201031920 六、發明說明： 【發明所屬之技術領域】 本發明係有關一種檢測試片及其檢測裝置，特別是關於一種具識別性 之檢測試片及其檢測裝置。 【先前技術】 - 隨著生物檢測技術的發展，一些原本需要特定場所如醫院、檢驗室、 實驗室，並藉助精密儀器或醫療專業人才如醫師、檢驗師、研究員才能獲 得的檢驗項目，如生化、免疫、基因檢驗等，目前不但可以在診所進行， 翁 4J- 甚至病人居家也可自行檢測，此一技術被稱為現場及時測試（p〇int 〇f cgre test ’ POCT)。常見的poct生化檢驗項目有血糖、膽固醇、尿酸，免疫檢 驗項目則有懷孕、藥物濫用、癌症指標、糖化血紅素和腸病毒基因等。此 技術及其衍生商品不僅能應用於生物醫學，更可應用在獸醫、農業、環保 與工業方面。 POCT提供使用者方便、快速、省時的檢驗，在精確度與精準度方面也 已大幅提升’很多以往只能定性檢驗的項目，現在已經進步到定量檢驗。 部分定量檢驗的精確度’也從以往的20%改進到15%甚至10%以下。因此 發展出各種不同功能的POCT檢測裝置’例如血糖儀、膽固醇儀、毒品分 析儀、腸病毒分析儀等等。 目前市場上普遍使用的POCT檢測試片’在樣品滴入檢測試片後，其 待測標的物會與吸入區或是檢測區之物質產生化學反應’引起吸入區或檢 測區之光學、電荷量等變化’再利用檢測裝置量測並運算得知待測標的物 濃度。 201031920 習知之光學檢測試片如第丨圏所示，基板1()上設有光學檢剩區域n， 制標的物會與光學檢測區域u物質產生反應，再利用檢測裝置量測並運 算得知待測標的物濃度。 習知之電化學檢測試片如第2 _示，其基板1G上設有電化學檢測區 域12，其分別與非相連之工作電極13、參考電極14相連接，待測標的物 會與電化學檢.域12之物質反應並產生化學變化，其電荷量變化之訊號 可經由電極傳送册峨置’再彻檢測裝置触減贿算得知制標 的物濃度。 習知之免疫檢測試片如第3圖所示，殼體15係將基板封裝於内部，在 樣品滴人敎區16後’制獅物會與狀區16反應，胁狀區16滴 入配合之溶劑，使溶劑利用毛細現象攜帶反應後之待測標的物擴散到呈色 比色區17 ,再利用檢測裝置量測並運算可得知待測標的物濃度。 為了得到正確的檢驗結果，上述各種定量檢測裝置，使用前都必須根 據所使用的試劑或試片特性進行分析參數的設定，有的儀器甚至要求生產 資料、產品效期、與品管相關資料的輸入與管理❶ 關於分析參數的設定’一般檢測裝置係採用以按鍵輸入方式，直接將 參數輸入檢測裝置的記憶體内’但對於不一定具有專業知識的p〇CT儀器 使用者來說，可能過於複雜而不實用。 美國專利118 5,053，199與1；8 5,366,609均使用電子抹除式唯讀記憶體 (Electrically Erasable Programmable Read-Only Memory，EEPROM)，一般 稱為密碼晶片（Code card)將校正參數傳輸到檢測裝置的記憶體’以達到簡化 201031920 設定分析參數的目的。雖然此方法的確可簡化設定步驟，但是仍有使用者 於使用不同批號的試劑或試片時，未將所附的密碼晶片***儀器更新設定 的參數’因此對POCT儀器使用者來說，仍有造成檢驗值不正確的風險。 .. 美國專利US 6,814,844’係將生產批號與效期資訊以條碼形式印刷於試 乂 片上，再以讀取條瑪的方式輸入到檢測裝置，試片的分析參數則印刷於另 外的工白式片上作為没碼條碼片，於使用每一批新試片前.，需將該設碼條 碼片***分析儀進行分析參數設定。雖然使用的參數設定方法與美國專利 藝US 5,〇53，1"與XJS 5,366,6〇9不同，但都需要一設瑪的步驟，仍然有遺漏 設定的風險。 為降低遺漏或誤設定的風險，目前已多種解決方案被提出並有產品上 市，說明如下： 具有條碼掃描功能的分析儀，係將條碼印製於試劑或試片的外包裝， 於檢驗時分析儀會自動讀取該條碼，以達到自動設定參數的目的本解決 方案雖然有效，但所需裝置體積較大’成本較高。 ® 拋棄式分析儀’該儀器於出廠前’已設定好所配備的試劑或試片參數， 在試劑或試片用畢時，同時拋棄，此方式雖說可以達到使用者免設定參數 的目的’但是耗費成本且造成資源浪費及環保問題。 單組參數分析儀’也就是提供分析相同參數的試劑或試片，此方式雖 說可以達到免設定參數的目的，但卻導致誤差範圍放大以及生產良率降低 的問題。 由以上說明可知，使用者免設定是POCT分析儀的—重要且必須的特 201031920 性，雖然有多種解決方案被提出，且已有商品上市，但都有其不完善待改 進之處°因此本發明提出一種具識別性檢測試片及其檢測裝置，以改善存 在於先前技術中之缺失。 【發明内容】 本發明之目的為提供一種具識別性檢測試片及其檢測裝置，其將檢測 試片與識別區域相結合，配合具有偵測器之檢測裝置，能偵測試片之數位 識別信號，並根據該數位識別信號將試片之分析參數、效期、生產批號等 資訊，自動傳輸到檢測裝置並自動設定該裝置，如此便可有效的改善p〇cT 分析儀使用者於使用時發生遺漏設定的風險。 為達上述目的，本發明在檢測試片上設有識別區域，可依試片特性在 識別區域上標示不}§]之翻記號，進而纽不同數傾別魏，使配合之 檢測裝置接收到數位識別信舰，觸出檢測設碼與試片資訊，達到正確、 快速判別各種試片參數的功效。 底下藉由具體實細配合所_圖式詳加制，當更容綠解本發明 之目的、技術内容、特點及其所達成之功效。 【實施方式】 本發明係提出-種具識別性之檢測試片及其檢測裝置，可用於各種 p〇ct分析裝置，如血糖儀、膽固醇儀、免疫分析鮮。其特徵為一試片具 ^測區域和識观域’檢測輯可為光學制輯、電化學感測區域或 是呈色比色區’酬區域則可為識別電極、識職口、識稠孔和識別感 光平面’而制裝置舰識舰域不_選擇不随質之偵測器。 本發明之檢測試片共有九個實施例，其中第―、第三第五第七實 201031920 施例之檢測區域均屬於光學檢測區域，但其識別區域分別為識別電極、識 別缺口、識別開孔和識別感光平面區域。第二、第四、第六、第八實施例 之檢測區域則均為電化學檢測區域，其連接兩非相連電極，便以將檢測區 . 域電化學反應產生之電流變化傳導至檢測裝置，識別區域亦分別為識別電 極、識別開口、識別開孔和感光平面區域。第九實施例係將基板封裝於殼 體内，並將識別區域設置在殼體上，其檢測區域屬於呈色比色區，識別區 域則為識別開孔區域。 φ 本發明檢測試片之第一實施例如第4圖所示，一具識別電極之光學檢 測試片’在基板20上設有光學檢測區域21和識別電極區域25，其中識別 電極區域25的四個識別電極係可預先形成’在檢測試片測試完成後，再根 據不同之參數或條件加工部分識別電極使其成為斷路，加工方式例如為沖 壓。如圖所示，識別電極25a係經加工成為斷路，其餘識別電極皆為通路， 可產生之數位識別訊號例如是（1，〇，1，1)。藉由該種手法，亦即使各個識別 電極成為斷路或是保持通路，並配合檢測裝置，可使各個識別電極產生0 ® 或1的數位識別訊號，一共可產生24組不同的數位識別訊號，其可代表不 同的檢測設瑪與參數、效期或批次設定。 本發明檢測試片之第二實施例如第5圖所示，一具識別電極之電化學 檢測試片’在基板20上設有電化學檢測區域22，其分別與工作電極23和 參考電極24相連接，基板上之識別電極區域25設計係與第一實施例相同 且與參考電極24連接。並且，可在檢測裝置内具有提昇電阻，而可將對應 的識別電極之電位提昇至預設的高電位，當此識別電極與參考電極24短 201031920 路’則其電位會降至低電位；因此，即可藉由讀取識別電極的高低電位， 得知識職姉參考輸μ躺路或短路。 本發明檢測4片之第三實施例如第6圖所示，一種具識別缺口之光學 檢測試片在基板2〇上設有光學檢測區域21和識別缺口區域26，其中該 削缺π H域26可在檢測試片測試完錢，再根據不同參數條件加工例如 使用沖壓方式形成識別缺口。 並可在檢赚置内將發光二極體和光電晶财^_咖_)分別設置 在檢測試片的兩侧，且與對應之識職口姻-條虛擬直線上，使發光二 極體的光線可輯過識別缺口而由光電晶體侧·’因此可藉由判斷光電晶 體所接收刺光線_ ’得知檢職片的對應位置有無缺口。另外，亦可 在檢測裝置⑽朗缺口設置有對應之微動_或導電制，當識別缺口 開孔的位置有缺口時，__關或導片不會受到擠壓。反之，如果 識別缺口_置沒有缺口時，則鶴_或導電彈片就會制擠麼。經由 賴(或不_撕轉電則，導驗赚置喃對躺電子迴路產 生短路(或斷路)抑或斷路(或短路），而可得知識別缺口的位置有沒有缺口。 如圖所示，識別缺口區域26具有4個識別缺口，其可代表一組數位訊號， 藉由使各個識別缺口位置形成或是不形成缺口，配合檢測裝置可產生多組 不同之數域別峨，絲*_制設猶纽、效賊批次設定。 本發明檢職片之第四實_如第7騎示，—具識別缺口之電化學 檢測試片，其識別缺口區域26設計係與第三實施例相同。 本發驗職狀第五實蘭㈣8 _示，―種具識綱孔之光學 201031920 檢測試片，在基板20上設有光學檢測區域和識別開孔區域27，其中該識別 開孔區域27可在檢測試片測試完成後，根據不同參數條件加工例如使用 沖壓方式形成識別開孔。 _有無開孔的方法可由上述第三實施例之光學的方絲達成。如圖 ‘所示’識別開孔區域27具有4個識別開孔，其可代表一組數位訊號，藉由 使各個識綱緣置軸妓不形綱孔，可赴乡組㈣之餘識別訊 號，代表不同的檢測設碼與參數、效期或批次設定。 本發明檢測試片之第六實關如第9 w所示，-具識顧孔之電化學 檢測試片’其識別開孔區域27設計係與第五實施例相同。 本發明檢測試#之第<b實關如第1〇 _示，—具識誠光平面之檢 測試片’在基板20上設有光學檢測區域21和識別感光平面區域28，其中 識別感光平28具有識观光平面，該絲平面可為明暗或色彩，在 檢測試片測試完成後，可另外利用如貼合、印刷或雷射方式加工形成感光 平面。 可在檢測裝置内將發光二極體和光電晶體(ph〇t〇transistor)設置在檢測 試片的上側，同時指向與之對應的識別感光平面，當發光二極體的光線照 射至識別感光平面並反射並由光電晶體所偵測，而可藉以判別識別感光平 面，是否具有良好的光反射性。如圖所示，識別區域具有4個感光平面， 其代表一組數位訊號，藉由使各個感光平面位置形成或是不形成感光平 面可產生多組不同之數位識別訊號，代表不同的檢測設碼與參數、效期 或批次設定。 201031920 本發明檢測試片之第八實施例如第u圖所示，一具識別感光平面之電 化學檢測試片，其識別感光平面區域28設計係與第七實施例相同。 第12圖為本發明之檢測裝置示意圖，如圖所示，檢測裝置設有顯示螢 幕31和控制按鈕32，檢測口 30係為試片***口，其内設有偵測器33，例 如電子接點式連接器或光電連接器，將檢測試片之識別區域端對準檢測裝 置之檢測口 31***，檢測試片之識別區域對應偵測器33 ,使偵測器幻能 偵測試片之數位識別信號，判斷其相對應之檢測設碼與參數、效期或批次 設定。檢測裝置内另設有微處理器（圖未示）用以分析樣品之檢測數據， 因屬習知構造非本發明特徵，故不加以敘述。 上述檢測試片之第一和第二之實施例(即採用識別電極方式），需配合偵 測器為電子接點式連接器之檢測裝置，以利用該偵測器與該試片上之識別 區域之識別電極與參考電極的導通與否，產生一數位識別信號提供給該檢 測裝置；檢測試片之第三和第四實施例(即採用識別缺口方式)則可配合偵測 器為電子接點式連接器或是發光二極體及光電晶體之檢測裝置，以利用該 伯測器與該试片上之識別區域的識別缺口的缺口與否，產生一數位識別信 號提供給該檢測裝置；而檢測試片之第五到第八實施例(即採用識別開孔或 識別感光方式），則需配合偵測器為發光二極體及光電晶體之檢測裝置，以 = 利用該偵測器與該試片上之識別區域之光束通過與否或光反射之強弱，產 ： 生一數位識別信號提供給該檢測裝置。 除上述八個檢測試片實施例之外，檢測試片之第九實施例如第13圖所 示，一具識別開孔之檢測試片’其基板位於殼體40内部，般體4〇上設有 10 201031920 吸入區41、呈色比色區42和殼體識別開孔區域43，其中殼體識別開孔區 域43可在檢測試片測試完成後，根據不同參數條件加工，例如使用沖壓方 式形成殼體識別開孔，如圖所示，殼體識別開孔區域43具有4個識別開孔， ‘ 其可代表一組數位訊號，藉由使各個識別開孔位置形成或是不形成開孔， ^ 可產生多組不同之數位識別訊號，代表不同的檢測設碼與參數、效期或批 次設定。檢測試片之第九實施例配合上述檢測試片第三實施例之檢測裝 置，可達到辨識不同試片之檢測設碼與參數、效期或批次設定之效。而檢 •測試片第九實施例之殼體識別開孔區域43亦可更改為識別缺口或是識別感 光平面區域。 以上所述之實施例僅係為說明本發明之技術思想及特點，其目的在使 熟習此項技藝之人士_瞭解本發明之内容並據以實施，當不能以之限定 本發明之專職圍，即大凡依本㈣所揭示之精神所作之均等變化或修 飾’仍應涵蓋在本發明之專利範圍内。 【圖式簡單說明】201031920 VI. Description of the Invention: [Technical Field] The present invention relates to a test strip and a detecting device thereof, and more particularly to a discriminating test strip and a detecting device therefor. [Prior Art] - With the development of bio-detection technology, some test items, such as biochemicals, that were originally required in specific places such as hospitals, laboratories, laboratories, and with precision instruments or medical professionals such as physicians, inspectors, and researchers. Immunization, genetic testing, etc., can not only be carried out in the clinic, Weng 4J- even patient home can also be self-testing, this technology is called on-site timely test (p〇int 〇f cgre test 'POCT). Common poct biochemical tests include blood sugar, cholesterol, and uric acid. Immunization tests include pregnancy, drug abuse, cancer indicators, glycosylated hemoglobin, and enterovirus genes. This technology and its derivatives can be applied not only to biomedicine but also to veterinary, agricultural, environmental and industrial applications. POCT provides users with convenient, fast and time-saving inspections, and has also been greatly improved in terms of accuracy and precision. Many projects that have only been qualitatively tested in the past have now progressed to quantitative testing. The accuracy of partial quantitative testing has also improved from the previous 20% to 15% or even less than 10%. Therefore, POCT detecting devices of various functions such as a blood glucose meter, a cholesterol meter, a drug analyzer, an enterovirus analyzer and the like have been developed. Currently, the POCT test strips commonly used on the market 'after the sample is dropped into the test strip, the object to be tested will chemically react with the substance in the inhalation area or the detection area', causing the optical and charge amount in the inhalation area or the detection area. The equal change 'reuse detection device measures and calculates the concentration of the object to be tested. 201031920 The optical detection test piece of the conventional knowledge is shown in Fig. ,, the optical detection residual area n is provided on the substrate 1 (), and the labeled object reacts with the substance of the optical detection area u, and is measured and calculated by the detection device. The concentration of the object to be tested. The electrochemical detection test piece of the prior art is shown in FIG. 2, and the substrate 1G is provided with an electrochemical detection region 12, which is respectively connected to the non-connected working electrode 13 and the reference electrode 14, and the object to be tested is combined with the electrochemical test. The substance of the domain 12 reacts and produces a chemical change, and the signal of the change in the amount of charge can be known by the electrode transfer device to detect the concentration of the labeled substance. As shown in Fig. 3, the housing 15 encloses the substrate inside, and after the sample is dropped into the human crotch region 16, the lion will react with the region 16 and the flank 16 is dripped. The solvent is used to diffuse the solvent to the colorimetric colorimetric region 17 after the reaction is carried by the capillary phenomenon, and then the concentration of the object to be tested can be known by measuring and calculating by the detecting device. In order to obtain the correct test results, all kinds of quantitative detection devices mentioned above must be set according to the characteristics of the reagents or test strips used before use. Some instruments even require production materials, product expiration dates, and quality control related materials. Input and management ❶ About the setting of the analysis parameters 'The general detection device uses the key input method to directly input the parameters into the memory of the detection device', but for the p〇CT instrument user who does not necessarily have professional knowledge, it may be too Complex and not practical. U.S. Patent Nos. 1,158,053,199 and 1,8,366,609 each use an Electrically Erasable Programmable Read-Only Memory (EEPROM), commonly referred to as a Code Card, to transmit calibration parameters to the detection device. Memory 'to achieve the purpose of simplifying the analysis parameters of 201031920. Although this method does simplify the setting procedure, there are still users who do not insert the attached cryptographic wafer into the parameters of the instrument update setting when using different batches of reagents or test strips. Therefore, for POCT instrument users, there is still The risk of incorrect inspection values. .. US Patent US 6,814,844' prints the batch number and expiration date information in bar code on the test piece, and then inputs it into the detection device by reading the bar code. The analysis parameters of the test piece are printed on another work white type. On-chip as a no-code chip, before using each batch of new test strips, you need to insert the code-coded chip into the analyzer for analysis parameter setting. Although the parameter setting method used is different from the US patent art US 5, 〇53, 1" and XJS 5, 366, 6〇9, all of them require a step of setting the horse, and there is still a risk of missing settings. In order to reduce the risk of omission or mis-setting, a variety of solutions have been proposed and products are available, as explained below: Analyzers with barcode scanning function are printed on the outer packaging of reagents or test strips, and analyzed at the time of inspection. The instrument will automatically read the bar code to achieve the purpose of automatically setting parameters. Although this solution is effective, the required device volume is large, and the cost is high. ® Disposable Analyzer 'The instrument is set at the factory' has been set with the reagents or test strip parameters. When the reagents or test strips are used, they are discarded at the same time. This method can achieve the purpose of user-free setting parameters. Costly and waste of resources and environmental issues. A single-group parameter analyzer' is a reagent or test piece that provides the analysis of the same parameters. Although this method can achieve the purpose of avoiding setting parameters, it leads to the problem of amplifying the error range and reducing the production yield. As can be seen from the above description, the user-free setting is an important and necessary feature of the POCT analyzer. Although a variety of solutions have been proposed and existing products are available, there are some imperfections to be improved. The invention proposes an identification test strip and a detection device thereof to improve the deficiency existing in the prior art. SUMMARY OF THE INVENTION An object of the present invention is to provide an identification test piece and a detecting device thereof, which combine a test piece and an identification area, and cooperate with a detecting device having a detector to detect digital identification of a test piece. Signal, and according to the digital identification signal, the analysis parameters, the validity period, the production batch number and the like of the test piece are automatically transmitted to the detecting device and automatically set, so that the user of the p〇cT analyzer can be effectively improved. The risk of missing settings. In order to achieve the above object, the present invention provides an identification area on the test strip, and can mark the mark on the identification area according to the characteristics of the test piece, and then the different numbers are different, so that the matching detection device receives the digital position. Identify the letter ship, touch the detection code and test piece information, and achieve the correct and quick identification of the parameters of various test pieces. The details of the present invention, the technical content, the features and the effects achieved by the present invention are further explained by the detailed and detailed cooperation. [Embodiment] The present invention proposes an identification test piece and a detection device thereof, which can be used for various p〇ct analysis devices, such as a blood glucose meter, a cholesterol meter, and an immunoassay. The feature is that the test piece has a measurement area and an observation field. The detection sequence can be an optical recording, an electrochemical sensing area or a color-matching color area, and the reward area can be an identification electrode, a knowledgeable mouth, and a thickening. The hole and the identification of the photosensitive plane', and the device's shipyard does not choose a detector that does not pass the quality. There are nine embodiments of the test strips of the present invention, wherein the detection areas of the first, third, fifth, seventh, and 201031920 embodiments belong to the optical detection area, but the identification areas are respectively identification electrodes, identification gaps, and identification apertures. And identify the photosensitive flat area. The detection regions of the second, fourth, sixth, and eighth embodiments are all electrochemical detection regions, which are connected to the two non-connected electrodes, so as to conduct current changes generated by the electrochemical reaction of the detection region to the detecting device. The identification areas are also the identification electrode, the recognition opening, the identification opening and the photosensitive plane area. In the ninth embodiment, the substrate is packaged in the casing, and the identification area is disposed on the casing, the detection area belongs to the colorimetric colorimetric area, and the identification area is the identification opening area. φ In the first embodiment of the test strip of the present invention, as shown in FIG. 4, an optical detecting test piece of the identification electrode is provided with an optical detection area 21 and an identification electrode area 25 on the substrate 20, wherein the identification electrode area 25 is four. The identification electrode system can be formed in advance. After the test piece is completed, the part identification electrode is processed to be broken according to different parameters or conditions, and the processing method is, for example, stamping. As shown in the figure, the identification electrode 25a is processed to be an open circuit, and the remaining identification electrodes are all paths, and the digital identification signal that can be generated is, for example, (1, 〇, 1, 1). According to this method, even if each of the identification electrodes is opened or maintained, and the detecting device is matched, the identification electrodes can generate 0 + or 1 digital identification signals, and a total of 24 different digital identification signals can be generated. It can represent different detection settings and parameters, validity or batch settings. In a second embodiment of the test strip of the present invention, as shown in FIG. 5, an electrochemical detection test piece of the identification electrode is provided with an electrochemical detection region 22 on the substrate 20, which is respectively associated with the working electrode 23 and the reference electrode 24. The design of the identification electrode region 25 on the substrate is the same as that of the first embodiment and is connected to the reference electrode 24. Moreover, the boosting resistor can be provided in the detecting device, and the potential of the corresponding identifying electrode can be raised to a preset high potential. When the identifying electrode is shorter than the reference electrode 24, the potential is reduced to a low potential; By reading the high and low potentials of the identification electrode, it is possible to refer to the input or the short circuit. According to a third embodiment of the present invention for detecting four sheets, as shown in FIG. 6, an optical detecting test piece having an identification notch is provided with an optical detecting area 21 and an identification notch area 26 on the substrate 2, wherein the missing π H field 26 The test piece can be tested for money, and then processed according to different parameter conditions, for example, using a stamping method to form an identification gap. The light-emitting diode and the photoelectric crystal money ^_coffee_) can be respectively disposed on both sides of the test piece in the check-making, and the corresponding light-sense-strip-virtual line is used to make the light-emitting diode The light can be edited over the identification gap and the photonic crystal side can be 'received by the photonic crystal to receive the thorn light _' to know whether there is a gap in the corresponding position of the inspection film. In addition, a corresponding micro-motion or conductive system may be provided on the detecting device (10), and when the position of the notch opening is notched, the __off or guide piece is not squeezed. On the other hand, if the gap _ is not found, then the crane _ or the conductive shrapnel will be squeezed. Via Lai (or not to tear the electricity, the test earns a short circuit (or open circuit) or open circuit (or short circuit) on the lying electronic circuit, and can know whether there is a gap in the position of the identification gap. The identification gap area 26 has four identification gaps, which can represent a group of digital signals. By forming or not forming gaps for each identification gap, the detection device can generate a plurality of different numbers of fields. Set the layout of the thief and the thief. The fourth version of the inspector of the present invention is as shown in the seventh riding, the electrochemical detection test piece with the identification gap, and the design of the identification notch region 26 is the same as that of the third embodiment. The present invention, the fifth real blue (four) 8 _ shows, the genre of the optical hole 201031920 test strip, on the substrate 20 is provided with an optical detection area and an identification aperture area 27, wherein the identification aperture area 27 After the test strip test is completed, the identification opening can be formed according to different parameter conditions, for example, using a stamping method. The method of forming the opening can be achieved by the optical square wire of the third embodiment described above. Hole area 27 has 4 identification openings, which can represent a set of digital signals. By making each axis of the axis a non-profile hole, the identification signal can be identified after the group (4), representing different detection codes and parameters, and validity period. Or the batch setting. The sixth actual test of the test strip of the present invention is as shown in the 9th wth, and the electrochemical detection test piece with the identification hole is the same as the fifth embodiment. The invention of the test test# is performed as shown in the first section, and the detection test piece of the light plane is provided with an optical detection area 21 and an identification photosensitive plane area 28 on the substrate 20, wherein the photosensitive flat surface 28 is recognized. Having a sightseeing plane, the silk plane can be light and dark or color. After the test strip is tested, it can be additionally processed by lamination, printing or laser to form a photosensitive plane. The light emitting diode and the light emitting diode can be used in the detecting device. A photoelectric crystal (ph〇t〇transistor) is disposed on the upper side of the detecting test piece while pointing to the corresponding identifying photosensitive plane, and when the light of the light emitting diode is irradiated to the identifying photosensitive plane and reflected and detected by the photoelectric crystal, Discriminating recognition sensitivity Whether the surface has good light reflectivity. As shown in the figure, the identification area has four photosensitive planes, which represent a set of digital signals, and multiple sets of different ones can be generated by forming or not forming the photosensitive plane positions. The digital identification signal represents different detection codes and parameters, expiration dates or batch settings. 201031920 The eighth embodiment of the test strip of the present invention, as shown in Fig. u, shows an electrochemical detection test piece for identifying a photosensitive surface, The design of the photosensitive surface area 28 is the same as that of the seventh embodiment. Fig. 12 is a schematic view of the detecting device of the present invention. As shown, the detecting device is provided with a display screen 31 and a control button 32, and the detecting port 30 is inserted into the test piece. The port is provided with a detector 33, such as an electronic contact connector or an optical connector, and the detection area end of the detection test piece is aligned with the detection port 31 of the detecting device, and the detection area of the test piece is detected. The device 33 enables the detector to detect the digital identification signal of the test piece, and determines the corresponding detection code and parameter, validity period or batch setting. A microprocessor (not shown) is additionally provided in the detecting device for analyzing the test data of the sample. Since the conventional structure is not a feature of the present invention, it will not be described. The first and second embodiments of the test strip (ie, using the identification electrode method) need to cooperate with the detector as a detecting device of the electronic contact connector to utilize the detector and the identification area on the test strip. Whether the identification electrode and the reference electrode are turned on or not, a digital identification signal is generated and supplied to the detecting device; and the third and fourth embodiments of the detecting test piece (that is, using the identification notch mode) can cooperate with the detector as an electronic contact The connector or the detecting device of the light emitting diode and the photoelectric crystal, to generate a digital identification signal and provide the detecting device by using the gap between the detecting device and the identification gap of the identification area on the test piece; In the fifth to eighth embodiments of the test piece (that is, using the identification opening or the identification light sensing mode), the detector is required to be a detecting device for the light emitting diode and the photoelectric crystal to use the detector and the test. The intensity of the light beam passing through the recognition area on the chip or the intensity of the light reflection produces: a digital identification signal is supplied to the detecting device. In addition to the above eight test strip embodiments, the ninth embodiment of the test strip is shown in Fig. 13, and a test strip for identifying the opening is provided with the substrate inside the casing 40. There are 10 201031920 suction zone 41, colorimetric colorimetric zone 42 and shell identification aperture area 43, wherein the housing identification aperture area 43 can be processed according to different parameter conditions after the test strip test is completed, for example, by stamping. The housing identifies the opening. As shown, the housing identification aperture area 43 has four identification apertures, 'which can represent a set of digital signals, by forming or identifying openings for each identification aperture. ^ Multiple sets of different digital identification signals can be generated, representing different detection codes and parameters, validity periods or batch settings. The ninth embodiment of the test strip cooperates with the detecting device of the third embodiment of the test strip to obtain the effect of identifying the test code and parameters, expiration date or batch setting of different test strips. The housing recognition opening area 43 of the ninth embodiment of the test piece can also be changed to identify the notch or to identify the photosensitive plane area. The embodiments described above are merely illustrative of the technical spirit and characteristics of the present invention, and the purpose thereof is to enable those skilled in the art to understand the contents of the present invention and to implement the present invention. That is, the equivalent changes or modifications made by the spirit of the present invention (4) should still be covered by the patent of the present invention. [Simple description of the map]
第1圖為習知光學檢測試片的俯視圖。 第2圖為習知電化學檢測試片的俯視圖。 第3圖為習知免疫試片的立體圖。 第4圖為本發明檢測試片之第一實施例的俯視圖。 第5圖為本發明檢測試片之第二實施例的俯視圖。 第6圖為本發明檢測試片之第三實施例的俯視圖。 第7圖為本發明檢測試片之第四實施例的俯視圖。 第8圖為本發明檢測試片之第五實施例的俯視圖。 201031920 第9圖為本發明檢測試片之第六實施例的俯視圖。 第10圖為本發明檢測試片之第七實施例的俯視圖。 第11圖為本發明檢測試片之第八實施例的俯視圖。 第12圖為本發明之檢測裝置的示意圖。 第13圖為本發明檢測試片之第九實施例的立體圖。 【主要元件符號說明】 10、20 基板 11 > 21 光學檢測區域 12、22 電化學檢測區域 13、23 工作電極 14、24 參考電極 15、40 殼體 16、41 吸入區 17、42 呈色比色區 25 識別電極區域 25a 識別電極 26 識別缺口區域 27 識別開孔區域 28 識別感光平面區域 30 檢測口 31 顯示螢幕 32 控制按鈕 12 201031920 33 43 偵測器 殼體識別開孔區域Fig. 1 is a plan view of a conventional optical detecting test piece. Figure 2 is a plan view of a conventional electrochemical test strip. Figure 3 is a perspective view of a conventional immunoassay. Fig. 4 is a plan view showing a first embodiment of the test strip of the present invention. Fig. 5 is a plan view showing a second embodiment of the test strip of the present invention. Figure 6 is a plan view showing a third embodiment of the test strip of the present invention. Figure 7 is a plan view showing a fourth embodiment of the test strip of the present invention. Figure 8 is a plan view showing a fifth embodiment of the test strip of the present invention. 201031920 Fig. 9 is a plan view showing a sixth embodiment of the test strip of the present invention. Figure 10 is a plan view showing a seventh embodiment of the test strip of the present invention. Figure 11 is a plan view showing an eighth embodiment of the test strip of the present invention. Figure 12 is a schematic view of the detecting device of the present invention. Figure 13 is a perspective view showing a ninth embodiment of the test strip of the present invention. [Major component symbol description] 10, 20 substrate 11 > 21 optical detection region 12, 22 electrochemical detection region 13, 23 working electrode 14, 24 reference electrode 15, 40 housing 16, 41 suction region 17, 42 color ratio Color area 25 Identification electrode area 25a Identification electrode 26 Identification of notch area 27 Recognition of aperture area 28 Identification of photosensitive plane area 30 Detection port 31 Display screen 32 Control button 12 201031920 33 43 Detector housing identification opening area