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TW201214184A - Management system for bio-sensing specimens - Google Patents

Management system for bio-sensing specimens Download PDF

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Publication number
TW201214184A
TW201214184A TW99131578A TW99131578A TW201214184A TW 201214184 A TW201214184 A TW 201214184A TW 99131578 A TW99131578 A TW 99131578A TW 99131578 A TW99131578 A TW 99131578A TW 201214184 A TW201214184 A TW 201214184A
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Taiwan
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batch number
batch
management system
status
parameters
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TW99131578A
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Chinese (zh)
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TWI502390B (en
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tian-cai Xu
qi-chang Nian
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Hmd Biomedical Inc
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Priority to TW99131578A priority Critical patent/TW201214184A/en
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Publication of TWI502390B publication Critical patent/TWI502390B/zh

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Abstract

This invention provides a management system for bio-sensing specimens, which includes a remote database unit, a test specimen, and a testing device. The remote database unit stores a batch number super set and the related parameters and status thereof. The test specimen includes a batch number identification codes. The testing device includes a batch number subset and the related parameters and status thereof. When the testing device receives the batch number identification code on the test specimen, it will determine whether the batch number identification code is included in this batch number subset for performing parameters setting or connecting to the remote database unit to download the batch number super set and the related parameter and status thereof. By this way, it only needs to set the batch number identification code on the test specimen for enabling the testing device to have an optimized parameter setting and realizing the function of one machine having multiple purposes.

Description

201214184 六、發明說明: 【發明所屬之技術領域】 本發明係有關一種生物感測試片,特別是指一種生物感測試片之管理 系統。 【先前技術】 在醫藥科技的進步下,發展出許多用來測定生物液體中某些分析物質 濃度的檢測試片與其對應的檢測裝置,以利於醫院、診所或者家庭中隨時 進行檢測’即時觀察健康狀態、調整飲食,並紀錄,以提供醫療人員診療 時的參考。 目前的檢測試片為因應各種不同的分析物質有不同的相關檢測參數, 如用以檢測血糖、膽固醇或者尿酸的檢測試片所設定的相關檢測參數各不 相同,現行的方式是在檢測試片上設定識別信號,其係代表檢測設碼與參 數、效期設定、批次設定、檢測試片種類等等。對樣品中特定的分析物質 進行檢測前,檢測襞置將先讀取識別信號,以識別出檢測試片種類、是否 •過期與檢測時的運算參數等。但在這樣的情況下,往往造成試片上需設置 多組的識別化號,這不僅造成試片的製作成本過高,也使得檢測試片整體 體積較大,在檢測試片—般是拋棄式型態下,考量環保課題,無疑不是一 種資源的浪費。 再者’市面上為減少識別信號設置,採行的方式為一種檢測試片對應 -種特定的檢職置。在這樣的情況下,使用者在施行檢測,需分辨將使 用的檢測試片是對應何檢測裝置,否則錯誤的量測結果,嚴重的話,將導 致無法彌補的傷害。這對使用者來說,是相當不便且潛藏危機的。 201214184 提出一種生物感測試 有鑑於此,本發明遂針對上述習知技術之缺失, 片之管理系統,以有效克服上述之該等問題。 【發明内容】 本發明之主要目的在提供—種生物感測試片之管理系統,其檢測試片 上僅需设置有-減卿碼,搭配_可連線更_檢測裝置與—遠端的資 料庫單7〇 ’即可使檢職置_檢測批賴觸賴最佳化的參數設定, 以及實現單-檢職置可量測各種生化值之—機多用途功能。 本發明之另—目的在提供—種生物感測試片之管理系統,其可大幅降 低檢測試片的整體體積與製作成本。 為達上述之目的,本發明提供一種生物感測試片之管理系統,其包含 有-遠端資料庫單元;-檢測試片;以及一檢測裝置。上述之遠端資料庫 單元儲存4比號母集合及其相關參數與狀態,檢測試片包含有一批號識別 碼’檢測裝置係供插設上述之檢測試片,檢測裝置包含有一批號次子集合 及其對應的相關參數與狀態。當檢測裝置接收到批號識別碼時,檢測裝置 判斷批號識別碼是否在此批號次子集合内,如果是,則依據此批號識別碼 所對應的相關參數與狀態進行參數設定,如果否,則檢測裝置連線至遠端 資料庫單元,下載批號母集合與其狀態,以更新該批號次子集合及其相關 參數與狀態。 底下藉由具體實施例詳加說明,當更容易瞭解本發明之目的、技術内 容、特點及其所達成之功效。 【實施方式】 首先請一併參閱第1圖與第2圖,其係本發明是一種生物感測試片之 201214184 管理系統的主要精神架構示意圖與遠端資料庫單元12的播案配置方式圖。 如圖所示’本發明之生物感測試片之管理系統10主要包含有一遠端資料庫 單元12 ; —檢測試片14 ;以及一檢測裝置16。 遠端資料庫單元12儲存有一批號母集合及其相關參數與狀態13,此批 •號母集合及其細參數與狀態13包含-過期的減子集合及其相關參數與 狀態17、一未過期的批號子集合及其相關參數與狀態18,未過期的批號子 集合及其相關參數與狀態18係於上述之遠端資料庫單元12進行定期且持 • 續的更新,此未過期的批號子集合及其相關參數與狀態18屬於上述批號母 集合及其相關參數與狀態13的-部分,去除了已超過有效期限的試片之過 期的批號子集合及其相關參數與狀態17。未過期的批號子集合及其相關參 數與狀態18更包含有一指定批號之相關參數與狀態19。檢測試片14上包 含有一批號識別碼20。 此檢測裝置16是具有透過網際網路24連線至遠端資料庫單元12進行 更新下載功旎,且檢測裝置16内儲存有一批號次子集合及其相關參數與狀 •態 22。 當檢測試片14插設至檢測裝置16時,檢測裝置16搜尋此批號識別碼 20是否在批號次子集合内。如果是,則依據搜尋到之對應批號與其相關參 數與狀態,進行檢測裝置16的參數設定,也就是最佳化參數設定,以對檢 測試片14上之檢測樣品中特定的分析物質進行檢測,如果該批號識別碼與 其所對應的狀態為非正常品,譬如需回收的批號,則顯示適當警告。如果 此批號識別碼20不在批號次子集合内,檢測裝置16將連線至遠端資料庫 單元12下载批號母集合及其相關參數與狀態13,其中包含了未過期的批號 201214184 子集合及其相關參數與狀態18’以更新檢測裝置16的批號次子集合及其相 關參數與狀態22,使檢測裝置16於每次上網連結後,都保有最新參數與狀 態。隨後,檢測裝置16依據更新後的批號次子集合及其相關參數與狀態22, 判斷此批號識別碼20是屬於正常品、過期品或者需回收品等,如果是過期 品或者需回收品,將顯示適當警告。如果是正常品,檢測裝置16在判斷後, 對檢測裝置16進行參數設定,以便對檢測試片14上之檢測樣品中特定的 分析物質進行檢測。如果該批號識別碼20仍不在更新後的批號次子集合 内,則顯示適當的警告提醒使用者該檢測試片為未知的試片或是已經超過 效期。 再者’當檢測試片14插設至檢測裝置16時’如果此批號識別碼2〇不 在批號次子集合内’檢測裝置16亦可連線至遠端資料庫單元12只下載未 過期的批號子集合及其相關參數與狀態18,而不下載過期的批號子集合及 其相關參數與狀態17 ’以更新批號次子集合及其相關參數與狀態22,使檢 測裝置16可以辨識此批號識別碼與其對應的相關參數,進行檢測裝置16 的參數設定。 除上述之架構外,當檢測試片14插設至檢測裝置16時,如果此批號 識別碼20不在批號次子集合内,檢測裝置16亦可連線至遠端資料庫單元 12只下载指定批號之相關參數與狀態19,該指定批號之相關參數與狀態19 即對應此批號識別碼20,以更新批號次子集合及其相關參數與狀態22,使 檢測裝置16可以辨識此批號識別碼20,進行檢測裝置16的參數設定。 除上述之架構外,使用者也可視使用需求,在無插設檢測試片14的情 況下,驅動檢測裝置16連線至遠端資料庫單元12進行更新,直接進行下 201214184 載批號母集合及其相關參數與狀態13至檢測裝置,其中包含了未過期的批 號子集合及其相關參數與狀態18,以更新批號次子集合及其相關參數與狀 態22,使檢測裝置16於每次上網連結後,都保有最新參數與狀態。 再者’使用者也可視使用需求,在無插設檢測試片14的情況下,驅動 檢測裝置16連線至遠端資料庫單元12進行更新,直接進行只下載未過期 的批號子集合及其相關參數與狀態丨8至檢測裝置’而不下載過期的批號子 集合及其相關參數與狀態17,以更新批號次子集合及其相關參數與狀態 φ 22 ’使檢測裝置16於每次上網連結後,都保有最新參數與狀態。 鐘此’在本發明之架構下,原本習知技術位於檢測試片上之所有相關 參數是轉移至檢測裝置16端與遠端資料庫單元12,因此檢測試片14上僅 而要6史置一批號識別碼2〇,能夠大幅降低檢測試片丨4的整體體積與製作複 雜度與成本。 再者’因檢測裝置16會依據檢測試片14上批號識別碼2〇進行最佳化 參數设定,因此一個檢測裝置16就可以量測各種生化值,例如血糖、尿酸、 籲膽固醇與乳糖等,達到一機多用途的功能。 ⑼參閱第3圖’其係建構在上述之本發明之生域測試>{之管理系統 =構精神下的—實施例架構示意圖。如圖所示,上述之本發明之檢測裝置 6匕3有-微處理單元26 ; 一參數下載單元28與一資料儲存單元,其 與微處理單①26紐触’資概存單元3()辦有—減好集合及 其相關參數與狀態22 ; 一與微處理單元26電性連接的伽單元Μ,其用 、】檢別式# I4上的試片批號2〇;以及一與微處理單元之6電性連接的 傳輪;丨面34 ’以連接到—上哺置36,例如個人電腦或行動電話,再透過 201214184 上網裝置36連線到網際網路24與遠端f料庫單元i2。此外,檢測試片μ 與微處理單元26間更設有―訊號放大單元%,⑽檢測抑μ所反應的 生化訊號放大。檢測裝置16 古彻视忐畑_ 衣1 m上更叹有與錢理单(26電性連接之一組按 鍵式選擇單元40與一顯示單元42。 在第3圖之架構下,當一檢測試片14插設至檢測裳置Μ之偵測單元 32後’檢測裝置16將先偵測檢_ 14上的批號識別仙,此批號識別 碼2〇可為她喊形錢者槪域形式或者兩相轉在,透過制單 几32偵測雜賴觸2〇後’ g卩傳輸至減理單元% ;接續,微處理草 元26將搜尋此批號識別碼2〇是否在批號次子集合及其相關參數與狀態a 内’如果是,則先判別此批號識別碼2〇的狀態,針對已超過效期或是需要 回收的批號’顯示單元42將出現請使用者更換—批新試片,若此批號識別 碼2〇並非過期或需回收的批號,則依據搜尋到之此批號識別碼2〇與其對 應的相關參數’將檢測裝置16進行最佳化參數設定,並對檢測試片14上 的標的物進行檢測’如果否,顯示單元42將出現請使用者將檢測裝置16 透過傳輸介面34連接至上網裝置36的提醒畫面,使用者可透過網際網路 24連接至遠端資料庫單元12,並由微處理器26驅動參數下載單元28下載 遠端資料庫單元12内之批號母集合與其狀態13,其中包含了未過期批號子 集合及其相關參數與狀態18,以便更新批號次子集合及其相關參數與狀態 22 ’並儲存至資料儲存單元30,以供微處理單元26判斷檢測試片的狀態, 決定是否提出適當警告。 接續’係針對檢測試片的結構與其上之批號識別碼結構進行說明。如 第4圖所示’其係本發明之檢測試片的一實施例示意圖。如圖所示,本發 201214184 明之檢測試片是一光學檢測試片50,其包含有一基板52,基板52之一端 設有一光學檢測區54,另一端設有一批號產生區56。批號產生區%具有 四個數位訊號電極58卜582、583、584 ; —類比訊號電極區(圖號未示); 以及一電阻元件60。數位訊號電極581〜584係用以產生數位訊號。類比訊 號電極區係由一接地電極62與一類比訊號電極64所組成,四個數位訊號 電極581〜584均與接地電極62相耦接。電阻元件60是與數位訊號電極581 〜584相並聯’且跨接在接地電極62與類比訊號電極64間,以產生類比訊 • 號。 此外,數位訊號電極581〜584與電阻元件60是預先形成於基板上, 且根據不同參數條件加工形成。例如可根據產品類別,決定印刷多少電阻 值大小的電阻元件。舉例來說,電阻元件6〇係經由電阻膠塗佈製成,且電 阻膠之材質可選自於厚膜電阻(TFR)、碳漿、碳漆等導電油墨、金屬或金 屬合金4,以產生大約是2〇歐姆至5M歐姆的電阻值。當光學檢測試片50 插入檢測裝置16時,檢測裝置16之偵測單元32與批號產生區56產生電 #性連接,以獲得一批號識別碼20。 再者,每一個數位訊號電極581〜584可以是斷路或者通路,以產生〇 或1的訊號,其中斷路的數位訊號電極581〜584可以是利用裁切或沖壓的 加工方式形成。在此情況下,數位訊號電極581〜584係可有24組,如第5 圓所示之其中一種數位訊號電極狀態,檢測試片之數位訊號電極582係斷 路狀態’數位訊號電極58卜583、584保持通路,故此時數位訊號電極581 584所產生的數位訊说係(〇,ι,〇,〇),再加上不同的電阻膠材質、成分就 可提供不同的m組電阻值,以產生„1組不同的類比訊號,故檢測試片能產 201214184 生的批號識別碼高達mU4組。因此可依據數位訊號電極581〜584之通路 結果與電阻元件60之電阻值產生不同的批號識別碼2〇。 光學檢測試片50設有-光學檢測區域54,其中光學檢測區域%係包 含有反顧之生化反應催化物,例如酵素,或者是其他非生物催化物。在 採集作為檢體之血㈣’吸人血液至光學檢奪域54,而吸人後的血液再 與反應催化繼生生化反應,而此生化反應的顏色深淺變化之訊號會經由 檢測裝置16巾的光學比色_|| (圖未示)進行量測,即可得知血液的血 糖濃度。 請參照第6自’係本發明之另一檢測試片的結構示意圖。如圖所 示’本發明之麵刻係電化學檢戦# 7Q,包括—基板72、一電化學檢 測區74與-減產生區76,其巾電化學檢砸%與—減產生區%分別 位在基板72兩端。批號產生區76具有4個數位訊號電極781至784以產 生數位錢,具有-祕f化學檢漸74的電極區,其係由-讀電極8〇 和對電極82所組成,其中4個數位訊號電極781至784均與對電極82相 耦接;以及-與數位訊號電極781至784相並聯的電阻元件84,其跨接在 工作電極80與對電極82之間以用以產生類比訊號。 而數位訊號電極781 S 784與電阻元件84的製作方式係如先前所述, 於此將不再進行贅述。此外’檢測試片7G職完成後,同樣从前所述, 可根據不同參數或條件對電化學檢測試丨7G之數位訊號電極781〜784之至 J其中之-以裁切或沖壓的加工方式成為斷路結構,以使電化學檢測試片 70可提供多種不同的批號識別碼2〇。 電化學檢測區域74係包含有反應用之生化反應催化物,例如酵素,或 201214184 者是其他非生物催化ι虹作電極8G及職極82之―端分顺電化學 檢測區域74連接。在採集作為檢體之血液時,吸入血液並將其引入電化學 檢測區域74,祕_錢恤細啦,㈣化反 應的電細μ繼㈣_ 8G與輪8⑷—觀到所 連接檢測裝置16進行4測,即可得知錢的血糖濃度。 ❿ 酵素和血糖(或其他生物感測信號)在檢測區74經電化學反應後’接 地端的對電極82與碎電極8G之間會產生微弱之電流信號,此電流作號 經工作電極80至檢測裝置16的接點(圖中未示)至訊號放大單錢放大 後’至多工器(圖中未示)至類比數位轉換器(圖中未示)再至微處理單 元26,經過演算及補償後,而得騎應該微㈣流信號的血糖值(或其他 生物感測信號)。 請參照第7圖’係本發明之另__種檢測試片的結構示賴^如圖所示, 本發明之檢測試片係紐檢測試片86,包括-基板88,且基板88上設有 吸入區90、檢測區92和一批號產生區94 ;及一殼體%,其係包覆基板跗 •之一部份,並露出吸入區90、檢測區92與批號產生區94 ^檢測區92係一 呈色比色區。批號產生區94則具有4個數位訊號電極971至974以產生數 位訊號;一電極區係由一接地電極98與一類比訊號電極99所組成,且4 個數位訊號電極971至974均與接地電極98相連接;以及一與數位訊號電 極971至974相並聯的電阻元件95,其跨接在接地電極98與類比訊號電極 99之間以產生類比訊號。 而數位訊號電極971〜974至與電阻元件95的製作方式係如先前所 述,於此將不再進行贅述。此外,同樣如先前所述,可根據不同參數或條 201214184 件對數位訊號電極97卜974之至少其中之一以裁切或沖壓的加工方式成為 斷路結構,以提供多種不同的批號識別碼20。 檢測區92係包含有反應用之抗原,例如蛋白質,並結合其他非抗原之 化學物,例如抗體與酵素。在採集作為檢體之血液時,由吸入區9〇吸入血 液並將其引至檢_ 92 ’祕人後的血液再與抗原及抗體產生免疫反應, 而此免疫反應的顏色深淺變化之訊號會經由檢測裝置16中的光學比色偵測 器(圖未示)進行制’即可得知錢巾是否存在蚊的抗原或抗體。 請參照第8 ® ’係本發明之另一種檢測試片的結構示意圖。如圖所示, 本發明之檢測試片係免疫檢測試片100,包括一基板1〇2 ,且基板1〇2上設 有吸入區104、檢測區106 ;及一鍾11〇,其係包覆基板1〇2之一部份, 並露出吸入區104'檢測區1〇6’此外’殼體11〇上設有一批號產生區1〇8, 其是由條碼(Bar-code) 112所組構成。檢測區106係一呈色比色區◊批號 產生區108可利用印刷或喷印設置在殼體11〇的上下任一面,也可直接以標 籤的型態貼合在殼體110的上下任一面。 此外,在此架構下,偵測單元32將是一掃描單元,以讀取批號產生區 108。 综上所述,本發明提供一種嶄新的生物感測試片之管理系統,在其架 構下,檢測s式片上僅需設置有一批號識別碼,搭配一可連線更新的檢測裝 置與-遠端的資解單元,即可使檢難置達到最佳化醇數設定與一機 多用途的功能。再者,也可大幅降低檢測試片的整體體積與製作成本。 唯以上所述者,僅為本發明之較佳實施例而已,並非用來限定本發明 實施之範圍。故即凡依本發明申請範圍所述之特徵及精神所為之均等變化 12 201214184 -或修飾,均應包括於本發明之申請專利範圍内。 【圖式簡單說明】 第1圖係本發明是-種生物感測試片之管理系統的主要精神架構示意圓。 第2圖係本發明之遠端資料庫單元12的檔案配置方式圖。 第3圖係建構在第1圖之本發明之生物感測試片之管理系統架構精神下的 一實施例架構示意圖。 第4圖係本發明之檢測試片的一實施例示意圖。 第5圖係本發明之檢測試片的另一實施例示意圖。 第6圖係本發明之檢測試片的再一實施例示意圖。 第7圖係本發明之檢測試片的又一實施例示意圖。 第8圖係本發明之檢測試片的又一實施例示意圖。 【主要元件符號說明】 10 生物感測試片之管理系統 12 遠端資料庫單元 13 批號母集合及其相關參數與狀態 14 檢測試片 16 檢測裝置 17 過期的批號子集合及其相關參數與狀態 18 未過期的批號子集合及其相關參數與狀態 19 指定批號之相關參數與狀態 20 批號識別碼 22 批號次子集合及其相關參數與狀態 13 201214184 24 網際網路 26 微處理單元 28 參數下載單元 30 資料儲存單元 32 偵測單元 34 介面傳輸單元 36 上網裝置 38 訊號放大單元 40 按鍵式選擇單元 42 顯示單元 50 光學檢測試片 52 基板 54 光學檢測區 56 批號產生區 581〜584 數位訊號電極 60 電阻元件 62 接地電極 64 類比訊號電極 70 電化學檢測試片 72 基板 74 電化學檢測區 76 批號產生區 201214184201214184 VI. Description of the Invention: [Technical Field] The present invention relates to a biosensor test piece, and more particularly to a management system for a biosensor test piece. [Prior Art] Under the advancement of medical technology, many test strips for measuring the concentration of certain analytes in biological fluids and their corresponding detection devices have been developed to facilitate testing at any time in hospitals, clinics or homes. State, adjust diet, and record to provide a reference for medical staff. The current test strips have different relevant test parameters for different kinds of analytes. For example, the relevant test parameters set for the test strips for detecting blood sugar, cholesterol or uric acid are different. The current method is on the test strips. The identification signal is set, which is representative of the detection code and parameters, the validity period setting, the batch setting, the type of the test piece, and the like. Before detecting a specific analyte in a sample, the detection device will first read the identification signal to identify the type of test strip, whether it is expired, and the operating parameters at the time of detection. However, in such a case, it is often required to set a plurality of sets of identification numbers on the test piece, which not only causes the production cost of the test piece to be too high, but also makes the overall size of the test piece larger, and the test piece is generally disposable. Under the model, considering environmental issues is no doubt a waste of resources. In addition, in order to reduce the identification signal setting, the method adopted is a specific inspection service corresponding to a test piece. In such a case, when the user performs the test, it is necessary to distinguish which test piece to be used corresponds to the test device, otherwise the wrong measurement result will cause irreparable damage. This is quite inconvenient and potentially dangerous for the user. 201214184 Proposes a biosensor test In view of the above, the present invention is directed to the above-described prior art lack of a slice management system to effectively overcome the above problems. SUMMARY OF THE INVENTION The main object of the present invention is to provide a management system for a biosensor test piece, which only needs to be provided with a minus-clear code, a collocation-and a more-detecting device and a remote database. Single 7〇's can make the inspection position _ detection approval depends on the optimization of the parameter settings, as well as the single-inspection position can measure various biochemical values - the machine multi-purpose function. Another object of the present invention is to provide a management system for a biosensor test sheet which can greatly reduce the overall volume and production cost of the test strip. To achieve the above object, the present invention provides a management system for a biosensor test piece comprising a presence-end database unit; a test strip; and a detecting device. The remote database unit stores the 4 ratio mother set and its related parameters and states, and the test strip includes a batch number identification code detecting device for inserting the above-mentioned test strip, and the detecting device includes a batch of number sub-collections and Its corresponding related parameters and status. When the detecting device receives the batch number identification code, the detecting device determines whether the batch number identification code is in the batch sub-subset, and if yes, performs parameter setting according to the relevant parameter and state corresponding to the batch number identification code, and if not, detects The device is connected to the remote database unit, and the batch number parent set and its state are downloaded to update the batch number sub-collection and its related parameters and status. The details, technical contents, features, and effects achieved by the present invention will become more apparent from the detailed description of the embodiments. [Embodiment] First, please refer to FIG. 1 and FIG. 2 together. The present invention is a schematic diagram of the main mental architecture of the 201214184 management system of the biosensor test piece and the broadcast configuration mode of the remote database unit 12. As shown in the figure, the management system 10 of the biosensor test strip of the present invention mainly comprises a remote database unit 12; a test strip 14; and a detecting device 16. The remote database unit 12 stores a set of numerators and their associated parameters and states 13, the batch of numerators and their fine parameters and state 13 contain-expired sub-sets and their associated parameters and status 17, one has not expired The batch number subset and its associated parameters and status 18, the unexpired batch number subset and its associated parameters and status 18 are periodically and continuously updated by the remote database unit 12 described above, this unexpired batch number The set and its associated parameters and state 18 belong to the above-mentioned batch number parent set and its associated parameters and state-part-parts, removing the expired batch number subset of the test piece that has exceeded the expiration date and its associated parameters and state 17. The unexpired batch number subset and its associated parameters and state 18 contain a parameter and status 19 for the specified batch number. The test strip 14 contains a batch of identification code 20. The detecting device 16 is configured to connect to the remote database unit 12 via the Internet 24 for update downloading, and the detecting device 16 stores a batch of number sub-sets and related parameters and states. When the test strip 14 is inserted into the detecting device 16, the detecting device 16 searches for whether the lot number identification code 20 is within the batch number sub-set. If yes, the parameter setting of the detecting device 16 is performed according to the corresponding batch number and its related parameters and status, that is, the parameter setting is optimized to detect the specific analyte in the test sample on the test strip 14. If the batch ID and its corresponding status are abnormal, such as the batch number to be recycled, an appropriate warning is displayed. If the lot number identification code 20 is not within the batch number sub-subset, the detecting device 16 will connect to the remote database unit 12 to download the batch number parent set and its associated parameters and state 13, which includes the unexpired batch number 201214184 sub-collection and The relevant parameters and state 18' are used to update the batch number sub-set of the detecting device 16 and its associated parameters and state 22, so that the detecting device 16 retains the latest parameters and status after each Internet connection. Subsequently, the detecting device 16 determines, according to the updated batch number sub-subset and its related parameters and state 22, that the batch number identification code 20 belongs to a normal product, an expired product, or a reclaimed product, etc., if it is an expired product or needs to be recycled, Show appropriate warnings. If it is a normal product, the detecting means 16 performs parameter setting on the detecting means 16 to detect a specific analyte in the test sample on the test strip 14. If the lot ID 20 is still not in the updated sub-subset of the lot number, an appropriate warning is displayed to alert the user that the test piece is an unknown test piece or has expired. Furthermore, 'when the test strip 14 is inserted into the detecting device 16', if the lot number identification code 2 is not in the batch sub-subset, the detecting device 16 can also be connected to the remote database unit 12 to download only the unexpired batch number. The subset and its associated parameters and state 18, without downloading the expired batch number subset and its associated parameters and state 17 'to update the batch number secondary subset and its associated parameters and state 22, enabling the detection device 16 to identify the batch identifier The parameter setting of the detecting device 16 is performed in accordance with the relevant parameters corresponding thereto. In addition to the above structure, when the test strip 14 is inserted into the detecting device 16, if the lot number identification code 20 is not in the batch sub-subset, the detecting device 16 can also be connected to the remote database unit 12 to download only the specified batch number. The relevant parameter and state 19, the relevant parameter and the status 19 of the specified batch number correspond to the batch number identification code 20, to update the batch number sub-subset and its related parameters and state 22, so that the detecting device 16 can recognize the batch number identification code 20, The parameter setting of the detecting device 16 is performed. In addition to the above-mentioned architecture, the user can also visually use the requirements. In the case where the test strip 14 is not inserted, the drive detecting device 16 is connected to the remote database unit 12 for updating, and directly carries the next batch of the 201214184 batch number and Its associated parameters and state 13 to the detection device, including the unexpired batch number subset and its associated parameters and state 18, to update the batch number secondary subset and its associated parameters and state 22, so that the detecting device 16 is connected every time. After that, the latest parameters and status are maintained. Furthermore, the user can also visually use the requirement, and in the case where the test strip 14 is not inserted, the drive detecting device 16 is connected to the remote database unit 12 for updating, and directly downloads only the batch number subset that has not expired and The relevant parameters and status 丨8 to the detecting device' do not download the expired batch number subset and its associated parameters and state 17 to update the batch number sub-set and its associated parameters and state φ 22 'to enable the detecting device 16 to connect to the Internet each time. After that, the latest parameters and status are maintained. Under the framework of the present invention, all the relevant parameters of the prior art on the test strip are transferred to the end of the detecting device 16 and the remote database unit 12, so that the test strip 14 is only required to be set to one. The batch number identification code 2〇 can greatly reduce the overall volume, manufacturing complexity and cost of the test strip 丨4. Furthermore, because the detecting device 16 performs the optimization parameter setting according to the batch number identification code 2 on the test strip 14, a detecting device 16 can measure various biochemical values such as blood sugar, uric acid, cholesterol and lactose. , to achieve a multi-purpose function. (9) Referring to Fig. 3', a schematic diagram of an embodiment structure constructed in the above-described management test of the invention of the present invention. As shown in the figure, the detection device 6匕3 of the present invention has a micro-processing unit 26; a parameter download unit 28 and a data storage unit, which is connected to the micro-processing unit 126. Having a reduced set and its associated parameters and state 22; a gamma unit 电 electrically connected to the microprocessing unit 26, using the test strip number 2 〇 on the check method # I4; and a micro processing unit 6 electrically connected transmission wheels; the rear surface 34' is connected to the upper feeding 36, such as a personal computer or a mobile phone, and then connected to the Internet 24 and the remote f library unit i2 through the 201214184 Internet device 36. . In addition, the detection sample μ and the micro processing unit 26 are further provided with a signal amplification unit %, and (10) detects the biochemical signal amplification reflected by the μ. Detecting device 16 Gucci 忐畑 _ _ 1 m on the sigh with the money list (26 electrical connection one of the group of button selection unit 40 and a display unit 42. Under the structure of Figure 3, when a check After the test piece 14 is inserted into the detecting unit 32 for detecting the sputum, the detecting device 16 will first detect the batch number identification sin on the _ 14 , and the batch number 2 〇 can be used for her screaming money type or The two phases are turned over, and after the system 32 detects the miscellaneous touch, the 'g卩 is transmitted to the reduction unit %; and the micro-processed grass element 26 searches for the batch number identification code 2 to be in the batch number sub-set and The relevant parameters and the status a are 'if yes, the status of the batch number identification code 2〇 is first determined. For the batch number that has exceeded the validity period or needs to be recycled, the display unit 42 will appear to be replaced by the user-grant new test piece. If the batch number identification code 2 is not expired or the batch number to be recycled, the detection device 16 is optimized according to the searched batch number identification code 2 and its corresponding related parameter, and the test piece 14 is tested. The subject matter is detected 'if no, the display unit 42 will appear please make The user connects the detecting device 16 to the reminder screen of the Internet device 36 through the transmission interface 34. The user can connect to the remote database unit 12 via the Internet 24, and the microprocessor 26 drives the parameter download unit 28 to download the remote terminal. The batch number parent set in database unit 12 and its state 13, including the unexpired batch number subset and its associated parameters and state 18, in order to update the batch number secondary subset and its associated parameters and state 22' and stored to data storage unit 30 For the micro processing unit 26 to determine the state of the test strip, and to determine whether to issue an appropriate warning. The continuation 'describes the structure of the test strip and the batch number identification code structure thereon. As shown in Fig. 4, the invention is A schematic view of an embodiment of the test strip is shown in the figure. As shown in the figure, the test strip of the present invention is an optical test strip 50, which comprises a substrate 52. One end of the substrate 52 is provided with an optical detecting area 54 and the other end is provided. There is a batch number generating area 56. The batch number generating area % has four digital signal electrodes 58 582, 583, 584; - analog signal electrode area (not shown); And a resistive element 60. The digital signal electrodes 581 to 584 are used to generate a digital signal. The analog signal electrode region is composed of a ground electrode 62 and an analog signal electrode 64, and four digital signal electrodes 581 to 584 are connected to the ground electrode. 62 is coupled. The resistive element 60 is connected in parallel with the digital signal electrodes 581 to 584' and is connected across the ground electrode 62 and the analog signal electrode 64 to generate an analog signal. Further, the digital signal electrodes 581 to 584 and the resistor The element 60 is formed on the substrate in advance and is formed according to different parameter conditions. For example, depending on the product category, a resistor element of a certain resistance value may be printed. For example, the resistor element 6 is made by resistive coating. The material of the resistive glue may be selected from conductive inks such as thick film resistors (TFR), carbon paste, carbon paint, metal or metal alloy 4 to produce a resistance value of about 2 ohms to 5 ohms. When the optical detecting test strip 50 is inserted into the detecting device 16, the detecting unit 32 of the detecting device 16 generates an electrical connection with the lot number generating portion 56 to obtain a batch number identification code 20. Furthermore, each of the digital signal electrodes 581 to 584 may be an open circuit or a path to generate a signal of 〇 or 1, and the digital signal electrodes 581 to 584 of the interrupted path may be formed by a cutting or stamping process. In this case, the digital signal electrodes 581 to 584 can have 24 groups, such as the state of one of the digital signal electrodes shown in the fifth circle, and the digital signal electrode 582 of the test strip is in the disconnected state, the digital signal electrode 58 583, 584 keeps the path, so the digital signal system (〇, ι, 〇, 〇) generated by the digital signal electrode 581 584, together with different resistance rubber materials and components, can provide different m group resistance values to generate „1 group of different analog signals, so the test piece can produce 201214184. The batch number identification code is up to mU4 group. Therefore, the batch number identification code 2 can be generated according to the path result of the digital signal electrodes 581~584 and the resistance value of the resistance element 60. The optical detecting test piece 50 is provided with an optical detecting area 54, wherein the optical detecting area % contains a biochemical reaction catalyst, such as an enzyme, or other non-biocatalyst, which is taken care of. The blood collected as a sample (4) 'Sucking blood to the optical detection field 54, and the blood after inhalation reacts with the reaction to catalyze the biochemical reaction, and the signal of the color change of the biochemical reaction will pass through the detection device. The optical colorimetric _|| (not shown) can be measured to know the blood glucose concentration. Please refer to the sixth structure of the test strip of the present invention. The surface is electrochemically examined 77 7Q, including a substrate 72, an electrochemical detection zone 74 and a subtraction generation zone 76, wherein the electrochemical detection 砸% and the 产生 generation zone % are respectively located at the ends of the substrate 72. The batch number generating area 76 has four digital signal electrodes 781 to 784 for generating digital money, and has an electrode region of -60, which is composed of a -reading electrode 8A and a counter electrode 82, wherein 4 digital signals are formed. The electrodes 781 to 784 are each coupled to the counter electrode 82; and a resistive element 84 in parallel with the digital signal electrodes 781 to 784 is connected across the working electrode 80 and the counter electrode 82 for generating analog signals. The digital signal electrodes 781 S 784 and the resistor element 84 are fabricated as described above, and will not be described herein. In addition, after the test strip 7G is completed, as described above, the electrification can be performed according to different parameters or conditions. Learn to test the 7G digital signal electrode 781~784 J, which is cut or stamped into a circuit breaker structure, so that the electrochemical test strip 70 can provide a plurality of different batch identification codes. The electrochemical detection region 74 contains a biochemical reaction catalyst for reaction. For example, the enzyme, or 201214184 is connected to the other end of the non-biocatalyzed imagine electrode 8G and the end electrode 82 of the electrode 82. When collecting blood as a sample, inhaling blood and introducing it into the electrochemical The detection area 74, the secret _ 钱 细 细 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , Or other biosensing signals) after the electrochemical reaction in the detection zone 74, a weak current signal is generated between the counter electrode 82 and the shredded electrode 8G of the ground, and the current is passed through the junction of the working electrode 80 to the detecting device 16. (not shown in the figure) to the signal amplification after the single money is enlarged, to the multiplexer (not shown) to the analog digital converter (not shown) and then to the micro processing unit 26, after calculation and compensation, it is necessary to ride Should be micro Blood glucose level current signal (or other biological sensing signals). Please refer to FIG. 7 for the structure of the test strip of the present invention. As shown in the figure, the test strip of the test strip of the present invention includes a substrate 88, and the substrate 88 is provided. There is a suction zone 90, a detection zone 92 and a batch generation zone 94; and a casing %, which covers one part of the substrate, and exposes the suction zone 90, the detection zone 92 and the batch generation zone 94 ^ detection zone 92 is a colorimetric colorimetric area. The batch number generating area 94 has four digital signal electrodes 971 to 974 for generating a digital signal; an electrode region is composed of a ground electrode 98 and an analog signal electrode 99, and four digital signal electrodes 971 to 974 are connected to the ground electrode. A 98-phase connection; and a resistive element 95 connected in parallel with the digital signal electrodes 971 to 974 are connected across the ground electrode 98 and the analog signal electrode 99 to generate an analog signal. The manner in which the digital signal electrodes 971 to 974 to the resistor element 95 are formed is as described above, and will not be described herein. In addition, as previously described, at least one of the different parameters or strips of the 201214184 pair of digital signal electrodes 97, 974 can be turned into a circuit breaker structure to provide a plurality of different lot number identification codes 20. Detection zone 92 contains antigens for reaction, such as proteins, and binds to other non-antigen chemicals, such as antibodies and enzymes. When collecting the blood as the sample, the blood is inhaled from the inhalation area 9 and is taken to the blood of the secret person to produce an immune reaction with the antigen and the antibody, and the signal of the color change of the immune reaction will be By means of an optical colorimetric detector (not shown) in the detecting device 16, it is known whether the money towel has an antigen or antibody of the mosquito. Please refer to the eighth diagram of the structure of another test strip of the present invention. As shown in the figure, the test strip of the present invention is an immunoassay test strip 100, comprising a substrate 1〇2, and a substrate 1〇2 is provided with a suction zone 104, a detection zone 106; and a clock 11〇, which is a package Covering one part of the substrate 1〇2, and exposing the suction area 104' detection area 1〇6', and the 'housing 11' is provided with a batch number generating area 1〇8, which is grouped by Bar-code 112 Composition. The detection area 106 is a colorimetric color area. The batch number generation area 108 can be disposed on the upper and lower sides of the casing 11 by printing or printing, or can be directly attached to the upper and lower sides of the casing 110 in the form of a label. . Moreover, under this architecture, the detection unit 32 will be a scanning unit to read the batch number generation area 108. In summary, the present invention provides a novel biosensor test piece management system. Under the framework, the detection s type film only needs to be provided with a batch of number identification code, and a connection line updated detection device and the remote end The capitalization unit can make the inspection difficult to achieve the optimal alcohol number setting and multi-purpose function. Furthermore, the overall volume and production cost of the test piece can be greatly reduced. The above is only the preferred embodiment of the present invention and is not intended to limit the scope of the present invention. Therefore, all changes and characteristics of the features and spirits described in the scope of the present application are intended to be included in the scope of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a schematic diagram showing the main spiritual structure of a management system for a biosensor test piece. Figure 2 is a diagram showing the file arrangement of the remote database unit 12 of the present invention. Fig. 3 is a block diagram showing the construction of an embodiment of the management system architecture of the biosensor test piece of the present invention in Fig. 1. Figure 4 is a schematic view showing an embodiment of the test strip of the present invention. Fig. 5 is a schematic view showing another embodiment of the test strip of the present invention. Figure 6 is a schematic view showing still another embodiment of the test strip of the present invention. Figure 7 is a schematic view showing still another embodiment of the test strip of the present invention. Figure 8 is a schematic view showing still another embodiment of the test strip of the present invention. [Main component symbol description] 10 Biosensor test piece management system 12 Remote database unit 13 Batch number master set and its related parameters and status 14 Test strip 16 Detection device 17 Expired batch number sub-set and its related parameters and status 18 Unexpired batch number subsets and their associated parameters and status 19 Related batch number related parameters and status 20 Batch number identification code 22 Batch number secondary subset and its associated parameters and status 13 201214184 24 Internet 26 Microprocessing unit 28 Parameter download unit 30 Data storage unit 32 Detection unit 34 Interface transmission unit 36 Internet device 38 Signal amplification unit 40 Push-button selection unit 42 Display unit 50 Optical detection test piece 52 Substrate 54 Optical detection area 56 Batch number generation area 581 to 584 Digital signal electrode 60 Resistance element 62 Grounding electrode 64 Analog signal electrode 70 Electrochemical detection test piece 72 Substrate 74 Electrochemical detection zone 76 Batch number generation area 201214184

781〜784 數位訊號電極 80 工作電極 82 對電極 84 電阻元件 86 免疫檢測試片 88 基板 90 吸入區 92 檢測區 94 批號產生區 95 電阻元件 96 殼體 971〜974 數位訊號電極 98 接地電極 99 類比訊號電極 100 免疫檢測試片 102 基板 104 吸入區 106 檢測區 108 批號產生區 110 殼體 112 條碼781~784 Digital signal electrode 80 Working electrode 82 Counter electrode 84 Resistance element 86 Immunodetection test piece 88 Substrate 90 Suction area 92 Detection area 94 Batch number generation area 95 Resistive element 96 Case 971~974 Digital signal electrode 98 Ground electrode 99 Analog signal Electrode 100 Immunoassay test strip 102 Substrate 104 Suction area 106 Detection area 108 Batch number generation area 110 Housing 112 Bar code

Claims (1)

201214184 七、申請專利範圍: 1. 一種生物感測試片之管理系統,其包含有: 一遠端資料庫單元,其係儲存一批號母集合及其相關參數與狀態; 一檢測S式片,其包含有一批號識別碼;以及 一檢測裝置,其係供插設該檢測試片,該檢測裝置包含有一批號次子集 合及其相關參數與狀態,當該檢測裝置接收到該檢測試片上之該批號 識別竭時’該檢測裝置判斷該批號識別碼是否在該批號次子集合内, 如果是’則依據該批號識別碼與其所對應的相關參數與狀態進行參數 設定’如果否’該檢測裝置連線至該遠端資料庫單元,下載該批號母 集合及其相關參數與狀態至該檢測裝置,以更新該批號次子集合及其 相關參數與狀態。 2·如申請專利範圍第1項所述之生物感測試片之管理系統,其中該批號母 集合及其相關參數與狀態包含有一過期的批號子集合及其相關參數與 狀態與一未過期的批號子集合及其相關參數與狀態。 3. 如申請專利範圍第2項所述之生物感測試片之管理系統,其中當該檢測 裝置發現該批號識別碼屬於該過期的批號子集合或未搜尋到時,則發出 一警告。 4. 如申請專利範圍第2項所述之生物感測試片之管理系統,該檢測裝置下 載之该批號母集合及其相關參數與狀態,並不包含該過期的批號子集人 及其相關參數與狀態,而只下載該未過期的批號子集合及其相關參數與 狀態。 5·如申請專利範圍第2項所述之生物感測試片之管理系統,其中該未過期 201214184 的批號子集合及其相關參數與狀態更包含有一指定批號之參數與狀 態’該檢職置τ載之祕號母集合及其侧參數與狀態,灯載該試 片批號對應的該指定批號之參數與狀態。 6.如申叫專利範圍第1項所述之生物感測試片之管理系統,其中該檢測裝 置更包含有: 一微處理單元; 一參數下載單元與一資料儲存單元,其係各與該微處理單元電性連接, φ 該資料儲存單凡儲存該批號次子集合與其對應的相關參數;以及 偵測單元,其一端與該微處理單元電性連接,—端用以偵測該批號識 別碼,並將該批號識別碼的資料傳遞至該微處理單元,以判斷該批號 識觸衫在祕銳子集細,如果是,·據娜賴別碼與其 所對應的相關參數進行參數奴,如果^,卿動該絲下載單元透 過一網際網路連接至該遠端資料庫單元,進行下載。 7.如申請專利範圍第6項所述之生物感測試片之管理系統,其中該檢測裝 參 置更包含有一組控制按紐與一顯示單元’其係皆電性連接至該微處理單 元。 8·如中請專利範圍第6項所述之生物感測試片之管理系統,其中該檢測裝 置更包含有-電性連接至該微處理單元的傳輸介面,以與一上網裝置連 接’以透過該上網裝置連上該網際網路與該遠端資料庫單元。 9.如申請專利範圍第i項所述之生物感測試片之管理系統,其中該批號識 別碼包含有一組數位訊號與一類比訊號。 K).如申請專利範圍第9項所述之生物感測試片之管理系統,其中該數位識 201214184 別訊號係由數N個識別電極所產生,且N22,該類比識別訊號是由至 少一與該識別電極並聯之電阻元件所產生。 11,如申請專利範圍第丨項所述之生物感測試片之管理系統,其中該批號識 別碼是條碼。 12. 如申請專利範圍第u項所述之生物感測試片之管理系統,其中該批號 識別碼疋條碼’該侧單元是一掃猫單元,用以掃描該批號識別碼。 13. 如申請專利範圍第1項所述之生物感測試片之管理系統,其中該檢測裝 置更包含有在無插設該檢測試#時,連線至該遠端_料元下載該批 號母集合及其相關參數與狀態。 14·如申μ專利制第13項所述之生物制試片之管理系統 ,其中該批號 #集σ及其相關參數與狀態包含有—過期的批號子集合及其相關參數 、狀』與未過期的批號子集合及其相關參數與狀態,該檢測裝置下載 & t母$°及其相關參數触態,並不包含該職的減子集合及 、參雜崎’ ^卩下賴未過細減合及其相數201214184 VII. Patent application scope: 1. A management system for biosensor test strips, comprising: a remote database unit, which stores a batch of mothers and their related parameters and states; Included is a batch number identification code; and a detecting device for inserting the test test piece, the detecting device includes a batch of number sub-subsets and related parameters and states, and when the detecting device receives the batch number on the test strip When the identification is exhausted, the detecting device determines whether the batch number identification code is in the batch number sub-subset, and if yes, performs parameter setting according to the batch number identification code and its corresponding related parameter and state. If no, the detecting device is connected. To the remote database unit, the batch number parent set and its related parameters and status are downloaded to the detecting device to update the batch number sub-collection and its related parameters and status. 2. The management system for a biosensor test piece according to claim 1, wherein the batch number set and its related parameters and states comprise an expired batch number subset and related parameters and status and an unexpired batch number Subsets and their associated parameters and states. 3. The management system for a biosensor test piece according to claim 2, wherein the warning device issues a warning when the detection device finds that the batch identification code belongs to the expired batch number subset or does not search. 4. The management system of the biosensor test piece described in claim 2, the batch of the mother and the related parameters and status downloaded by the detecting device do not include the expired batch number subset and related parameters. With the status, only the unexpired batch number subcollection and its associated parameters and status are downloaded. 5. The management system for the biosensor test piece described in claim 2, wherein the batch number sub-set of the unexpired 201214184 and its related parameters and status further include a parameter and status of the specified batch number. The set of secret numbers and their side parameters and status, and the parameters and status of the specified batch number corresponding to the lot number of the test strip. 6. The management system for a biosensor test piece according to claim 1, wherein the detecting device further comprises: a micro processing unit; a parameter download unit and a data storage unit, each of which is associated with the micro The processing unit is electrically connected, φ, the data storage unit stores the relevant sub-subsets and corresponding parameters; and the detecting unit has one end electrically connected to the micro processing unit, and the end is used to detect the batch identification code And transmitting the data of the batch identification code to the micro processing unit to determine that the batch number of the contact shirt is fine in the secret sharp subset, and if so, according to the Naray code and the corresponding parameters corresponding to the parameter slave, if ^, Qingshi's download unit is connected to the remote database unit via an internet connection for download. 7. The management system for a biosensor test strip according to claim 6, wherein the detection device further comprises a set of control buttons and a display unit for electrically connecting to the micro processing unit. The management system of the biosensor test piece according to the sixth aspect of the invention, wherein the detecting device further comprises a transmission interface electrically connected to the micro processing unit to connect with an internet device to transmit The internet device is connected to the internet and the remote database unit. 9. The management system for a biosensor test piece according to claim i, wherein the batch identification code comprises a set of digital signals and an analog signal. K). The management system for the biosensor test piece according to claim 9, wherein the digital identification 201214184 is generated by a plurality of N identification electrodes, and the N22 is identified by at least one The identification electrode is generated by a parallel resistance element. 11. The management system for a biosensor test strip according to the scope of the patent application, wherein the batch identification code is a barcode. 12. The management system for a biosensor test piece according to claim 5, wherein the batch identification code bar code' is a swept cat unit for scanning the lot number identification code. 13. The management system of the biosensor test piece according to claim 1, wherein the detecting device further comprises: when the detecting test# is not inserted, connecting to the remote source to download the batch number Collections and their associated parameters and states. 14. The management system for a biological test piece according to Item 13 of the patent application system, wherein the batch number σ and its related parameters and states include - expired batch number subsets and related parameters, states and conditions The expired batch number sub-collection and its related parameters and status, the detection device downloads & t mother $° and its related parameter touch state, does not include the sub-subset of the job, and the 杂 崎 ' ' ^ 卩 赖 赖 赖Reduction and its number
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