而言，其 他幾何形狀亦提供了凝集粒子之有利的圖案形成，例如， 第二路徑中之兩側壁可被形成為圓凸狀，以形成如圖9中 所示之大約呈半圓形或碗形之型態，或者，縱然傜較不理 想的，第二路徑之兩側壁可被形成為用來提供如圖10中 所示之大略呈矩形之第二路徑。 然而，若需要的話，反應室末稍部地帶中之每單位面 積之流動比率可藉該反應室之地板及屋頂間沿著液體流動 方向逐漸增加其空間而沿著流動之一般性方向逐漸減低， 例如，藉逐漸地向上81曲末稍部地帶中之反應室之屋頂及 -18 - 本纸張尺度適用中國國家樣準（CNS) f 4規格(210x297公釐） t Λ 6 Β6 201824 五、發明説明（^ (請先閱讀背面之注意事項再填寫本頁) /或逐漸地向下彎曲末稍部中之反應室之屋頂，且已發現 :其反應室之末稍部地帶中之反應室之屋頂，且已發現： 其反應室之末稍部地帶中之反應室的地板及屋頂間之空間 的此種修飾亦可成為被形成於該室之末稍部地帶中之凝集 粒子之規則圖案的形成因素，例如，其反應室之地板及屋 頂間之空間可藉於第三層（3 )之一區域中黏貼一球狀圓 頂形或圓筒狀之圓頂形結構而予以逐漸增加，像當其第三 層（3)被附著至其第二靥（2)時，其第三層中之圓頂 即覆蓋於反應室之末稍地帶，於反應室之末稍地帶之地板 及屋頂間提供一逐漸增加的空間之一種方式之另一例子俗 以此方式（當第一層（1丨被黏著至第二層（2)時，其 碗形窪地即形成於反應室之末稍地帶之地板中）將一球狀 碗形或圖筒狀碗形窪地黏貼於第一層（1)之基部中。 經濟部中央標準局貝工消t合作社印製 所有以凝集為基礎之試驗型態均可適應根據本發明之 一種裝置，在某些例子中，一可溶解的試劑可於反應室中 被乾燥成若干點或若干條片，例如，於血液樣本中，在其 他例子中，諸如一橡漿試劑之一徹粒子試劑即可於該室中 被乾燥，在另一處理方式中，一試劑則可被擴散於放置在 該室内之一溶液中，一較佳的試劑溶液係葡聚糖及蔗糖之 一溶液中之微粒子，該徹粒子試劑最好俗被混合於大約 2. 5至大約5. 0%重之葡聚糖及從大約15至大約 2 0%重之蔗糖之溶液中，用以混合試.劑之其他較佳的溶 液像F1C0LL (密蘇里州聖路易士之Sigma化學公司供一 蔗糖之非離子的合成聚合物之商標）從大約20至大約 本紙張^度逍用中國·家楳準(CHS)甲4規格(210x297公没） -19 - «201824 Λ 6 Β6 經濟部中央標準局员工消費合作社印製 五、發明説明（1忌 30%之重量，又，依此試驗所需，經過該室之液體流動 可如上述般地控制，以適應任何必需的潛伏時間及試驗程 序。 本發明之一特別地有利的待擻俗在於其提供了於利用 例如一單一滴之非常小量的樣本材料時能同時進行多種試 驗之能力，又，凝集試驗基本上俗於一旦該滴樣本材料被 加至凝集反應裝置時即自行實施，然而，在本發明的這些 具體化實施例中，係利用一附加的設備來控制流經其裝置 之反應室之液鼸流動，亦即藉修飾如上述之反應室之末稍 部地帶之幾何型態或其反應室之内部形狀之一種裝置，額 外的加強結果即可被獲得，諸如其反應室之末稍地帶中之 凝集粒子之集成的觀察力之加強。 本發明之一種裝置係特別地適於使用在可藉一光學掃 描機予以監視之凝集反應之一自動化型態中，例如，其凝 集反應之結構即促使吾人使用來自奧林巴斯（Olympus， C U E - 2，L a k e S u c c e s s，N · Y .)之有用的影像分析条統， 以決定凝集材料之數量及濃度，其凝集反應裝置即被顯示 成：其傳送的或反射的光線可藉閲讀機將其讀出，其影像 隨後即以電腦加以分析以決定已發生之凝集之數量且加強 供非常準確且敏感之決定用之影像，藉著諸如被形成於凝 集反應裝置中般地將樣本局限至一室内，即毫無疑問地具 有能干擾由閲讀機所見之影像之小滴或水之曲率，若此， 藉凝集反應裝置逹成之反應樣本及試劑之齊一性卽提供了 供一閲讀機或其他影像装置用之一绝佳的影像格式，此外 {請先閱讀背面之注意事項再填寫本頁) 裝< -5 - 線- 本紙張尺度逍用中國8家標準(CNS)肀4規格(210X297公«) -20 - 經濟部+央標準局員工消費合作社印製 201824_Be 五、發明説明（ ，亦可閲讀經過凝集反應底部之傳輸光線，因其樣本及反 應試劑偽被局限至凝集反應裝置所形成之毛細室内而亦可 閲讀反射之光線。 再請參閲圖1,像顯示本發明之一具體化實施例，圖 1顯示由一底層（12)被一頂層（14)所覆蓋之兩層 材料所結構而成之裝置（10)之立體圖，底層（12) 具有多數値溝道（16)及形成於表面内之一樣本井部（ 20),其樣本井部（20)僳位於每一室（16)之入 口附近，在該裝置（10)之結構中，不論其底層（12 )或其頂層（14)均可為不透明者，最好更進一步地來 自一光學掃描裝置之該層俗不透明的以加強其背景，其底 層（12)需是親水的或可濕的，故當一樣本被置放於與 一室（18)之入口相接觸之位置時其毛細流動即被減少 ,此則可藉使用一親水材料作為表面（12)而予以達成 ;然而，亦可化學處理或披覆其他非可濕（疏水的）材料 而將其變成可濕的，此可濕表面之準備亦可被用來影饗如 此地被形成之毛細室（18)中之流動比率。 適於用來準備供本發明之各種具體化實施例用之一可 濕層之各種材料包括例如醋酸一丁酸纖維素，一可濕的尼 龍材料或披覆以一丙烯橡漿乳膠以塗佈其表面成一可水濕 性層，例如在本發明之一具體化實施例中，一凝集反應室Λ 6 13 6 201824 V. Description of the invention (Jade) The background of the present invention (please read the precautions on the back before filling in this page) The present invention is related to a device for performing agglutination reaction of an immunochemical particle, the agglutination reaction It is designed to provide a convenient device for performing an agglutination reaction and reading the results. The agglutination reaction and its procedures are generally pseudo-well-known in the art. A typical agglutination includes antigens or antibodies carrying cells and living organisms. Or clustering (or integrating) particles or suspensions of particles appearing in a special analysis. Such clustering or agglomeration of each particle is then monitored to determine whether to use an analysis based on detection. A method printed by the Employee Consumer Cooperative of the Ministry of Economic Affairs ’Standards Bureau for the use of immunochemical particle reagents includes placing a liquid reagent on a glass slide, and generally the glass Η is shaken back or forth to promote reagent mixing and agglutination Each method has also been developed to avoid the necessity of shaking the particle reagent in order to see its agglutination. For example, U.S. Patent No. 4,596,695, which is one of the agglutination reaction chambers used to react the immunochemical particle reagent, The reaction chamber includes a first transparent plate having a first surface and a second plate having a second surface spaced apart from the first surface to define a reaction chamber between the two plates, the reaction chamber is essentially During the flow of the reactive immunochemical particle reagent, the flow of the immunochemical particle reagent is promoted by capillary action rather than a transfer to an external lotus in the chamber. An object of the present invention is to provide a device that can be easily and conveniently used for automatic chemical diagnosis of a large number of samples. Another object of the present invention is to provide a plurality of high-level tests on a single sample in a single device For a diagnostic test of sensitivity, in a certain aspect, in an apparatus of the present invention, the agglutination reaction can be quickly performed and monitored with a minimum of sample material. Specifications (210X297mm) 1: 3-Printed by the Employees ’Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs 201824_Be 5. Description of the invention (2) On the one hand, the present invention refers to a type of channel with a large number of radiating from a central well Device, the central well can quickly and easily monitor and monitor the results of a simple and observable result with a minimum amount of sample material. On the other hand, the present invention refers to the improvement of agglutination reaction The device has a device for controlling the flow of liquid through the device. The device contains a porous absorbent material in liquid communication with the capillary chamber. The ratio of all liquid flows in the device. SUMMARY OF THE INVENTION The present invention provides an apparatus having an agglutination reaction chamber for performing an agglutination immunoassay reaction. In one aspect, the apparatus includes a first wettable (hydrophilic) layer and a parallel second layer, wherein The first layer has channels, so when the first layer and the second layer are in contact with each other, an agglutination reaction chamber is formed to transfer liquid by capillary action, and the agglutination reaction chamber can additionally include adjacent A sample is received at the entrance of the reaction chamber formed by the first and second layers, and when a predetermined amount of reagent used to conduct a test is dispersed between them (for example, in a well), the reaction The chamber has equipment for controlling the flow of liquid (fluid). The equipment for controlling the ratio of all liquids flowing through the reaction chamber includes the use of porous absorbability such as an absorbent paper in liquid communication with the reaction chamber The material is typically located at the end of the reaction chamber. In one of the agglutination reaction chambers of the present invention, the reagent may be displayed in a dry place or in an elongated area, or the reagent may be suspended in a water-soluble polymer. This paper uses the Chinese National Standard (CNS) Grade 4 (210x297 male dragon) (please read the precautions on the back before filling out this page). Binding-Order_ -4-Λ 6 0 6 201824 V. Description of invention ( 3) (Please read the precautions on the back before filling in this page) The name of the application on February 23, 1987 is the agglutination reaction device 〃 and the application number is 07/138, one of 253. U.S. Patent Application (whose disclosures are specifically incorporated herein by reference), which indicates that the agglutination reaction chamber is typically very small in size for proper automation and efficient use of samples and reagents, typically The length of this chamber is from about 10 mm to about 75 mm (mm), and the depth of its channel is from about 0.01 to about 5.0 mm; its width is from about 0.1 to 10. 0 mm, for The typical overall size of this agglutination reaction device with four compartments and a sample receiving well is about 37.5mmXl2. 5mmXl. 5mm (芡 X w X h) 〇Stamp of the Ministry of Economic Affairs Bureau of Standards and Staff Cooperative Society U.S. patent applications that made the aforementioned joint application are generally disclosed for use in agglutination A device for controlling the flow of liquid in a chamber. The coagulation reaction chamber includes a channel or a ridge formed in the channel, especially a ridge formed over the entire width of the channel and at least a portion of the length of the channel The geometric structure, the aforementioned joint US patent application also discloses another device for controlling the flow of liquid in its room, that is, the use of a water-soluble material that dries in the channel part, such as a water-soluble A polymer (for example, polyethylene Utt yoke ketone (P 〇1 y ν i η 1 ypyrr ο 1 id ο ne), polyvinyl alcohol, gel or bovine serum albumin). However, when Yu Pu helps to control the overall ratio of liquid (fluid) flow in the channel, it can be found that such a method is extremely difficult to use so as to obtain consistent uniform results, such as, for example, polyvinylpyrrolidone (P -olyvinypyrrlidone) One of the water-soluble polymers was found by Lotus when it was used in this paper. The standard is used in the middle of the paper (CNS) A 4 specifications (210X297 public goods) -5-Λ 6 Β6 Γ01324 V. Description of the invention (4) (Please read the precautions on the back before writing this page) It is difficult to obtain a dry coating of polyvinylpyrrolidone, so as to obtain consistent stability of all flowing liquids in each channel, and use more such as paper The porous absorbent media and the use of coatings such as dried polyvinylpyrrolidone are very advantageous for the ease of manufacturing of each device. The present invention refers to an apparatus for performing agglutination reactions with improved characteristics, including improved equipment for controlling the liquid flow rate per unit area passing through the coagulation chamber. The device has a convenient and disposable structure. This device can be arbitrarily installed in a sturdy container that can be used and discarded. Brief Description of the Drawings Fig. 1 is a top perspective view of a concrete embodiment of the agglutination reaction device of the present invention, showing a rectangular sample receiving well and a four-value reaction chamber. Fig. 2 is a top perspective view of one embodiment of one of the bottom surfaces of its agglutination reaction device, showing a rectangular sample receiving well with a strip of porous material at its distal end and four channels (for the reaction chamber) ). Printed by the Employee Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs Figure 3 is a top perspective view exploded like one of the other specific embodiments, showing a three-layer structure, including: a first or base layer; Part of the receiving well and a second layer of a generally straight-line aggregation chamber and a strip of porous absorbent material; and a third layer or top layer. Fig. 4 is an exploded top perspective view of one of the other skeletalized embodiments, showing a three-layer structure, including: a first or base layer; showing a cut-out portion for use as a round receiving well and its There is an extended part of the paper at the end. The standard is used in the β national standard (CNS) A 4 specifications (210X297 mm) -6-Λ 6 13 6 201824 5. Description of the invention (5) One of the coagulation chamber and one more A strip of porous absorbent material; and a third or top layer (please read the precautions on the back before filling in this page) 〇 Figure 5 is another exploded top perspective view of another specific embodiment, showing a layer of three The structure includes: a first or base layer; a second layer, showing a cut-out portion as a circular receiving well and a generally linear shape with an entire porous absorbent strip in the distal end of the second end One agglutination reaction chamber; and one third or top floor. Fig. 6 is a three-dimensional structure exploded like one of the other specific embodiments, showing a three-layer structure including a first or base layer; a second layer showing a cut-out portion as a circular receiving well and The end of the reaction chamber has an extended part of the agglutination reaction chamber, and the end of the reaction chamber in the second layer has an entire porous absorbent strip; and a third or top layer. Printed by the Employee Consumer Cooperative of the Bureau of Standards of the Ministry of Economic Affairs. Figure 7 is a top plan view of another skeletonized embodiment. As a circular receiving well and a plurality of radial agglutination reaction chambers with an extended end of rice section; an annular structure with spaced liquid absorption area (4) and liquid storage area (26); and The ring structure together forms another circular layer of the top layer. FIG. 8 is a schematic diagram showing areas with different flow ratios per unit area from the receiving well to an aggregation chamber with an extended end, and showing the A group of agglomerated particles. Fig. 9 is a schematic diagram showing areas of different flow ratios per unit area from the receiving well to the coagulation chamber with a semicircular or bowl-shaped end, and showing the semicircular ends A group of agglomerated particles. The size of this paper is easy to use. The national standard (CNS) A 4 specifications (210x297 male dragon) -7-Λ 6 Β6 201824 5. Description of the invention (6) (please read the precautions on the back and fill in this page) Figure 10 It is a schematic diagram showing an area with different flow ratios leading from the receiving well to an agglomeration chamber with a large rectangular shape, and showing a band of agglomerated particles in a rectangular area with an increased width. Detailed Description of the Preferred Embodiments The present invention refers to a variety of improved devices suitable for performing agglutination reactions. An embodiment of the present invention with a skull is shown in FIG. 1 as shown in FIG. 1 ( 10) Usually includes a first surface (12) and a parallel second surface (14), one of the two planes has a number of channels (16) formed in between, so when the two planes are placed together, a chamber or Withdrawal of the room (printed by the Employees ’Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 18) is formed, and the liquid flows through the room or the room through capillary action (18). In order to have capillary flow, it needs the channel surface. A series of water-tide (hydrophilic), each surface is preferably designed to produce a plurality of chambers or chambers (18) when they are combined, each channel (18) is ideal at its less end It has a fibrous material, preferably a piece of porous absorbent material of paper, to control the ratio of all liquids flowing through its channels, for example, the aforementioned porous material of paper is selected from materials such as polyvinylpyrrolidone (P-olyvinylpyrrolidone ), Polyvinyl alcohol (polyvinylalcohol), gel Of dried bovine serum albumin, such as a water-soluble polymer of the water-soluble coating material Phi distinguish, be used in the present invention, the porous water-absorbent water-insoluble material itself is generally like. The surface in which several channels are opened preferably also has a sample receiving well (20), the well (20) is opened to each channel (16), the receiving well (20) is positioned As shown in Figure 1, the paper size is not used in the Chinese National Standard (CNS) A 4 specifications (210 father 297 male dragon) -8-201824_ill V. Description of the invention (7) The second surface (14 ) Covered, a liquid sample can be placed in the receiving well (20), so that it is transferred to its reaction chamber (18) by capillary action, if so, it may be formed with a large number of chambers and a large A device that receives the sample in the well, so that a single drop of sample can be placed in the well and capillary transferred to many chambers, each of which can then perform a different agglutination test with a single sample The porous absorbent strip in the end of each channel advantageously controls the ratio of all liquids flowing through its channel. Another object of the present invention is to provide a device with enough pseudo water to be used in an automated instrument and to monitor the occurrence of each agglomerated particle in each chamber by an automated device. In a specific embodiment, the bottom surface (12) will be opaque and the top surface (14) will be pseudo-transparent to transmit or reflect light and an optical scanner can be placed on the device (10), if so, Its opaque bottom surface (12) gives a better background for the detection of aggregated particles in this embodiment. Printed by the Beigong Consumer Cooperative of the Central Bureau of Economic Affairs of the Ministry of Economic Affairs (please read the precautions on the back before filling in this page) For example, when a cell solution is introduced into one end of a chamber (18), the antibodies it contains are The above antigen is relatively resistant and dries inside each channel (16), its solution will migrate through its channel and mix with the antiserum, and its cells will gather together, this will be without any ions or mixture steps Occurs, it is necessary to control the liquid flow through the channel because the agglutination reaction preferably occurs during the liquid flow, and sufficient latency must be incorporated into the liquid plaque flow period to complete the most suitable reaction of the reagent. In the example, the flow rate of the liquid flowing through a capillary chamber is on the paper size. The B home sample standard (CNS) A 4 specifications (210X297 mm) -9-Λ 6 Β6 201824 V. Invention description (8) (please Read the precautions on the back first and then fill out this page.) It is controlled by a strip of porous absorbent material (2 2) placed at the end of each channel (16) of the coagulation reaction chamber. It's a fibrous material, Especially for paper such as Whatman filter paper, in this specific embodiment shown in FIG. 1, one can regard the reaction chamber of the agglutination reaction chamber as the end, and the reaction zone regarded as the end is located in the paper At the beginning of the strip (22), a porous material such as paper used as a fluid flow control device provides both manufacturing and implementation on a lotus coated with a water-soluble material such as polyvinylpyrrolidone (PVP) The advantages of the Ministry of Economic Affairs + Central Bureau of Standards and Staff Cooperative Printing 3 and FIG. 4 show another specific embodiment of a device for performing agglutination reactions according to the present invention, and these specific embodiments have a false appearance. A first wettable layer (1) capable of absorbing liquid, covering a second liquid absorbing layer (2) on the first layer (1) in parallel, preferably non-wet and covering the first in parallel The second layer (2) is provided with a third liquid storage layer (3) for viewing particles or a window or observation area, and the first layer (1) is stored by a liquid with a water-wet surface Made of materials, in this embodiment, the third layer (3) is It is made of a transparent, non-wet liquid storage film, such as a transparent polycarbonate film, so it is also used as a window or observation area for observing particles in the aggregation chamber, which The second layer (2) is inserted and attached between the first layer (1) and the third layer (3), for example by facing the first layer (1) on each side of the second layer (2) ) On the top side and the adhesive layer on the bottom side of the third layer (3), the second layer (2) has a groove (25), the groove (25) is pseudo cut through the thickness of the second layer (2) and A channel is defined to guide the groove (25) together with the first layer (1) This paper standard is used in the Chinese National Standard (CNS) A 4 specifications (210X297 mm) -10-Λ 6 13 6 201824 V. The description of the invention (9) and the combination of the third layer (3) define the liquid transported by capillary action in the chamber. In other words, when the first, second, and third layers are combined together in a sheet shape, each part of the first and third layers serves as the floor and roof of the coagulation chamber, respectively, while the second Each part of the wall surface of the groove (25) of the layer (2) is defined as the wall (9) of the chamber, and its agglutination reaction chamber has a near base zone (6) and a final zone (7), for example The near-base zone (6) in Fig. 4 is represented by a general rectangular part of the groove (25) of the second layer (2), and its final zone (7) is represented by its second layer (2) The triangle or extension of the groove (25) is shown. Each of the embodied embodiments shown in FIGS. 3 and 4 has a well-shaped groove (8) in the third lute (3) and the third layer (3) in the second layer (2). ) The second well-shaped groove (5) of the same size and structure with the same size and structure of the well-shaped groove (8), the well-shaped groove (5) in the second layer (2) is located directly at the first Under the well-shaped trench (8) in the three layers (3), so when all three layers are combined to become a thin Η-shape, the second well-shaped trench (5) together with the well-shaped trench The trough (8) defines a well along a considerable part of the first floor to receive the liquid. The well is in a state of fluid communication with the base zone (6) of the chamber, and the bottom of the well is pseudo It is formed by an equivalent circular part of the first layer (1), which can be regarded as the projection of the grooves (5) and (8) on the surface of the first layer (1). The flow of all the liquid flowing through the coagulation chamber in these specific examples is based on the paper standard of China National Standard (CNS) 4 (210x297 g *) (please read the precautions on the back before filling this page) t Ding printed by the Ministry of Economic Affairs, Central Bureau of Standardization and Employee Consumer Cooperatives -11-Printed by the Ministry of Economic Affairs, Central Standards Bureau and Employee Consumer Cooperatives 201824 λ6 _ V. Description of invention (1 (^ Ratio borrowed from a porous absorbent material (4) To control, it is best to place the filter paper near the end of the chamber to communicate with the liquid in the chamber. The filter paper preferably extends partially into the end of the chamber (when Figures 3 and 4 When the structures are combined together to form a sheet), in a preferred embodiment, the third layer (3) as shown in FIGS. 3 and 4 has a slightly larger size than the porous paper strip 4 The groove (28), so when the individual layers are adhered together, the paper strip (4) of the porous water-absorbing material is partially placed in the groove (28), and more particularly, the paper strip (28) 4) The smaller front part is located in the end zone (7) of the groove (25) so that the remaining main part of the paper strip (4) Partly positioned in the groove (28), so as not to be adversely formed along the length of the paper strip (4) and the thorough capillary channels on both sides. The final thin plate-like structure can be regarded as a thin and A disposable card can be used, which has a paper strip (4) that communicates with the end of the coagulation chamber (7) in liquid. 圔 5 and 6 show a device of other specific embodiments, when displayed When the layers in these swollen layers are adhered together to form a sheet-like card for the agglutination reaction, these specific embodiments have the first wettable layer with a liquid storage type in an adhering relationship, covered in parallel A second liquid storage layer on the first layer and a third liquid storage layer covering the second layer in parallel and having several windows for observing the particles, preferably like a non-wettable liquid, the first layer ( 1) It is made of a liquid storage material with a water-wettable surface, as shown in each of the specific embodiments shown in FIGS. 3 and 4, these specific embodiments also use a third layer (3) , The third layer (3) is used by the Chinese paper standards (CNS) A4 regulations (210x297 public *) (Please read the precautions on the back before writing this page) _ _ line. -12-Λ 6 Β6 201824 V. Description of the invention ((please read the precautions on the back before filling in this page) as if transparent The polysilicate film or a non-wettable cellophane tape is preferably made of a pseudo-non-wettable transparent liquid storage film. The third layer can thus be used as a window for observation in the coagulation chamber The second layer of the particles is inserted and adhered between the first layer (1) and the third layer (3), for example, by facing the first layer on each side of the second layer (2) ( 1) The top surface and the bottom surface of the third layer (3) are adhered by an adhesive, and the second layer (2) has a general groove (25) cut through one of its thickness, the groove (25) A channel is defined to guide the liquid transported by capillary action performed by the reaction chamber defined by the first layer (1) and the third layer (3) through the groove (25) respectively . The R-Consumer Cooperation Printing Co., Ltd. of the Central Standards Bureau of the Ministry of Economic Affairs has produced specific embodiments as shown in Figures 3 and 4. When the first, second, and third layers are combined to form a sheet, each first Part of the first and third floors are used as the floor and roof of the coagulation chamber, respectively, and the part of each wall surface of the groove (25) of the second layer (2) is defined as each wall surface of the chamber ( 9), the other part of each wall surface of the groove (25) is defined as the wall surface of the circular receiving well (5), and its coagulation chamber has a near base zone (6) and a final zone (7) ), For example, the near-basic zone (6) shown in Figure 6 is represented by the generally rectangular portion of the trench (25) of the second layer (2), and its final zone (7) is represented by The triangular or extended part of the groove (25) of the second layer (2) is represented. Each embodied embodiment shown by FIGS. 5 and 6 has a trench (8) defined by the well in the third layer (3) and a trench defined by the well in the third layer (3) ( 8) One of the second layer (2) with the same size and structure is equivalent to the groove (5) defined by the second value well, and the second layer of the original paper scale is not in accordance with the Chinese Standard for Sleeping (CNS) A 4 Specifications (210x297 male dragon) -13-Λ 6 Β6 01824 V. Description of the invention ((Please read the precautions on the back before filling in this page) (2) The trench defined by the well (5) is directly located on the third floor (3) The trench defined by the middle well is directly below the groove (8), so when all three layers are combined together to form a thin sheet, the second well defined trench (5) is defined by the combined well The trench (8) defines a well part for receiving liquid along a considerable part of the first layer, the well part can communicate with the liquid near the base zone (6) of the reaction chamber, and the bottom surface of the well part Tong is formed by a relatively circular part of the first layer (1), which can be regarded as the projection of the pseudo grooves (5) and (6) on the surface of the layer (1). Central Printed by the Quasi-Ministry Consumer Cooperative. However, in the specific embodiment of FIGS. 5 and 6, its second layer (2) is made of a liquid absorbent material such as absorbent paper, and is selectively A substance such as a waterproof ink penetrates through the thickness to form a permeated area (26) and a non-permeable area (4), the non-permeable area (4) is like a liquid-absorbable and permeable area (2 6 ) Is a liquid-sucking type, in these specific embodiments, its non-permeable area (4) and the end zone of the reaction chamber (7) are in liquid communication state to control the flow through the coagulation chamber For all liquid flow rate devices, the second layer (2) also has a groove (25) in the penetrated area (26) to define a channel, so as to guide the groove (25) in combination with its The liquid conveyed by capillary action in a reaction chamber defined by the first layer (1) and the third layer (3), this chamber also has a near base zone (6) and a final zone (7), here The agglutination reaction can be carried out in the chamber. As can be seen in Figures 5 and 6, the non-permeable area (4) is located adjacent to At the end of the coagulation chamber and in liquid communication with the chamber. In addition, each of the skeletalized embodiments shown in FIGS. 5 and 6 has a paper-scale Chinese standard (CNS) A 4 specifications (2〗 0 297 g *) -14-Λ 6 13 6 201824 V. Description of the invention (d The trench (8) defined by the well in the third layer (3) and the third layer (3 ) The trench (8) defined by the middle well has the same size and structure as the second layer (2). The equivalent trench (5) defined by the second well is defined in the second layer (2). The trench (5) is located directly below the trench (8) defined by the well in the third layer (3), so when all three layers are combined to form a thin Η shape, the first The second well part defines the groove (5), which is a circular well part for receiving liquid along a considerable part of the first layer in combination with the well part defining groove (8), which can be connected to the reaction chamber The zone near the base (6) communicates with liquid, and the bottom surface of the well is formed by a relatively circular part of the first layer (1). FIG. 7 shows an exploded plan view of one of the preferred embodiments of the present invention. This embodiment is used to perform a majority of agglutination reactions with a minimum amount of liquid sample. Such a device in a combined form can be considered It has a relatively thin sheet-like disposable structure with one of the six coagulation chambers radiating outward from a common liquid receiving well to be marked separately. The device of FIG. 3 includes The roughly circular first wettable but liquid storage layer (1), the roughly circular second liquid storage layer (2) covering the first layer (1) in parallel and the parallel covering On the second layer (2), a third liquid embedding layer (3), these different layers can be combined together by, for example, an adhesive located between the different layers, in this embodiment, the The third layer (3) is made of a round transparent plastic film such as a ρο 1 ycarbonate film, so it is used as a window for observing particles in the six-radial coagulation chamber Or the observation area, inserted and adhered to the second thalium between the first and the third thalium (2) There is a groove (in this paper with the Chinese national scale Xiao Shu quasi (CNS) A 4 size (210X297 mm) (Please read the notes on the back of this page and then fill in) installed < Printed by the Employee Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs -15-Λ 6 Β6 201824 V. Description of the invention (^ (Please read the precautions on the back before writing this page) Employee Consumer Cooperative of the Central Bureau of Economic Affairs Print 25), the groove (25) is in the form of a central circular portion (5) of a radial groove arm that extends outwards, and each of the grooves (25) of the radiation The arm defines six channels for guiding the liquid transferred by the capillary action through the radial groove arm combined with the chambers defined by the first layer (1) and the third layer (3) respectively The reaction can be carried out simultaneously in the final six chambers, each of which has a general rectangular near base zone (6) and a general extended or triangular final zone (7), In this skeletalized embodiment, the flow rate of all liquids flowing through each coagulation chamber is controlled by a strip (4) of porous absorbent material, preferably a filter paper, with a hole (28) The general ring (27) of this porous material extends into the boundary defined by the radial groove arms At the end of each channel of the channel (7), the ring (27) is selectively permeated with a substance through its thickness to provide a non-permeable liquid absorption area (4) and Permeated liquid storage area (26), selective absorption area (4) from the ring (27) and permeated liquid storage area (26), these non-permeable extending inward from the ring (27) The paper strips (4) are in liquid communication with each of the chambers, and the concubine is located near the end of each chamber, preferably partly in the end (when the structures in FIG. 3 are combined When they are together in the shape of a sheet) 〇The third layer (3) of the device shown in FIG. 7 has a circular well-defined groove (8), and its second layer has a third layer (3) The middle well-defining trench (8) is a round second well-defining trench of the same size and type, and the second-tier (2) well-defining trench is used for the paper size. China National Standards (CNS) A 4 specifications (210 father 297 male dragons) -16 _ Λ 6 Β6 201824 V. Invention description (id (please read the precautions on the back before filling out this page) (5) Wong is in his group The well portion of the third layer (3) in the structure is directly below the trench, if so, the second well portion of the structure (5) defines the trench (8) in conjunction with the well portion of the third layer (3) ) And the individual circular part of the first layer (1) define the well for receiving liquid, the well is in fluid communication with the near base zone (6) of each of the chambers As a result, the general circular sheet-like structure can be regarded as a relatively thin and freely usable card, and has a liquid-absorbing paper in liquid communication with the final zone (7) of the coagulation chamber Strip (4), if so, in all the embodiments of the present invention, the device of the present invention has equipment for controlling the flow ratio of all liquids flowing through the reaction chamber, which is in fluid communication with the reaction chamber A porous absorbent material in a state, which is typically pseudo-located near the end of the reaction chamber and usually extends partially into the end of the reaction chamber, however, each of the devices of the present invention (In order to carry out agglutination reaction) can be further added by the use of an additional device To control the flow of the liquid flowing through the reaction chamber of the apparatus, the trip to a by 4, 6, 7 and 8 shown in camel modified geometric patterns or the inner shape of the reaction chamber of the reaction chamber. Printed by the Employee Consumer Cooperative of the Ministry of Economic Affairs of the Ministry of Economic Affairs. For example, in Nos. 4, 6, and 7, the general groove (25) of the second floor (2) is located near the base of the room (6) Defines at least roughly parallel walls (9), thus defining a first channel with a width that is approximately constant, viewed from the direction towards the end of the chamber (7), its general groove The groove (2) defines a plurality of walls in the last zone (7), and each of the walls is spaced from each other to define a second channel with an increased width compared to the first channel near the base zone (6) The standard adopts the Chinese Beta Family Standard (CNS) Grade 4 specification (210x297 g *) -17-A6 B6 201824 5. Description of the invention ((please read the precautions before filling in this page), obviously; The agglutination reaction proceeding in this chamber can advantageously occur, such as one or more patterns of agglomerated particles in the final zone (7) of the chamber, such as a ribbon, are formed, the pattern is more commonly produced before The non-patterned agglomeration of the agglomerated particles in the agglutination chamber of the technology is easier to pass through the window of the third Tara (3) Observe that circle 8 shows a rough representation of one of the aggregated particles in the zone where the width of the chamber is increased, which is roughly a semi-circular band (27), that is, in the zone (7) at the end of the chamber The extension of the chamber> in the second channel 〃 (here, it looks like a triangle), as shown in the schematic form of arrows of different lengths used along the reaction path in the chamber in FIG. 7) Each of the wall surfaces in the image is spaced from each other to provide a reduced liquid flow rate per unit area along the second channel. In FIG. 8, the shorter arrow is of course used to represent Its longer arrow represents a smaller current ratio per unit area in the path. • Hit. Ministry of Economic Affairs " 棂?-局 肖 工 消 '; ”Cooperative ^ 卬 制 • Line as for the room The shape of the triangle of the second path at the end of the middle is better, and it has been found that for this so-called a second path, other geometric shapes also provide favorable pattern formation of aggregated particles, For example, the two side walls in the second path may be formed into a round convex shape In the configuration shown in FIG. 9 that is approximately semicircular or bowl-shaped, or, even if it is less ideal, the two side walls of the second path may be formed to provide a rough outline as shown in FIG. 10 The second path is rectangular. However, if necessary, the flow ratio per unit area in the final zone of the reaction chamber can be increased by gradually increasing its space between the floor and roof of the reaction chamber along the liquid flow direction. The general direction is gradually reduced, for example, by gradually increasing the roof of the reaction chamber and -18 in the upper part of the curve at the end of the 81 curve-this paper scale is applicable to the Chinese National Standards (CNS) f 4 specifications (210x297 mm) t Λ 6 Β6 201824 V. Description of the invention (^ (please read the precautions on the back before filling in this page) / or gradually bend the roof of the reaction chamber in the final part downward, and it has been found that: The roof of the reaction chamber in the zone, and it has been found that this modification of the floor of the reaction chamber in the final zone of the reaction chamber and the space between the roofs can also be formed in the final zone of the chamber Of regular patterns of agglomerated particles Factors, for example, the space between the floor and the roof of the reaction chamber can be gradually increased by pasting a spherical dome-shaped or cylindrical dome-shaped structure in an area of the third floor (3), like When the third layer (3) is attached to the second layer (2), the dome in the third layer covers the end of the reaction chamber, and the floor and roof between the end of the reaction chamber Another example of a way to provide a gradually increasing space is this way (when the first layer (1 丨 is adhered to the second layer (2), its bowl-shaped depression is formed at the end of the reaction chamber In the floor) stick a spherical bowl or figure-shaped bowl to the base of the first layer (1). All the test types based on agglutination printed by the Beigongxiaot Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs can be adapted to a device according to the present invention. In some cases, a soluble reagent can be dried into Several points or pieces, for example, in a blood sample, in other examples, such as a mortar reagent, a particle reagent can be dried in the chamber, and in another processing method, a reagent can be diffused 0% 重 In a solution placed in the chamber, a preferred reagent solution is microparticles in a solution of dextran and sucrose, the particle reagent is preferably commonly mixed in about 2.5 to about 5.0% Dextran and from about 15 to about 20% by weight of sucrose solution for mixing test. Other preferred solutions of the agent are like F1C0LL (Sigma Chemical Co., St. Louis, Missouri, a non-ion of sucrose Trademarks of synthetic polymers) from about 20 to about 20% of this paper ^ Duxiao used in China · 楳 楳 准 (CHS) A 4 specifications (210x297 public) -19-«201824 Λ 6 Β6 Employee Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs Print 5. Description of invention 1 Avoid 30% of the weight, and according to the needs of this test, the liquid flow through the chamber can be controlled as described above to adapt to any necessary latency and test procedures. One of the inventions is particularly advantageous to wait for customs Because it provides the ability to perform multiple tests simultaneously when using a very small amount of sample material, for example, a single drop, and the agglutination test is basically customary when the drop of sample material is added to the agglutination reaction device. However, in these specific embodiments of the present invention, an additional device is used to control the flow of liquid mule flowing through the reaction chamber of its device, that is, by modifying the geometry of the end zone of the reaction chamber as described above A device of the state or its internal shape of the reaction chamber, additional reinforcement results can be obtained, such as the enhanced observation power of the aggregated particles in the final zone of the reaction chamber. A device of the invention is particularly suitable Used in an automated type of agglutination reaction that can be monitored by an optical scanner, for example, the structure of the agglutination reaction prompts us to use The useful image analysis system of Olympus (Olympus, CUE-2, Lake Success, N.Y.) to determine the amount and concentration of agglutination materials, the agglutination reaction device is displayed as: The reflected light can be read by a reader, and its image is then analyzed by a computer to determine the amount of agglutination that has occurred and strengthen the image for very accurate and sensitive decisions, such as by being formed in the agglutination reaction device Normally limit the sample to a room, that is, undoubtedly have the curvature of the droplet or water that can interfere with the image seen by the reader. If so, the uniformity of the reaction sample and reagent formed by the agglutination reaction device卽 provides an excellent image format for a reader or other image device, in addition {please read the precautions on the back before filling this page) < -5-Thread-This paper scale uses 8 Chinese standards (CNS) 4 specifications (210X297) «-20-Printed by the Ministry of Economic Affairs + Central Standards Bureau employee consumer cooperative 201824_Be V. Description of invention (, also Reading the transmitted light passing through the bottom of the agglutination reaction, because its samples and reaction reagents are pseudo confined to the capillary chamber formed by the agglutination reaction device and can also read the reflected light. Please refer to FIG. 1 again, as shown in one embodiment of the invention Embodiment, FIG. 1 shows a perspective view of a device (10) formed by two layers of material covered by a bottom layer (12) and a top layer (14). The bottom layer (12) has a plurality of channels (16) and is formed In a sample well (20) in the surface, the sample well (20) is located near the entrance of each chamber (16), in the structure of the device (10), regardless of its bottom layer (12) or its top layer (14) Both can be opaque, it is better to further this layer from an optical scanning device to enhance its background, the bottom layer (12) needs to be hydrophilic or wettable, so it should be the same as the original The capillary flow when placed in contact with the entrance of a chamber (18) That is reduced, this can be achieved by using a hydrophilic material as the surface (12); however, it can also be chemically treated or coated with other non-wettable (hydrophobic) materials to make it wettable, this wettable The surface preparation can also be used to determine the flow ratio in the capillary chamber (18) so formed. Various materials suitable for preparing a wettable layer for various embodiments of the present invention include, for example Cellulose acetate monobutyrate, a wettable nylon material or coated with an acrylic latex latex to coat its surface into a water-wettable layer, for example, in one embodiment of the present invention, a coagulation reaction chamber
係藉將來自 Eastman Chem. Prod. Inc· Kingsport，TN 之商業上有用的醋酸一丁酸纖維素（CAB)予以模鏵而 形成，以具有從大約.010至大約5公釐之深度及從大 本紙張尺度遑用中國國家楳準(CNS)甲4規格（2Κ)Χ29·7公龙） (請先閱讀背面之注意事項再填寫本頁) 裝· -*°_ -21 - Λ 6 Β6 201824 五、發明説明 (2(ί 約Ο. 1至大約10公釐之寬度之多數個溝道（16), 毎一從一較大的井部（20)延伸出來之溝道（16)均 被模鑄入CAB之底層（12)之一端，接下來，一片足 以覆蓋被模鏵入CAB内之所有溝道（16)之透明膠帶 (14)即被提供至底層（12)以形成其毛細室（18 ),一段黏著玻璃紙帶則可被用來提供作為凹陷的表面（ 14)之頂蓋或表面之用以形成其毛細室（18),其他 非可濕的（疏水的）材料則可被用來形成其室（1 8 )之 頂面（14),本發明之一凝集反應裝置之此具醱化實施 例之所有較佳的尺寸之長度像從大約10至大約75mm 而寬度則從大約5至大約20mm;厚度則從大約0. 5 至大約5. 0mm,在可濕表面中的這些溝道之尺寸之深 度最好是從大約0. 01至大約5. 0mm而寬度則從大 約0.1至大約10. 0mm。 本發明之反應裝置之非常小的尺寸容許快速且方便地 處理多數個裝置及樣本，一裝置隨後即可被載入一自動化 裝置内，該自動化裝置可為試驗結果编目錄並掃描個別的 溝道，其凝集反應裝置之小尺寸亦提供足夠使用之樣本及 試劑。 下面的例子傜用來更進一步地顯示本發明之具體化實 施例且將不被用來限制本發明之範圍。 例1 薄片狀可隨用隨丢之卡片偽藉將一可濕基部餍，一衝 本紙ft尺度遑用中β β家楳準(CNS)甲4規格(210x297公釐) (請先閱讀背面之注意事項再填寫本頁) 裝- *?τ. 經濟部屮央標準局員工消费合作社印製 -22 - A 6 B6 201824 五、發明説明（ 切之黏著的核心層，紙條片組件及如圖3中所示之一透明 的聚碩酸鹽頂組件結合一起而完成，為準備其可濕基部層 ，一密爾厚之尼龍薄膜（Capran Emblem 2500，Allied Signal，Morristown，New Jersey)卽首先被呈薄片狀地 經由一雙面膠帶層之使用而被結合於一硬紙板内壁（Wes-tvaco Hi Yield Printkote· 16 mil» New York. NY) _h ，基部副組件（3 〃 x 6 〃，亦即3英寸乘6英寸）即切 自此材料，並小心地保持外露的尼龍表面之淸潔，鏑尺鑲 模即預備來從已解除兩黏著面上之墊圈之一第二片雙面膠 帶（3. 1 密爾），專業膠帶，Division of Rsw Inc.，It is formed by molding commercially useful cellulose acetate butyrate (CAB) from Eastman Chem. Prod. Inc. Kingsport, TN to have a depth of from about .010 to about 5 mm and from large This paper uses the Chinese National Standard (CNS) A4 specifications (2Κ) Χ29 · 7 male dragon) (Please read the precautions on the back before filling out this page) Installation ·-* ° _ -21-Λ 6 Β6 201824 5. Description of the invention (2 (ί about Ο. 1 to about 10 mm in width of the plurality of channels (16), each channel (16) extending from a larger well (20) are One end of the bottom layer (12) of the CAB is molded, then a piece of transparent tape (14) sufficient to cover all the channels (16) molded into the CAB is provided to the bottom layer (12) to form its capillary chamber (18), a piece of adhesive cellophane tape can be used to provide a cover or surface as a recessed surface (14) to form its capillary chamber (18), other non-wettable (hydrophobic) materials can be Used to form the top surface (14) of its chamber (18), the length of all the preferred dimensions of this coagulated embodiment of the agglutination reaction device of the present invention From about 10 to about 75 mm and a width from about 5 to about 20 mm; a thickness from about 0.5 to about 5.0 mm, the depth of the dimensions of these channels in the wettable surface is preferably from about 0.01 Up to about 5.0 mm and width from about 0.1 to about 10. 0 mm. The very small size of the reaction device of the present invention allows for quick and easy processing of many devices and samples, one device can then be loaded into an automated device The automatic device can catalog the test results and scan individual channels, and the small size of the agglutination reaction device also provides enough samples and reagents. The following examples are used to further show the specific implementation of the present invention For example, it will not be used to limit the scope of the invention. Example 1 A sheet-like card that can be used and thrown away is used as a wettable base, and a piece of paper ft scale is used in the β β family seal (CNS) 4 Specifications (210x297mm) (Please read the precautions on the back before filling in this page) Outfit-*? Τ. Printed by the Staff Consumer Cooperative of the Bureau of Standards, Ministry of Economic Affairs-22-A 6 B6 201824 V. Description of invention (cut Sticky core layer, paper strip The module and one of the transparent polysilicate top modules shown in Figure 3 are combined together to prepare its wettable base layer, a mil thick nylon film (Capran Emblem 2500, Allied Signal, Morristown, New Jersey ) 卽 was first bonded to the inner wall of a cardboard through the use of a double-sided adhesive tape layer (Wes-tvaco Hi Yield Printkote · 16 mil »New York. NY) _h, base sub-assembly (3 〃 x 6 〃, that is, 3 inches by 6 inches) is cut from this material, and carefully keep the exposed nylon surface clean, and the dysprosium insert is ready to remove the second piece of the double washer from the two adhesive surfaces. Face Tape (3.1 mil), professional tape, Division of Rsw Inc.,
Racine，WI)切出如圖1中所示之溝道形狀，一片解除的 墊圈即從衝切部份被移開而此黏著層則被置放於基部組件 之尼龍表面上，具有一層單面黏著物之多Η過濾紙 2 . 5X9 公蟹,1 CHR, Whatman. Clitton. New Jers- ey)則被黏著至定位於使其單面黏著物（ARCare 7597. 黏著物研究，Glen Rock，PA)遠離卡片之基部/核心组 件上之一表面，最後，一片透明的聚碩酸鹽薄膜（GE Ρα-χ· t 8 0 4 0 -112 » C a d i 1 1 a c P 1 a s t i 。 s ， E v a n s v i 1 1 e ， I N ) 即 被衝切成如圔3之項目（3)中所示者，而使用一以機械 製成薄片之機組在50ps i及◦. 2f t/sec下將 其結合至基部/核心/紙張組件上。 例2 薄片狀之可自由使用的卡片傜使用披覆以一可濕的丙 本紙張尺度逍用中 β家《準(CNS)甲4規格(210X297公釐) (請先閲讀背面之注意事項再填寫本頁) 裝· 線- 經濟部中央標準局员工消費合作杜印製 -23 - Λ 6 Β6 S018^4- 五、發明説明（ 稀橡榮乳躍披覆（Part 150HT(26-1)，Daubert Coated Products，Dixon，IL)之一片3 6 "之硬紙板取代 例子1中所述之尼龍基部副組件而製成，衝切核心層則以 3, 1密爾之雙面黏著層URCa re 7580，黏著物研究，Racine, WI) cut out the channel shape as shown in Fig. 1, a piece of relieved gasket was removed from the die-cut part and the adhesive layer was placed on the nylon surface of the base component, with a single side Multi-adhesion filter paper 2.5X9 male crab, 1 CHR, Whatman. Clitton. New Jers-ey) is adhered to its single-sided adhesive (ARCare 7597. Adhesive Research, Glen Rock, PA) Far away from the surface of the base / core component of the card, and finally, a transparent polysilicate film (GE Ρα-χ · t 8 0 4 0 -112 »C adi 1 1 ac P 1 asti. S, E vansvi 1 1 e, IN) is punched into the item (3) as shown in 圔 3, and using a machine made of mechanical sheet to join it to the base under 50ps i and ◦. 2f t / sec. On the core / paper assembly. Example 2 The thin-shaped free-to-use card is covered with a wettable C-sheet paper and is used in the beta family of "CNS" A4 (210X297mm) (Please read the precautions on the back first (Fill in this page) Equipment · Line-Central China Bureau of Economic Affairs Employee Consumer Cooperation Du Printed -23-Λ 6 Β6 S018 ^ 4- V. Description of the invention (Part 150HT (26-1), Daubert Coated Products, Dixon, IL), a piece of cardboard 3 6 " is made to replace the nylon base sub-assembly described in Example 1, and the die-cut core layer is made of 3, 1 mil double-sided adhesive layer URCa re 7580, Adhesive Research,
Glen Rock, PA)製成，卡Η組合中之所有其他的步驟均與 例1中者相同。 例3 固定的人體紅血球（Duracytes ΤΜ，艾伯特實驗室， 北芝加哥，I L )則被披覆以親和性，純淨的山羊抗髏則 被用來對抗存在有0. 0 5% (重量/容積）氣化鉻於 〇.1M (克分子）之一pH為4. 0的醋酸鹽缓衝劑中 之一最終濃度係10〇ug/ml之B型肝炎表面抗原（ HBsAg),這些細胞則被披覆以於25mM(毫克分 子）的三氯化氫（Tris-HCi?, ΡΗ·7.4)缓衝劑中之1% (重量/容積；w/v)之人類血清白朊（Sigma化學公 司，St. Louis，M0),然後再懸浮以磷酸鹽缓衝劑的鹽 水（ρΗ = 7· 4)中之0. 1%之牛的血清白朊（ BSA) (Sigma 化學公司，St. Louis，Μ0),該碟酸 鹽缓衝劑的鹽水包含10% (容積/容積）之最終的細胞 濃度中之5% (容積/容積）之正常的山羊血淸，包含 0，6 . 2 5或2 5 n g /m 1 (十億分之一克/公撮） 之HBsAg之血淸樣本則被混合以l〇ul (徹公升） 整分的這些披覆的Duracytes，而其溶液則立即被加至如 本紙張尺度逍用中國國家«準(CNS)甲4規格(210x297公釐） (請先閲讀背面之注意事項再塡寫本頁) 裝· 經濟部屮央標準局貝工消费合作社印製 -24 - Λ 6 Β6 201824 五、發明説明（2：^ (請先閱讀背面之注意事項再塡寫本頁) 例子1中所述者般製造之薄片狀的可自由使用之卡Η之樣 本附加井部，該溶液即快速地流過毛細溝道（1一2秒） ，然後慢慢地流入紙條片内，該液體則花費大約7分鐘來 完金地滲透該紙條片，於該紙條片已完全潮濕後，Durac-yte細胞之凝集反應産品即可於其薄片狀可隨用随丢的卡 片之某些毛細溝道中被觀察，如表1中所見，已被混合物 以包含HBsAg之樣本之Duracytes即凝集，然而， 被混合以未包含Η B s A g之血清之Duracytes則不會 凝集。 表1 HBsAg濃度 集成 0 - 6.25ng/m $ +/- 25 ng/m j? + 例子4 經濟部中央標準局員工消費合作社印製 薄片狀之可隨用隨丢的卡片則被製成如例子2中所述 之具有如圖1中所示之一延伸溝道設計，披覆以抗一 HBsAg (例如3)之Duracytes則被混合以包含各種 濃度的HBsAg之血清，且被導入具有延伸的溝道之薄 片狀的可隨用隨丢的卡片内，5分鐘後，集成的粒子即出 現且形成易於觀察的凝集帶，該凝集帶即延伸過如圖4中 所示之溝道的延伸部份，在無任何HBsAg出現之溝道 本紙張尺度通用中S國家標毕（CNS)甲4規格（210x297公龙） -25 - Λ 6 Β 6 經濟部中央標準局貝工消t合作社印製 201824 五、發明説明（2 j 中，其Duracyte即不會集成，且無可看見之細胞帶。 (請先閲讀背面之注意事項再填寫本頁) 本紙張尺度逍用中國國家標準(CNS)甲4規格(210x297公龙) -26 -Glen Rock, PA), all other steps in the card combination are the same as in Example 1. Example 3 Fixed human erythrocytes (Duracytes TM, Albert Laboratories, North Chicago, IL) are covered with affinity, and pure goat anti-crossbones are used to combat the presence of 0.05% (weight / volume) ) Vaporized chromium in one of the acetate buffers with a pH of 4.0 in 0.1 M (mole) and a final concentration of 10 ug / ml hepatitis B surface antigen (HBsAg), these cells were Human serum albumin coated with 1% (weight / volume; w / v) of 25mM (mg molecule) of hydrogen trichloride (Tris-HCi ?, PH · 7.4) buffer (Sigma Chemical Company, St. Louis, M0), and then resuspended with 0.1% bovine serum albumin (BSA) (Sigma Chemical Company, St. Louis, M0) in saline (pH = 7.4) with phosphate buffer Saline salt buffer saline contains 10% (volume / volume) of the final cell concentration of 5% (volume / volume) of normal goat blood, including 0, 6.2 5 or 25 ng / The blood sample of HBsAg m 1 (one billionth of a gram per centimeter) was mixed with 10 ul (liter liters) of these coated Duracytes, and the solution was immediately added to the original paper Standards are used in China National Standards (CNS) Grade 4 (210x297 mm) (please read the notes on the back before writing this page). Printed by the Beigong Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs-24-Λ 6 Β6 201824 V. Description of the invention (2: ^ (Please read the precautions on the back before writing this page) A sample of the sheet-shaped freely usable card H manufactured as described in Example 1 is attached to the well, the The solution flows quickly through the capillary channel (1-2 seconds), and then slowly flows into the paper strip. The liquid takes about 7 minutes to penetrate the paper strip completely, after the paper strip is completely wet Afterwards, the agglutination reaction products of Durac-yte cells can be observed in certain capillary channels of their thin, disposable cards. As seen in Table 1, Duracytes that have been mixed with HBsAg-containing samples are agglomerated. However, Duracytes mixed with serum that does not contain HBsAg will not agglutinate. Table 1 HBsAg concentration integration 0-6.25ng / m $ +/- 25 ng / mj? + Example 4 Central Bureau of Standards, Ministry of Economic Affairs Employee consumer cooperatives print cards that are thin and can be used and discarded. As described in Example 2, one with an extended channel design as shown in FIG. 1, Duracytes coated with anti-HBsAg (eg 3) is mixed with serum containing various concentrations of HBsAg, and is introduced with In the lamella-shaped, disposable card of the extended channel, after 5 minutes, the integrated particles appear and form an easy-to-observe agglomeration band, which extends through the channel as shown in FIG. 4 The extended part, in the absence of any HBsAg, the standard of this paper standard is S National Standard (CNS) A 4 specifications (210x297 male dragon) -25-Λ 6 Β 6 Printed by Beigongxiaot Cooperative, Central Bureau of Standards, Ministry of Economic Affairs System 201824 V. Description of the invention (In 2 j, its Duracyte will not be integrated and there is no visible cell band. (Please read the precautions on the back before filling in this page) This paper standard uses the Chinese National Standard (CNS) A4 specifications (210x297 male dragon) -26-