WO2013020307A1 - 分析读数装置及分析读数方法 - Google Patents

分析读数装置及分析读数方法 Download PDF

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Publication number
WO2013020307A1
WO2013020307A1 PCT/CN2011/078967 CN2011078967W WO2013020307A1 WO 2013020307 A1 WO2013020307 A1 WO 2013020307A1 CN 2011078967 W CN2011078967 W CN 2011078967W WO 2013020307 A1 WO2013020307 A1 WO 2013020307A1
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Prior art keywords
light
reading device
test strip
analytical
source
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PCT/CN2011/078967
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English (en)
French (fr)
Inventor
王继华
王治才
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广州万孚生物技术股份有限公司
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Application filed by 广州万孚生物技术股份有限公司 filed Critical 广州万孚生物技术股份有限公司
Priority to US13/702,468 priority Critical patent/US9097665B2/en
Priority to EP11867578.4A priority patent/EP2587249B1/en
Publication of WO2013020307A1 publication Critical patent/WO2013020307A1/zh

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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
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/55—Specular reflectivity
    • 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
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/8483—Investigating reagent band

Definitions

  • the invention relates to the field of laboratory testing, in particular to an analytical reading device for an assay reaction and an analytical reading method.
  • EP291194 discloses a cross-flow immunoassay device for measuring HCG, which is a single-use test strip, which requires the user to read the result, has a certain degree of subjectivity, and requires an additional timer, and the result is The color is displayed, and the color of the result will be deepened with time, which will affect the interpretation effect; the device disclosed in EP653625 uses optical methods to obtain the result, and the analysis test strip disclosed in EP291194 is inserted into the reader to position the test strip.
  • the reader On the optical element of the reader, light emitted from the light source illuminates the test strip and the reflected light or transmitted light is detected by the photodetector.
  • the reader contains at least one light emitting diode, and each light emitting diode is provided with a corresponding light detector, which is a multiple use electronic pen. Similar to this type of analytical instrument, the analytical reader and test strip need to be carefully positioned because the visible signal formed in the detection zone and the control zone is rather weak, so the detection or control zone has a small displacement for the corresponding photodetection zone. Will significantly affect the detector's readings.
  • the photodetector is close to the test strip because the photodiode captures a relatively small amount of light, and the signal strength generally follows the inverse square law, so it rapidly decreases with the distance between the test strip and the photodetector. .
  • the user needs to carefully position the test stick and the analysis result reader, especially for household equipment.
  • the analytical instruments used many times, especially such small ones, are easily displaced due to repeated insertion of the test strips, and a slight misalignment causes errors.
  • the replacement of the paper strip is prone to improper installation, so that the reader that is sensitive to the optical path will cause a judgment error due to a slight error.
  • No. 5,837,546 discloses a method of autoimmune device by providing an additional electrode through a cross-flow carrier, detecting the presence of fluid on the carrier, and generating a signal to turn the detection electronics on, displaying the test results, but in different tests
  • the velocity of the liquid flowing along the carrier varies, and different types of liquid flow characteristics can result in inaccurate readings. Due to the inconsistent properties of the materials used in the wick and the porous membrane, the optimum time point for reading results will be different.
  • CN1573315B discloses an assay result reading device for reading the results of an assay performed using a liquid transport carrier, for solving the problem of how to determine an optimal reading period, but still failing to solve the problem of different flow rate standards for different fluids.
  • some testing and analysis instruments are too long.
  • an assay-based commercial cross-flow testing tool for detecting heart damage requires up to 15 minutes to complete the test.
  • CN 1573316B discloses an analytical reading optical device which also includes a light source and a photodetector, but which is complicated and has many optical paths, which are prone to change and thus affect the result. Did not achieve the goal of optimization.
  • the invention provides an analytical reading device for reading and analyzing a test strip of an assay test
  • the test strip is provided with a detection area and a blank area
  • the analysis reading apparatus comprises a photoelectric detection circuit and a processor
  • the photoelectric detection The circuit detects the light reflection intensity signal of the detection area and the blank area, and feeds back the detection information to the processor
  • the photoelectric detection circuit includes: at least two light sources, corresponding to the test area and the blank area position of the test strip, capable of being issued Light corresponding to the test zone and the blank zone of the test strip; and at least one photodetector that receives reflected light from two regions; the light emitted by the at least two light sources illuminates the test strip The area and the blank area, and the reflection is received via the photodetector, and then the detection information is fed back to the processor.
  • the analysis reading device provides an optimal optical path between the light source and the photodetector, and has a short optical path and a simple structure, and can retain a strong signal without performing optical compensation, and the light intensity signal is passed through the processor.
  • the setting is converted into a judgment value for judgment comparison.
  • the analytical reading device disclosed herein can include any number of light sources and any number of light detectors.
  • three light sources are included, each of which illuminates a corresponding area of the test strip.
  • the three areas can share a single detector, and the order of detection is also received sequentially in the order in which the light is emitted by the light source.
  • the analytical reading device is characterized primarily by the presence of a shared photodetector. According to the same principle, the number of photodetectors can be increased or decreased according to the needs of specific tests.
  • the light source uses a light emitting diode
  • the light detector is a photoelectric sensor
  • the analytical reading device uses two light sources, a first light source and a second light source, respectively, and the emitted light is irradiated to the test area and the blank area of the test strip, and the reflection is received via the photoelectric sensor.
  • the first light source and the second light source are both light emitting diodes.
  • the first light source and the second light source respectively correspond to the illumination test area and the blank area.
  • the two light sources emit light sequentially, and the reflected light is received by a common photoelectric sensor. The structure is simplified, the interference is less, and the detection result is more accurate.
  • the first light source and the second light source are both green light emitting diodes.
  • the emitted light is respectively irradiated on the colored detection area and the blank area, and the contrast effect is increased, and the reflection effect is increased. The accuracy of the reading, especially when the detection zone is red after the reaction.
  • the first light source and the second light source have the same wavelength.
  • the at least two light sources emit light with a difference in time before and after, and the photoelectric sensor also has a difference in front and back time when receiving light reflected from different regions.
  • the light sources are optimally arranged such that each light source is only specifically illuminated by a particular area, and between the light sources, there is a partition between the light source and the light detector to Limit the area of the test strip that is illuminated by each source, the effect between the light sources, and eliminate the effects of the detected light.
  • the analytical reading device further comprises a T-shaped partition separating the first light source, the second light source, and the photosensor. This prevents light from interfering between the two detection areas of the blank area and the detection area, and between the light emitting area and the receiving area.
  • Two light sources and photoelectric sensors are located on the opposite side of the detection area and the blank area, wherein the two light sources are in the same column, and the photoelectric receiver is opposite to the two light sources, and is separated by a T-shaped partition in the middle to prevent the same from being different. Or light of different wavelengths interferes.
  • Such an arrangement makes that light from different light sources can be respectively irradiated on the detection area and the blank area in the process of use, and the photoelectric sensors sequentially receive the diffuse reflection light of different light sources.
  • the photosensor produces a voltage that is approximately positively related to the intensity of the light incident thereon.
  • This voltage is caused by the accumulation of the label, and also depends on the amount of the analyte in the sample, and then the amount present in the sample is detected, and then the processor calculates the judgment value according to the calculation principle of the judgment value and compares it with the threshold value.
  • the reflected light can be measured by a photosensor, which means that the light from the light source is reflected by the test strip and enters the photodetector (photosensor).
  • the test strip may be affected by the dry humidity due to the passage of time.
  • the present invention calculates the judgment value by setting the calculation method, and compares it with the changed threshold value, thereby obtaining the best judgment result. .
  • the preferred source of light for the configuration is a light emitting diode
  • the preferred photodetector is a photosensor equipped with a processor that converts the light intensity signal into comparable decision values.
  • the T-shaped partition portion between the first light source, the second light source and the photosensor, and the detection area and the blank area of the test strip, and the light emitted by the first light source and the second light source is irradiated A test zone and a blank zone of the test strip through which reflected light enters the photosensor to be received.
  • the photoelectric sensor and the light source are disposed on the same side.
  • the reflected light is mainly light that is diffusely reflected through the gap between the light source and the intermediate partition of the photoreceiver.
  • the signals accumulated during the detection include the formation or accumulation of substances that are easily detected (such as the result of a color reaction).
  • the assay preferably includes the accumulation of markers, typically the accumulation of markers in the detection zone.
  • the label may be colored particles such as an enzyme, a radioisotope tracer, fluorescein, colloidal gold, or color latex.
  • a particular test in a sample causes accumulation of the signal, but in some cases, such as competition, the absence of the particular test will cause accumulation of the associated signal.
  • the reaction leading to signal accumulation can be any suitable reaction, such as a conventional chemical reaction, an enzyme-linked reaction, or an immuno-coupling reaction between two chemical entities.
  • a preferred immunoconjugate reaction will include the binding of at least one biomolecule.
  • a preferred reaction comprises the labeling complex binding to a specific reagent in a strip of detection reagent immobilized in the detection zone, the marker accumulating in the binding zone.
  • the blank control area is only the area that acts as a "background” signal, as the signal can be used to calibrate the analytical reading device and/or provide a referenceable background signal for the signal.
  • the test strip comprises a porous water-permeable carrier comprising a label-specific binding reagent and a specific binding reagent without a label.
  • the analysis reading device detects the cumulative amount of the marker, and the detection signal is proportional to the cumulative amount of the marker, and the determination value and the cumulative amount of the marker are also proportional to the calculation manner of the determination value.
  • the analytical reading device can measure optical properties such as the amount of reflected light in the detection zone or blank zone. Reflected light is reflected from the porous water-permeable carrier or other liquid transport device to the photosensor.
  • the analytical reading device further comprises an outer casing of opaque synthetic plastic, typically a synthetic plastic material such as ABS, polystyrene, and the like.
  • opaque synthetic plastic typically a synthetic plastic material such as ABS, polystyrene, and the like.
  • the outer casing of the analytical reading device has an aperture for receiving at least a portion of the test strip inside the analytical reading device; and providing the position, shape and size of the aperture, light source, and photodetector for installation
  • the test strip After the test strip, the light emitted by the light source is incident on the detection area and the blank area, and the light reflected from the area is incident on the photoelectric sensor, so that an assay signal is generated, indicating that the test in the area The amount of matter.
  • the test strip fixes the small hole.
  • the test strip includes a sample stick, the half of the sample stick is exposed outside the small hole, and the other half is inside the outer casing of the analytical reading device.
  • the outer part of the sample stick is used for sucking the sample liquid, and the test strip
  • the detection zone and the blank zone provided above are inside the housing of the analysis reading device, opposite to the light source and photodetector of the photodetection circuit.
  • the test strip is fixed in the analytical reading device, avoiding errors caused by the movement of the test strip, and the test strip does not need to be repositioned.
  • the aspirating rod of the test strip can be any conventional cross-flow test aspirating rod, preferably comprising a porous water-permeable carrier comprising a specific reagent bound to the label and a specific binding reagent without label.
  • the marker is a colored particle.
  • the light source and the photodetector are disposed no more than 0.5 cm 2 in accordance with the demand for volume miniaturization.
  • the present invention also provides an analytical reading method using the analytical reading device as described above, comprising the steps of: the processor separately controlling the at least two light sources to respectively illuminate according to the timing design, and the light is irradiated on the blank area and the test area of the test strip Thereafter, the reflection is received by the photodetector, and then the detection information is fed back to the processor, and the processor performs analysis and determination based on the received detection information.
  • the timing design of the processor is implemented by software.
  • the analytical reading device provides an optimal optical path between the light source and the photodetector, and the light intensity signal is converted to a decision value for comparison by the setting of the processor.
  • This optical path optimized device and reading method can be used on other similar spectral sensing devices.
  • the analysis reading device of the invention has the advantages of simple structure, economical and practicality, and the overall price is relatively low based on the selected material.
  • the analysis reading device and the analytical reading method of the invention have less reading interference and high precision.
  • FIG. 1 is a schematic exploded view showing the structure of an analytical reading device of the present invention
  • 2 is a schematic view showing the distribution of a light source and a photoelectric sensor of the analytical reading device of the present invention
  • Figure 3 is a schematic view of a T-shaped separator of the analytical reading device of the present invention
  • 4 is a schematic view showing a combination of a light source and a photoelectric sensor of the present invention and a T-shaped separator
  • 5 is a schematic view showing the principle of light reflection in the detection area and the blank area of the present invention
  • 6 is a schematic structural view of a photodetection circuit of the present invention
  • Figure 7 is a schematic flow chart of the analytical reading method of the present invention.
  • the analysis reading device of the present invention specifically includes a processor 1 (CPU) or a micro controller, a test strip 2, a photodetection circuit (not shown), a substrate 3, a bracket 4, and a shell.
  • the processor 1 and the photodetection circuit are disposed on the substrate 3.
  • the test strip 2 is disposed on one side of the bracket 4, and the substrate 3 is located on the other side of the bracket 4, and the bracket 4 is provided with a detection window. 41.
  • the test strip 2 is provided with a detection area and a blank area.
  • the photodetection circuit and the detection area and the blank area are respectively located on two sides of the detection window 41 and correspond to each other.
  • the photoelectric detecting circuit comprises two LEDs (as a light source) and a photoelectric sensor.
  • the light emitted by the two LEDs is respectively transmitted through the detecting window 41 to the detection area and the blank area, and the light is reflected and received by the photoelectric sensor, and the processor is used for detecting
  • the cumulative amount of the signal is determined from the output of the photosensor, and the determination value is calculated, and the determination value is compared with the threshold.
  • the carrier 4 is also provided with a desiccant 40 to maintain the dryness inside the device to ensure the accuracy of the detection.
  • the power source used in the analytical reading device is a 3V button battery 30 in this embodiment.
  • the housing includes an upper housing 51, a lower housing 52, a front cover 53, and a battery cover 54, and the processor 1, the test strip 2, the photodetection circuit, the substrate 3, and the bracket 4 are placed in the shell.
  • the battery cover 54 can be opened separately to replace the battery.
  • the outer casing is approximately 15 cm long, 2.5 cm wide, and 1.5 cm high and is constructed of an opaque material, typically a synthetic plastic material (e.g., ABS, polystyrene, etc.).
  • the photodetection circuit includes two green LEDs. 61, 62 (first light source and second light source, respectively), and a photosensor 63, the emitted light is irradiated to the test zone 21 and the blank area 22 of the test strip 2, and the reflection is received via the photosensor 63.
  • the light source and the photosensor are set no more than 0.5 cm2, which meets the requirements of volume miniaturization.
  • Two LEDs 61, 62 and the photosensor 63 are separated by a T-shaped spacer 42 provided in the detection window 41, thereby preventing the detection area between the blank area 21 and the detection area 22, and the light emission area and receiving Light between the zones interferes with each other.
  • Two LEDs on one side of the detection window 41 61, 62 and photosensor 63, the other side is a blank area 21 and a detection area 22.
  • Two of the light sources are in the same column, and the photoreceiver is opposite to the two light sources, and is separated by a T-shaped spacer in the middle to prevent the interference of light of the same or different wavelengths of the two different light sources.
  • the T-head position a of the T-shaped partition 42 is slightly lower, forming a gap between the T-shaped partition 42 and the test strip 2.
  • Two LEDs 61, 62 respectively correspond to the illumination test area 21 and the blank area 22, the two light sources emit light successively, and then illuminate the test area 21 and the blank area 22 and then reflect, and the reflected light passes between the T-shaped partition 42 and the test strip 2.
  • the gap is reflected to be received by a common photosensor 63, which is disposed on the same side.
  • the reflected light is mainly light that is diffusely reflected through the gap between the light source and the intermediate partition of the photoreceiver. The structure is more simplified, the interference is less, and the detection result is more accurate.
  • the front end of the outer casing of the analytical reading device has a small hole (not shown) which can be covered by the front cover 53 and the test strip 2 is fixed in the small hole.
  • the test strip includes the suction rod 23, and the suction rod 23 is half exposed in the small hole.
  • the other half is inside the outer casing of the analytical reading device, and the outer portion of the aspirating rod 23 is used for sucking the sample liquid, and the detecting area 21 and the blank area 22 provided on the test strip are inside the outer casing of the analytical reading device, and the photodetecting circuit
  • the light source is opposite the photodetector.
  • the test strip 2 is fixed inside the analytical reading device, and can be fixed on the bracket 4 to avoid errors caused by the movement of the test strip, and the test strip does not need to be repositioned.
  • the aspirating rod 23 of the test strip can be any conventional cross-flow test aspirating rod, preferably comprising a porous water-permeable carrier comprising a label-specific binding reagent and a specific binding reagent without labeling.
  • the analysis reading device detects the cumulative amount of the marker, and the detection signal is proportional to the cumulative amount of the marker, and the determination value and the cumulative amount of the marker are also proportional to the calculation manner of the determination value.
  • the analytical reading device can measure optical properties such as the amount of reflected light in the detection zone or blank zone. Reflected light is reflected from the porous water-permeable carrier or other liquid transport device to the photosensor.
  • the label is a colored particle.
  • the label may be colored particles such as an enzyme, a radioisotope tracer, fluorescein, colloidal gold, or color latex.
  • the upper housing 51 of the analytical reading device is further provided with a liquid crystal display connected to the processor for outputting the working state and the determination result of the analytical reading device.
  • the two LEDs together. 61, 62 emit light with a difference of time before and after, through the programming in the processor, the photoelectric sensor also receives the difference between the front and back time when receiving light reflected from different areas.
  • the photoelectric sensor sequentially receive the diffuse reflection light of different light sources.
  • the photosensor produces a voltage that is approximately positively related to the intensity of the light incident thereon.
  • This voltage is caused by the accumulation of the label, and also depends on the amount of the analyte in the sample, and then the amount present in the sample is detected, and then the processor calculates the judgment value according to the calculation principle of the judgment value and compares it with the threshold value.
  • the reflected light can be measured by a photosensor, which means that the light from the light source is reflected by the test strip and enters the photosensor.
  • the present invention also provides an analytical reading method using the analytical reading device as described above.
  • the method includes the following steps: the processor separately controls the at least two light sources to be respectively illuminated according to the timing design, and the light is irradiated on the blank of the test strip. After the zone and the test zone, the light detector is received by the reflection, and then the detection information is fed back to the processor, and the processor analyzes and determines according to the received detection information.
  • the timing design of the processor is implemented by software.
  • a particular test in a sample causes accumulation of the signal, but in some cases, such as competition, the absence of the particular test will cause accumulation of the associated signal.
  • the reaction leading to signal accumulation can be any suitable reaction, such as a conventional chemical reaction, an enzyme-linked reaction, or an immuno-coupling reaction between two chemical entities.
  • a preferred immunoconjugate reaction will include the binding of at least one biomolecule.
  • the device is in a dormant state after being shipped to reduce energy consumption. Only when the sample is sucked, the flow of the liquid in the aspirating rod causes a change in the resistance of the circuit, so that the device automatically activates from the "sleep" mode and enters the working state. .
  • the device When in use, in use, directly insert the front end of the sample stick into the sample, the device is activated after the sample is applied, the left electrode 11 and the right electrode 12 of the photodetection circuit are turned on and the normal measurement starts, wait for 8 seconds, then enter Working mode, two LEDs are time-divisional, the reader starts to execute, and the corresponding voltage is detected by the photoelectric sensor, and sent to the processor.
  • the signal is obtained to obtain the initial value of the detection area and the blank as the pre-loading reference. More than the signal. Wait for N seconds and then repeat the detection action.
  • the detected signal is used as the result determination signal, and the detection result is obtained by combining the corresponding algorithm.
  • the algorithm can refer to the general operation of the industry, and will not be described here.
  • the light intensity signal is received according to the chronological order in which the light sources are illuminated.
  • the initial value is scanned so that it is used as a base for calculating the decision value.
  • the sample can also be directly drenched on the sample stick of the test equipment. Be careful not to wet other parts.
  • the funnel type symbol on the observation window starts to flash (while the buzzer sounds)
  • the device is removed. Place the sample on top; or collect the sample in a clean disposable or clean container, and then insert the sample stick of the test pen into the sample.
  • the sample level should be immersed in more than three-folds of the sample stick.
  • the type symbol starts to flash (while the buzzer sounds)
  • the device detection pen is taken out, and the liquid crystal display is placed face up. The device will start measuring one or more values for comparison according to the programmed procedure.
  • the analytical reading device provides an optimal optical path between the light source and the photodetector, and the light intensity signal is converted to a decision value for comparison by the setting of the processor.
  • This optical path optimized device and reading method can be used on other similar spectral sensing devices.

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Abstract

一种分析读数装置及分析读数方法，用于对化验检测的测试条（2）进行读数和分析，该测试条（2）上设有检测区（21）和空白区（22）。该分析读数装置包括光电检测电路和处理器（1），该光电检测电路包括：至少两个光源（61，62），其与该测试条（2）的检测区（21）和空白区（22）位置相应，能够发出与该测试条（2）的检测区（21）和空白区（22）相应的光；和至少一个光电检测器（63），该光电检测器（63）接收来自两个区域的反射光线；至少两个光源（61，62）所发出的光照射到测试条（2）的检测区（21）和空白区（22），并反射经由光电检测器（63）接收，然后反馈检测信息给处理器（1）。该分析读数方法包括：处理器（1）根据时序设计分别控制至少两个光源（61，62）分别点亮，光线照射在测试条（2）的空白区（22）和检测区（21）后，经反射由光电检测器（63）接收，然后反馈检测信息给处理器（1），处理器（1）根据所接收的检测信息进行分析和判定。该分析读数装置及分析读数方法具有读数干扰少、精确度高的优点。

Description

分析读数装置及分析读数方法
【技术领域】
本发明涉及化验检测领域，尤其是指一种化验反应的分析读数装置及分析读数方法。
【背景技术】
市场上已经有不少的对化验物分析的设备，具体的，也有一些相关的发明专利。如EP291194中公开了一种横流式免疫分析装置，用于测量HCG，属于一次性使用试纸条，需要用户读取结果，具有一定程度的主观性，而且需要另外加设计时器，而且结果以颜色显示出来，结果的颜色会随着时间的递增而加深，从而会影响判读的效果；EP653625公开的装置，利用光学方法获得结果，将EP291194中公开的分析测试条插入读数器，使得测试条定位于读出器的光学元件上，从光源发射的光照射试纸条，并用光检测器检测反射光或透射光。典型地，该读数器至少含有一个发光二极管，并且每个发光二极管都设有相应的光检测器，属于多次性使用电子笔。类似的这种分析仪器，需将分析读数器和测试条仔细定位，这是因为在检测区和控制区中形成的可见信号相当弱，所以检测或控制区对于相应的光检测区发生小位移就会显著地影响检测器的读数。另外光检测器要与测试条靠近是非常重要的，因为光敏二极管捕获的光量相当少，而且信号强度通常遵守平方反比定律，因此，它随着测试条和光检测器之间的距离而迅速减小。这样一来，就需要用户将测试棒和分析结果读出器仔细定位，尤其是家用设备。而多次使用的分析仪器，特别是这种小型的，很容易会因为试纸条的反复插入，造成错位，而微量的错位就会进而产生误差。纸条的替换，容易发生安装不当的操作，这样对本来对光程敏感的读数器会因为一点的误差而引起判断错误。
US5837546公开一种自动免疫设备的方法，通过一个横流载体提供附加的电极，检测该载体上是否存在流体，并产生一个信号来接通所述检测电子装置，显示检测结果，但是在不同的测试中，液体沿载体流动的速度各不相同，不同类型的液体流速特性会导致读取不准确的结果。由于吸液芯和多孔渗水膜所用材料不一致的属性，读取结果的最佳时间点也会不同。
CN1573315B公开一种化验结果读出设备，用于读取使用液体传输载体执行的化验结果，针对解决如何确定最佳的读数时期的问题，但是还是解决不了不同流体不同流速标准的问题。同时，有些检测分析仪器检测时间过长，如检测心脏损伤的基于化验的商业横流检测工具要求长达15分钟才能完成所述化验。
CN 1573316B公开了一种分析读数光学装置，里面也包括了光源和光检测器，但是其较为复杂，光路较多，容易发生变故进而影响结果。没达到最优化的目的。
因此，提供一种检测光路简单、干扰少、检测电路结构简单、读数精确的分析读数装置及分析读数方法实为必要。
【发明内容】
本发明的目的在于提供一种检测电路结构简单、读数精确的分析读数装置。
本发明的再一目的在于提供一种读数精确的分析读数方法。
为实现本发明目的，提供以下技术方案：
本发明提供一种分析读数装置，用于对化验检测的测试条进行读数和分析，该测试条上设有检测区和空白区，该分析读数装置包括光电检测电路和处理器，所述光电检测电路对检测区和空白区的光反射强度信号进行检测，并反馈检测信息给处理器，该光电检测电路包括：至少两个光源，与所述测试条的测试区和空白区位置相应，能够发出与所述测试条的测试区和空白区相应的光；和至少一个光检测器，光检测器接收来自两个区域的反射光线；所述至少两个光源所发出的光照射到测试条的测试区和空白区，并反射经由所述光检测器接收，然后反馈检测信息给处理器。
该分析读数装置在光源和光检测器之间提供了一种最佳的光路路径，且光程短，结构简单，可以保留较强的信号，不需要做光补偿，得出光强信号通过处理器的设置，转化成供判断比较的判定值。
理论上，本发明公开的分析读数装置可以包含任意数量的光源和任意数量的光检测器。如，在一个实施例中包含三个光源，每个光源照射测试条的一个相应区域，三个区域可以共用一个检测器，检测的顺序也是按照光源发射光的顺序先后接收。
在优选的实施例中，该分析读数装置的特征主要是存在共享的光检测器。根据相同的原理，可以根据具体测试的需要，增减或者减少光检测器的数量。
优选的，该光源采用发光二极管，所述光检测器为光电传感器。
优选的，该分析读数装置采用两个光源，分别为第一光源和第二光源，所发出的光照射到测试条的测试区和空白区，并反射经由所述光电传感器接收。优选的，该第一光源和第二光源均为发光二极管。第一光源和第二光源分别单独对应照射测试区和空白区，两个光源先后发出光线，反射的光线由共同的光电传感器接收，该结构更简化，干扰少，检测结果更精确。
优选的，该第一光源和第二光源均为绿光发光二极管，在化验反应发生的条件上，发出光线分别照射在有颜色的检测区和空白区上，有对比较大的反射效果，增加读数的精确性，特别是反应后检测区为红色时。
优选的，该第一光源和第二光源的波长一样。
优选的，该至少两个光源发射光线有前后时间的差异，光电传感器接收不同区域反射光线时也存在前后时间的差异。
优选地，当分析读数装置包含多个光源的时候，将这些光源优化设置，使得每一个光源只特定照射一个特定的区域，并在光源之间，光源和光检测器之间有隔板相隔，以限制测试条上被每个光源照射的区域、光源之间的影响，以及消除检测光线的影响。
优选的，该分析读数装置进一步包括一个将第一光源、第二光源、光电传感器分隔开的T形隔板。这样可以防止空白区和检测区这两个检测区域之间，以及光线发射区和接受区之间光线相互干扰。
两个光源和光电传感器位于与检测区和空白区相对的一侧，其中两个光源同为一列，光电接收器在两个光源的对面，中间用T型隔板相隔，以防止不同光源的相同或不同波长的光发生干预。这样的排列使得在使用的过程中，来自不同光源的光，可以先后分别照射在检测区和空白区上，光电传感器也先后的接收不同的光源的漫反射的光线。该光电传感器产生一个与照在其上的光的强度约成正相关的线性关系的电压。这个电压是由标记物的积累量导致的，同时，也取决于样品中化验物的量，进而检测样品中存在的量，再由处理器根据判定值的计算原理计算判定值进而和阈值进行比较。反射光可以用光电传感器来测量，反射光指的是来自光源的光经过测试条反射后进入光检测器（光电传感器）。
所述的测试条会因为时间的推移干湿度会受到影响，本发明在检测光强度之后，通过设定计算方式计算出判定值，与变动的的阈值相比较，进而得出最佳的判定结果。
所述的配置优选的光源是发光二极管，并且优选的光检测器是光电传感器，配备一个处理器，将光强信号转化成可比较的判定值。
优选的，在第一光源、第二光源与光电传感器之间的T形隔板部分，与测试条的检测区和空白区之间存在间隙，第一光源和第二光源所发出的光照射到测试条的测试区和空白区，反射光通过所述间隙进入所述光电传感器由其接收。光电传感器和光源设置在同侧。反射的光主要是透过光源和光电接收器中间隔板的间隙漫反射的光线。
在检测过程中累积的信号包括容易检测的物质的形成或累积（如颜色反应的结果）。具体地，所述化验最好是包括标记物的累积，通常是标记物在检测区的累积。所述的标记物可以是酶、放射性同位素示踪、荧光素、胶体金、彩色胶乳等有色粒子。
通常，在样品中的特定化验物会引起所述信号的累积，但是在某些情况下，如竞争等反应中，所述的特定化验物不存在会引起有关信号的累积。导致信号累积的反应可以是任何合适的反应，如两种化学实体间的常规化学反应、酶联反应、或免疫偶联反应。优选的免疫偶联反应将包括至少一个生物分子的结合。
优选的反应包含标记物复合体与固定在检测区的检测试剂条中特定的试剂结合，标记物在结合区中累积。
通常，空白对照区只是起到“背景”信号的区域，如该信号可用于校准分析读数装置和/或为信号可提供可参考的背景信号。
优选的，所述测试条包括多孔渗水载体，该载体包含一个标记物特定结合试剂和一个不带标记物的特定结合试剂。
该分析读数装置检测所述标记物的累积量，检测信号和标记物的累积量成正比，根据判定值的计算方式，判定值和标记物的累积量也成正比。该分析读数装置可以测量光学属性，如检测区或空白区反射光的量。反射光表示的是从所述的多孔渗水载体或其他液体传输装置反射到所述光电传感器。
优选的，该分析读数装置进一步包括由不透光合成塑料构成的外壳，通常是合成塑料材料，如ABS、聚苯乙烯等。
优选的，该分析读数装置的外壳有一小孔，用于在所述分析读数装置内部接收测试条的至少一部分；且设置所述小孔、光源、和光检测器的位置、形状和大小，使得安装测试条后，所述的光源发出的光入射到检测区和空白区上，且从所述区反射出来的光入射到所述光电传感器上，使其产生一个化验信号，表示所述区中化验物的量。测试条固定小孔其中，测试条包括有吸样棒，该吸样棒一半外露在小孔外，另外一半在分析读数装置的外壳里面，吸样棒外面的部分用于吸取样品液，测试条上设置的检测区和空白区在分析读数装置的外壳里面，与光电检测电路的光源和光检测器相对。测试条是固定在分析读数装置里面，避免了因为测试条的移动而造成的误差，测试条不需要重新定位。
测试条的吸样棒可以是任何常规的横流测试吸样棒，优选地包括多孔渗水载体，该载体包含一个与标记物结合的特定试剂和一个不带标记物的特定结合试剂。
优选的，所述标记物为有色粒子。
优选的，其中所述光源和所述光检测器被设置不超过0.5cm2，符合体积小型化的需求。
本发明还提供一种采用如上所述分析读数装置的分析读数方法，其包括如下步骤：处理器根据时序设计分别控制该至少两个光源分别点亮，光线照射在测试条的空白区和测试区后，经反射由光检测器接收，然后反馈检测信息给处理器，处理器根据所接收的检测信息进行分析和判定。
所述处理器的时序设计是通过软件实现的。
该分析读数装置在光源和光检测器之间提供了一种最佳的光路路径，得出光强信号，通过处理器的设置，转化成供判断比较的判定值。这种光路优化的装置和读数方法，可以用于其它类似的光谱检测设备上。
对比现有技术，本发明具有以下优点：
本发明所述的分析读数装置结构简单、经济实用，基于所选取的材质，整体价格比较低廉，采用本发明分析读数装置及分析读数方法，读数干扰少，精确度高。
【附图说明】
图1为本发明分析读数装置结构分解示意图；
图2为本发明分析读数装置的光源和光电传感器的分布示意图；
图3为本发明分析读数装置的T形隔板的示意图；
图4为本发明的光源和光电传感器与T形隔板相结合的示意图；
图5为本发明的检测区和空白区的光线反射原理示意图；
图6为本发明的光电检测电路结构示意图；
图7为本发明的分析读数方法的流程示意图。
【具体实施方式】
请参阅图1，在本实施例中，本发明分析读数装置具体包括处理器1（CPU）或微控器、测试条2、光电检测电路（图未示）、基板3、托架4、壳体，该处理器1和光电检测电路设置在基板3上，该测试条2设置在托架4的一侧，该基板3位于托架4的另一侧，该托架4上设有检测窗口41，该测试条2上设有检测区和空白区，该光电检测电路与该检测区和空白区分别位于检测窗口41的两侧并相对应。该光电检测电路包括两个LED（作为光源），以及一个光电传感器，两个LED发出的光线透过检测窗口41分别照射在检测区和空白区，光线反射后由光电传感器接收，处理器用来检测从光电传感器的输出确定信号的累积量，并计算判定值，以及将判定值和阈值进行比较。
该托架4上还设有干燥剂40，以保持装置内的干燥度，确保检测的准确性。
该分析读数装置所采用的电源在本实施例中为3V的纽扣电池30。本实施例中，该壳体包括上壳体51、下壳体52、前盖53和电池盖54，所述处理器1、测试条2、光电检测电路、基板3、托架4置于壳体内，电池盖54可单独打开，以更换电池。在优选实施例中，外壳大约15cm长，2.5cm宽，1.5cm高，由不透光材料构成，通常是合成塑料材料（如ABS、聚苯乙烯等）。
请一并参阅图2~5，该光电检测电路包括两个绿光LED 61、62（分别为第一光源和第二光源），以及一个光电传感器63，所发出的光照射到测试条2的测试区21和空白区22，并反射经由所述光电传感器63接收。其中所述光源和所述光电传感器被设置不超过0.5cm2，符合体积小型化的需求。
两个LED 61、62以及光电传感器63之间通过设置在检测窗口41中的T形隔板42分隔开，这样可以防止空白区21和检测区22这两个检测区域之间，以及光线发射区和接受区之间光线相互干扰。在检测窗口41的一侧为两个LED 61、62以及光电传感器63，另一侧为空白区21和检测区22。其中两个光源同为一列，光电接收器在两个光源的对面，中间用T型隔板相隔，以防止两种不同光源的相同或不同波长的光发生干预。
T形隔板42的T头位置a略低，形成T形隔板42与测试条2之间的间隙。两个LED 61、62分别单独对应照射测试区21和空白区22，两个光源先后发出光线，照射到测试区21和空白区22然后反射，反射的光线通过T形隔板42与测试条2之间的间隙，反射到由共同的光电传感器63接收，光电传感器和光源设置在同侧。反射的光主要是透过光源和光电接收器中间隔板的间隙漫反射的光线。该结构更简化，干扰少，检测结果更精确。
该分析读数装置的外壳的前端有一小孔（未标示），可通过前盖53遮盖，测试条2固定小孔中，测试条包括有吸样棒23，该吸样棒23一半外露在小孔外，另外一半在分析读数装置的外壳里面，吸样棒23外面的部分用于吸取样品液，测试条上设置的检测区21和空白区22在分析读数装置的外壳里面，与光电检测电路的光源和光检测器相对。测试条2是固定在分析读数装置里面，具体可固定在托架4上，避免了因为测试条的移动而造成的误差，测试条不需要重新定位。
测试条的吸样棒23可以是任何常规的横流测试吸样棒，优选地包括多孔渗水载体，该载体包含一个标记物特定结合试剂和一个不带标记物的特定结合试剂。该分析读数装置检测所述标记物的累积量，检测信号和标记物的累积量成正比，根据判定值的计算方式，判定值和标记物的累积量也成正比。该分析读数装置可以测量光学属性，如检测区或空白区反射光的量。反射光表示的是从所述的多孔渗水载体或其他液体传输装置反射到所述光电传感器。
所述标记物为有色粒子。所述的标记物可以是酶、放射性同位素示踪、荧光素、胶体金、彩色胶乳等有色粒子。
作为较佳实施例，该分析读数装置的上壳体51上还设有与处理器连接的液晶显示屏，用于输出该分析读数装置的工作状态和判定结果。
请一并参阅图6和图7，该两个LED 61、62发射光线有前后时间的差异，通过处理器中编程实现，光电传感器接收不同区域反射光线时也存在前后时间的差异。这样的排列使得在使用的过程中，来自不同光源的光，可以先后分别照射在检测区和空白区上，光电传感器也先后的接收不同的光源的漫反射的光线。该光电传感器产生一个与照在其上的光的强度约成正相关的线性关系的电压。这个电压是由标记物的积累量导致的，同时，也取决于样品中化验物的量，进而检测样品中存在的量，再由处理器根据判定值的计算原理计算判定值进而和阈值进行比较。反射光可以用光电传感器来测量，反射光指的是来自光源的光经过测试条反射后进入光电传感器。
本发明还提供一种采用如上所述分析读数装置的分析读数方法，参考图7，其包括如下步骤：处理器根据时序设计分别控制该至少两个光源分别点亮，光线照射在测试条的空白区和测试区后，经反射由光检测器接收，然后反馈检测信息给处理器，处理器根据所接收的检测信息进行分析和判定。
所述处理器的时序设计是通过软件实现的。
通常，在样品中的特定化验物会引起所述信号的累积，但是在某些情况下，如竞争等反应中，所述的特定化验物不存在会引起有关信号的累积。导致信号累积的反应可以是任何合适的反应，如两种化学实体间的常规化学反应、酶联反应、或免疫偶联反应。优选的免疫偶联反应将包括至少一个生物分子的结合。
该设备在出厂后处于休眠状态以减低能耗，只有当检测吸样棒上样后，液体在吸样棒的流动引起电路的电阻的改变，使设备自动从“休眠”模式激活，进入工作状态。
使用时，在使用中，直接用吸样棒的前端插入样品中，加样后设备被激活，光电检测电路的左电极11和右电极12导通而开机开始正常测量，等待8秒后，进入工作模式，两个LED分时发光，读数器开始执行，并由光电传感器分别检出相应电压，并送入处理器，此时检得信号得出检测区和空白的初始值作为上样前参比信号用。等待N秒后再重复检测动作，此时检得信号作为结果判定信号用，再结合相应算法得出检测结果，该算法可参考业界一般操作，在此不赘述。根据光源发光的时间先后次序接收光强信号。初始值的扫描是为了使得其作为计算判定值的基数。
操作时，也可将样品直接淋在检测设备的吸样棒上，小心不要淋湿其他部分，待观察窗口上漏斗型符号开始闪动（同时蜂鸣器响）时取出设备，液晶显示器面朝上平放；或将样本收集于干净的一次性或洁净容器中，然后把检测笔的吸样棒插入样本中，样本液面应浸过吸样棒四份之三以上，待观察窗口上漏斗型符号开始闪动（同时蜂鸣器响）时取出该设备检测笔，液晶显示器面朝上平放。该设备会根据设定的程序开始测量一个或者多个数值进行比较。
该分析读数装置在光源和光检测器之间提供了一种最佳的光路路径，得出光强信号，通过处理器的设置，转化成供判断比较的判定值。这种光路优化的装置和读数方法，可以用于其它类似的光谱检测设备上。
以上所述仅为本发明的较佳实施例，本发明的保护范围并不局限于此，任何基于本发明技术方案上的等效变换均属于本发明保护范围之内。

Claims (14)

  1. 一种分析读数装置，用于对化验检测的测试条进行读数和分析，该测试条上设有检测区和空白区，该分析读数装置包括光电检测电路和处理器，所述光电检测电路对检测区和空白区的光反射强度信号进行检测，并反馈检测信息给处理器，其特征在于，该光电检测电路包括：
    至少两个光源，与所述测试条的测试区和空白区位置相应，能够发出与所述测试条的测试区和空白区相应的光；和
    至少一个光检测器，光检测器接收来自两个区域的反射光线；
    所述至少两个光源所发出的光照射到测试条的测试区和空白区，并反射经由所述光检测器接收，然后反馈检测信息给处理器。
  2. 如权利要求1所述的分析读数装置，其特征在于，所述光检测器为光电传感器。
  3. 如权利要求2所述的分析读数装置，其特征在于，所述至少两个光源为第一光源和第二光源，所发出的光照射到测试条的测试区和空白区，并反射经由所述光电传感器接收。
  4. 如权利要求3所述的分析读数装置，其特征在于，该第一光源和第二光源均为发光二极管。
  5. 如权利要求4所述的分析读数装置，其特征在于，该第一光源和第二光源均为绿光发光二极管。
  6. 如权利要求5所述的分析读数装置，其特征在于，该第一光源和第二光源的波长一样。
  7. 如权利要求1~6任一项所述的分析读数装置，其特征在于，该至少两个光源发射光线有前后时间的差异。
  8. 如权利要求1所述的分析读数装置，其特征在于，该分析读数装置进一步包括一个将该至少两个光源以及该至少一个光电传感器分隔开的隔板。
  9. 如权利要求3所述的分析读数装置，其特征在于，该分析读数装置进一步包括一个将第一光源、第二光源、光电传感器分隔开的T形隔板。
  10. 如权利要求9所述的分析读数装置，其特征在于，在第一光源、第二光源与光电传感器之间的T形隔板部分，与测试条的检测区和空白区之间存在间隙，第一光源和第二光源所发出的光照射到测试条的测试区和空白区，反射光通过所述间隙进入所述光电传感器由其接收。
  11. 如权利要求1所述的分析读数装置，其特征在于，其进一步包括由不透光合成塑料构成的外壳。
  12. 如权利要求1所述的分析读数装置，其特征在于，所述测试条包括多孔渗水载体，该载体包含一个标记物特定结合试剂和一个不带标记物的特定结合试剂。
  13. 如权利要求12所述的分析读数装置，其特征在于，所述标记物为有色粒子。
  14. 一种采用如权利要求1~13任一项所述分析读数装置的分析读数方法，其特征在于，其包括如下步骤：处理器根据时序设计分别控制该至少两个光源分别点亮，光线照射在测试条的空白区和测试区后，经反射由光检测器接收，然后反馈检测信息给处理器，处理器根据所接收的检测信息进行分析和判定。
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