TW201710675A - Test strip with capacity of sensing humidity, method and apparatus thereof - Google Patents
Test strip with capacity of sensing humidity, method and apparatus thereof Download PDFInfo
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Abstract
Description
本揭露是有關於一種具有濕度感測元件的檢測試片及其測試方法與裝置。 The present disclosure relates to a test strip having a humidity sensing element and a test method and apparatus therefor.
近年來越來越多的生物檢測裝置被開發與利用，一方面增加了檢測的效率並縮短了等待的時間，另一方面居家使用普及也降低醫療單位的工作負擔。一般而言，生物檢測裝置通常具有兩個主要部份，其一為能感測並與生理液狀樣本中的目標化學物質反應的感測器；另一為能處理該感測器所產生的訊號的計量器。在許多應用實例中，該感測器往往是以可拋式的檢測試片的方式來實踐。該可拋式的檢測試片通常需要儲藏於具有乾燥措施的容器內，增加保存期限，以免檢測試片受潮，導致影響其檢測品質、正確性與精密度。 In recent years, more and more bio-detection devices have been developed and utilized. On the one hand, the efficiency of detection has been increased and the waiting time has been shortened. On the other hand, the popularity of home use has also reduced the workload of medical units. In general, a biodetection device typically has two main components, one being a sensor that senses and reacts with a target chemical in a physiological liquid sample; the other is capable of processing the sensor. Signal meter. In many application examples, the sensor is often practiced in the form of a disposable test strip. The disposable test piece usually needs to be stored in a container with drying measures, and the storage period is increased to prevent the test piece from being damp, which affects the quality, correctness and precision of the test.
然而，檢測試片是否受潮而導致影響其檢測結果，往 往不一定能由肉眼判斷，不正確的檢測結果往往造成嚴重的後果。例如，一般常見的血糖機的檢測試片一旦受潮後，若所檢測出之血糖值不正確時，最嚴重的後果可能導致病患陷入昏迷。因此，基於使用的便利性與效度，有些的檢測試片便附加有濕度檢測的功能，以檢視該檢測試片是否受潮；其原理在於當檢測試片的濕度改變時，其電性特徵表現會出現變化。藉由量測檢測試片的電性特徵表現，即可判斷檢測試片是否受潮。 However, if the test piece is wet, it will affect its detection result. It may not be judged by the naked eye, and incorrect test results often have serious consequences. For example, once the test piece of a common blood glucose machine is wet, if the blood sugar level detected is not correct, the most serious consequences may cause the patient to fall into a coma. Therefore, based on the convenience and validity of use, some test strips are attached with a humidity detecting function to check whether the test strip is damp; the principle is that when the humidity of the test strip changes, its electrical characteristic performance There will be changes. By measuring the electrical characteristic of the test piece, it can be judged whether the test piece is damp.
根據一實施範例揭露一種具有濕度感測元件的檢測試片，包含：一基板；一電路層，設置於該基板之上，至少包含一第一電極、一第二電極、與一介電物質構層的濕度感應區域，該濕度感應區域係設置於該第一電極與第二電極之間，或涵蓋該第一電極與第二電極，該第一電極、第二電極、與濕度感應區域形成一溼度感測電路，以感測該試片的溼度；一試劑層，設置於該電路層之上，用於進行生化物質檢測；一黏著層，設置於該試劑層之上，使得該試劑層部分露出，以利進行生化物質檢測，係為一兩面皆塗佈黏著劑的墊片；以及一覆蓋層，設置於該黏著層之上，以覆蓋該黏著層，並部分露出其底下之試劑層。 According to an embodiment, a test strip having a humidity sensing element includes: a substrate; a circuit layer disposed on the substrate, comprising at least a first electrode, a second electrode, and a dielectric material structure a humidity sensing region of the layer, the humidity sensing region is disposed between the first electrode and the second electrode, or covers the first electrode and the second electrode, and the first electrode, the second electrode, and the humidity sensing region form a a humidity sensing circuit for sensing the humidity of the test piece; a reagent layer disposed on the circuit layer for detecting the biochemical substance; an adhesive layer disposed on the reagent layer to make the reagent layer portion Exposed to facilitate biochemical detection, which is a gasket coated with adhesive on both sides; and a cover layer disposed on the adhesive layer to cover the adhesive layer and partially expose the underlying reagent layer.
另根據一實施範例揭露一種檢測試片的濕度感測方法，適用於一具有濕度感測元件的檢測試片，0包含：置入一 檢測試片至一具有濕度感測功能的檢測儀；施加一特定頻率的一連續震盪波至此檢測試片；量測此檢測試片所呈現的一電容值；將此電容值與一門檻值比對；當此電容值高於或等於此門檻值時，顯示此檢測試片之濕度過高，品質受損，應停止使用；以及當此電容值低於此門檻值時，顯示此檢測試片可進行後續之生化物質檢測。 In addition, according to an embodiment, a humidity sensing method for detecting a test piece is disclosed, which is applicable to a test piece having a humidity sensing element, and 0 includes: placing one Detecting the test piece to a detector having a humidity sensing function; applying a continuous oscillating wave of a specific frequency to the test piece; measuring a capacitance value exhibited by the test piece; comparing the capacitance value with a threshold value When the capacitance value is higher than or equal to the threshold value, it indicates that the humidity of the test piece is too high, the quality is damaged, and should be stopped; and when the capacitance value is lower than the threshold value, the test piece is displayed. Subsequent biochemical testing can be performed.
100‧‧‧具有濕度感測元件的檢測試片 100‧‧‧Test strips with humidity sensing elements
110‧‧‧基板 110‧‧‧Substrate
120‧‧‧電路層 120‧‧‧ circuit layer
121‧‧‧第一電極 121‧‧‧First electrode
122‧‧‧第二電極 122‧‧‧second electrode
123‧‧‧濕度感應區域 123‧‧‧Humidity sensing area
130‧‧‧試劑層 130‧‧‧Reagent layer
140‧‧‧黏著層 140‧‧‧Adhesive layer
150‧‧‧覆蓋層 150‧‧‧ Coverage
210‧‧‧置入一檢測試片至一具有濕度感測功能的檢測儀 210‧‧‧Insert a test strip to a detector with humidity sensing
220‧‧‧施加一特定頻率的一連續震盪波至此檢測試片 220‧‧‧ Apply a continuous oscillation wave of a specific frequency to the test strip
230‧‧‧量測此檢測試片所呈現的一電容值 230‧‧‧Measure the capacitance value exhibited by this test piece
240‧‧‧將此電容值與一門檻值比對 240‧‧‧Compare this capacitance value with a threshold value
250‧‧‧顯示此檢測試片之濕度過高，品質受損，應停止使用 250‧‧‧The humidity of this test piece is too high and the quality is damaged. It should be stopped.
260‧‧‧顯示此檢測試片可進行後續之生化物質檢測 260‧‧‧ shows that this test strip can be used for subsequent biochemical testing
301‧‧‧試片電極 301‧‧‧ test electrode
302‧‧‧第一處理器 302‧‧‧First processor
303‧‧‧第二處理器 303‧‧‧second processor
304‧‧‧測試震盪模組 304‧‧‧Test Oscillation Module
305‧‧‧系統震盪模組 305‧‧‧System oscillation module
306‧‧‧開關 306‧‧‧Switch
307‧‧‧顯示器 307‧‧‧ display
308‧‧‧記憶體 308‧‧‧ memory
圖1所示為本揭露之具有濕度感測元件的檢測試片之結構圖。 FIG. 1 is a structural view of a test strip having a humidity sensing element according to the present disclosure.
圖2所示為本揭露之一種檢測試片的濕度感測方法之流程圖。 FIG. 2 is a flow chart showing a humidity sensing method for detecting a test piece according to the present disclosure.
圖3所示為本揭露之一種具有檢測試片的濕度感測能力之裝置。 FIG. 3 shows a device having a humidity sensing capability for detecting a test piece according to the present disclosure.
以下，參考伴隨的圖示，詳細說明依據本揭露的實施例，俾使本領域者易於瞭解。所述之發明創意可以採用多種變化的實施方式，當不能只限定於這些實施例。本揭露省略已熟知部分(well-known part)的描述，並且相同的參考號於本揭露中代表相同的元件。 Hereinafter, the embodiments according to the present disclosure will be described in detail with reference to the accompanying drawings, which will be readily understood by those skilled in the art. The inventive concept described above may take a variety of variations, and should not be limited to only these embodiments. The disclosure omits the description of well-known parts, and the same reference numerals represent the same elements in the present disclosure.
依據本揭露的實施例，圖1提供一種具有濕度感 測元件的檢測試片100，包含：一基板110；一電路層120，設置於該基板110之上，至少包含一第一電極121、一第二電極122、與一介電物質構成的濕度感應區域123，該濕度感應區域123係設置於該第一電極121與第二電極122之間，或涵蓋該第一電極121與第二電極122，該第一電極121、第二電極122、與濕度感應區域123形成一溼度感測電路，以感測該試片的溼度；一試劑層130，設置於該電路層120之上，用於進行生化物質檢測；一黏著層140，設置於該試劑層130之上，使得該試劑層130部分露出，以利進行生化物質檢測，係為一兩面皆塗佈黏著劑的墊片；以及一覆蓋層150，設置於該黏著層140之上，以覆蓋該黏著層140，並部分露出其底下之試劑層130。其中該基板係用於承載整個檢測試片的載體，可由下列之一種物質所製成：聚對苯二甲酸乙二酯(PET)、聚酰亞氨(Polyimide)、聚氯乙烯(PVC)、或其他非導電性物質。 According to an embodiment of the present disclosure, FIG. 1 provides a sense of humidity The test strip 100 of the measuring component comprises: a substrate 110; a circuit layer 120 disposed on the substrate 110, comprising at least a first electrode 121, a second electrode 122, and a humidity sensing formed by a dielectric substance The region 123, the humidity sensing region 123 is disposed between the first electrode 121 and the second electrode 122, or covers the first electrode 121 and the second electrode 122, the first electrode 121, the second electrode 122, and the humidity The sensing area 123 forms a humidity sensing circuit to sense the humidity of the test piece; a reagent layer 130 is disposed on the circuit layer 120 for biochemical detection; and an adhesive layer 140 is disposed on the reagent layer. Above the 130, the reagent layer 130 is partially exposed for biochemical detection, and is a gasket coated with an adhesive on both sides; and a cover layer 150 is disposed on the adhesive layer 140 to cover the The layer 140 is adhered and partially exposed to the underlying reagent layer 130. The substrate is used for carrying the entire test strip carrier, and can be made of one of the following materials: polyethylene terephthalate (PET), polyimide (polyimide), polyvinyl chloride (PVC), Or other non-conductive substances.
值得注意的是，當該檢測試片受潮時，該濕度感應區域123的介電常數會產生變化，進而導致該第一電極121與該第二電極122之間的電容值發生變化；因此，該第一電極121與該第二電極122之間的電容值可用來做為量測該檢測試片的濕度指標。 It is to be noted that when the test strip is wet, the dielectric constant of the humidity sensing region 123 changes, thereby causing a change in the capacitance between the first electrode 121 and the second electrode 122; The capacitance value between the first electrode 121 and the second electrode 122 can be used as a humidity index for measuring the test piece.
由於兩電極之間電容值可以下列式子表示：C≒ε×A/d其中，C為電容值、ε為介電質的介電常數、A為涵蓋該電容的電極 部分的面積、d為該電容兩電極之間的距離。 Since the capacitance between the two electrodes can be expressed by the following equation: C ≒ ε × A / d where C is the capacitance value, ε is the dielectric constant of the dielectric, and A is the electrode covering the capacitance. The area of part, d is the distance between the two electrodes of the capacitor.
在本實施例中，該第一電極121係為工作電極，可由鈀、鉑、金、碳、或鈦等其中一種物質所製成；而該第二電極122係為對電極，可由鈀、鉑、金、銀、銀合金、鎳鉻合金、碳、鈦、或銅等其中一種物質所製成。再者，該介電物質更包含一高分子聚合物、以及一電解質；其中該高分子聚合物可為聚氯乙烯(PVC)、聚酰亞氨(Polyimide)、聚二甲基矽氧烷(PDMS)之其中一種物質，該電解質可為一種鹽類。在其他的實施例中，上可加入一第三電極，作為量測電容值時的參考電極。 In this embodiment, the first electrode 121 is a working electrode, and may be made of one of palladium, platinum, gold, carbon, or titanium; and the second electrode 122 is a counter electrode, which may be palladium or platinum. Made of gold, silver, silver alloy, nickel-chromium alloy, carbon, titanium, or copper. Furthermore, the dielectric substance further comprises a high molecular polymer and an electrolyte; wherein the high molecular polymer may be polyvinyl chloride (PVC), polyimide (polyimide), polydimethyl methoxy oxane ( One of the substances of PDMS), which may be a salt. In other embodiments, a third electrode can be added to the reference electrode as the capacitance value is measured.
如前所述，該試劑層130係用於進行生化物質檢測。為了進一步確保該檢測試片電容值量測的正確性與準確度，試劑層130更可加入格外的化學物質。例如，可在該第一電極121與該第二電極122塗佈一層聚合物和聚電解質的多微孔高分子物質。其中該試劑層130係用浸塗(dip coating)、噴繪(airbrushing)、網版印刷(screen printing)方式形成，其試劑更包含：一酵素(enzyme)、一中介劑(mediator)、以及一穩定劑(stabilizer)；該中介劑係為鐵氰化鉀、二茂鐵、鐵氰化鉀、對苯二酚、或其他氧化還原的有機化合物中的一種；該穩定劑係為一種氨基酸、或氨基酸衍生物。 As previously mentioned, the reagent layer 130 is used for biochemical detection. In order to further ensure the correctness and accuracy of the capacitance measurement of the test strip, the reagent layer 130 can be added with extra chemicals. For example, a layer of a microporous polymer material of a polymer and a polyelectrolyte may be applied to the first electrode 121 and the second electrode 122. The reagent layer 130 is formed by dip coating, airbrushing, screen printing, and the reagent further comprises: an enzyme, a mediator, and a stable Stabilizer; the intermediate agent is one of potassium ferricyanide, ferrocene, potassium ferricyanide, hydroquinone, or other redox organic compound; the stabilizer is an amino acid, or an amino acid derivative.
舉例來說，若是該檢測試片為一血糖檢測試片，則該 試劑層130可包括一能夠辨識血糖的酵素(例如，葡萄糖氧化酶或葡萄糖脫氫酶)、一中介劑或電子捕捉劑(electron trapper)、以及一對濕度敏感的化學物質(如前述之介電質)，製成薄膜之長條狀，以加速感應時間。 For example, if the test strip is a blood glucose test strip, then the The reagent layer 130 may include an enzyme capable of recognizing blood sugar (for example, glucose oxidase or glucose dehydrogenase), an intermediate agent or an electron trapper, and a pair of humidity-sensitive chemicals (such as the aforementioned dielectric) Quality), made into a strip of film to accelerate the induction time.
圖2所示為本揭露之一種檢測試片的濕度感測方法，適用於一具有濕度感測元件的檢測試片，濕度感測方法200包含：置入一檢測試片至一具有濕度感測功能的檢測儀(如步驟210所示)；施加一特定頻率的一連續震盪波至此檢測試片(如步驟220所示)；量測此檢測試片所呈現的一電容值(如步驟230所示)；將此電容值與一門檻值比對(如步驟240所示)；當此電容值高於或等於此門檻值時，顯示此檢測試片之濕度過高，品質受損，應停止使用(如步驟250所示)；以及當此電容值低於此門檻值時，顯示此檢測試片可進行後續之生化物質檢測(如步驟260所示)。 2 is a humidity sensing method for detecting a test piece according to the present disclosure, which is applicable to a test piece having a humidity sensing element, and the humidity sensing method 200 includes: placing a test piece to have a humidity sensing a functional detector (as shown in step 210); applying a continuous oscillation wave of a specific frequency to the test strip (as shown in step 220); measuring a capacitance value exhibited by the test strip (as in step 230) The capacitance value is compared with a threshold value (as shown in step 240); when the capacitance value is higher than or equal to the threshold value, the humidity of the detection test piece is too high, and the quality is damaged, and should be stopped. Use (as shown in step 250); and when the capacitance value is below the threshold, the test strip is displayed for subsequent biochemical detection (as shown in step 260).
其中，該試片所量測的電容值受到該試片溼度的影響；當溼度越高時，所量測的電容值越大。而所量測的結果係由該具有濕度感測功能的相關檢測儀顯示。 The capacitance value measured by the test piece is affected by the humidity of the test piece; when the humidity is higher, the measured capacitance value is larger. The measured results are displayed by the relevant detector with humidity sensing function.
圖3所示為本揭露之一種具有檢測試片的濕度感測能力之裝置，適用於一具有濕度感測元件的檢測試片。如圖3所示，該具有檢測試片的濕度感測能力之裝置包含：一對試片電極301、一第一處理器302、一第二處理器303、一測試震盪模組304、一 系統震盪模組305、一開關306、一顯示器307以及一記憶體308；其中，該對試片電極301係用於接受一具有濕度感測元件的檢測試片；該第一處理器302係接於該對試片電極301並負責整個裝置的整體運作，包含檢測、紀錄並儲存試片的偵測結果於該記憶體308，及顯示檢測資訊於該顯示器307；該第二處理器303亦接於該對試片電極301並負責該試片的潮濕度偵測，包含判斷試片濕度是否合格、如不合格將於該顯示器307顯示一不合格訊號以提醒使用者；該測試震盪模組304係接於該對試片電極301與該第二處理器303，負責提供一震盪頻率以偵測試片濕度所產生的電容值，此震盪頻率依據待測物性質而有所不同；該系統震盪模組305係連接於該第一處理器302以提供穩定震盪頻率使其運作，該所需頻率為該第一處理器302供應商所提供規格；該開關306係連接於該第一處理器302與該第二處理器303之間，以負責在測試流程中該第一處理器302與該第二處理器303之間的切換；該顯示器307係同時連接於該第一處理器302與該第二處理器303之間以顯示來自該第二處理器303的試片濕度不合格訊息或來自該第一處理器302的試片測試結果等相關資訊；以及，該記憶體308係連接於該第一處理器302以儲存試片測試結果等相關資訊。 FIG. 3 shows a device having a humidity sensing capability for detecting a test piece according to the present disclosure, which is suitable for a test piece having a humidity sensing element. As shown in FIG. 3, the device for detecting the humidity sensing capability of the test piece includes: a pair of test strip electrodes 301, a first processor 302, a second processor 303, a test oscillation module 304, and a a system oscillation module 305, a switch 306, a display 307, and a memory 308; wherein the pair of test strip electrodes 301 are used to receive a test strip having a humidity sensing element; the first processor 302 is coupled The test strip electrode 301 is responsible for the overall operation of the entire device, including detecting, recording and storing the test result of the test piece in the memory 308, and displaying the detection information on the display 307; the second processor 303 is also connected The test strip electrode 301 is responsible for the moisture detection of the test strip, and includes determining whether the test piece humidity is qualified. If the test piece is not qualified, the display 307 displays an unqualified signal to remind the user; the test oscillation module 304 Connected to the pair of test strip electrodes 301 and the second processor 303, responsible for providing an oscillation frequency to detect the capacitance value generated by the test piece humidity, the oscillation frequency is different according to the nature of the test object; the system is oscillating The module 305 is connected to the first processor 302 to provide a stable oscillation frequency for operation. The required frequency is a specification provided by the first processor 302. The switch 306 is connected to the first processor 302. versus Between the second processor 303, responsible for switching between the first processor 302 and the second processor 303 in the testing process; the display 307 is simultaneously connected to the first processor 302 and the second processing The device 303 displays related information such as a test piece moisture failure message from the second processor 303 or a test piece test result from the first processor 302; and the memory 308 is connected to the first process. The device 302 stores relevant information such as test piece test results.
如前所述，該測試震盪模組304所提供之震盪頻率依據待測物性質而有所不同，通常範圍是在10MHz~120Hz，在本實施例中約為1M~1kHz。另一面，本實施例第二處理器303所使用頻率為4MHz及32.768kHz，係依供應商規格而定，但不以此為限。 As described above, the oscillation frequency provided by the test oscillation module 304 varies according to the nature of the object to be tested, and is usually in the range of 10 MHz to 120 Hz, which is about 1 M to 1 kHz in this embodiment. On the other hand, the frequency used by the second processor 303 in this embodiment is 4 MHz and 32.768 kHz, which is determined by the vendor specifications, but is not limited thereto.
以上所述者僅為依據本揭露的實施範例，當不能依此限定本揭露實施之範圍。即大凡發明申請專利範圍所作之均等變化與修飾，皆應仍屬本揭露專利涵蓋之範圍。 The above is only the embodiment according to the disclosure, and the scope of the disclosure is not limited thereto. That is, the equivalent changes and modifications made by the scope of the patent application should remain within the scope of the disclosure.
100‧‧‧具有濕度感測元件的檢測試片 100‧‧‧Test strips with humidity sensing elements
110‧‧‧基板 110‧‧‧Substrate
120‧‧‧電路層 120‧‧‧ circuit layer
121‧‧‧第一電極 121‧‧‧First electrode
122‧‧‧第二電極 122‧‧‧second electrode
123‧‧‧濕度感應區域 123‧‧‧Humidity sensing area
130‧‧‧試劑層 130‧‧‧Reagent layer
140‧‧‧黏著層 140‧‧‧Adhesive layer
150‧‧‧覆蓋層 150‧‧‧ Coverage
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| TW104129391A TWI591329B (en) | 2015-09-04 | 2015-09-04 | Test strip with capacity of sensing humidity |
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| TW104129391A TWI591329B (en) | 2015-09-04 | 2015-09-04 | Test strip with capacity of sensing humidity |
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| TWI591329B TWI591329B (en) | 2017-07-11 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109943473A (en) * | 2019-04-02 | 2019-06-28 | 邦睿生技股份有限公司 | Inspection test piece device |
| TWI672770B (en) * | 2017-05-09 | 2019-09-21 | Ams International Ag | Sensor semiconductor device and method of produsing the same |
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2015
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI672770B (en) * | 2017-05-09 | 2019-09-21 | Ams International Ag | Sensor semiconductor device and method of produsing the same |
| US11262325B2 (en) | 2017-05-09 | 2022-03-01 | Sciosense B.V. | Sensor semiconductor device |
| CN109943473A (en) * | 2019-04-02 | 2019-06-28 | 邦睿生技股份有限公司 | Inspection test piece device |
| CN109943473B (en) * | 2019-04-02 | 2022-04-05 | 邦睿生技股份有限公司 | Test strip device |
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