TW201814274A - Optical detection system - Google Patents
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- G—PHYSICS
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/01—Arrangements or apparatus for facilitating the optical investigation
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
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Abstract
Description
本發明係關於一種光學檢測系統,特別是關於一種用於檢測一檢測試片的光學檢測系統。The invention relates to an optical detection system, in particular to an optical detection system for detecting a test strip.
現行的側流層析法(Lateral Flow Assay, LFA)技術因使用方便且製程技術成熟,被廣泛應用於快篩檢測相關領域之中,而其檢測結果除了肉眼判斷以外,反射式光學檢測及互補性氧化金屬半導體(Complementary Metal-Oxide Semiconductor,CMOS)影像擷取裝置亦是常見的判讀技術。然而,當使用肉眼判斷檢測結果時,除了存在人為判斷的差異外,對於呈色較不明顯的微弱反應,常常導致使用者誤判;而反射式光學檢測技術則是僅能偵測到檢測試紙條表面的顏色變化,對於潛藏在試紙條纖維內部的顏色變化無法反應到檢測信號中。此外,反射式光學檢測信號容易受到試紙條表面與光學讀取裝置的距離變化影響,量測變異較大且需要精確的機構配合,因此無法適用於便攜式檢測的需求。The current Lateral Flow Assay (LFA) technology is widely used in fast screening detection related fields due to its convenient use and mature process technology, and its detection results are in addition to visual judgment, reflective optical detection and complementary Complementary Metal-Oxide Semiconductor (CMOS) image capture devices are also common interpretation technologies. However, when using the naked eye to judge the detection results, in addition to the differences in human judgment, the weak response to less obvious color rendering often leads to misjudgment by the user; while the reflective optical detection technology can only detect the test strip The color change on the surface of the strip cannot reflect the detection of the color change hidden inside the fiber of the test strip. In addition, the reflective optical detection signal is easily affected by the change in the distance between the surface of the test strip and the optical reading device. The measurement variation is large and requires precise mechanism cooperation, so it cannot be applied to the requirements of portable detection.
另外,CMOS影像擷取裝置可透過相機拍攝快篩試紙條的影像,再藉由影像分析技術來圈選特定反應區塊影像的色彩或明暗並加以量化,雖然解決了肉眼判斷的問題,但其靈敏度的判讀極限並未有明顯的提升。因此,如何提升檢測儀器的方便性及靈敏度已成為檢測試片讀取裝置發展的主要議題。In addition, the CMOS image capture device can capture the image of the fast screening test strip through the camera, and then use the image analysis technology to circle the color or brightness of the specific reaction block image and quantify it. Although the problem of visual judgment is solved, but The sensitivity limit of its sensitivity has not improved significantly. Therefore, how to improve the convenience and sensitivity of the detection instrument has become a major issue in the development of the test strip reading device.
有鑑於上述課題,本發明之目的為提供一種穿透式光學檢測系統,以降低判讀裝置設計的複雜度並提高檢測的可靠度,亦可感測潛藏於試紙條內部的反應信號,進而提升檢測的靈敏度。In view of the above problems, the object of the present invention is to provide a penetrating optical detection system to reduce the complexity of the design of the reading device and improve the reliability of the detection. It can also sense the reaction signal hidden inside the test strip, thereby improving Detection sensitivity.
為達上述目的,依據本發明之一種光學檢測系統包括一發光模組、一檢測試片以及一接收模組。發光模組包括一光源及一第一遮光單元,光源提供一光束。第一遮光單元具有一第一孔隙,第一孔隙與光源對應設置。檢測試片包括一卡匣及一試紙條。卡匣具有一第一視窗、一第二視窗及一檢體開口,檢體開口設置於卡匣的一表面,第一視窗與第二視窗對應設置並分別開設於卡匣的相對兩側,第一視窗與第一孔隙對應設置。試紙條設置於卡匣內。接收模組包括一第二遮光單元及一光學感測器。第二遮光單元具有一第二孔隙,且第二孔隙與第二視窗對應設置。光學感測器用以接收光束並發出一量測信號。其中,光束經由第一孔隙出射第一遮光單元後,光束依序穿透第一視窗、試紙條、第二視窗並經由第二孔隙入射於第二遮光單元內。To achieve the above object, an optical detection system according to the present invention includes a light emitting module, a detection test piece, and a receiving module. The light emitting module includes a light source and a first light shielding unit, and the light source provides a light beam. The first shading unit has a first aperture, and the first aperture is disposed corresponding to the light source. The test strip includes a cassette and a test strip. The cassette has a first window, a second window, and a specimen opening. The specimen opening is disposed on a surface of the cassette. The first window and the second window are correspondingly arranged and are respectively opened on opposite sides of the cassette. A window is disposed corresponding to the first aperture. The test strip is set in the cassette. The receiving module includes a second shading unit and an optical sensor. The second light shielding unit has a second aperture, and the second aperture is disposed corresponding to the second window. The optical sensor is used for receiving a light beam and sending a measurement signal. After the light beam exits the first light-shielding unit through the first aperture, the light beam sequentially penetrates the first window, the test strip, and the second window and enters the second light-shielding unit through the second aperture.
在一實施例中,試紙條包含至少一測試帶及一質控帶,且測試帶及質控帶分佈於第一視窗與第二視窗於試紙條上的垂直投影面的交集範圍內。In one embodiment, the test strip includes at least a test strip and a quality control strip, and the test strip and the quality control strip are distributed in an intersection range of a vertical projection surface of the first window and the second window on the test strip.
在一實施例中,第一孔隙的直徑小於或等於測試帶的寬度及質控帶的寬度。In one embodiment, the diameter of the first pore is less than or equal to the width of the test strip and the width of the quality control strip.
在一實施例中,第二孔隙的直徑小於或等於第一孔隙的直徑。In one embodiment, the diameter of the second pore is smaller than or equal to the diameter of the first pore.
在一實施例中,第一孔隙的直徑介於0.1~5.0mm。In one embodiment, the diameter of the first pore is between 0.1 and 5.0 mm.
在一實施例中,光源為一發光二極體,且試紙條更具有一呈色材料,發光二極體發射的光波長為呈色材料吸收的光波長。In an embodiment, the light source is a light-emitting diode, and the test strip further has a color-producing material, and the light wavelength emitted by the light-emitting diode is the wavelength of light absorbed by the color-producing material.
在一實施例中,光源、第一孔隙、第二孔隙以及光學感測器共同構成一光學檢測路徑,光學檢測路徑實質垂直於檢測試片。In one embodiment, the light source, the first aperture, the second aperture, and the optical sensor together form an optical detection path, and the optical detection path is substantially perpendicular to the test strip.
在一實施例中,更包括一試片移動裝置,用以固定並帶動檢測試片沿第一視窗的長軸方向作直線運動,使光束沿長軸方向照射到部分的卡匣及第一視窗。In one embodiment, it further includes a test piece moving device for fixing and driving the test piece to move linearly along the long axis direction of the first window, so that the light beam is irradiated to a part of the cassette and the first window along the long axis direction .
在一實施例中,試片移動裝置為一自動驅動裝置或一手動驅動裝置。In one embodiment, the test strip moving device is an automatic driving device or a manual driving device.
在一實施例中,自動驅動裝置包括一滑軌、一螺桿、一齒輪或一皮帶等傳動裝置,並連接一馬達。In one embodiment, the automatic driving device includes a transmission device such as a slide rail, a screw, a gear or a belt, and is connected to a motor.
在一實施例中,手動驅動裝置係搭配一卡槽滑塊及一滑槽的設計,以一手指直接移動檢測試片作直線運動。In one embodiment, the manual driving device is designed with a slotted slider and a slotted groove, and a finger moves directly to detect the test piece for linear motion.
在一實施例中,更包括一信號分析模組,信號分析模組包括一信號分析單元以及一信號演算單元。信號分析單元接收量測信號,並依據量測信號輸出一參數,其中參數為一背景信號參數、一質控信號參數、一測試信號參數或一第一視窗時間參數。信號演算單元運用至少一參數作運算推算出待測檢體中的特定物質濃度。In one embodiment, a signal analysis module is further included. The signal analysis module includes a signal analysis unit and a signal calculation unit. The signal analysis unit receives the measurement signal and outputs a parameter according to the measurement signal, wherein the parameter is a background signal parameter, a quality control signal parameter, a test signal parameter, or a first window time parameter. The signal calculation unit uses at least one parameter to perform calculation to estimate a specific substance concentration in the test object.
在一實施例中,光學檢測系統係藉由一穿透式光學檢測路徑量測潛藏在試紙條之纖維內部的一檢測信號。In one embodiment, the optical detection system measures a detection signal hidden inside the fiber of the test strip through a penetrating optical detection path.
承上所述,本發明之光學檢測系統是藉由穿透式光學檢測路徑量測潛藏在試紙條纖維內部的檢測信號,提升檢測訊號的強度;利用光學檢測路徑的掃描式設計,沿檢測試片的第一視窗的長軸方向依序掃描第一視窗內的試紙條空白區塊、測試帶以及質控帶,以減少光學感測器的數量,降低讀取裝置設計的複雜度,並增加檢測試片上測試帶數量增減的彈性,同時降低對測試帶及質控帶的畫線精度要求。最後,利用第一孔隙及第二孔隙的配合,以增加量測信號的可靠度,提高量測信號的訊雜比及強度,進而達到提升檢測儀器的方便性及靈敏度之目的。As mentioned above, the optical detection system of the present invention measures the detection signal hidden in the fiber of the test strip through the penetrating optical detection path to enhance the intensity of the detection signal; the scanning design of the optical detection path is used to The long axis of the first window of the test piece sequentially scans the blank areas, test strips and quality control strips of the test strip in the first window in order to reduce the number of optical sensors and reduce the complexity of the design of the reading device. It also increases the flexibility of increasing and decreasing the number of test strips on the test strips, while reducing the precision requirements for drawing test strips and quality control strips. Finally, the cooperation of the first pore and the second pore is used to increase the reliability of the measurement signal, improve the signal-to-noise ratio and intensity of the measurement signal, and thereby achieve the purpose of improving the convenience and sensitivity of the detection instrument.
以下將參照相關圖式,說明依本發明一實施例的一種光學檢測系統,其中相同的元件將以相同的參照符號加以說明。Hereinafter, an optical detection system according to an embodiment of the present invention will be described with reference to related drawings. The same components will be described with the same reference symbols.
請同時參照圖1、圖2、圖3A以及圖3B,圖1為本發明一實施例的一種光學檢測系統的示意圖,圖2為本發明一實施例的光學檢測路徑的示意圖,為求畫面簡潔,故省略檢測試片的卡匣,圖3A為本發明一實施例的檢測試片立體示意圖,圖3B為圖3A所示檢測試片的爆炸示意圖。Please refer to FIG. 1, FIG. 2, FIG. 3A and FIG. 3B simultaneously. FIG. 1 is a schematic diagram of an optical detection system according to an embodiment of the present invention, and FIG. 2 is a schematic diagram of an optical detection path according to an embodiment of the present invention. Therefore, the cassette of the test strip is omitted. FIG. 3A is a schematic perspective view of the test strip according to an embodiment of the present invention, and FIG. 3B is an explosion schematic view of the test strip shown in FIG. 3A.
本發明提供一種光學檢測系統OD包括一發光模組1、一檢測試片2以及一接收模組3。發光模組1包括一光源11及一第一遮光單元12,光源11提供一光束111,而第一遮光單元12具有一第一孔隙121,且第一孔隙121與光源11對應設置,使光束111經由第一孔隙121出射第一遮光單元12。The present invention provides an optical detection system OD including a light emitting module 1, a test strip 2 and a receiving module 3. The light-emitting module 1 includes a light source 11 and a first light-shielding unit 12. The light source 11 provides a light beam 111, and the first light-shielding unit 12 has a first aperture 121, and the first aperture 121 is arranged corresponding to the light source 11 so that the light beam 111 The first light shielding unit 12 is emitted through the first aperture 121.
而檢測試片2包括一卡匣21及一試紙條22,其中卡匣21具有一第一視窗211、一第二視窗212及一檢體開口213,檢體開口213設置於卡匣21的一表面,第一視窗211與第二視窗212對應設置並分別開設於卡匣21的相對兩側,第一視窗211與第一孔隙121對應設置,且試紙條22設置於卡匣21內,使光束111出射第一遮光單元12後,光束111依序穿透第一視窗211及試紙條22,並經由第二視窗212出射檢測試片2。The test strip 2 includes a cassette 21 and a test strip 22, wherein the cassette 21 has a first window 211, a second window 212, and a specimen opening 213. The specimen opening 213 is disposed on the cassette 21 On one surface, the first window 211 and the second window 212 are disposed correspondingly and are respectively disposed on opposite sides of the cassette 21, the first window 211 is disposed correspondingly to the first aperture 121, and the test strip 22 is disposed in the cassette 21, After the light beam 111 is emitted from the first light-shielding unit 12, the light beam 111 penetrates the first window 211 and the test strip 22 in sequence, and exits the test strip 2 through the second window 212.
其接收模組3包括一第二遮光單元31元及一光學感測器32。第二遮光單元31元具有一第二孔隙311,且第二孔隙311與第二視窗對應設置,使光束111出射檢測試片後,經由第二孔隙311入射於第二遮光單元31內,而光學感測器32用以接收光束111並發出一量測信號。光束111經由第一孔隙121出射第一遮光單元12後,光束111依序穿透第一視窗211、試紙條22、第二視窗212並經由第二孔隙311入射於第二遮光單元31內。The receiving module 3 includes a second shading unit 31 and an optical sensor 32. The second light-shielding unit 31 has a second aperture 311, and the second aperture 311 is arranged corresponding to the second window. After the light beam 111 exits the test strip, it enters the second light-shielding unit 31 through the second aperture 311, and optically The sensor 32 is used for receiving the light beam 111 and sending a measurement signal. After the light beam 111 exits the first light shielding unit 12 through the first aperture 121, the light beam 111 penetrates the first window 211, the test strip 22, and the second window 212 in sequence and enters the second light shielding unit 31 through the second aperture 311.
本發明提供的光學檢測系統是藉由穿透式光學檢測路徑量測潛藏在試紙條纖維內部的檢測信號,其中,光束經由第一孔隙出射第一遮光單元後,光束依序穿透第一視窗、試紙條、第二視窗並經由第二孔隙入射於第二遮光單元內。因此在本實施例中,光源11、第一孔隙121、第二孔隙311以及光學感測器32共同構成一光學檢測路徑OP,而光學檢測路徑OP實質垂直於檢測試片2。檢測試片2的檢測反應區域為鏤空式設計,因此檢測試片2具有第一視窗211與第二視窗212彼此對應設置,試紙條22包含至少一測試帶T及一質控帶C,且測試帶T及質控帶C分佈於第一視窗211與第二視窗212於試紙條22上的垂直投影面的交集範圍內,換句話說,試紙條22上測試帶T及質控帶C分佈的區域,使光束111從發光模組1出射後,即可入射於第一視窗211,穿透試紙條22上的測試帶T或質控帶C,最後經由第二視窗212出射檢測試片2,使測試帶T或質控帶C的檢測信號被接收模組3所接收。The optical detection system provided by the present invention measures a detection signal hidden inside a test strip fiber through a penetrating optical detection path. After the light beam exits the first light-shielding unit through the first aperture, the light beam sequentially penetrates the first The window, the test strip, and the second window are incident into the second light shielding unit through the second aperture. Therefore, in this embodiment, the light source 11, the first aperture 121, the second aperture 311, and the optical sensor 32 together constitute an optical detection path OP, and the optical detection path OP is substantially perpendicular to the test strip 2. The detection reaction area of the test strip 2 is a hollow design, so the test strip 2 has a first window 211 and a second window 212 corresponding to each other. The test strip 22 includes at least one test strip T and one quality control strip C, and The test strip T and the quality control strip C are distributed at the intersection of the vertical projection surface of the first window 211 and the second window 212 on the test strip 22, in other words, the test strip T and the quality control strip on the test strip 22 In the area of C distribution, after the light beam 111 is emitted from the light emitting module 1, it can be incident on the first window 211, penetrate the test strip T or the quality control band C on the test strip 22, and finally exit the inspection through the second window 212 The test piece 2 enables the detection signal of the test zone T or the quality control zone C to be received by the receiving module 3.
在本實施例中,第一孔隙121的直徑介於0.1~5.0mm,且第一孔隙121的直徑小於或等於測試帶T的寬度及質控帶C的寬度時,可使光束111穿透於測試帶T或質控帶C時,光束111的寬度小於測試帶T的寬度及質控帶C的寬度,再加上第二孔隙311的直徑小於第一孔隙121的直徑,可使光學感測器32於接收光束111時,可過濾掉過多的接收雜訊,達到提升量測信號的可靠度。In this embodiment, when the diameter of the first aperture 121 is between 0.1 and 5.0 mm, and the diameter of the first aperture 121 is less than or equal to the width of the test strip T and the width of the quality control strip C, the light beam 111 can be transmitted through When the test zone T or the quality control zone C, the width of the beam 111 is smaller than the width of the test zone T and the quality control zone C. In addition, the diameter of the second aperture 311 is smaller than the diameter of the first aperture 121, which enables optical sensing. When the receiver 32 receives the light beam 111, excessive receiver noise can be filtered out to improve the reliability of the measurement signal.
藉由透光式光學檢測路徑的設計,光源與光學感測器的位置為固定,因此檢測信號不易受到試紙條與光學感測器的間距變動所影響,且第一孔隙的直徑小於或等於測試帶及質控帶的寬度,且第二孔隙的直徑小於或等於第一孔隙的直徑,可以減少光源強度不均的問題,於檢測時不需使用光學擴散片,且僅需使用單一光學感測器,可使檢測儀器的機構較為精簡,亦可簡化量測校正的作業。With the design of the light-transmitting optical detection path, the positions of the light source and the optical sensor are fixed, so the detection signal is not easily affected by the change in the distance between the test strip and the optical sensor, and the diameter of the first aperture is less than or equal to The width of the test strip and the quality control strip, and the diameter of the second aperture is smaller than or equal to the diameter of the first aperture, which can reduce the problem of uneven light source intensity. No optical diffuser is required for detection, and only a single optical sensor is needed. The measuring device can make the mechanism of the testing instrument more streamlined, and it can also simplify the measurement and calibration operation.
在本實施例中,光學檢測系統OD更包括一試片移動裝置4,試片移動裝置4用以固定並帶動檢測試片2沿第一視窗211的長軸方向MA211 作直線運動,使光束沿長軸方向MA211 照射到部分的卡匣21及第一視窗211。更進一步說明,利用試片移動裝置4帶動檢測試片2與固定位置的光學檢測路徑OP產生直線相對運動,使光學檢測路徑OP沿第一視窗211的長軸方向MA211 依序照射到部分的卡匣21、進入第一視窗211內試紙條22的空白區塊221、測試帶T及質控帶C、再照射到試紙條22的空白區塊221,最後光學檢測路徑OP離開第一視窗211照射至部分的卡匣21後,檢測試片2即停止運動。In this embodiment, the optical detection system OD further includes a test strip moving device 4 for fixing and driving the test strip 2 to move linearly along the long axis direction MA 211 of the first window 211 to make the light beam MA 211 along the major axis is irradiated to the first cartridge 21 and the window portion 211. To further explain, the test piece moving device 4 is used to drive the test piece 2 and the optical detection path OP at a fixed position to generate a linear relative movement, so that the optical detection path OP is sequentially irradiated to a part of the first window 211 in the long axis direction MA 211 . The cassette 21, the blank block 221 of the test strip 22 in the first window 211, the test strip T and the quality control strip C, and then the blank block 221 of the test strip 22 is irradiated, and finally the optical detection path OP leaves the first After the window 211 is irradiated to a part of the cassette 21, the test strip 2 stops moving.
在本實施例中,試片移動裝置4為一自動驅動裝置或一手動驅動裝置;自動驅動裝置是以滑軌、螺桿、齒輪或皮帶等傳動裝置,連接馬達所構成(圖式未示),使檢測試片2沿第一視窗211的長軸方向MA211 作直線運動,而手動驅動裝置是搭配卡槽滑塊及滑槽的設計(圖式未示),以手指直接移動檢測試片2作直線運動。In this embodiment, the test piece moving device 4 is an automatic driving device or a manual driving device; the automatic driving device is a transmission device such as a slide rail, a screw, a gear, or a belt, and is connected to a motor (not shown in the figure). Make the test strip 2 move linearly along the long axis direction MA 211 of the first window 211, and the manual driving device is designed with a slotted slider and a slide groove (not shown in the figure), and the test strip 2 is directly moved by the finger. Make a linear motion.
藉由掃描式光學檢測路徑,使檢測試片與光學檢測路徑產生直線相對運動,使光學檢測路徑依序掃描試紙條上各測試帶及質控帶,可克服因製程變異與產品相容性所造成光學感測器與試紙條的位移問題,更可降低試紙條製作的精度要求,並增加測試帶的數量增減的彈性。By scanning the optical detection path, the test piece and the optical detection path generate linear relative movement, so that the optical detection path sequentially scans each test strip and quality control strip on the test strip, which can overcome the process variation and product compatibility. The problem of displacement of the optical sensor and the test strip can further reduce the precision requirements for the production of the test strip, and increase the flexibility of increasing or decreasing the number of test strips.
請同時參照圖4、圖5及圖6,圖4為本發明一實施例的輸出量測信號的電位波形示意圖,圖5為本發明另一實施例的輸出量測信號的電位波形示意圖,圖6為本發明一實施例的測試帶訊號雜訊比的示意圖。Please refer to FIGS. 4, 5 and 6 at the same time. FIG. 4 is a schematic diagram of a potential waveform of an output measurement signal according to an embodiment of the present invention. FIG. 5 is a schematic diagram of a potential waveform of an output measurement signal according to another embodiment of the present invention. 6 is a schematic diagram of a test strip signal-to-noise ratio according to an embodiment of the present invention.
在一實施例中,光源11為一發光二極體,且試紙條22更具有一呈色材料222,發光二極體發射的光波長為呈色材料222吸收的光波長,而呈色材料222塗佈於試紙條22上各測試帶T及質控帶C。因此,當光束111通過各測試帶T或質控帶C時,部分光波長將被呈色材料222吸收,使光束111的光強度減弱,光學感測器32接收到光束111的光強度變化後,反應於輸出的量測信號。In an embodiment, the light source 11 is a light-emitting diode, and the test strip 22 further has a color-emitting material 222. The wavelength of light emitted by the light-emitting diode is the wavelength of light absorbed by the color-emitting material 222, and the color-emitting material 222 is coated on each test strip T and quality control strip C on the test strip 22. Therefore, when the light beam 111 passes through each test zone T or quality control zone C, part of the light wavelength will be absorbed by the coloring material 222, which weakens the light intensity of the light beam 111. After the optical sensor 32 receives the light intensity change of the light beam 111 , In response to the output measurement signal.
在一實施例中,光學檢測系統OD更包括一信號分析模組,信號分析模組包括一信號分析單元以及一信號演算單元。信號分析單元接收量測信號,並依據量測信號輸出一參數,其中參數為一背景信號參數、一質控信號參數、一測試信號參數或一第一視窗時間△A參數。一信號演算單元運用至少一參數作運算並輸出一訊號雜訊比。In one embodiment, the optical detection system OD further includes a signal analysis module. The signal analysis module includes a signal analysis unit and a signal calculation unit. The signal analysis unit receives the measurement signal and outputs a parameter according to the measurement signal, wherein the parameter is a background signal parameter, a quality control signal parameter, a test signal parameter, or a first window time ΔA parameter. A signal calculation unit uses at least one parameter for calculation and outputs a signal-to-noise ratio.
以下將利用圖4、圖5及圖6說明本實施例信號分析模組的運作模式。The operation modes of the signal analysis module of this embodiment will be described below using FIG. 4, FIG. 5, and FIG. 6.
當光學檢測路徑OP沿第一視窗211的長軸方向MA211 依序掃描檢測試片2時,即得到如圖4所示的輸出量測信號的電位波形,橫軸為光學檢測路徑OP檢測的採樣時間,縱軸為量測信號的電壓大小。由於檢測試片2的卡匣21為不透光材質,因此光學檢測路徑OP檢測到的量測信號接近零點的信號,隨著檢測試片2持續推進,當光學檢測路徑OP開始進入到第一視窗211時,光束111通過具透光性試紙條22的空白區塊221時,量測信號急遽增加,將其時間軸設為零點。其後,當測試帶T及質控帶C分別通過光學檢測路徑OP時,部分光波長被呈色材料222吸收,光束111的光強度減弱,得到兩個明顯的沉降量測信號即為測試帶信號及質控帶信號(圖式中T及C處)。而當光學檢測路徑OP開始離開到第一視窗211時,光束111照射於檢測試片2的卡匣21時,量測信號回歸於接近零點處,至此完成整個檢測程序。When the optical detection path OP sequentially scans the test strip 2 along the long axis direction MA 211 of the first window 211, the potential waveform of the output measurement signal is obtained as shown in FIG. 4, and the horizontal axis is detected by the optical detection path OP. Sampling time, the vertical axis is the voltage of the measurement signal. Since the cassette 21 of the test strip 2 is opaque, the measurement signal detected by the optical detection path OP is close to zero. As the test strip 2 continues to advance, when the optical test path OP starts to enter the first In the window 211, when the light beam 111 passes through the blank block 221 of the light-transmitting test strip 22, the measurement signal increases sharply, and its time axis is set to zero. Thereafter, when the test strip T and the quality control strip C respectively pass through the optical detection path OP, part of the light wavelength is absorbed by the coloring material 222, and the light intensity of the light beam 111 is weakened, and two obvious sedimentation measurement signals are obtained as the test strip. Signal and quality control band signal (T and C in the figure). When the optical detection path OP starts to leave to the first window 211, when the light beam 111 is irradiated to the cassette 21 of the test strip 2, the measurement signal returns to near zero, and the entire detection process is completed.
前述的檢測程序,試片移動裝置4為自動驅動裝置或是手動驅動裝置皆可使用,檢測試片2推進速度的快慢,僅影響整體量測訊號的反應時間長短,而沉降的量測信號(圖式中T及C處)不受推進速度的影響,因此可作為量測與分析的依據。In the foregoing detection procedure, the test piece moving device 4 can be used as an automatic drive device or a manual drive device. The detection speed of the test piece 2 advancement speed only affects the response time of the overall measurement signal, and the measurement signal of settlement ( T and C in the figure) are not affected by the advance speed, so they can be used as the basis for measurement and analysis.
以下將定義具特徵意義的參數與數值:The following will define characteristic parameters and values:
第一視窗時間△A係指光束111開始進入第一視窗211,至離開第一視窗211的歷經時間。The first window time ΔA refers to the elapsed time from when the light beam 111 starts to enter the first window 211 and leaves the first window 211.
背景信號係指光束111通過具透光性試紙條22的空白區塊221,其量測信號的平均值Vav。The background signal refers to the average value Vav of the measurement signal of the light beam 111 passing through the blank block 221 of the translucent test strip 22.
測試帶信號T係指光束111通過測試帶T,其量測信號的最低值。The test strip signal T refers to the lowest value of the measurement signal of the light beam 111 passing through the test strip T.
質控帶信號C係指光束111通過質控帶C,其量測信號的最低值。The quality control band signal C refers to the lowest value of the measurement signal of the light beam 111 passing through the quality control band C.
△T = ABS│背景信號 – 測試帶信號│△ T = ABS│Background signal – Test strip signal│
△C = ABS│背景信號 – 質控帶信號│△ C = ABS│Background Signal-Quality Control Band Signal│
測試帶訊號雜訊比SNR(T) = △T / 背景信號Test band signal to noise ratio SNR (T) = △ T / background signal
質控帶訊號雜訊比SNR(C) = △C / 背景信號Quality control with signal to noise ratio SNR (C) = △ C / background signal
將具透光性試紙條22的空白區塊221的量測信號平均值Vav設為背景信號,並分別計算測試帶T與質控帶C的沉降量測信號(圖式中T及C處)為測試帶信號T及質控帶信號C,將測試帶信號T及質控帶信號C分別與背景信號的差值(△T、△C)與背景信號作正規化(Normalization),即可得到測試帶訊號雜訊比SNR(T)及質控帶訊號雜訊比SNR(C)。Set the average value of the measurement signal Vav of the blank block 221 of the light-transmitting test strip 22 as the background signal, and calculate the sedimentation measurement signals of the test zone T and the quality control zone C (T and C in the figure) ) To test band signal T and quality control band signal C, normalize the difference between the test band signal T and quality control band signal C and the background signal (△ T, △ C) and the background signal, respectively. Obtain the test band signal noise ratio SNR (T) and quality control band signal noise ratio SNR (C).
如圖4,在此定義之下的量測信號數值為0〜1之間;當光束111尚未進入於第一視窗211時,光束111照射於檢測試片2的卡匣21時,光束111被卡匣21遮蔽,幾乎沒有光束111進入光學感測器32中,其量測信號數值趨近於0;當光束111進入於第一視窗211,照射於試紙條22上的空白區塊221時,會有大量的光束111通過試紙條22,進入光學感測器32中,其量測信號數值急遽增加,使反應曲線由零點處向上,隨後當質控帶C與測試帶T分別通過檢測路徑時,因部分光強為呈色材料222吸收,可分別看到兩個清楚的沉降信號,當檢測的光束111通過第一視窗211後,光束111再次被卡匣本體21遮蔽而回復到零點,分別計算質控帶C與測試帶T沉降信號與與背景信號的差值,即可分別得到測試帶訊號雜訊比SNR(T)及質控帶訊號雜訊比SNR(C)。而隨著檢測試片2待檢測標的濃度的增加,其訊號雜訊比SNR的數值將會隨著測試帶T與質控帶C內的呈色材料222聚集密度增加而逐漸升高。As shown in Figure 4, the value of the measurement signal under this definition is between 0 and 1. When the light beam 111 has not entered the first window 211, the light beam 111 is irradiated on the cassette 21 of the test strip 2. The cassette 21 is shielded, and almost no light beam 111 enters the optical sensor 32, and the value of the measurement signal approaches 0; when the light beam 111 enters the first window 211 and shines on the blank block 221 on the test strip 22 A large amount of light beam 111 passes through the test strip 22 and enters the optical sensor 32. The measurement signal value increases sharply, so that the response curve rises from the zero point, and then when the quality control zone C and the test zone T pass the detection, respectively. During the path, because some of the light intensity is absorbed by the coloring material 222, two clear settlement signals can be seen respectively. After the detected beam 111 passes through the first window 211, the beam 111 is again blocked by the cassette body 21 and returns to zero. , Calculate the difference between the settlement signal of the quality control zone C and the test zone T and the background signal, respectively, to obtain the signal-to-noise ratio SNR (T) of the test zone and the signal-to-noise ratio SNR (C) of the quality control zone, respectively. As the concentration of the target to be detected in the test strip 2 increases, the value of the signal-to-noise ratio SNR will gradually increase as the density of the coloring material 222 in the test zone T and the quality control zone C increases.
進一步探討光學檢測路徑OP中的第一孔隙121與第二孔隙311不同的直徑寬度對量測信號的影響,即得到如圖5所示的輸出量測信號的電位波形示意圖。當發光模組1固定波長及頻率的光源11條件之下,且當第一孔隙121的直徑固定為1.0mm時,第二孔隙311分別以0.1mm、0.3mm的條件對hCG樣品蛋白濃度為100mIU的檢測試片2做檢測,並對所得到的輸出量測信號的電位波形的第一視窗時間△A進行正規化(Normalization)。The influence of different diameter widths of the first aperture 121 and the second aperture 311 in the optical detection path OP on the measurement signal is further explored, that is, a potential waveform diagram of the output measurement signal as shown in FIG. 5 is obtained. When the light source module 1 has a fixed wavelength and frequency of the light source 11 and the diameter of the first aperture 121 is fixed at 1.0 mm, the second aperture 311 has a protein concentration of 100 mIU on the hCG sample under the conditions of 0.1 mm and 0.3 mm, respectively. The test strip 2 is tested, and the first window time ΔA of the obtained potential waveform of the output measurement signal is normalized.
以下將介紹第一視窗時間進行正規化(Normalization)的運算方式,在此定義具特徵意義的參數與數值:The following will introduce the normalization operation method in the first window time, and define the parameters and values with characteristic significance here:
第一視窗時間△A=A1-A0First window time △ A = A1-A0
時間差值△a1 = a1 - a0 Time difference △ a 1 = a 1 -a 0
時間差值△a2 = a2 - a0 Time difference △ a 2 = a 2 -a 0
時間差值△an = an - a0 Time difference △ a n = a n -a 0
第一視窗時間進行正規化= △a1 … n /△ANormalize the first window time = △ a 1 … n / △ A
如圖4所示,當光束111開始進入第一視窗211,光束111通過試紙條22的空白區塊221,先將光學感測器32開始接收到量測信號的時間點設為時間軸零點A0、a0 ,光束111離開第一視窗211的時間軸為A1,A1-A0為△A,即為第一視窗時間。在第一視窗時間內,每個量測信號的時間值分別為a1 、a2 …an ,與時間軸零點的時間值a0 相減後,可得到每個量測信號的時間差值分別為△a1 、△a2 …△an 。最後將所有時間差值△a1 、△a2 …△an 分別除上第一視窗時間△A,即完成完整的量測訊號的第一視窗時間△A進行正規化。As shown in FIG. 4, when the light beam 111 starts to enter the first window 211, the light beam 111 passes through the blank area 221 of the test strip 22, and the time point at which the optical sensor 32 starts to receive the measurement signal is set to the time axis zero point. A0, a 0, a first light beam 111 leaving the timeline window 211 is A1, A1-A0 is △ a, that is, the first time window. In the first time window, the time value of each measured signal are a 1, a 2 ... a n , and a time axis zero value after subtracting a 0, a time difference is obtained for each measurement signal △ a 1 , △ a 2 … △ a n . Finally, all the time difference values Δa 1 , Δa 2 … △ a n are divided by the first window time ΔA, respectively, that is, the first window time ΔA of the complete measurement signal is normalized.
經由量測訊號的第一視窗時間△A進行正規化後,當第一孔隙121的直徑固定為1.0mm時,第二孔隙311的直徑為0.3mm的量測信號電位波形高於第二孔隙311的直徑為0.1mm的量測信號電位波形。因此,本實施例的光學檢測系統OD,於固定第一孔隙121直徑,固定出光條件下,增加第二孔隙311的直徑會導致背景信號與量測信號同時提升。而進一步分析兩者的測試帶訊號雜訊比SNR(T),如圖5所示,卻發現第二孔隙311的直徑為0.1mm的測試帶訊號雜訊比SNR(T)曲線,高於第二孔隙121的直徑為0.3mm的測試帶訊號雜訊比SNR(T)曲線。After the first window time ΔA of the measurement signal is normalized, when the diameter of the first aperture 121 is fixed at 1.0 mm, the measured signal potential waveform of the diameter of the second aperture 311 at 0.3 mm is higher than that of the second aperture 311 The measured signal potential waveform is 0.1mm in diameter. Therefore, in the optical detection system OD of this embodiment, when the diameter of the first aperture 121 is fixed and the light output condition is fixed, increasing the diameter of the second aperture 311 will cause the background signal and the measurement signal to increase at the same time. Further analysis of the test band signal-to-noise ratio SNR (T) of the two, as shown in Fig. 5, found that the test band signal-to-noise ratio SNR (T) curve of the second aperture 311 with a diameter of 0.1 mm is higher than that of the first band 311. The test signal-to-noise ratio SNR (T) curve of the two apertures 121 having a diameter of 0.3 mm.
此外,如圖5所示,當試片移動裝置4係利用手動驅動裝置移動檢測試片2時,雖然會造成各別量測信號的第一視窗時間△A的量測長短差異,但其量測信號經過正規化後,各別測試帶信號T及質控帶信號C的沉降量測信號時間點一致,因此,第一視窗時間△A正規化有助於後續量測信號分析流程的簡化。In addition, as shown in FIG. 5, when the test strip moving device 4 uses the manual driving device to move and test the test strip 2, although the measurement length of the first window time ΔA of each measurement signal may be different, the amount of measurement After the measurement signals are normalized, the time points of the settling measurement signals of the respective test band signals T and the quality control band signals C are consistent. Therefore, the normalization of the first window time ΔA helps to simplify the subsequent measurement signal analysis process.
光學檢測系統OD係藉由第一孔隙121與第二孔隙311的搭配,限制照射在檢測試片2上的光束111寬度,限制測試帶T及質控帶C區域以外的背景信號進入光學感測器32,可避免試紙條22空白區塊221與測試帶T或質控帶C的量測信號同時進入光學感測器32中,導致背景信號及訊號雜訊比SNR上升的現象。The optical detection system OD uses the combination of the first aperture 121 and the second aperture 311 to limit the width of the beam 111 irradiated on the test strip 2 and restrict the background signals outside the test zone T and quality control zone C from entering the optical sensing. The device 32 can prevent the blank block 221 of the test strip 22 and the measurement signals of the test strip T or the quality control band C from entering the optical sensor 32 at the same time, which causes the phenomenon that the background signal and the signal-to-noise ratio SNR rise.
圖6為本實施例的測試帶訊號雜訊比的示意圖,以不同hCG樣品蛋白濃度0.25mIU、100mIU的檢測試片2與第一孔隙121、第二孔隙311相互配合,並分析各別的測試帶訊號雜訊比SNR(T)值變化。在本實施例中,當第一孔隙121的直徑固定為0.1mm時,第二孔隙311的直徑為1.0mm的測試帶訊號雜訊比SNR(T)值高於第二孔隙311的直徑為6.0mm的測試帶訊號雜訊比SNR(T)值。而當第二孔隙311的直徑固定為6.0mm時,第一孔隙121的直徑為0.1mm的測試帶訊號雜訊比SNR(T)值高於第一孔隙121的直徑為1.0mm的測試帶訊號雜訊比SNR(T)值。由此得知,無論在固定第一孔隙121或第二孔隙311的直徑固定條件下,縮小另一孔隙的直徑均可提升檢測訊號雜訊比SNR值,且藉由第一孔隙121與第二孔隙311的配合,可得到清楚且易於分析的量測信號電位波形及可得較佳的訊號雜訊比SNR值。特別是將第一孔隙121的直徑縮小為0.1mm及第二孔隙311的直徑都縮小為1.0mm的條件下,可得到最佳的訊號雜訊比SNR值。FIG. 6 is a schematic diagram of the signal-to-noise ratio of the test strip of this embodiment. The test strip 2 with different protein concentrations of 0.25mIU and 100mIU of hCG samples cooperates with the first pore 121 and the second pore 311, and analyzes each test. With signal to noise ratio SNR (T) value changes. In this embodiment, when the diameter of the first aperture 121 is fixed at 0.1 mm, the test band signal-to-noise ratio SNR (T) value of the test strip with a diameter of 1.0 mm of the second aperture 311 is higher than the diameter of the second aperture 311 is 6.0. The test band signal noise ratio (mm) of the mm. When the diameter of the second aperture 311 is fixed at 6.0 mm, the signal-to-noise ratio SNR (T) value of the test strip with a diameter of 0.1 mm of the first aperture 121 is higher than that of the test strip with a diameter of 1.0 mm of the first aperture 121 Noise ratio SNR (T) value. It can be seen that no matter whether the diameter of the first aperture 121 or the second aperture 311 is fixed, reducing the diameter of another aperture can improve the detection signal-to-noise ratio SNR value, and through the first aperture 121 and the second aperture The cooperation of the aperture 311 can obtain a clear and easy-to-analyze measurement signal potential waveform and a better signal-to-noise ratio SNR value. Especially under the condition that the diameter of the first aperture 121 is reduced to 0.1 mm and the diameter of the second aperture 311 is reduced to 1.0 mm, the best signal-to-noise ratio SNR value can be obtained.
如圖6所示,藉由上述訊號雜訊比SNR值的量化,可進一步推算出檢測試片2之待檢測標的濃度。As shown in FIG. 6, by quantifying the signal-to-noise-to-noise ratio SNR value, the concentration of the target to be detected in the test strip 2 can be further calculated.
綜上所述,本發明之光學檢測系統是藉由穿透式光學檢測路徑量測潛藏在試紙條纖維內部的檢測信號,提升檢測訊號的強度;利用光學檢測路徑的掃描式設計,沿檢測試片的第一視窗的長軸方向依序掃描第一視窗內的試紙條空白區塊、測試帶以及質控帶,以減少光學感測器的數量,降低讀取裝置設計的複雜度,並增加檢測試片上測試帶數量增減的彈性,同時降低對測試帶及質控帶的畫線精度要求。In summary, the optical detection system of the present invention measures the detection signal hidden inside the test strip fiber through a penetrating optical detection path to improve the intensity of the detection signal; the scanning design of the optical detection path is used to The long axis of the first window of the test piece sequentially scans the blank areas, test strips and quality control strips of the test strip in the first window in order to reduce the number of optical sensors and reduce the complexity of the design of the reading device. It also increases the flexibility of increasing and decreasing the number of test strips on the test strips, while reducing the precision requirements for drawing test strips and quality control strips.
本發明之光學檢測系統利用穿透式光學檢測路徑中的第一孔隙及第二孔隙相互配合,以增加量測信號的可靠度,提高量測信號的訊雜比及強度,提升量測信號的訊號雜訊比SNR值,進而降低檢測試片的最低檢測極限(Limitation of Detection, LOD),進而達到提升檢測儀器的方便性及靈敏度之目的。The optical detection system of the present invention uses the first pore and the second pore in the penetrating optical detection path to cooperate with each other to increase the reliability of the measurement signal, improve the signal-to-noise ratio and strength of the measurement signal, and improve the measurement signal. The signal-to-noise ratio SNR value further reduces the minimum detection limit (LOD) of the test strip, thereby achieving the purpose of improving the convenience and sensitivity of the testing instrument.
1‧‧‧發光模組 1‧‧‧light emitting module
11‧‧‧光源 11‧‧‧ light source
111‧‧‧光束 111‧‧‧ Beam
12‧‧‧第一遮光單元 12‧‧‧The first shading unit
121‧‧‧第一孔隙 121‧‧‧ first pore
2‧‧‧檢測試片 2‧‧‧test strip
21‧‧‧卡匣 21‧‧‧ Cassette
211‧‧‧第一視窗 211‧‧‧first window
212‧‧‧第二視窗 212‧‧‧Second window
213‧‧‧檢體開口 213‧‧‧ specimen opening
22‧‧‧試紙條 22‧‧‧ test strip
221‧‧‧空白區塊 221‧‧‧Blank block
222‧‧‧呈色材料 222‧‧‧Coloring material
3‧‧‧接收模組 3‧‧‧Receiving module
31‧‧‧第二遮光單元 31‧‧‧Second shading unit
311‧‧‧第二孔隙 311‧‧‧second pore
32‧‧‧光學感測器 32‧‧‧optical sensor
4‧‧‧試片移動裝置 4‧‧‧ Test piece moving device
C‧‧‧質控帶、質控帶信號 C‧‧‧Quality control zone, quality control zone signal
T‧‧‧測試帶、測試帶信號 T‧‧‧test strip, test strip signal
MA211‧‧‧長軸方向MA 211 ‧‧‧ Long axis direction
OD‧‧‧光學檢測系統 OD‧‧‧optical detection system
OP‧‧‧光學檢測路徑 OP‧‧‧Optical detection path
SNR、SNR(21)、SNR(221)、SNR(T)、SNR(C)‧‧‧訊號雜訊比 SNR, SNR (21), SNR (221), SNR (T), SNR (C) ‧‧‧Signal to noise ratio
Vav‧‧‧平均值 Vav‧‧‧Average
A0、A1、a0、a1、a2、an‧‧‧時間值A0, A1, a 0 , a 1 , a 2 , an n ‧‧‧ time value
△A‧‧‧第一視窗時間 △ A‧‧‧First window time
△a1、△a2、△an‧‧‧時間差值△ a 1 , △ a 2 , △ a n ‧‧‧ time difference
圖1為本發明一實施例的一種光學檢測系統的示意圖。 圖2為本發明一實施例的光學檢測路徑的示意圖。 圖3A為本發明一實施例的檢測試片立體示意圖。 圖3B為圖3A所示檢測試片的爆炸示意圖。 圖4為本發明一實施例的輸出量測信號的電位波形示意圖。 圖5為本發明另一實施例的輸出量測信號的電位波形示意圖。 圖6為本發明一實施例的測試帶訊號雜訊比的示意圖。FIG. 1 is a schematic diagram of an optical detection system according to an embodiment of the present invention. FIG. 2 is a schematic diagram of an optical detection path according to an embodiment of the present invention. FIG. 3A is a schematic perspective view of a test strip according to an embodiment of the present invention. FIG. 3B is an exploded view of the test piece shown in FIG. 3A. FIG. 4 is a schematic diagram of a potential waveform of an output measurement signal according to an embodiment of the present invention. FIG. 5 is a schematic diagram of a potential waveform of an output measurement signal according to another embodiment of the present invention. FIG. 6 is a schematic diagram of a test strip signal-to-noise ratio according to an embodiment of the present invention.
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