TWI301888B - - Google Patents
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- TWI301888B TWI301888B TW94110748A TW94110748A TWI301888B TW I301888 B TWI301888 B TW I301888B TW 94110748 A TW94110748 A TW 94110748A TW 94110748 A TW94110748 A TW 94110748A TW I301888 B TWI301888 B TW I301888B
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案號 94110748Case number 94110748
1301888 五、發明說明(1) [發明所屬之技術領域 本發明係有關一種個人用的生化檢測試片,尤指_ _ 單〆片可以多次使用的血液生化檢測試片,以及可以以一 滴jfe*同時測®兩種以上相同或不同檢驗項的生化檢測古戈 片。 【先前技術】 目前所有市面上的血糖檢測試片都是 _ ^ 一尺、 用完即丟的試片。這種試片對於開發中或未開發國家^糖 尿病患者來說,貫在太過昂貴、負擔不起,而無法定期依 1據病情作血糖檢測,甚而危及生命。他們非常需要一種更 便宜的血糖檢測試片。同時,目前市面上的血糖試片精 度也不夠,限於他們使用的材質及方法,常常造成超^百 分之三十以上的誤差。而且,除了歐美少數品牌以 需要十五到三十秒的測量時間。目此,本發明的主要 就是能提供一種更便宜、更準處、、、丨旦主 測試片。 更早確、測罝時間更短的血糖檢 本發明的另一個主要目的钟曰处 片,只要採-滴金、痛—次,:疋:、一種血糖檢測試 或不同的檢品讀值;用血::滴上就能測得數種相同 ^值的目的是A 了& $ I Μ 就此測侍數種相同的檢品讀 值的曰的疋為了此多做幾次血 準確度,但不必多採幾次血 採::均值以增: 血就能測得數.種不同的檢品讀 木^痛·’而用-滴 同項目的檢測,但不必多接继、目的疋為了能同時做不 到目前為止,全世界产右^血以減少採血的疼痛。 ’又有任何一個專利提出在單一個1301888 V. INSTRUCTION DESCRIPTION (1) [Technical Field] The present invention relates to a biochemical test strip for personal use, especially a blood biochemical test strip which can be used multiple times, and can be used as a drop of jfe * Simultaneous measurement of biochemical detection of two or more identical or different test items. [Prior Art] At present, all the blood glucose test strips on the market are _ ^ one foot, and the test piece that is used up and lost. Such test strips are too expensive and unaffordable for patients with diabetes in developing or untapped countries, and cannot be routinely tested for blood sugar according to their condition, even life-threatening. They really need a cheaper blood glucose test strip. At the same time, the accuracy of blood glucose test strips currently on the market is not enough, limited to the materials and methods used by them, often resulting in more than 30% error. Moreover, in addition to a few brands in Europe and America, it takes 15 to 30 seconds to measure. Accordingly, the main object of the present invention is to provide a cheaper, more accurate, and superior test piece. Blood glucose test with a shorter detection time and a shorter test time. Another main object of the invention is the use of a blood glucose test or a different test sample. Blood:: The purpose of measuring several identical values on the drop is A & $ I Μ Μ 测 测 测 测 测 相同 相同 相同 相同 相同 相同 相同 相同 相同 相同 相同 相同 相同 相同 相同 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋 疋More than a few blood collection:: The average value is increased: The blood can be measured. Different kinds of inspection products read wood ^ pain · 'use - drop the same project test, but do not have to continue, the purpose 疋 in order to be able to do at the same time So far, the world has produced right blood to reduce the pain of blood collection. ‘Any other patent is presented in a single
13018881301888
皇號 94110748 五、發明說明(2) 法= = 匕能:次使用的結構設 請案(美國發明專利n\負擔。我們前一個專利申 ^ ^ Λ/7//Λ 1 0 /704^7〇1^ ^ τ 案不同。 电亿予。式片,但内容與本申請Emperor No. 94110748 V. Invention Description (2) Law == 匕 Energy: The structure of the sub-use is requested (US invention patent n\burden. Our previous patent application ^ ^ Λ / 7 / / Λ 1 0 / 704 ^ 7 〇1^^ τ case is different. Electric billion.. film, but the content and this application
Shiro Nankai等人申古杳的盖网奄 一種在一 Η 1 η ·· 士夕 的國專利5, 1 20, 420揭示了 °式片上有夕條電極導線,以便同時為數個;^口 檢測其血糖濃度’再取其平均值,以增加=數巧:: 種方法需要比較多的血液量,—又仁疋这 •r,並不可行。同時,这稀方、=心在豕自我檢測者而 測費用。 块種方法也無助於降低使用者的檢 θ沾:t *有很夕研九報告及專利提出各種方法以提高測 ^準確度或檢測速*。例如,Thomas γ· s. shen“、] =專利6, 491,803有提到採用奈米金屬粉以增加導電度及 減 >、反應時間,但仍然需要十五秒鐘的時 (Biosensors & Βΐ〇β1βοΪΓΟηί€δ, 1 3 : 333-339Λ 996^ ί Ϊ :極表面力:入白金粉末可以增加導電度以改善測量的 '又,然而這些效果還不夠好。C. D. ffisiey等人的美 _國專利6, 541,216指出利用電漿處理銀電極和碳電極的表、 Γ面可以增加試片測量的準確度。但是,以上這些方法並不 能達到本專利所要求的更便宜、更準確、及量測速度更快 的目標,也不是本專利所採用的方法。 【發明内容】 為達上述之目的,本發明係提供一種能多次使用的生Shiro Nankai et al., Shen Guzhen’s cover net, a kind of national patent 5, 1 20, 420 in a Η 1 · ·· Shi Xi reveals that there are eve electrode wires on the ° type film, so as to simultaneously detect several The blood glucose concentration 'takes the average value again to increase = number of coincidences:: The method requires a relatively large amount of blood, and it is not feasible. At the same time, this rare party, = heart is self-testing and measuring costs. The block method also does not help to reduce the user's inspection. θ: There are a lot of research reports and patents to propose various methods to improve the accuracy or speed of detection*. For example, Thomas γ· s. shen “,] = Patent 6, 491, 803 mentions the use of nano metal powder to increase conductivity and reduce the reaction time, but still takes fifteen seconds (Biosensors &; Βΐ〇β1βοΪΓΟηί€δ, 1 3 : 333-339Λ 996^ ί Ϊ : Extreme surface force: Into the platinum powder can increase the conductivity to improve the measurement' again, but these effects are not good enough. The beauty of CD ffisiey et al _ Patent No. 6,541,216 states that the use of plasma to treat the surface and surface of the silver and carbon electrodes can increase the accuracy of the measurement of the test piece. However, these methods do not achieve the cheaper and more accurate requirements of the patent. And the target of measuring faster speed is not the method adopted in this patent. [Invention] For the above purpose, the present invention provides a life that can be used multiple times.
第6頁 1301888 案號 94110748 五 '發明說明(3) 修正Page 6 1301888 Case No. 94110748 V 'Invention Description (3) Amendment
“化,試試片,其主要包含一種每片能多次使用的一次性、 用即丢式的念:物檢辦-彆極試片之結構及所含之化學载 體’用以配合生物感測檢測裝置使用,並根據檢品於 反應中所產生的電效應,檢出該檢品的成分及測定其产 度。本發明之結構是由四層的薄片黏貼而成,而薄片: 各種沖孔所形成的空間可以產生三個相同的反應區, 各反應區上置有生化反應載體,僅需要2 // 1的血液量,’= .由虹吸的原理,血液會被吸入反應區後隨即與其上的藉 應反應載體起電化學反應,並且藉由分析該電化學反應的= 修果能得知該血液檢品的血糖濃度。同時該薄片另有各種% 孔所形成的空間能使該試片因應力集中因素而能將用中 =片輕,折斷,以利第二、三次再使用其他未使用的g的 伤’在最底層的薄片上有兩條正負極導電電極以傳導 的電化學訊號,且該電極導線被設計成使每個電化學2 區的正負電極與測量電極頭上的正負電極間具有相同電… 阻’具有相同電阻是本發明所揭示的試片能多次使用的 鍵因素,也是不可或缺的要素,這種方法全世界我們首^ 採用。每個電化學反應區的正負電極會將其上的化學载= 參與血液反應所產生的電化學反應訊號傳到測量電極頭上的 正負電極,然後可被血糖測試機判讀其血液檢品的血糖读 值。至於 唄 基纖維素(hydroxypropyl methyl cellulose),以使其化 學反應物質平均分佈,這與美國專利5, 12〇, 42〇所"Chemical, test film, which mainly contains a one-time, use-and-drop type of each piece that can be used multiple times: the structure of the physical inspection office - the special test piece and the chemical carrier contained in it" The sensing device is used, and the component of the test product is detected and the productivity is determined according to the electrical effect generated by the test product in the reaction. The structure of the present invention is formed by sticking four layers of sheets, and the sheet: various The space formed by the punching can produce three identical reaction zones, and each reaction zone is provided with a biochemical reaction carrier, which requires only 2 // 1 of the blood volume, '= . By the principle of siphon, the blood will be inhaled into the reaction zone. Immediately, an electrochemical reaction is carried out with the borrowing reaction carrier thereon, and the blood glucose concentration of the blood test product can be known by analyzing the electrochemical reaction. The space formed by the various other pores of the sheet can also The test piece can be used in the middle of the sheet due to the stress concentration factor, and is broken, so as to benefit the second and third times, and then use the other unused g. The uppermost sheet has two positive and negative conductive electrodes for conduction. Electrochemical signal, and the electrode lead is It is calculated that the positive and negative electrodes of each electrochemical zone 2 have the same electrical power as the positive and negative electrodes on the measuring electrode head. The resistance of the same resistance is the key factor that can be used repeatedly for the test piece disclosed in the present invention, and is also indispensable. The element, this method is adopted by the world. The positive and negative electrodes of each electrochemical reaction zone will transmit the electrochemical reaction signal generated by the chemical reaction in the blood reaction to the positive and negative electrodes on the measuring electrode head. The blood glucose tester interprets the blood glucose reading of the blood test. As for the hydroxypropyl methyl cellulose, the chemical reaction substance is evenly distributed, which is in accordance with U.S. Patent 5,12,42
、我們獨家開發的化學反應物質之配方係含有氫氧丙曱 1301888 案號 94110748 五、發明說明(4) 國專利374 1 1 6號及美國專利6, 41 3, 394B1所採用的超微粒 纖維素(Microcrystalline cellulose)不同,這也是入 世界我們首次採用。 疋王 除此之外,我們也添加多壁及單壁(Multi-wa丨led和 single wal led)奈米碳管以增加導電速率、減少檢測時^ 間,它可以將反應時間由一般的三十秒減少到四秒甚至一 秒鐘’並可提供適當的表面張力及表面能,以防止血液I 固,這種方法全世界我們首次採用。如此一來,本發=^ 揭示的試片可以多次重複使用,而且可以很迅速地 2 •準確的結果。 仅 再者,若將上述四層所形成的試片於其最上層再加貼 同樣的四層或八層,但其虹吸進血位置皆在相同位置,則 以一滴jk可以被虹吸到兩個或三個不同的、獨立的反廣 區’做相同的或不同的生化反應檢測,因此以一滴血$以 同時測量兩種以上的相同或不同檢品。如果以一滴血同時 測3:兩種以上的相同檢品時,可以取其平均值以增加其準 確度;但如果以一滴血同時測量兩種以上的不相同檢口 時,則可以減少每一次採血的疼痛。 據而,本發明所述之血糖測試試片,可以降低使用者 每次使用的檢測成本,同時也具有準確度最高、測試時間 最短的功能要求。 曰 【實施方式】 為使 貴審查委員對本發明之構造及其特徵能有更深 一層的認識與了解,茲舉其可行實施例並配合圖是詳細說The formula for the chemical reaction material we have developed exclusively contains oxyhydrin 1301888. Case No. 94110748. 5. Invention Description (4) National Patent No. 374 1 16 and U.S. Patent 6, 41 3, 394B1 (Microcrystalline cellulose) is different, this is also the first time we have adopted the world. In addition to this, we also add multi-wall and single-wall (Multi-wa丨led and single wal led) carbon nanotubes to increase the conductivity rate and reduce the detection time. It can adjust the reaction time from the general three. Ten seconds to four seconds or even one second 'and can provide the appropriate surface tension and surface energy to prevent blood I solid, this method is the first time we use the world. In this way, the test piece disclosed by the present invention can be reused many times, and can quickly and accurately. In addition, if the test piece formed by the above four layers is attached to the same four layers or eight layers on the uppermost layer, but the siphon blood inlet positions are all in the same position, a drop of jk can be siphoned to two. Or three different, independent anti-wide areas 'do the same or different biochemical reaction tests, so use a drop of blood $ to simultaneously measure two or more identical or different samples. If you measure 3 with two drops of the same test at the same time, you can take the average value to increase its accuracy; but if you measure two or more different check points simultaneously with one drop of blood, you can reduce each time. The pain of blood collection. Accordingly, the blood glucose test strip of the present invention can reduce the cost of testing each time the user uses, and also has the highest accuracy and the shortest test time.曰 [Embodiment] In order to enable the reviewing committee to have a deeper understanding and understanding of the structure and characteristics of the present invention, the feasible embodiments and the drawings are detailed.
1301888 主月曰 修正 _案號 94110748 五、發明說明(5) 明如下: 清參閱第一圖、第二圖及第三圖所示,本發明所述之 能多次使用的生物檢測試片1〇,係由四層薄片π、12、 1 3、1 4所黏貼而成,並於薄片丨丨、丨2之間放置有二條導線 1 5、1 6 ’導線1 5連接到三個參考電極丨51、丨5 2、丨5 3,而 導線1 6連接到三個工作電極1 6 1、1 6 2、1 6 3 (如第二 圖)。 薄片11上有兩個沖孔1 7、1 8,可以產生應力集中以利 試片折斷,該薄片11上另有一個内凹1 9,以標明進血位 •置° 薄片1 2分成三片小薄片1 21、1 2 2、1 2 3貼在導線1 5、 16及薄片11上;該三片小薄片121、122、123中間有空隙 是為了組合後的試片好折斯(如第三圖C ),又該三片小 薄片121、122、123上各有三個沖孔201、202、203以放置 化學載體251、252、253於工作電極161、162、163和參考 電極1 5 1、1 5 2、1 5 3上(如第三圖A )而成為三個不同的 反應區,以及在該三片小薄片1 2 1、1 22、1 2 3端部各設有 一個内凹191、192、193以標明進血位置。 _ 薄片13分成三片小薄片131 、1 32、133貼在薄片12 上,同理,在該三片小薄片131、1 32、133中間有空隙是 為了組合後的試片好折斷;且在其上具有三個内凹3 0 1、 30 2、3 0 3可以讓血液40藉由虹吸原理吸入與化學載體 251、252、253起電化學反應(如第三圖A與B)。因 此’該試片每次檢測僅需要2 // 1的jk液量,藉由虹吸的原1301888 Main Moonlight Correction_Case No. 94110748 V. Invention Description (5) As follows: Refer to the first, second and third figures, the biodetection test piece 1 which can be used multiple times according to the present invention 〇, is made of four layers of π, 12, 1 3, 1 4, and placed between the 丨丨 and 丨 2 with two wires 1 5, 1 6 ' wire 15 connected to three reference electrodes丨51, 丨5 2, 丨5 3, and the wire 16 is connected to the three working electrodes 1 6 1 , 1 6 2, 1 6 3 (as shown in the second figure). The sheet 11 has two punching holes 17 and 18, which can generate stress concentration to break the test piece. The sheet 11 has a concave portion 9 to indicate the blood level. The sheet is divided into three pieces. The small sheets 1 21, 1 2 2, and 1 2 3 are attached to the wires 15 and 16 and the sheet 11; the gap between the three small sheets 121, 122, and 123 is for the combined test piece. 3) C), the three small sheets 121, 122, 123 each have three punching holes 201, 202, 203 for placing chemical carriers 251, 252, 253 on the working electrodes 161, 162, 163 and the reference electrode 1 5 1 , 1 5 2, 1 5 3 (as in the third figure A) to become three different reaction zones, and a recess in each of the three small sheets 1 2 1 , 1 22, 1 2 3 191, 192, 193 to indicate the location of the blood. _ The sheet 13 is divided into three small sheets 131, 1 32, 133 and attached to the sheet 12. Similarly, there is a gap between the three small sheets 131, 1 32, 133 for the combined test piece to be broken; Having three recesses 3 0 1 , 30 2 , 3 0 3 thereon allows the blood 40 to electrochemically react with the chemical carriers 251, 252, 253 by siphoning (eg, Figures A and B). Therefore, the test piece only needs 2 // 1 jk liquid volume per test, by siphoning the original
第9頁 1301888 _____案號94110748_年月 η 修正 五、發明說明(6) 理,血液會被吸入反應區後隨即與其上的生化載體起電化 學反應,並且藉由分析該電化學反應的結果能得知該血液 檢品的血糖濃度。 薄片1 4分成三片小薄片1 41 、1 4 2、1 4 3貼在薄片1 3 上,其上有三個内凹194、195、196,是為了標明進血位 置;其上另有沖孔4 0 1、4 0 2、4 0 3作為虹吸原理血液的出 氣口。 而導電電極15、16則被設計為參考電極15ι、152、 1 5 3到電極頭5 1需有相同的導線長度,亦即相同電阻,而 隹且工作電極1 6 1、1 6 2、1 6 3到電極頭5 2需有相同的導線長 度’亦即相同電阻,如此,在這三個不同反應區的生化反 應結果才會一致。如上述,各導電電極15與16具有相同電 阻是本發明所揭示的試片能多次使用的關鍵因素,也是不 可或缺的要素,這種方法全世界我們首次採用。 如上述之結構中,薄片11、1 2、1 3、1 4可以為塑膠、 陶質基板、紙板或FRP(玻璃纖維強化塑膠)材質;而導電 電極15、16可以為以網版印刷製程的銀膠或碳膠導線,也 可以是以加成法(Additive Process),以化學反應的方 瞻法產生所須導電電路;也可以以減乘法(Subtractive process),以化學反應的方法將表面局部無用的導體去 除;然後再以化學浸鍍法(俗稱化金)將貴金屬如金、白 金等貴金屬,以化學置換反應將貴金屬置換在底材上,以 足種方法在一次生產一百多片的大量生產時,貴金屬的厚 度才此平均’也就是每片試片上的三個反應區的電阻都能Page 9 1301888 _____ Case No. 94110748_Year η Amendment 5, Invention Description (6) The blood will be inhaled into the reaction zone and then electrochemically react with the biochemical carrier thereon, and by analyzing the electrochemical reaction As a result, the blood glucose concentration of the blood test product can be known. The sheet 14 is divided into three small sheets 1 41 , 1 4 2 , 1 4 3 and attached to the sheet 13 , and has three concave portions 194, 195, 196 thereon for marking the blood feeding position; 4 0 1 , 4 0 2, 4 0 3 as the siphon principle blood outlet. The conductive electrodes 15, 16 are designed to have the same wire length, that is, the same resistance, as the reference electrodes 15i, 152, and 153 to the electrode tip 51, and the working electrodes 1 6 1 , 1 6 2 6 3 to the electrode tip 5 2 need to have the same wire length 'that is the same resistance, so the biochemical reaction results in these three different reaction zones will be consistent. As described above, the fact that each of the conductive electrodes 15 and 16 has the same resistance is a key factor for the multiple use of the test piece disclosed in the present invention, and is an indispensable element. This method is first adopted worldwide. In the above structure, the sheets 11, 12, 13 and 14 may be plastic, ceramic substrate, cardboard or FRP (glass fiber reinforced plastic) material; and the conductive electrodes 15, 16 may be screen printing processes. Silver-glued or carbon-adhesive wires can also be used in the additive process to generate the required conductive circuits by chemical reaction; or by subtractive process, chemically reacting the surface locally. Useless conductors are removed; then precious metals such as gold, platinum, and other precious metals are replaced by chemical substitution reactions on the substrate by chemical immersion plating (commonly known as gold), and more than one hundred pieces are produced at one time by a sufficient method. In the case of mass production, the thickness of the precious metal is averaged, that is, the resistance of the three reaction zones on each test piece can be
1301888 案j虎 94110748 五、發明說明(7) 維持在百分之一以内的緣#。, 的决爰我們的方法與美國專利 5,437,999不同,也與華民國直4Ϊ1 、卡民寻利496110不同,因為後者 是利用電鍍法鍍上貴金屬,所右4 u μ + 土 ^ ^ 所有忒片都需連到同一電極 (我們的方法不需要),合诰忐4 μ L ^主a β — 一 曰I成5式片上的貴金屬電鍍厚度不 均,而在三個反應區的電阻都超過百分之三十以上的誤 差,因此誤差太大,不能適用。 一如上述之構造使用時,請在參閱第三圖Α〜D所示顯 不了本發明於血液40進入試片10的使用過程。當血液4〇由 試片10右側端部的内凹3〇1經虹吸作用進入並充滿沖孔2〇1 修内之反應區後(第三圖A到B ),經過數秒鐘等血糠讀值 出現後’該使用過的第一反應區之試片即可折斷(如第三 圖C ),而露出中間那個未使用的第二反應區(如第三圖 D ) ’隨即可再進行下一次的血液檢測。以此類推,等到 第二反應區用完後,可再將該第二反應區的試片折斷,使 其露出第三個未反應的反應區,隨即可該一試片1〇上再進 行第三次的血液檢測,達到在同一試片可多次使用之目 的。 再請參閱第圖四及圖五所示,其中顯示了將構造相同 ⑩而長度不同的三組如第一圖所示的試片1 〇重疊組合成一片 使用的實施例圖,其讓進血的沖孔3 〇 1的入口位置相同, 且其中作為出氣口的沖孔404、40 5、40 6係至少由上貫穿 至隶底層薄片,則可以以一滴血液同時做二個相同或不同 項目的檢測。本實施例使用時如第五圖所示,當一滴血液 4 0被吸入而充滿其右侧端重疊設置的三個反應區&、b、1301888 Case j Tiger 94110748 V. Invention Description (7) Maintaining within one percent of the ##. The method of our decision is different from the US patent 5,437,999. It is also different from Huamin Guozhi 4Ϊ1 and Kamin Xuli 496110, because the latter is plated with precious metals by electroplating, and the right 4 u μ + soil ^ ^ All the cymbals need to be connected to the same electrode (not required by our method), combined with 4 μL ^ main a β - one 曰 I into 5 pieces of precious metal plating thickness uneven, and the resistance in the three reaction areas Both exceed 30% of the error, so the error is too large to be applicable. As used in the above construction, the use of the present invention in the blood 40 into the test strip 10 is not shown in the drawings shown in Figs. When blood 4〇 is siphoned by the concave 3〇1 at the right end of the test piece 10 and filled with the reaction zone of the punch 2〇1 repair (third picture A to B), after a few seconds of blood reading After the value appears, the test piece of the used first reaction zone can be broken (as shown in the third figure C), and the unused second reaction zone (such as the third figure D) is exposed. One blood test. By analogy, after the second reaction zone is used up, the test piece of the second reaction zone can be broken to expose the third unreacted reaction zone, and then the test piece can be further processed. Three times of blood testing, the purpose of the same test piece can be used multiple times. Referring to FIG. 4 and FIG. 5 again, there are shown three embodiments in which the three sets of the same 10 and different lengths are overlapped and assembled into one piece as shown in the first figure, which allows blood to enter. The punching holes 〇1 have the same inlet position, and the punching holes 404, 40 5, and 40 6 as the air outlets are at least from the top to the bottom layer, so that one or two different identical items can be simultaneously made with one drop of blood. Detection. When the embodiment is used, as shown in the fifth figure, when a drop of blood 40 is inhaled and filled with three reaction zones &
1301888 - — 94j,10748_ 年月曰__修正_ 五、發明說明(8) c ’、各反應區裡的化學載體251會同時與吸入各反應區内的 血液4 0起電化學反應。而其中在三個反應區a、匕、c中的 化學載體2 5 1可以是同一種,以產生相同的讀值,再取其 平均值以得到較佳的準確度;也可以是不同種類,以一滴 血得到三種不同讀值。同樣的,這種試片一樣的在第一次 測試用完後可以折斷再使用。 以上所述的試片構造亦可變化實施如第六及第七圖所 示,如第六圖所顯示的實施例,該試片1 〇係設計成由三層 薄片11、12、13黏貼而成,其中内凹的血液入口 71、72、 .3設於第二層薄片1 2,且都設計在延長度方向電極頭5 i、 5 2的另一側,致血液得由侧面之血液入口 7 1、7 2、7 3進 入,而沖孔404、40 5、40 6 (至少貫穿至最底層的薄片) 為血液虹吸的出氣口,又為因應不同的血液入口位置可改 變其導電電極1 5、1 6的設計形式(如圖七所示),並將化 學載體251塗佈於第一層薄片11的工作電極161、162、163 和參考電極1 5 1、1 5 2、15 3所形成的反應區上;據而即可 達到如第一圖之實施例所示,可以同一試片1 〇作多次檢測 使用之目的。又,這種血液由側面進入的試片另可設計成 多重堆疊之實施方式(如第八圖)’其中的企液進入口 •71、72、73、74、75、76、77、78、79 係設於該試片 1〇 的 侧邊,而沖孔404、40 5、406為血液虹吸的出氣口,據而 同樣可達到如第四圖之實施例所述,以一滴血可作多種測 試的試片功效。如上述,同樣的在母一段的試片上可作進 ^少的堆疊至四組或五組以上的反應〔1301888 - - 94j, 10748_ 月月曰__ Amendment_ V. Inventive Note (8) c ', the chemical carrier 251 in each reaction zone will simultaneously react electrochemically with the blood inhaled in each reaction zone. Wherein the chemical carriers 251 in the three reaction zones a, 匕, c may be the same type to produce the same reading value, and then averaged to obtain better accuracy; or different types, Three different readings were obtained with one drop of blood. Similarly, the same test piece can be broken and reused after the first test is used up. The test piece structure described above may also be modified as shown in the sixth and seventh figures. As shown in the sixth embodiment, the test piece 1 is designed to be adhered by three layers of sheets 11, 12, and 13 In which the concave blood inlets 71, 72, . . . are disposed on the second layer of the sheet 12, and are designed on the other side of the extension direction electrode heads 5 i, 5 2 to cause blood to be passed from the side of the blood inlet 7 1, 7, 2, 7 3 enter, and punching 404, 40 5, 40 6 (at least through the bottommost sheet) is the gas siphon outlet, and the conductive electrode 1 can be changed according to different blood inlet positions. 5, 16 design form (as shown in FIG. 7), and the chemical carrier 251 is applied to the working electrodes 161, 162, 163 of the first layer 11 and the reference electrodes 1 5 1 , 1 5 2, 15 3 The reaction zone is formed; according to the embodiment shown in the first figure, the same test piece 1 can be used for multiple inspection purposes. Moreover, the test piece in which the blood enters from the side can be designed as a multi-stacking embodiment (such as the eighth figure), wherein the liquid liquid inlet port is 71, 72, 73, 74, 75, 76, 77, 78, 79 is disposed on the side of the test piece 1 ,, and the punching holes 404, 40 5, 406 are the air outlets of the blood siphon, and according to the embodiment of the fourth figure, a drop of blood can be used for various purposes. The test strips tested. As described above, the same test can be carried out on the test piece of the mother section to a group of four or more groups.
1301888 -一 案號94110748 玍曰日 修正^__ 五、發明說明(9) 如上所述之一個試片可多次使用的試片結構,我們也 提出另一種適合市面上少數以光學方法檢測血糖濃度的血 糖測試儀(如:ROCHE )使用之設計的實施例,如圖&九所 示’其可在一試片90上可設有三個具有化學栽體μ、92、 93之反應區,並在每二反應區之間的二側邊對應的設有二 缺口 9 4 ’以能輕易的將已用過的反應區折斷。 至於本發明中所採用的化學載體配方,詳述如下。 該反應區内0勺化學載體,其組成包含: 1· IL氧丙曱基纖維素(Hydroxypropyl methyl • el lui〇se),含量:〇· 4% 2·擰檬酸(Citric acid),含量:0.096% 3·磷酸氫二卸(Dibasic potassium phosphate),含 量:0 · 4 5 3 〇/〇 4 ·非離子性介面活性劑τ r i ΐ ο η X - 1 0 〇,含量:〇 · 〇 4 % 5·葡萄糖氧化酵素(Glucose oxidase),含量:0.7 % 6·赤血鹽(Potassium ferricyanide),含量:3. 5% 7·去離子水(Deionized water),含量:94·81% 8·奈米碳管(Nanotube carbon),含量:0. 05% _ 其中氫氧丙甲基纖維素是我們首次採用,用以使化學 載體在乾燥於試片上時能均勻地分佈;檸檬酸是用來調2 酸驗值,同時它也有抗凝血的作用;麟酸氫二鉀是二 整酸鹼值;非離子性介面活性劑Triton X-100是用來降 水的表面張力,有助於添加物的溶解;葡萄糖氧化酵素低 會與血液產生電化學反應;赤血鹽則作為導電介皙·二則 μ ,奈来1301888 - First Case No. 94110748 Next Day Correction ^__ V. Invention Description (9) As mentioned above, a test piece structure that can be used multiple times as a test piece, we also propose another suitable optical detection method for blood glucose concentration. An embodiment of a blood glucose tester (eg, ROCHE) is used, as shown in FIG. & IX, which can be provided with three reaction zones having chemical carriers μ, 92, and 93 on a test piece 90, and Two notches 94' are provided corresponding to the two sides between each two reaction zones to easily break the used reaction zone. As for the chemical carrier formulation used in the present invention, it is described in detail below. 0 scoop chemical carrier in the reaction zone, the composition of which comprises: 1·Hydroxypropyl methyl • el lui〇se, content: 〇· 4% 2·Citric acid, content: 0.096% 3·Dibasic potassium phosphate, content: 0 · 4 5 3 〇/〇4 · Nonionic surfactant τ ri ΐ ο η X - 1 0 〇, content: 〇· 〇 4 % 5. Glucose oxidase, content: 0.7% 6. Red blood salt (Potassium ferricyanide), content: 3. 5% 7 · Deionized water, content: 94.81% 8 · nm Carbon tube, content: 0. 05% _ where hydroxypropylmethyl cellulose is used for the first time, so that the chemical carrier can be evenly distributed when dried on the test piece; citric acid is used to adjust 2 Acid test, and it also has anticoagulant effect; dipotassium hydride is the second acid value; nonionic surfactant Triton X-100 is used for precipitation surface tension, which helps the dissolution of additives Glucose oxidase is low in electrochemical reaction with blood; red blood salt is used as conductive mediator ·Two μ μ, Nai Lai
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1301888 五、發明說明(10) 碳管也是我們首次採用,用以增加反應速率、減少反應時 間’如圖十所示。奈米碳管可以用,也可以不用;用了可 以減少反應時間,不是絕對必要的元素。 前述的化學載體(251~ 253 )是以武藏牌(Musashi)精密 點膠機點在沖孔(201〜203 )内的工作電極(161〜163)及來考 電極(151〜153)上,用以吸附載體的生物活性物質及導電 介質,並且使該電極部份由疏水性變為親水性,以利檢品 ^附著’ 1進而彳以保護該生物活性物質於較高溫的乾燥 ^耘不致文扣,而珂述的生物活性物質則是只包括經固定 Μ匕或甚至未經固定化之酵素(如葡萄糖氧化酵素GUc〇se = idase)、抗原、抗體、微生物細胞、動植物細胞、動植 物組織具有生物性辨識能力.的成分’用以與之接觸的檢品 0血液等生物組織)產生生化或化學反應;而前述之導電 介質(如 Potassium ferricyanide,quin〇nes)含量 3 5%, 乃用以接收酵素與檢品反應後所產生的電子,並再將此電 子經由電極導線傳給感測器轉換為檢品濃度。1301888 V. INSTRUCTIONS (10) Carbon tubes are also our first use to increase the reaction rate and reduce the reaction time as shown in Figure 10. Carbon nanotubes can be used or not; use of elements that reduce reaction time is not absolutely necessary. The aforementioned chemical carriers (251 to 253) are used on the working electrodes (161 to 163) and the test electrodes (151 to 153) in the punching holes (201 to 203) by a Musashi precision dispenser. The biologically active substance and the conductive medium of the carrier are adsorbed, and the electrode portion is changed from hydrophobic to hydrophilic, so as to facilitate the adhesion of the product to protect the biologically active substance from drying at a higher temperature. Deductions, while the biologically active substances described are only those that have been fixed or even not immobilized (such as glucose oxidase GUc〇se = idase), antigens, antibodies, microbial cells, animal and plant cells, animal and plant tissues. The biological identification ability of the component 'the biological tissue that is used to contact with the test sample 0 blood, etc.) produces a biochemical or chemical reaction; and the aforementioned conductive medium (such as Potassium ferricyanide, quin〇nes) content of 3 5%, is used The electrons generated after the reaction of the enzyme and the sample are received, and the electrons are transmitted to the sensor via the electrode wire to be converted into a sample concentration.
第14頁 1301888 案號 94110748 年 月 曰 修正 圖式簡單說明 【圖示簡單說明】 第一圖為本發明能多次使用的生物檢測試片的立體組合圖 弟二圖為本發明能多次使用的生物檢測試片的立體分解圖 第三圖為本發明能多次使用的生物檢測試片的剖面圖 第四圖為本發明的一片可多次使用、且一滴血可檢驗三種 相同或不相同檢測項目的生物檢測試片的立體組合圖 第五圖為本發明的一片可多次使用、且一滴血可檢驗三種 相同或不相同檢測項目的生物檢測試片的剖面圖 第六圖為本發明的一片可多次使用、且血液入口在侧面的 1 生物檢測試片的立體組合圖 第七圖為本發明的一片可多次使用、且血液入口在側面的 生物檢測試片中的導電電極貫施例不意圖 第八圖為本發明的一片可多次使用、血液入口在側面、且 一滴血可檢驗三種相同或不相同檢測項目的生物檢測 試片的立體組合圖 第九圖為本發明的另一種實施例的示意圖 第十圖為有加奈米碳管與沒加奈米碳管的化學載體與寫意 的電化學反應圖 【主要元件符號說明】 試片 1 0、9 0 薄片 11 、1 2、1 3、1 4 小薄片 1 2 1 、1 2 2、1 2 3、1 3 1 、1 3 2 、1 3 3、1 41 、1 4 2 、1 4 3 沖孔 2 0 1 、2 0 2 、2 0 3Page 14 1301888 Case No. 94110748 Simple explanation of the monthly correction diagram [Simple description of the illustration] The first figure is a three-dimensional combination diagram of the biological detection test piece which can be used repeatedly for the present invention. The three-dimensional exploded view of the bioassay test piece is a cross-sectional view of the bio-detection test piece which can be used multiple times in the present invention. The fourth figure is a piece of the present invention which can be used multiple times and one drop of blood can be tested for the same or different. The third figure of the bioassay test piece of the test item is a cross-sectional view of the bioassay test piece which can be used multiple times and one drop of blood can be tested for three identical or different test items. A three-dimensional combination diagram of a biodetection test piece which can be used multiple times and has a blood inlet side. The seventh figure of the present invention is a conductive electrode of a bioreactive test piece which can be used multiple times and has a blood inlet side. The embodiment is not intended to be a bioassay test of the present invention which can be used multiple times, the blood inlet is on the side, and one drop of blood can test three identical or different test items. FIG. 9 is a schematic view showing another embodiment of the present invention. FIG. 10 is a chemical reaction diagram of a chemical carrier having a carbon nanotube and a carbon nanotube without a carbon nanotube and a freehand electrochemical reaction diagram. 1 0, 9 0 sheet 11 , 1 2 , 1 3 , 1 4 small sheets 1 2 1 , 1 2 2, 1 2 3, 1 3 1 , 1 3 2 , 1 3 3, 1 41 , 1 4 2 , 1 4 3 punching 2 0 1 , 2 0 2 , 2 0 3
第15頁 1301888 案號 94110748 年 月 曰 修正 圖式簡單說明 内凹 19 、 191 、 192 、 193 、 194 、 195 、 196 内凹 301 、 302 、 303 沖孔 401 、40 2 、403 、404 、4 05 >40 6 化學載體 2 5 1、2 5 2、2 5 3、9 1、9 2、9 3 血液 4 0 血液進入 π 71、72、73、74、75、76、77、78、79 電極頭 51、52、53、54、55、56 電極導線1 5、1 6 工作電極161、162、163 _參考電極151、152、153 沖孔 1 7、1 8Page 15 1301888 Case No. 94110748 The monthly correction pattern simply describes the recesses 19, 191, 192, 193, 194, 195, 196 recesses 301, 302, 303 punches 401, 40 2, 403, 404, 4 05 >40 6 Chemical carrier 2 5 1 , 2 5 2, 2 5 3, 9 1 , 9 2, 9 3 Blood 4 0 Blood enters π 71, 72, 73, 74, 75, 76, 77, 78, 79 electrodes Head 51, 52, 53, 54, 55, 56 electrode lead 1 5, 16 6 working electrode 161, 162, 163 _ reference electrode 151, 152, 153 punching 1 7 , 1 8
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