201823 A6 B6 五、發明說明（1} 本發明之背景 本發明像有關一種用以進行免疫化學粒子之凝集反應 之改進的裝置，該凝集反應裝置僳用以提供一種方便的設 備以進行且閲謓一凝集反應之結果，一特殊的改進包括改 變沿著裝置中藉毛細作用流通液體之路徑之一部份的幾何 大小，亦即其寬度及/或深度。 凝集反應及其程序於該技藝中一般而言俗眾所週知的 ，一典型的凝集作用包括抗原或抗體撝蓮細胞、撤生物。 或待殊分析所出現之粒子等之懸浮髏之叢生一起（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。 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，且一般上傜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像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。 本發明之一目的係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，本發明之另一目的傜在 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 矛.紙弦r、熒i? «:中K S家样a fre»«Η甩格(210x297公踅) ~ 3 - (請先聞讀卄面之注意事項再填寫本頁) •裝· •打· •線. 201823 A6 B6 五、發明説明（2) 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 一方面，本發明係指具有從一中央井部向外輻射之多數傾 溝道之一種裝置，該中央井部即可以一最少置的樣本材料 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，本發明傺指用以進行凝集反應之裝置， 該反應具有蓮用一設備以控制液讎體流經該裝置之反應室 之加強的執行特性，亦即，經由凝集反應室或該室之内部 形狀之幾何結構之修改以提供一集成凝集之非任意的圖案 排列，該非任意的圖案則較成一任意排列之集成凝集更易 於看見。 本發明之概要 祕濟部十处標';,1-场：^工消^合作;1"贤 {請先聞讀背面之注意事項再填荈本页) 本發明僳提供一種用以進行凝集反應之裝置，包括： 呈附著關俗之一第一可濕層，平行地覆蓋於第一靥上之一 第二液體吸收層及平行地覆蓋於第二層上且具有用以觀察 粒子之一窗戶之一第三層，其第一層傜插於中間且與第一 及第三層僳呈附著關俗，其第二層具有至少一個一般性溝 槽，其中即界定出一溝道用以導引藉由經藉其溝槽連同第 一及第三層所界定出之一室之毛細作用所傳導之液體，凝 集反應即可於該室中進行，該室具有一近基部地帶及一末 稍部地帶，前述第二層中之溝槽於近基部地帶界定出至少 大約平行之壁面，因而界定出具有大略固定不變的寬度之 一第一路徑，前述第二層中之溝槽於末稍部地帶亦界定出 表紙帒尸、度这用中E E家丨ί CN9甲4境烙（21 〇X297公楚） -4 - A6 B6 201823 五、發明；13^月（3 ) {請先閱讀背面之注意事項再填寫本頁) 若干壁面，各該壁面係相同隔以界定出與第一路徑相較具 有加大的寬度之一第二路徑，於該室中之此種不同路徑之 配置至少部份地能於該室中進行凝集反應，以於該室之末 稍部地帶中促使集成粒子之一顯著的非任意圖案得以形成 ，此一非任意的圖案較若集成粒子之一任意圔案替代性地 産生更易於經第三層予以觀察。 經濟郎屮央標肀局锊工消';'合作杜印欠 本發明亦特別地提供一種裝置，藉以進行凝集反應， 其中，其第二層至少具有一個一般性的溝槽，於其中即界 定出一溝界，用以導引由經溝槽及第一及第三層所界定之 一室之毛細作用所傳導之液體，其中，其室内之凝集反應 即可被進行，該室具有一近基部地帶及末稍部地帶，第二 層中之溝槽即界定出近基部地帶中之若干壁面而與第一及 第三層界定出具有大略上固定不變之深度之一第一路徑， 第二層中之溝槽亦於末稍部地帶中界定出若干壁面而與第 一及第三層共同界定出與第一路徑相較具有加大的深度之 —第二路徑，因此該室内之凝集反應即導致該室内之末稍 部地帶中之集成粒子之一非任意圖案之形成，該非任意之 圖案較若替代地産生之一集成粒子之任意圖案更易於經第 三層之窗戶予以觀察。 此外，本發明亦提供用以同時進行多數個凝集反應之 一種裝置，該裝置包括：呈附著關係之一第一可濕層，平 行地覆蓋於第一層上之一第二液體吸收層及平行地覆蓋於 第二層上且具有用以觀察粒子之若干窗戶之第三層，其第 二層係插於其間且與第一及第三層係呈附著關係，其第二 佑尺 β R： * K S t 挖 ίί ^ Γ、.Ά )項饬（210 X 297 公 AM -5 - A6 B6 201823 五、發明說明（4) {請先閲讀背面之注意事項再填窵本页) 層之一般性溝槽具有彼此呈間隔關像之多數個放射狀溝槽 臂（又稱溝槽），這些輻射狀溝槽且分別界定出若干溝道 以導引經分別由各該溝槽連同第一及第三靥所界定之各該 室所進行的毛細作用所傳送之液體，凝集反應可同時於這 些室内被進行，這些室中的每一室均具有一近基部地帶及 一末稍部地帶，且這些溝槽中之每一溝槽均於相當的近基 部地帶中界定出至少大略平行之若干壁面，因此而界定出 寬度大略像固定不變之一相當的第一路徑；且於相當的末 稍部地帶中界定出若干壁面，各該壁面傈彼此間隔之界定 出與第一路徑相較其寬度較增加之一相當的第二路徑，於 相當的那些室中所進行之凝集反應可導致每一室内之末稍 部地帶中之集成粒子之一非任意圖案之形成，該非任意圖 案較若替代地産生集成粒子之一任意的圖案更易於經第三 層之窗戶予以觀察。 本發明之一凝集反應裝置額外地可包含鄰接於凝集室 入口附近之一樣本接收井部。 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 対濟郎十失標;1,'^H工""合仃"卬製 中。 於1 987年1 2月23日申錶之名為''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應自動 化及樣本和試劑之有效使用之一凝集反應室，典型地，此 木《張尺度適用中KK玄標iiiCNS丨甲4規格（210x297公m ~ 6 ~ 201823 A6 B6 部 屮 'k 標 η: ‘發明説明（5) 一室之長度傺從大約10公釐至大約75公釐（mm), 其溝道之深度像從大約0. 01至大約5. 0mm;其寬 度則從大約0.1至大約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 像大約37. 5mmXl2. 5mmXl. 5mm ( 芡 x w X h ) 〇 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量之另一種設備，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 如聚乙嫌Dtt略院酮（polyvinlypyrrolidone)、聚乙嫌醇 、凝膠或牛的血清白朊）。 然而，當於幫助在溝道中控制液體（流體）流量之整 値比率上係有用時，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，在一名為a利用多孔性吸收材料 的改進的凝集反應裝置〃之同日提出申請之美國專利申請 案之主題中亦已發現：諸如一有吸收力的紙之一多孔性吸 收材料僳被作為流體流動之控制設備，藉以於諸如聚乙稀 吡咯烷酮（PVP)之水溶性材料之披覆的整個蓮用過程 中在製造及蓮作上提供利益，例如，諸如聚乙烯吡咯烷酮 之一水溶性聚合之被使用處，即已被發現難於獲得乾涸的 (請先聞讀背面之注意事項再填寫本页) -7 - "4 A6 B6 201823 五、發明説明（6) 聚乙烯吡咯烷酮披覆以致於獲得溝道内之整個液體流動之 一致之穩定性。 本發明偽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每單位面積之液體流 動比率之改良設備，以産生集成的凝集粒子之非任意的圖 案，本發明亦指諸如可隨用隨丟之薄片狀卡片之結構成便 利而可隨用隨丢的結構型態之此種裝置，各該裝置可任意 地安裝於可隨用隨丢之堅固的容器内。 圖式之簡單說明 圖1傲一具體化實施例之分解的及上視的透視圖，顯 示一三層結構，包括：一第一或基靥；一第二靥，具有被 挖掉之一圖形的接收井部及於其末稍端有一延伸部份之一 凝集室；一條多孔的吸水性材料及一第三或頂層。 圖2係另一具體化實施例之分解的及上視的透視圖， 顯示一三層結構，包括：一第一或基層；一第第二層，具 有被挖掉之一圓形的接收井部及於其末稍端具有一延伸部 份之一凝集室，且於第二層中之該室的末稍端處具有一整 體性之多孔吸水條片；及一第三或頂層。 圖3傺另一具體化實施例之上梘圖，顯示一薄Η狀結 構之零件，包括：一基層；具有被挖掉之一圓形的接收井 部及具有延伸的末稍地帶之多數個輻射狀凝集室之一第二 層；供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（即環）；及與環狀結構共同形成其頂 (請先閱讀背面之注意事項再填寫本頁) •装· •打· •線. -8 - 201823 五、發明說明（7) 層之另一圓形層。 圖4僳一概略圖，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每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5傺一概略圔，用以顯示從接收井部向外通往具有 一半圖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。 圖6傜一概略圖，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 {請先w'tt面之注意事項再填寫本页) •装· 較佳具髏化實施例之詳細描述 •訂· •線· 本發明係指適於用來進行凝集反應之多種改良裝置， 明顯地，用來進行凝集反應之本發明之多種裝置係用以提 供優於先前技術裝置之加強的特徽，本發明之多種裝置偽 利用一種設備來控制經過該裝置之反應室之液體之每單位 面積的流動比率，特別地，這些設備包括如圖1, 2, 3 ,4, 5及6中所示之修飾的該室之幾何結構及該室之内 部形狀。 圖1顯示用以根據本發明進行凝集反應之一種裝置之 具體化實施例，此具髏化實施例具有呈附著關係之一能吸 藏液髏之第一可濕層（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 太*ί· A尺吃it m中E E充疗a W *1格（210 X 2 9 7公梵） -9 - Μ;ί?郎屮处桴十曷肖Χ;Λ''·^11Η,,Τ," 201823 Α6 Β6 五、發明說明（8) 區之一第三液體吸藏層（3),其第一層（1)像由具有 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)像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視窗 或觀察區，其第二層（2)則插入並附著於第一靥（1) 及第三層（3)之間，例如藉由分別位於第二層（2)之 毎一側之面對第一層（1)的頂側及第三層（3)的底側 之黏著層，其第二層（2)具有一個一般性的溝槽（25 ),該溝槽（25)僳切割過第二層（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 )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Η狀地結 合一起時，每一第一及第三層之一部份僳分別作為凝集室 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),該近基部地 帶（6)係由第二層（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1中之該具體化實施例具有第三層（3)中 之一井狀溝槽（8)及於第二層（2)中之如同第三層（ 3)中之并狀溝槽（8)之相同的尺寸及結構之一相當的 表纸弦&度迕疋中ΚΚ家捃準（CNM甲4境烙（210x297公⑺ -10 - (請先閱讀背面之注意事項再瑱寫本頁) •装， *線· 201823 ^ 五、發明説明（9) 第二値井狀溝槽（5)，第二層（2)中之井狀溝槽（5 )像直接位於第三層（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片狀時，其第二個 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，該井部係與該室之近基 部地帶（6)呈液體相交流之狀態，其井部之底面像由第 一層（1)之一相當的圓形部份所形成，該部份可被當作 傺溝槽（5)及（8)在第一層（1)表面上之投影。 在圖1所示之具體化實施例中，流經其凝集室之所有 液體的流動比率傜藉一條多孔性吸收材料（4 )予以控制 ,最好俗以過濾紙置於靠近該室之末稍端處以為與該室之 液髏交流，該過濾紙最好僳部份地延伸入該室之末稍端（ 當圖1之結構分別被結合一起而成薄片狀時），當被使用 於本説明書内時，例如紙之吸水性多孔材料俗被從諸如聚 乙嫌舭略院酮（polyvinylpyrrolidone),聚乙稀醇（口_ olyvinylalcohol),凝膠或牛的血淸白肢之諸如水溶性 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傜非水溶性，在一較佳 具髏化實施例中，如同圖1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),故當値別的 各層被黏著一起時，多孔性吸水材料之紙條（4)即部地 安置於溝槽（28)内，更特別地，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（2 8 )内，以 {請先«1讀讦面之注意事項再填寫本百) .笑· .訂. •線. 太紙張;·、度速用中R E家俅準f ΓSS!中4規格（2 Η) X 297公嫠） -11 - A6 B6 201823 五、發明説明ί 10 免沿著紙條（4)之長度及其兩側處之微毛細溝道之不利 地形成，其最後的薄板狀結構可被當作俗一薄且可隨用隨 丢之卡片，該卡片則具有與凝集室之末稍部地帶（7)以 液髏交流之紙條（4)。 例如，當一細胞溶液被導入本發明之一裝置之接收井 部時，該細胞僳與反應室之近基部部呈液體交流狀態；含 有抗體之該室即監督細胞上之抗原，而該抗原即乾涸於該 室之地板上，該溶液將藉毛細作用移經該室而與抗毒血清 相混合，故各該細胞將聚集一起，此將全部發生而無任何 離比或混合步驟，因凝集反應最好像發生於液體流動期間 ，即需經由溝道控制所有的液醱流動比率，於液體流動期 間且有足夠的潛伏時間以完成試劑之適當的反應。 在圖1、2及3中，第二層（2)中之一般性的溝槽 (2 5)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，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層（3) 之窗戶予以觀察，圖4顯示出在增加室寬之地帶中之凝集 {請先W讀背面之注意事項再填寫本頁) .襄· .訂· 本纸張尺度迚用中SB家懔準(CNM甲4規格(210x297公茫) -12 - A6 B6 201823 五、發明說明（1ί 粒子之一大略呈半圓形帶狀（2 7)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1"第二通 道〃中（此處傜大約呈三角形），如同圖4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)中之各該壁面傺彼此相間隔以沿著此第 二通道提供液髏通道之一毎單位面積之降低的液體流動比 率，在圖4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毎單位面積之較小的流動比率。 至於該室中之末稍地帶之第二路徑之三角形的型態則 像較好的，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5中 所示之大約呈半圓形或碗形之型態，或者，縱然像較不理 想的，第二路徑之兩側壁可被形成為用來提供如圖6中所 示之大略呈矩形之第二路徑。 圖2顯示用以進行凝集反應之一種裝置之另一具體化 實施例（當顯示於圖2中之各層被粘著一起而呈一薄片狀 型態時），此具髏化賁施例具有呈附著關像之一吸水性的 可濕層（1)，平行地覆蓋於第一靥（1)上之一第二層 (2)及平行地覆蓋於第二層（2)上且具有用以觀察粒 子之一窗戶或觀察區之吸水性而最好是非濕之第三層（3 )，其第一層（1)僳由具有一可水潮表面之液髏吸藏式 材料所製成，如同圖1所表示之具體化實施例中，此具體 化實施例亦使用由諸如一透明的聚碩酸鹽薄膜（ p〇 1 year- {請先閱讀背面之注意事項再填寫本页) .裝· •訂· •線· 太《依严、«迂Ιί中E K家梂1 iCΜ?} 辦格（2]ί)X297公穿） -13 - 經濟部中央標準局員工消费合作社印製 201823 a6 ____B6 五、發明說明（12 ) bonate film)或一非可濕的玻璃紙帶之一透明的，液體 吸藏式而最好僳非可濕性薄膜所製成之一第三層（3)， 該第三層（3)因此而可作為供觀察凝集室中之粒子用之 一視窗，其第二靥（2)則插入且附著至第一層（1)及 第三層（3)之間，例如，藉由第二層（2)之每一側上 分別面對著第一層（1)之頂面及第三層（3)之底面之 —黏物物將其黏著，其第二層（2)具有切割過其厚度之 一個一般性的溝槽（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。 如同圖1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Η狀時，毎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（25)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),該近基部地帶（6)俗由 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1及圖2所示之每一具髏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 本紙張尸、度適用中國g家標準（CN?)甲4規格（21Πχ29了公楚）—14 _ {請先閱讀背面之注意事項再填寫本页) .故· .訂· .線· 201823 A6 B6 五、發明説明（13 , )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)傜直接定位於第三層（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圃形井部，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。 然而，在圖2之具體化實施例中，其第二層（2)係 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)俗可吸收液體的而被滲透的區域（2 6)則為液體吸 藏式者，在此具體化實施例中，其無滲透區域（4)俗與 其反應室之末稍部地帶（7)呈液髏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 送之液髏，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2中所可 見者，其無滲透區域（4)係位於鄰近凝集室之末稍端處 且與該室呈液體交流狀態。 圖3顯示本發明之一較佳具體化實施例之一分解的平 本紙張尺度逡用中國S家標準f CN?)甲4 格（2 Κ，X 297分犛)-15 - (請先閱請背面之注意事項再填寫本頁) •装. .訂. •線· 經濟部中央標準局員工消費合作社印製 經濟部中央標準局員工消費合作社印製 201823 A6 ______B6_ 五、發明説明（14 ) 面圖，此具體化實施例僳用來以最小量的液體樣本進行多 數個凝集反應，呈組合型態之此種裝置可被試為是具有特 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Η狀之可隨用隨丢的卡H,圖3 之裝置包括呈附著關僳之大略呈圃形的第一可濕但液髏吸 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 之一第三液髖吸藏層（3),這些個別層可藉例如位於其 個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)像由諸如一聚硝酸鹽（polycarbonate )薄膜之一圓形的透明塑膠薄膜所製成，因此而作為用以 觀察在六個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層間之第二層（2)具有一溝槽（ 25),該溝槽（25)像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値溝道，用以導引藉毛細作用 經由輻射狀溝槽臂結合第一靥（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 之六値室内進行，該六値室中之每一値均具有一値一般性 之矩形近基部地帶（6)及一個一般性之延伸或三角形狀 之末稍部地帶（7),在此具髁化實施例中流經毎一凝集 室之所有液體流動比率傜藉由最好是過濾紙之一多孔吸收 性材料之條Η (4)予以控制，像從此多孔性材料之一般 性的圓環（2 7)延伸入由輻射狀溝槽臂所界定之各該溝 本紙張尺度適用中SS家標準（CNS)甲4規格（2ΐηχ297公¢) - 16 - (請先聞讀背面之注意事項再填寫本页) .沃. •訂. .線· 201823 A6 B6 五、發明說明（15) 道之毎一溝道之末稍部地帶（7),其圓環（27)像選 擇性地以一種物質經由其厚度將其滲透，以提供無摻透的 液體吸收區域（4)及被滲透的液體吸藏區域（26), 從圓環（27)向内延伸的這些無滲透的紙條片（4)係 與各該室呈液體交流狀態且係位於鄰近各該室之末稍端處 ,最好僳部份地位於末稍端内（當圖3之結構分別被結合 —起而呈薄片狀時）。 由圖3所表示之裝置之第三層（3)具有一圖形的井 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),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國形 第二井部界定溝槽（5),其第二層（2)之井部界定溝 槽（5)像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髏之一井部，該井部 像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)呈液髏交流狀態之液髏吸收紙條片（4)。 若需要的話，本發明之一具體化實施例之反應室之末 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 {請先W讀背面之注意事項再填寫本頁) .裝. 線· 木M、弦 圪 iJ ；?；中 R S 玄悻;ϊ πf q11格（21 〇X297公if) -17 - 201823 A6 B6 五、發明説明（ 一般性方向逐漸減低，例如，藉逐漸地向上鸞曲末稍部地 帶中之反應室之屋頂及/或逐漸地向下鼙曲末稍部中之反 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國頂形或圓筒狀之圓頂形結構而予 以逐漸增加，僳當其第三層（3)被附著至其第二層（2 )時，其第三層中之圖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係以此方式（當第一層（1)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）將一球狀碗形或圓筒狀碗形窪地黏貼於第 一層（1 )之基部中。 經濟部十处標·;ι,·ί?貞工消贽合作：^卬製 (請先聞讀背面之注意事項再填寫本頁) 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微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，一較佳的試劑溶液僳葡聚糖及蔗糖之 一溶液中之微粒子，該撤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 20%重之蔗糖之溶液中，用以混合試劑之其他較佳的溶 液係Flcoll (密蘇里州聖路易士之Sigma化學公司供 太纸張灵度迷ΐ中RS家桴iMCNS)甲4規格（210x297公釐） ~ 18 ~ 201823201823 A6 B6 V. Description of the invention (1) Background of the present invention The present invention relates to an improved device for carrying out the agglutination reaction of immunochemical particles. The agglutination reaction device is intended to provide a convenient device for carrying out and reading. As a result of an agglutination reaction, a particular improvement includes changing the geometrical size of a portion of the path along the device through which capillary fluid circulates, namely its width and / or depth. The agglutination reaction and its procedures are generally in this art It is well known that a typical agglutination includes antigens or antibodies, lotus cells, and withdrawal of organisms. Or a cluster of suspended skeletons (or integration) of particles and other particles that appear to be analyzed specially, each such cluster of or The agglutination is then monitored to determine whether to use an analysis based on the detection. One method for acting as an immunochemical particle reagent includes placing a liquid reagent on a glass slide, and generally shaking or swinging the glass back and forth to promote The reagents mix and form agglutination, and each method has also been developed to avoid the need to shake the particle reagent in order to see its agglutination, For example, U.S. Patent No. 4, 596, 695, namely a dew condensation reaction chamber for reacting immunochemical particle reagents, the reaction chamber includes a first transparent plate having a first surface and having a spaced apart from the first surface A second plate on a second surface to define a reaction chamber between each of the two plates. The reaction chamber is essentially transferred to one of the chambers by capillary action during the flow of reactive immunochemical particle reagents External lotus movement to promote the flow of immunochemical particle reagents. One 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, and another object of the present invention is to provide a single device A large number of spears are carried out simultaneously on one of the single samples. Paper string r, fluori? «: 中 KS 家 样 a fre» «Η 掛 格 (210x297 公 踅) ~ 3-(please read the attention of reading noodles first Please fill in this page for details) • Installed • • Played • • Line. 201823 A6 B6 V. Description of the invention (2) Sensitivity diagnostic test, in a certain aspect, in a device of the present invention, the agglutination reaction can be a minimum sample Material quickly Operation and monitoring. On the other hand, the present invention refers to a device with a plurality of inclined channels radiating outward from a central well, which can make the reaction simple and simple with a minimum amount of sample material. The visible significant results are quickly carried out and monitored. On the other hand, the present invention refers to a device for performing an agglutination reaction, which has a device for controlling the flow of liquid through the reaction chamber of the device Enhanced execution characteristics, that is, modification of the agglutination reaction chamber or the geometric structure of the interior shape of the chamber to provide a non-arbitrary pattern arrangement of integrated agglomerations, which is easier to see than an agglomeration of arbitrary arrangements Summary of the present invention Ten secrets of the Ministry of Economic Affairs' ;, 1-field: ^ Work Consumers ^ Cooperation; 1 " Xian (please read the precautions on the back before filling this page) The present invention provides a The device for agglutination reaction includes: a first wettable layer attached to the customs, a second liquid absorbing layer covered in parallel on the first thallium and a second layer in parallel covered with a particle for observing the particles The third layer of a window, the first layer of which is inserted in the middle and is attached to the first and third layers, and the second layer has at least one general groove, which defines a channel To guide the liquid conducted by capillary action of a chamber defined by its groove and the first and third layers, the agglutination reaction can proceed in the chamber, which has a zone near the base and a In the last zone, the trench in the second layer defines at least approximately parallel walls near the base zone, thus defining a first path with a substantially constant width, the trench in the second layer is at The last part of the zone also defines the surface of paper and corpses, which are used by Chinese EE homes. CN9 A 4-Brand (21 〇X297 Gongchu) -4-A6 B6 201823 V. Inventions; 13 ^ month (3) {Please first Read the precautions on the back and then fill out this page) Several wall surfaces, each of which is equally spaced to define a second path with an increased width compared to the first path, the arrangement of such different paths in the room At least partially able to carry out the agglutination reaction in the chamber at the end of the chamber Some areas promote the formation of a significant non-arbitrary pattern of one of the integrated particles. This non-arbitrary pattern is easier to observe through the third layer than if one of the integrated particles is randomly generated. The economical Lang Pingyang standard bureau 唊 工 消 ';' Cooperative Du Yin owe the invention also specifically provides a device to carry out agglutination reaction, wherein the second layer has at least one general groove, which defines a The trench boundary is used to guide the liquid conducted by the capillary action of a chamber defined by the trench and the first and third layers, wherein the agglutination reaction in the chamber can be carried out, and the chamber has a zone near the base And the last zone, the grooves in the second layer define the walls near the base zone and the first and third layers define a first path with a substantially fixed depth, the second layer The trench in the middle also defines a number of walls in the final zone, and together with the first and third layers defines a second path with an increased depth compared to the first path, so the agglutination reaction in the room is This leads to the formation of a non-arbitrary pattern of integrated particles in the final zone of the room. This non-arbitrary pattern is easier to observe through the window on the third floor than if an arbitrary pattern of integrated particles is generated instead. In addition, the present invention also provides an apparatus for simultaneously performing a plurality of agglutination reactions. The apparatus includes: a first wettable layer in an adhering relationship, a second liquid absorbing layer covering the first layer in parallel and parallel A third layer with a number of windows covering the second layer and observing the particles. The second layer is interposed therebetween and is in an adhering relationship with the first and third layers. * KS t dig ί ^ Γ, .Ά) Item (210 X 297 public AM -5-A6 B6 201823 V. Description of the invention (4) (Please read the precautions on the back before filling this page) Generality of layers The groove has a plurality of radial groove arms (also called grooves) spaced apart from each other. These radial grooves respectively define a plurality of channels to guide the grooves together with the first and the first The liquid transported by the capillary action performed by each of the chambers defined by Sanchao, the agglutination reaction can be carried out simultaneously in these chambers, each of these chambers has a near base zone and a final zone, and these Each of the grooves is located near the base Defines at least roughly parallel walls, and thus defines a first path with a width that is roughly fixed and equivalent; and defines a number of walls in the corresponding final zone, each of which is spaced apart from each other The second path is equivalent to the one with a larger width than the first path. The agglutination reaction in the corresponding chambers can lead to a non-arbitrary pattern of one of the integrated particles in the final zone of each chamber As a result, the non-arbitrary pattern is easier to observe through the window of the third layer than an arbitrary pattern that instead generates one of the integrated particles. An agglutination reaction device of the present invention may additionally include a sample receiving well adjacent to the inlet of the agglutination chamber. In one of the agglutination reaction chambers of the present invention, the reagents can be displayed in a dry place or in an elongated area, and the reagents can also be suspended in the water-soluble polymer. " 合 䀃 " The system is in progress. The United States patent application jointly filed on February 23, 1987, named "Agglutination Reactor" and the application number is 07/138, No. 253. (Incorporated in this article as a reference), that is, one of the agglutination reaction chambers is designed to be very small in size to adapt to automation and the effective use of samples and reagents. Typically, this wood 4 Specifications (210x297 mm ~ 6 ~ 201823 A6 B6 part ’k standard η: 'Invention description (5) The length of a room is from about 10 mm to about 75 mm (mm), the depth of the channel is like From about 0.01 to about 5.0 mm; its width is from about 0.1 to about 10. 0 mm, for a four-chamber and a sample receiving well of this agglutination reaction device with a typical overall size of about 37. 5mmXl2. 5mmXl. 5mm (芡 xw X h) 〇 The aforementioned common application of the US patent application generally also disclosed a device for controlling the flow of liquid in a coagulation reaction chamber, the coagulation reaction chamber contains a channel or formed Such as ridges in the channel, especially formed over extended The entire width of the channel and the geometry of the ridge that extends at least over a portion of the length of the channel. The aforementioned US Patent Application for Common Application also discloses another device for controlling the flow of liquid in its room, that is, drying up in the trench The use of a water-soluble material such as a water-soluble polymer (such as polyvinylpyrrolidone, polyvinyl alcohol, gel, or bovine serum albumin). However, when When it is useful to help control the integral 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. The subject of the US patent application filed on the same day has also found that a porous absorbent material such as an absorbent paper is used as a fluid flow control device, such as polyethylene The coating of water-soluble materials of pyrrolidone (PVP) provides benefits in manufacturing and lotus production throughout the lotus use, for example, water such as polyvinylpyrrolidone Where the sexual polymerization is used, it has been found that it is difficult to get dry (please read the precautions on the back and then fill out this page) -7-" 4 A6 B6 201823 V. Description of the invention (6) Polyvinylpyrrolidone coating In order to obtain a consistent stability of the entire liquid flow in the channel. The present invention pseudo-refers to a device for performing agglutination reactions with improved characteristics, including an improvement to control the liquid flow rate per unit area passing through the coagulation chamber Equipment to produce a non-arbitrary pattern of integrated agglomerated particles, the present invention also refers to such a device such as a structure of a sheet-like card that can be used and thrown into a convenient and disposable structure type, each of the devices Can be arbitrarily installed in a sturdy container that can be used anytime. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded and top-view perspective view of a specific embodiment of FIG. 1, showing a three-layer structure, including: a first or base thallium; a second thallium, with a figure dug out The receiving well part and an coagulation chamber with an extension part at its distal end; a porous absorbent material and a third or top layer. 2 is an exploded and top perspective view of another embodiment, showing a three-layer structure, including: a first or base layer; a second layer, with a circular receiving well dug out And a coagulation chamber with an extended portion at its distal end, and an integral porous absorbent strip at the distal end of the chamber in the second layer; and a third or top layer. Fig. 3 is a top view of another embodiment of the embodiment, showing a thin Η-shaped structure of parts, including: a base layer; a circular receiving well with a dug out and a plurality of extended end zones The second layer of one of the radial coagulation chambers; a ring structure (ie ring) for the spaced liquid absorption area (4) and the liquid storage area 26; and together with the ring structure to form the top (please read first) (Notes on the back and then fill in this page) • Installed • • Played • • Line. -8-201823 V. Description of the invention (7) Another round layer of the layer. FIG. 4 is a schematic diagram showing the area of different flow ratios per unit area from the receiving well to the coagulation chamber with an extended end, and showing the extended end A group of agglomerated particles. Fig. 5 is a schematic diagram showing the areas of different flow ratios per unit area from the receiving well to the coagulation chamber with a half figure or bowl-shaped end, and showing the semicircular ends A group of agglomerated particles. Figure 6 is a schematic diagram showing the different flow ratios from the receiving well to the coagulation chamber with a large rectangular shape. Please fill in this page first. • Installation • Detailed description of the preferred skeletalized embodiment • Order • • Lines The present invention refers to various improved devices suitable for performing agglutination reactions. Obviously, the various device systems of the present invention used for performing agglutination reactions To provide a stronger emblem than the prior art devices, the various devices of the present invention use a device to control the flow rate per unit area of the liquid passing through the reaction chamber of the device. In particular, these devices include , 2, 3, 4, 5 and 6 show the modified geometry of the chamber and the internal shape of the chamber. FIG. 1 shows a specific embodiment of a device for performing agglutination reaction according to the present invention. This skeletalized embodiment has a first wettable layer (1) in an adhering relationship capable of absorbing liquid skulls, covered in parallel A second liquid storage layer (2) on the first layer (1), preferably non-wet and covering the second layer (2) in parallel and having a window or observation window for observing particles * ί · A ruler eat it m EE filling therapy a W * 1 grid (210 X 2 9 7 guru) -9-Μ; ί? Lang Pang Office 桴 十 曷 肖 Χ; Λ '' · ^ 11Η ,, Τ, " 201823 Α6 Β6 V. Description of invention (8) One of the third liquid storage layers (3) in the area, the first layer (1) is made of a liquid storage material with a water-wet surface In this embodiment, the third layer (3) is made of a transparent, non-wet liquid storage film such as a transparent polycarbonate film. The agglutination chamber is also used as a window or observation area for observing particles. The second layer (2) is inserted and attached between the first layer (1) and the third layer (3), for example by The second floor (2) The adhesive layer on each side facing the top side of the first layer (1) and the bottom side of the third layer (3), the second layer (2) has a general groove (25), the groove The groove (25) is cut through the thickness of the second layer (2) to define a channel for guiding the combination of the groove (25) together with the first layer (1) and the third layer (3) The liquid defined by the capillary in this chamber. In other words, when the first, second and third layers are combined together in a thin Η shape, a part of each first and third layer serves as the floor and roof of the aggregation chamber, respectively, and the Each part of the wall surface of the groove (25) of the second floor (2) is defined as the wall (9) of the chamber, and its agglutination reaction chamber has a zone near the base (6) and a zone at the end (7), The near-basic zone (6) is represented by a generally rectangular part of the groove (25) of the second layer (2), and its final zone (7) is represented by its second layer (2) The groove (25) is represented by a triangle or an extension. The embodied embodiment shown in FIG. 1 has a well-shaped groove (8) in the third layer (3) and a parallel groove in the second layer (2) as in the third layer (3) One of the same size and structure of the slot (8) is equivalent to a paper string & degree in the middle of the KK family's standard (CNM armor 4 state (210x297 ⑺ -10-(please read the precautions on the back first and then (Write this page) • Installed, * line · 201823 ^ V. Description of the invention (9) The second-shaped well-shaped groove (5), the well-shaped groove (5) in the second layer (2) is located directly on the third Under the well-shaped groove (8) in the layer (3), so when all three layers are combined together to become a thin sheet, the second well-shaped groove (5) together with the well-shaped groove ( 8) A well is defined along a considerable part of the first layer to receive liquid. The well is in a state of liquid communication with the base zone (6) of the chamber, and the bottom of the well is like One layer (1) is formed by a relatively circular part, which can be regarded as the projection of the Ye grooves (5) and (8) on the surface of the first layer (1). As shown in Figure 1 In a specific embodiment, the place flowing through its agglutination chamber The flow rate of the liquid is controlled by a porous absorbent material (4). It is best to use a filter paper placed near the end of the chamber to communicate with the liquid skeleton of the chamber. Extend into the end of the chamber (when the structures in Fig. 1 are combined together to form a sheet), when used in this specification, water-absorbing porous materials such as paper are generally Distinguished water-soluble materials such as polyvinylpyrrolidone, polyvinyl alcohol (mouth_olyvinylalcohol), gel or dried coats of bovine blood and white limbs such as water-soluble polymers are used in this book The porous water-absorbing material in the invention is usually insoluble in water. In a preferred skeletonized embodiment, the third layer (3) shown in FIG. 1 has a slightly larger size than the porous paper strip 4 The groove (28), so when the other layers are adhered together, the paper strip (4) of porous water-absorbing material is partially placed in the groove (28), more particularly, the paper strip (4) ) The smaller front part is located in the end zone (7) of the groove (25) to make the paper (4) The rest of the main part is located in the groove (2 8), with {please first «1 read the precautions before filling in the hundred). Laugh ·. Order. • Line. Too paper; ·, For speed use, the RE family standard f ΓSS! Medium 4 specifications (2 Η) X 297 gong) -11-A6 B6 201823 5. Description of invention ί 10 Free along the length of the paper strip (4) and its sides The micro capillary channel is disadvantageously formed, and its final thin plate-like structure can be regarded as a thin and disposable card, which has a zone with the final part of the aggregation chamber (7) Note of exchange (4). For example, when a cell solution is introduced into the receiving well of one of the devices of the present invention, the cell is in liquid communication with the near base of the reaction chamber; the chamber containing the antibody supervises the antigen on the cell, and the antigen is Dried on the floor of the chamber, the solution will move through the chamber by capillary action and mix with the anti-toxic serum, so the cells will gather together, which will all happen without any separation or mixing steps, due to agglutination reaction It is best to happen during the liquid flow, that is, to control all liquid flow ratios through the channel, and to have sufficient latency during the liquid flow to complete the proper reaction of the reagents. In Figures 1, 2 and 3, the general groove (25) in the second layer (2) defines at least roughly parallel walls (9) in the near base zone (6) of the chamber Therefore, a first channel with a fixed width is defined, as viewed from the direction towards the end zone (7) of the chamber, the general groove (2) is in the end zone (7) A number of wall surfaces are defined, each of which is spaced apart from each other to define a second channel with an increased width compared to the first channel near the base zone (6), obviously; the agglutination reaction in this chamber Advantageously, one or more patterns of agglomerated particles in the final zone (7) of the chamber, such as ribbons, are formed, and the pattern is more commonly produced in agglomerated particles in prior art agglomeration chambers Non-patterned agglutination is easier to observe through the windows of the third floor (3). Figure 4 shows the agglomeration in the area where the room width is increased (please read the precautions on the back before filling this page). .Order · The standard of this paper is used in the SB standard (CNM A4 specification (210x297)) -12-A6 B6 201823 1. Description of the invention (1) One of the particles is roughly a semi-circular band (27), which is a schematic representation of the second channel of the extension of the chamber in the zone (7) at the end of the chamber (7) 〃 (here, 傜 is approximately triangular), as shown in the schematic form of arrows of different lengths used along the reaction path in the room in FIG. 4, each of the wall surfaces in the last zone (7) is mutually Spaced apart to provide a reduced liquid flow rate per unit area along this second channel, in Figure 4, the shorter arrows are of course used to represent the longer arrows The smaller flow ratio per unit area in the path. As for the triangle shape of the second path at the end of the chamber, it looks like better, and has been found: the so-called a second path " In other words, other geometric shapes also provide favorable pattern formation of the aggregated particles, for example, the two side walls in the second path can be formed into a convex shape to form an approximately semi-circular shape or bowl as shown in FIG. 5 Shape, or, even if it looks less ideal, The two side walls of the second path can be formed to provide a substantially rectangular second path as shown in Figure 6. Figure 2 shows another embodiment of an apparatus for performing agglutination reaction (when shown in (The layers in FIG. 2 are adhered together to form a lamellar form), this skeletonized Ben embodiment has a water-absorbable wettable layer (1) in the form of an attached image, which is covered in parallel with the first salamander (1) The upper second layer (2) and the third layer (3) which is parallel to the second layer (2) and has a window or observation area for observing the particles, and is preferably non-wet ), The first layer (1) is made of a liquid-skull storage type material with a water-tide surface, as in the embodiment shown in FIG. 1, this embodiment also uses materials such as a Transparent polysilicate film (p〇1 year- {please read the precautions on the back before filling in this page). Install · • Order · • Line · Too "Yiyan,« Circular Ιί 中 EK 家 梂 1 iCΜ? } Office (2) ί) X297 public wear) -13-201823 a6 ____B6 printed by the Employee Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs V. Description of invention (12 ) bonate film) or one of the non-wettable cellophane tapes is a third layer (3) made of a transparent, liquid storage type and preferably made of a non-wettable film, the third layer (3) is therefore And it can be used as a window for observing the particles in the coagulation chamber, and its second tantalum (2) is inserted and attached between the first layer (1) and the third layer (3), for example, by the second layer (2) on each side facing the top surface of the first layer (1) and the bottom surface of the third layer (3)-the sticky substance adheres it, and the second layer (2) has been cut through it A general groove (25) of thickness, the groove (25) defines a channel for guiding the first layer (1) and the third layer (3) to be combined by the groove (25) respectively ) The liquid transferred by capillary action in the defined reaction chamber. As in the embodiment shown in FIG. 1, when the first, second, and third layers are combined to form a thin Η shape, a part of each of the first and third layers serves as the coagulation chamber, respectively The floor and the roof, and the part of each wall surface of the groove (25) of the second layer (2) is defined as each wall surface (9) of the chamber and other parts of each wall surface of the groove (25) The part 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). The near base zone (6) is generally composed of the second floor ( 2) The groove (25) is generally represented by a rectangular portion, and the final zone (7) is represented by the triangular or extended portion of the groove (25) of the second layer (2) . Each skeletonized embodiment shown in FIGS. 1 and 2 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) The second layer with the same size and structure (2 paper corpses, degrees apply to China's g standard (CN?) A 4 specifications (21Πχ29 了 公 楚) — 14 _ {Please read the precautions on the back before filling in This page). Therefore. Ordered. Line. 201823 A6 B6 V. Invention description (13,) One of the grooves (5) defined by the equivalent second well, the second layer (2) of the middle well The defined trench (5) is directly under 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 second well-defining trench (5) defines a garden-shaped well for receiving liquid along a considerable part of the first layer in combination with the well-defining trench (8). The well can be connected to the reaction chamber The zone near the base (6) communicates with liquid, and the bottom of the well is formed by a relatively circular part of the first layer (1). However, in the embodiment of FIG. 2, the second layer (2) is made of a liquid absorbent material such as absorbent paper, and selectively penetrates through the thickness with a substance such as a waterproof ink In order to form a permeated area (26) and a non-permeable area (4), the non-permeable area (4) is generally liquid-absorbable and the permeable area (26) is a liquid storage type, here In a specific embodiment, the non-permeable area (4) and the end zone of the reaction chamber (7) are in the state of liquid skull exchange as the equipment for controlling the flow ratio of all liquids flowing through the coagulation chamber, the second The layer (2) also has a trench (25) in the penetrated area (26) to define a channel, thereby guiding the trench (25) to combine its first layer (1) and third layer ( 3) One of the defined reaction chambers is transported by capillarity. The chamber also has a zone near the base (6) and a zone at the end (7), where agglutination reactions can be carried out, such as As can be seen in Figure 2, the non-permeable area (4) is located near the end of the aggregation chamber and is in liquid with the chamber Flow state. Figure 3 shows one of the preferred embodiments of the present invention, which decomposes the plain paper scale using the Chinese S home standard f CN?) A 4 grids (2 Κ, X 297 分 Yak) -15-(Please read first Please fill out the notes on the back and then fill out this page) • Installed .. Ordered. • Line · Printed by the Ministry of Economy Central Standards Bureau Employee Consumer Cooperative Printed by the Ministry of Economic Affairs Central Standards Bureau Employee Consumer Cooperative 201823 A6 ______B6_ V. Description of Invention (14) Figure, this specific embodiment is used to perform multiple agglutination reactions with a minimum amount of liquid sample. Such a device in a combined form can be tested as specifically marked out from a common liquid receiving well One of the six coagulation chambers in a radial shape is a relatively thin, thin, H-shaped, disposable card H. The device in Figure 3 includes a first wettable but liquid skull storage that is attached to a large, generally garden-like shape. Layer (1), a substantially circular second liquid storage layer (2) covered in parallel on the first layer (1) and a third liquid hip suction covered in parallel on the second layer (2) Reservoir (3), these individual layers can be combined together by an adhesive located between their individual layers, for example In a specific embodiment, the third layer (3) is made of a round transparent plastic film such as a polycarbonate film, so it is used to observe the six radial coagulation chambers. A window or observation area for particles, the second layer (2) inserted and adhered between the first and third layers has a groove (25), and the groove (25) looks like a radial shape with an intersecting extension The shape of the central circular part (5) of one of the groove arms of the groove, each of the radial arms of the groove (25) defines a six-valued channel for guiding through the radial groove arm by capillary action Combining the liquids transferred from the chambers defined by the first and second layers (1) and (3) respectively, each of the agglutination reactions can be performed simultaneously in the final six chambers, and each of the six chambers has A general rectangular near base zone (6) and a general extended or triangular shaped final zone (7), in this condylarized embodiment the ratio of all liquid flows through each coagulation chamber is borrowed It is controlled by the strip Η (4), which is preferably one of the filter paper's porous absorbent materials. The general ring (27) of the porous material extends into each of the grooves defined by the radial groove arms. The paper size is applicable to the SS home standard (CNS) A 4 specifications (2 l η 297 public ¢)-16-( Please read the precautions on the back and then fill out this page) .Wo. • Order. .Line · 201823 A6 B6 Fifth, the description of the invention (15) Daozhi every end of a channel (7), its ring (27) The image selectively permeates a substance through its thickness to provide a non-impregnated liquid absorption area (4) and an infiltrated liquid storage area (26), extending inward from the ring (27) The non-permeable paper strips (4) are in liquid communication with each of the chambers and are located adjacent to the end of each chamber, preferably partially in the end (when the structure of FIG. 3 When they are combined together to form a sheet). The third layer (3) of the device represented by FIG. 3 has a well-defined trench (8) with a pattern, and the second layer thereof has the same well-defined trench (8) as the third layer (3) ), And its second layer has the same shape and shape as the well-defined trench (8) in the third layer (3). The well-defined trench (5) of the layer (2) is located just below the well-defined trench of the third layer (3) in its combined structure, and if so, the second well-defined trench (5) That is, a well portion for receiving the liquid skull is defined in combination with the well portion defining groove (8) in the third layer (3) and the individual circular portions of the first layer (1). The zone near the base (6) of each of the chambers is in the state of liquid and skull communication. As a result: the general circular sheet-like structure can be regarded as a relatively thin and freely usable card, and has a liquid skull absorbent paper in the state of liquid skull communication with the last part of the aggregation chamber (7) Strips (4). If necessary, the flow ratio per unit area in the final zone of the reaction chamber in one embodiment of the present invention can be increased by gradually increasing its space between the floor and roof of the reaction chamber along the liquid flow direction. Mobile (please read the precautions on the back before filling in this page). Install. Thread · Wood M, Xianji iJ;?; Middle RS Xuandi; ϊ πf q11 grid (21 〇X297 public if) -17-201823 A6 B6 V. Description of the invention (The general direction is gradually reduced, for example, by gradually ascending the roof of the reaction chamber in the area near the end of the Luanqu and / or gradually descending the roof of the reaction chamber in the area of the end of the Qu, And it has been found that this modification of the space between the floor and roof of the reaction chamber in the final zone of the reaction chamber can also be a factor in the formation of a regular pattern of aggregated particles formed in the final zone of the chamber For example, the space between the floor and the roof of the reaction chamber can be gradually increased by sticking a spherical dome-shaped or cylindrical dome-shaped structure in an area of the third floor (3). When the third layer (3) is attached to its second layer (2), The top of the picture in the third floor is covered at the end of the reaction chamber. Another example of a way to provide a gradually increasing space between the floor and the roof at the end of the reaction chamber is in this way (When the first When the first layer (1) is adhered to the second layer (2), its bowl-shaped depression is formed in the floor at the end of the reaction chamber) A spherical bowl or cylindrical bowl-shaped depression is adhered to the first In the base of the layer (1). Ten landmarks of the Ministry of Economic Affairs; ι, · ί? Zhengong Consumers Cooperation: ^ 卬 System (please read the precautions on the back before filling this page) All tests based on agglutination The type can be adapted to a device according to the present invention. In some examples, a soluble reagent can be dried into several points or several pieces in the reaction chamber, for example, in a blood sample, in other examples, A fine particle reagent such as a syrup reagent can be dried in the chamber. In another treatment method, a reagent can be diffused in a solution placed in the chamber. A preferred reagent solution is dextran. The fine particles in the solution of one of sugar and sucrose The vulgar is mixed in a solution of about 2.5 to about 5.0% by weight of dextran and from about 15 to about 20% by weight of sucrose. The other preferred solution for mixing reagents is Flcoll (St. Missouri) Louis Sigma Chemical Co., Ltd. ’s supply of paper-based spirituality fans (RSMC) iMCNS A 4 specifications (210x297 mm) ~ 18 ~ 201823
A B 五、發明說明（17) (請先閱讀背面之注意事項再填寫本頁) 一蔗糖之非離子的合成聚合物之商標）從大约2 0至大約 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特徵傺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，凝集試驗基本上像於一旦該滴樣本材料被 加至凝集反應裝置時即自行實施，故知利用設備來控制通 過反應室之每單位面積的液體流置傜極重要的，特別是流 過該室之末稍部地帶者，前述設備即為根據本發明之一種 裝置，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。 本發明之一種裝置像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，CUE-2, Lake Success，N.Y.)之有用的影像分析糸統，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，即亮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 太纸度速；?；中E g家甲4視格（210x297公¢) ~ 19 ~ 經濟部中央標準局員工消费合作社印製 201823 A6 ___ B6 五'發明説明4 j 應裝置達成之反應樣本及試劑之齊一性即提供了供一閲讀 機或其他影像裝置用之一絶佳的影像格式，此外，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僳 被局限至凝集反應裝置所形成之毛細室内而亦可閲謓反射 之光線。 本發明之一凝集室之需有一表面，最好是底面係親水 的或可濕的，故當樣本被置入而與其反應室之近基部地帶 之入口相接觸時其毛細流動即減少，此即可藉於其表面上 使用一親水的可水濕之材料而予以完成，然而，亦可化學 式地處理或披覆其他非可濕性（疏水的）材料故各該材料 將變成可濕的，此可濕表面之準備亦可被用來影辑毛細室 中之流動比率。 適於用來準備供本發明之各種具髏化實施例用之一可 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，本發明之一凝集室之a屋頂〃可為可濕性或非可濕 性。 本發明之反應裝置之小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。 下面的例子僳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圔。 本紙張尺变適用士國g家標準（CNM甲4規格Γ_η〇χ297公蹵）-20 - (請先閱讀背面之注意事項再填寫本頁) •裝· •線· A6 B6 201823 五、發明説明y ; 例1 {請先閲讀背面之注意事項再填寫本頁) 薄片狀可隨用隨丢之卡片像藉將一可濕基部層，一衝 切之黏著的核心層，紙條片組件及如圃1中所示之一透明 的聚硪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)即首先被呈薄 H 狀地 經由一雙面膠帶層之使用而被結合於一硬紙板内壁（We-stvaco Hi Yield Printkote. 16 mil，New York» NY ) 上，基部副組件（3 〃XS ",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清潔，銷尺 鏵模即預備來已解除兩黏著面上之墊圈之一第二Η雙面膠 帶（3. 1 密爾），專業膠帶，Division of Rsw Inc.， 經濟部中央標準局員工消費合作社印製AB 5. Description of the invention (17) (please read the precautions on the back before filling in this page) a trademark of non-ionic synthetic polymer of sucrose) from about 20 to about 30% by weight, and according to this laboratory The liquid flow through the chamber can be controlled as described above to suit any necessary latency and test procedures. One particularly advantageous feature of the present invention is that it provides the ability to perform multiple tests simultaneously when using, for example, a very small amount of sample material in a single drop, and the agglutination test is basically like once the drop of sample material is It is self-implemented when it is added to the agglutination reaction device, so it is very important to use equipment to control the liquid flow per unit area passing through the reaction chamber, especially if it flows through the last part of the chamber. The aforementioned equipment is based on this A device of the invention, that is, a device that modifies the geometric shape of the end of the reaction chamber as described above or the internal shape of the reaction chamber, additional reinforcement results can be obtained, such as the end of the reaction chamber The integrated observation of the aggregated particles in the zone is strengthened. An apparatus of the present invention is suitable for use 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 Olympus (Olympus, CUE-2 , Lake Success, NY) useful image analysis system to determine the amount and concentration of agglutination materials, the agglutination reaction device is displayed as: the transmitted or reflected light can be read out by the reader, its image Afterwards, it is analyzed by a computer to determine the amount of agglutination that has occurred and enhances the image for very accurate and sensitive decisions. By limiting the sample to a room, such as being formed in an agglutination reaction device, it is bright and no doubt The ground has the curvature of droplets or water that can interfere with the image seen by the reader. If so, the speed is measured by agglomeration; too; 4 frames (210x297 cm) in the middle of the Eg family ~ 19 ~ Central Ministry of Economic Affairs Printed by the Bureau of Standards and Staff Consumer Cooperatives 201823 A6 ___ B6 Five'Invention Description 4 j The uniformity of the reaction samples and reagents achieved by the device provides one of the best for a reader or other imaging device The video format, in addition, can read through the bottom of the agglutination reaction of light transmission, because the sample and the reagents is limited to su capillary chamber formed by the aggregation reaction apparatus may read Chen reflection of light. One of the coagulation chambers of the present invention requires a surface, preferably the bottom surface is hydrophilic or wettable, so when the sample is placed into contact with the inlet near the base of the reaction chamber, the capillary flow is reduced, that is This can be done by using a hydrophilic water-wettable material on its surface, however, it can also be chemically treated or coated with other non-wettable (hydrophobic) materials so each material will become wettable. The preparation of the wettable surface can also be used to edit the flow ratio in the capillary chamber. Various materials suitable for preparing a wettable layer for use in the various skeletonized embodiments of the present invention include, for example, cellulose acetate monobutyrate, a wettable nylon material or coated with an acrylic latex latex The surface of the cloth forms a water-wettable layer. The roof of the agglomeration chamber of the present invention can be wettable or non-wettable. The small size of the reaction device of the present invention allows quick and convenient processing of many devices and samples. A device can then be loaded into an automated device that can catalog test results and scan individual channels. The small size of the agglutination reaction device also provides enough samples and reagents for use. The following examples are used to further show specific embodiments of the present invention and will not be used to limit the scope of the present invention. This paper ruler is applicable to Shiguo's g standard (CNM A4 specifications Γ_η〇χ297 public stamp) -20-(please read the precautions on the back before filling in this page) • Installation · • Line · A6 B6 201823 V. Description of invention y; Example 1 (please read the precautions on the back before filling in this page) A sheet-like card that can be thrown away is a wettable base layer, a die-cut adhesive core layer, paper strip components and such as One of the transparent polysilicate top components shown in Garden 1 is combined together. To prepare its wettable base layer, a mil thick nylon film (Capran Emblem 2500, Allied Signal, Morristown. New Jersey) is the first It is thin H-shaped and bonded to the inner wall of a cardboard (We-stvaco Hi Yield Printkote. 16 mil, New York »NY) through the use of a double-sided tape layer, the base sub-assembly (3 〃XS ", (That is, 3 inches by 6 inches) is cut from this material, and carefully keep the exposed nylon surface clean, and the pin ruler mold is ready to release one of the two gaskets on the two adhesive surfaces. The second H double-sided tape (3 . 1 mil), professional tape, Division of Rsw Inc., Central Ministry of Economic Affairs Printed by the Bureau of Standards and Staff Consumer Cooperative
Racine, WI)切出如圖1中所示之溝道形狀，一 H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片過濾紙2· 5 X 9 公發，1 CHR，Whatman，Clitton，New Jersey)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/核心組件上之 一表面，最後，一 Η透明的聚碩酸鹽薄膜（GE Part 8040 -112, Cadillac Plastics，Evansville» IN)即被衝切成 如圔1之項目（3)中所示者，而使用一以機械製成薄片 之機組在50psi及0. 2ft/sec下將其結合至 基部/核心/紙張組件上。 本紙張尺度適用中國g家桴準（CNS)甲4規格（2]Πχ297公¢) - 21 - 201823 A6 B6 經濟部中央標準局員工消費合作社印製 五、發明説明<2(); 例2 薄Η狀之可自由使用的卡片像使用披覆以一可濕的丙 稀橡獎乳腰披覆（Part 150HT(26-1)，Daubert Coated Products，Dik〇n，IL)之一 H3々X6 "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密爾之雙面黏箸靥（ARCare 7580,黏箸物研究， Glen Rock，PA)製成，卡片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 TM，艾伯特實驗室， 北芝加哥，I L )則被披覆以親和性，純淨的山羊抗體則 被用來對抗存在有0. 05% (重量/容積）氛化鉻於 〇.1M (克分子）之一 pH為4. 0的醋酸鹽缓衝劑中 之一最終濃度傜1 0 0 u g/m 1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）的三氯人氫（Tris-HCJ?, ρΗ·7.4)緩衝劑中之1% (重量/容積；w/v)之人類血清白肢（Sigma化學公 司，St. L〇u is, M0),然後再懸浮以磷酸鹽緩衝劑的鹽 水（PH=7. 4)中之◦.1%之牛的血清白朊（ B S A ) (Sigma 化學公司，St. Louis，MO),該礎酸 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）之正常的山羊血清，包含〇 ,6, 25或25ng/ml (十億分之一克/公撮）之 本紙張尺度適用中國國家標準（CNS)甲4規格（21ΠΧ?97公¢) - 22 - (請先閱讀背面之注意事項再填芎本頁) .裝· .訂. .線， 201823 經濟部中央標準局員工消费合作社印製 A6 B6 五、發明説明h , HBsAg之血淸樣本則被混合以l〇ul (微公升）整 分的這些披覆的Duracytes，而其溶液則立即被加至如例 子1中所述者般製造之薄Η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_2秒）， 然後慢慢地流入紙條Η内，該液體則花費大約7分鐘來完 全地滲透該紙條Μ,於該紙條Η已完全潮濕後，Duracyte 細胞之凝集反應産品即可於其薄Μ狀可隨用隨丢的卡片之 某些毛細溝道中被觀察，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 HBsAg之血淸之Duracytes則不會凝集。 例子4 薄片狀之可隨用隨丢的卡Η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則被混合物以包含各 種濃度的HBsAg之血清，且被導入具有延伸的溝道之 薄Η狀的可隨用隨丢的卡Η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Η B s A g出現之溝 道中，其Duracyte即不會集成，且無可看見之細胞帶。 (請先閱讀背面之注意事,fi再填寫本頁) .¾. .訂. •線· 本紙張尺度適用中國國家標準（CNS)甲4規格（2]0><297公发：）Racine, WI) cut out the channel shape as shown in Fig. 1, a H-released gasket is removed from the die-cut part and the adhesive layer is placed on the nylon surface of the base assembly, with a single layer Multiple pieces of filter paper with surface adhesives 2 · 5 X 9 Gongfa, 1 CHR, Whatman, Clitton, New Jersey) were adhered to be positioned on their single-sided adhesive (ARCare 7597, Adhesive Research, Glen Rock, PA ) Away from the surface of the base / core component of the card, and finally, a transparent polysilicate film (GE Part 8040 -112, Cadillac Plastics, Evansville »IN) was punched into a project like 圔 1 (3 ), As shown in the figure, and a mechanically-made sheet unit is used to bond it to the base / core / paper assembly at 50 psi and 0.2 ft / sec. This paper scale is applicable to China's g Jiazhen standard (CNS) A 4 specifications (2) Π 297 public)-21-201823 A6 B6 Printed by the Employee Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economy V. Description of invention < 2 (); Example 2 A thin Η-shaped free-to-use card like the one covered with a wettable acrylic rubber award breast cover (Part 150HT (26-1), Daubert Coated Products, Dikon, IL), H3々X6 " The cardboard replaces the nylon base sub-assembly described in Example 1, and the die-cut core layer is 3, 1 mil double-sided stickies (ARCare 7580, Stickies Research, Glen Rock, PA ) Made, 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) were coated with affinity, and pure goat antibodies were used to counteract the presence of an atmosphere of 0.05% (weight / volume) Chromium is in one of 0.1M (mole) of an acetate buffer with a pH of 4.0, and the final concentration is 10,000 ug / m 1 of hepatitis B surface antigen (HBsAg). Human serum white limb coated with 1% (weight / volume; w / v) of 25 mM (mg molecule) trichlorohydrogen (Tris-HCJ ?, pH 7.4) buffer (Sigma Chemical Company, St . L〇u is, M0), and then resuspended in phosphate buffer saline (PH = 7.4) ◦. 1% bovine serum albumin (BSA) (Sigma Chemical Company, St. Louis, MO), the saline buffered saline contains 10% (volume / volume) of the final cell concentration of 5% (volume / volume) of normal goat serum, including 0, 6, 25 or 25ng / ml (One billionth of a gram per gram) This paper scale is applicable to the Chinese National Standard (CNS) A4 specifications (21ΠΧ? 97 公 ¢)-22-(Please read the precautions on the back before filling this page). Outfit . Order.. Line, 201823 A6 B6 printed by the Employee Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs 5. Description of invention h, HBsAg blood samples were mixed with 10ul (microliter) of these coated Duracytes, The solution was immediately added to the additional well portion of the thin, H-shaped, freely usable card H manufactured as described in Example 1, and the solution flowed quickly through the capillary channel (1_2 seconds), then Slowly flow into the paper strip Η, the liquid takes about 7 minutes to fully penetrate the paper strip M, after the paper strip H has been completely wet, the agglutination reaction product of Duracyte cells can be in its thin M shape It was observed in some capillary channels with the lost cards that Duracytes that had been mixed with samples containing HBsAg were agglutinated. However, Duracytes mixed with blood that did not contain HBsAg would not agglutinate. Example 4 A thin-shaped card that can be used and thrown away is made as described in Example 2 and has an extended channel design as shown in FIG. 1, coated with a DuraCytes resistant to an HBsAg (eg 3) The mixture was mixed with serum containing various concentrations of HBsAg, and was introduced into a thin H-shaped card with an extended channel that can be used as a disposable card H. After 5 minutes, the integrated particles appeared and formed an easily observed agglutination. Band, the agglutination band extends the extended part of the channel as shown in Figure 4. In the channel without any HBsAg, Duracyte will not be integrated and there is no visible cell band. (Please read the precautions on the back, and then fill out this page). ¾.. Order. • Line · This paper scale is applicable to China National Standard (CNS) A 4 specifications (2) 0 > < 297 public issue :)