CN1616969A - Mobile scanning analysis device - Google Patents
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Abstract
本发明是关于一种机动型扫描分析装置，是使用组合式扫描器探头进行扫描工作。其中，组合式扫描器探头是以阵列式发光二极管光源与阵列式光电二极管侦测器组合而成。当试纸与检体反应后，可利用扫描装置对试纸进行扫描，并得到对应于该检体的检验信号；进行扫描的同时，扫描装置可将检验信号馈入信号放大器中，将检验信号放大后输出至类比/数位转换器，对检验信号执行类比/数位转换后输出至计算机主机处加以分析，以得知客观检验结果。再者，计算机主机可与控制装置耦接，并藉控制装置控制一启动装置，使扫描装置可进行试纸的扫描工作。其使整体系统微小化便于携带，能在不同场合快速进行检测，以争取病患最佳的就医时机，从而更加适于实用。
The present invention relates to a mobile scanning and analysis device, which uses a combined scanner probe to perform scanning work. The combined scanner probe is composed of an array-type light-emitting diode light source and an array-type photodiode detector. After the test paper reacts with the specimen, the scanning device can be used to scan the test paper and obtain a test signal corresponding to the specimen; while scanning, the scanning device can feed the test signal into the signal amplifier, amplify the test signal and output it to the analog/digital converter, perform analog/digital conversion on the test signal and output it to the computer host for analysis to obtain the objective test result. Furthermore, the computer host can be coupled with the control device, and the control device controls a starting device so that the scanning device can perform the scanning work of the test paper. It makes the overall system miniaturized and easy to carry, and can quickly perform detection in different occasions to strive for the best time for patients to seek medical treatment, so that it is more suitable for practical use.
Description
技术领域technical field
本发明涉及一种检体分析装置，特别是涉及一种机动型扫描分析装置。The invention relates to a specimen analysis device, in particular to a motorized scanning analysis device.
背景技术Background technique
随着科技的不断进步，医疗设备的功能也日趋完善，目前医师诊断病情，必需抽取病患的检体送检，如血液或其它体液、排泄物等，待检验报告出来后再作为病情研判的依据。在等待检验报告的过程中，少则需数小时，多则需要数天甚至一星期，方可得知检验结果；如此，不仅造成诊疗费时，病患往返医院的次数增加，严重的更可能造成病患的伤害。举例来说，当心肌梗塞发生时，若能在四小时内采取医疗措施，则后遗症会较小，且存活的机率也较大；但在现实的情况中，经常是病患在到达医院前即已耗费了许多宝贵的时间，再加上抽取检体、将检体送检及等待检验结果的时间，早已错过了最佳的就医时机，对生命造成严重的危害。With the continuous advancement of science and technology, the functions of medical equipment are becoming more and more perfect. At present, doctors must take samples of patients for examination, such as blood or other body fluids, excrement, etc., to diagnose the disease. in accordance with. In the process of waiting for the test report, it takes hours at least, days or even a week at most to know the test results; this will not only cause time-consuming diagnosis and treatment, but also increase the number of times patients go to and from the hospital. patient injury. For example, when a myocardial infarction occurs, if medical measures can be taken within four hours, the sequelae will be smaller and the probability of survival will be greater; A lot of precious time has been spent, coupled with the time for taking samples, sending them for inspection and waiting for the test results, the best time to seek medical treatment has long been missed, causing serious harm to life.
另一方面，随着免疫检验技术的发展，在进行检体的检验工作时，尿液试纸与免疫试纸的应用范围也越来越广，举凡肿瘤标志、传染性疾病、性传染病、毒品、药物及心脏疾病等，多已有试纸商品；但囿于检测设备的欠缺，只能以肉眼判读试纸的检测结果，因此只能作定性判断，无法做定量分析。再者，人为的判读方式，检验结果的解读常会因人而异，一旦遇有非阴非阳的情况，往往造成判读的困扰，且无法精确纪录检验结果，相当不客观。On the other hand, with the development of immunoassay technology, the scope of application of urine test strips and immune test strips is becoming wider and wider during the inspection of specimens, such as tumor markers, infectious diseases, sexually transmitted diseases, drugs, Drugs and heart diseases, etc., mostly have test strips. However, due to the lack of testing equipment, the test results of the test strips can only be interpreted with the naked eye, so only qualitative judgments can be made, and quantitative analysis cannot be done. Furthermore, the interpretation of the test results is often different from person to person due to artificial interpretation methods. Once encountering a situation that is neither Yin nor Yang, it often causes troubles in interpretation, and it is impossible to accurately record the test results, which is quite unobjective.
综观以上所述，现有习知的检体检测方法至少存在有以下缺点：：In view of the above, the existing known sample detection methods have at least the following disadvantages:
一、病患自发病至检验结果出来的时间过于冗长，延误病患的最佳就医时机。1. The time from the onset of the disease to the result of the test is too long, which delays the best time for the patient to seek medical treatment.
二、检验试纸仅能作定性检测，且检验结果的判读工作并不客观。2. Test strips can only be used for qualitative testing, and the interpretation of test results is not objective.
由此可见，上述现有的机动型扫描分析装置仍存在有诸多的缺陷，而亟待加以进一步改进。为了解决机动型扫描分析装置存在的问题，相关厂商莫不费尽心思来谋求解决之道，但长久以来一直未见适用的设计被发展完成，而一般产品又没有适切的结构能够解决上述问题，此显然是相关业者急欲解决的问题。It can be seen that the above-mentioned existing mobile scanning analysis device still has many defects, and needs to be further improved urgently. In order to solve the problems existing in mobile scanning analysis devices, relevant manufacturers have tried their best to find a solution, but no suitable design has been developed for a long time, and there is no suitable structure for general products to solve the above problems. This is obviously a problem that relevant industry players are eager to solve.
有鉴于上述现有的机动型扫描分析装置存在的缺陷，本发明人基于从事此类产品设计制造多年丰富的实务经验及其专业知识，积极加以研究创新，以期创设一种新型结构的机动型扫描分析装置，能够改进一般现有的机动型扫描分析装置，使其更具有实用性。经过不断的研究、设计，并经反复试作样品及改进后，终于创设出确具实用价值的本发明。In view of the defects existing in the above-mentioned existing mobile scanning analysis device, the inventor actively researches and innovates based on his rich practical experience and professional knowledge in the design and manufacture of this type of product, in order to create a mobile scanning analysis device with a new structure. The analysis device can improve the general existing mobile scanning analysis device to make it more practical. Through continuous research, design, and after repeated trial samples and improvements, the present invention with practical value is finally created.
发明内容Contents of the invention
本发明的目的在于，克服现有的机动型扫描分析装置存在的缺陷，而提供一种新的机动型扫描分析装置，所要解决的技术问题是使其配合所使用阵列(即数组)式的组合式扫描器探头，而使整体系统微小化而便于携带，能够在不同的场合快速进行检测，可机动进行检体的检验工作，以争取病患的最佳就医时机，从而更加适于实用。The purpose of the present invention is to overcome the defects existing in the existing mobile scanning analysis device, and provide a new mobile scanning analysis device, the technical problem to be solved is to make it match the combination of the array (ie array) type Type scanner probe, so that the overall system is miniaturized and easy to carry. It can quickly detect in different occasions, and can perform the inspection of specimens flexibly, so as to strive for the best time for patients to seek medical treatment, so it is more suitable for practical use.
本发明的另一目的在于，提供一种机动型扫描分析装置，所要解决的技术问题是使其可在现场机动快速检测，并由计算机分析检验结果，而使病情判读更加准确客观。Another object of the present invention is to provide a mobile scanning analysis device. The technical problem to be solved is to make it mobile and fast to detect on the spot, and analyze the test results by computer, so as to make the diagnosis of the disease more accurate and objective.
本发明的再一目的在于，提供一种机动型扫描分析装置，所要解决的技术问题是使其可以利用试纸作定量分析，检验程序快速简单，充分发挥检验试纸简便的特性。Another object of the present invention is to provide a mobile scanning analysis device. The technical problem to be solved is to make it possible to use test paper for quantitative analysis. The test procedure is fast and simple, and the characteristics of the test paper are fully utilized.
本发明的目的及解决其技术问题是采用以下技术方案来实现的。依据本发明提出的一种机动型扫描分析装置，用以扫描一试纸及该试纸上的一检体，该机动型扫描分析装置包括：一光机组合，用以扫描该试纸，并输出与该检体相对应的一检验信号，其中该光机组合包括具有至少一阵列式发光二极管光源与至少一阵列式光电二极管侦测器的一组合式扫描器探头；一计算机主机，与该光机组合耦接以接收并分析处理该检验信号，且该计算机主机接受一命令输入，输出一控制信号；一控制装置，与该计算机主机耦接，并依据该控制信号输出一启动信号；以及一启动装置，与该控制装置耦接并与该光机组合耦接，并依据该启动信号驱动该光机组合，用以扫描该试纸。The purpose of the present invention and the solution to its technical problems are achieved by adopting the following technical solutions. A motorized scanning analysis device according to the present invention is used to scan a test paper and a sample on the test paper. The motorized scanning analysis device includes: an optical machine combination for scanning the test paper and outputting A test signal corresponding to the sample, wherein the optomechanical combination includes a combined scanner probe with at least one arrayed light emitting diode light source and at least one arrayed photodiode detector; a computer host, combined with the optomechanical Coupled to receive and analyze the test signal, and the computer mainframe accepts a command input and outputs a control signal; a control device is coupled with the computer mainframe and outputs an activation signal according to the control signal; and an activation device , coupled with the control device and the optical-mechanical combination, and drives the optical-mechanical combination according to the start signal to scan the test paper.
本发明的目的及解决其技术问题还可采用以下技术措施进一步实现。The purpose of the present invention and its technical problems can also be further realized by adopting the following technical measures.
前述的机动型扫描分析装置，其中所述的光机组合更包括一试纸槽，以容纳该试纸。In the aforementioned motorized scanning analysis device, the optical-mechanical combination further includes a test paper slot for containing the test paper.
前述的机动型扫描分析装置，其更包括一信号放大器，与该光机组合耦接，用以接收该检验信号并予以放大后输出。The aforementioned mobile scanning analysis device further includes a signal amplifier coupled to the optical-mechanical combination for receiving the test signal and amplifying it for output.
前述的机动型扫描分析装置，其更包括有一类比/数位转换器，与该信号放大器耦接，用以接收放大后的该检验信号，并将该检验信号执行类比/数位转换后馈入该计算机主机。The aforementioned mobile scanning analysis device further includes an analog/digital converter coupled with the signal amplifier to receive the amplified test signal, and feed the test signal into the computer after analog/digital conversion host.
前述的机动型扫描分析装置，其更包括一串列介面，介于该计算机主机与该控制装置间，以作为该控制信号的传输介面。The aforementioned mobile scanning analysis device further includes a serial interface interposed between the host computer and the control device as a transmission interface for the control signal.
前述的机动型扫描分析装置，其中所述的串列介面是符合RS-232的规格。In the aforementioned mobile scanning analysis device, the serial interface complies with the RS-232 standard.
前述的机动型扫描分析装置，其中所述的检体是一血液。In the aforementioned mobile scanning analysis device, the sample is blood.
前述的机动型扫描分析装置，其中所述的检体是一体液。In the aforementioned mobile scanning analysis device, the sample is body fluid.
前述的机动型扫描分析装置，其中所述的扫描分析装置可应用于癌症标的物的检测。The aforementioned mobile scanning analysis device, wherein the scanning analysis device can be applied to the detection of cancer targets.
前述的机动型扫描分析装置，其中所述的扫描分析装置可应用于急性心肌梗塞的检验。The aforementioned mobile scanning analysis device, wherein said scanning analysis device can be applied to the examination of acute myocardial infarction.
前述的机动型扫描分析装置，其中所述的扫描分析装置可应用于违禁药物的检验。The aforementioned mobile scanning analysis device, wherein the scanning analysis device can be applied to the inspection of prohibited drugs.
前述的机动型扫描分析装置，其中所述的扫描分析装置可应用于肝炎分型与测定。The aforementioned mobile scanning analysis device, wherein said scanning analysis device can be applied to hepatitis typing and determination.
前述的机动型扫描分析装置，其中所述的扫描分析装置可应用于传染性疾病的检测。The aforementioned mobile scanning analysis device, wherein the scanning analysis device can be applied to the detection of infectious diseases.
本发明的目的及解决其技术问题还采用以下技术方案来实现。依据本发明提出的一种机动型扫描分析装置，扫描一试纸及该试纸上的一检体，该机动型扫描分析装置包括：一扫描装置，用以扫描该试纸，并输出与该检体相对应的一检验信号，其中该扫瞄装置包括具有至少一阵列式发光二极管光源与至少一阵列式光电二极管侦测器的一组合式扫描器探头；一信号放大器，与该扫描装置耦接，用以接收该检验信号并予以放大后输出；一类比/数位转换器，与该信号放大器耦接，用以接收放大后的该检验信号，并将该检验信号执行类比/数位转换后输出；一计算机主机，与该类比/数位转换器耦接，用以接收并分析转换后的该检验信号，且该计算机主机接受一命令输入，输出一控制信号；一控制装置，与该计算机主机耦接并依据该计算机主机传来的该控制信号而输出一启动信号；一串列介面，介于该计算机主机与该控制装置间，以作为该控制信号的传输介面；以及一启动装置，与该控制装置耦接并与该扫瞄装置耦接，并依据该控制装置所传的该启动信号而驱动该扫瞄装置，用以扫描该试纸。The purpose of the present invention and the solution to its technical problem also adopt the following technical solutions to achieve. According to a motorized scanning analysis device proposed by the present invention, a test paper and a sample on the test paper are scanned. The motorized scanning analysis device includes: a scanning device for scanning the test paper and outputting a sample corresponding to the sample. A corresponding test signal, wherein the scanning device includes a combined scanner probe with at least one arrayed light emitting diode light source and at least one arrayed photodiode detector; a signal amplifier, coupled with the scanning device, for To receive the inspection signal and amplify it for output; an analog/digital converter, coupled with the signal amplifier, for receiving the amplified inspection signal, and output the inspection signal after analog/digital conversion; a computer The host is coupled with the analog/digital converter to receive and analyze the converted test signal, and the computer host receives a command input and outputs a control signal; a control device is coupled with the computer host and according to The control signal from the host computer outputs an activation signal; a serial interface intervenes between the host computer and the control device as a transmission interface for the control signal; and an activation device coupled with the control device connected and coupled with the scanning device, and drives the scanning device according to the start signal sent by the control device to scan the test paper.
本发明的目的及解决其技术问题还可采用以下技术措施进一步实现。The purpose of the present invention and its technical problems can also be further realized by adopting the following technical measures.
前述的机动型扫描分析装置，其中所述的串列介面是符合RS-232的规格。In the aforementioned mobile scanning analysis device, the serial interface complies with the RS-232 standard.
前述的机动型扫描分析装置，其中所述的检体是一血液。In the aforementioned mobile scanning analysis device, the sample is blood.
前述的机动型扫描分析装置，其中所述的检体是一体液。In the aforementioned mobile scanning analysis device, the sample is body fluid.
前述的机动型扫描分析装置，其中所述的扫描分析装置可应用于癌症标的物的检测。The aforementioned mobile scanning analysis device, wherein the scanning analysis device can be applied to the detection of cancer targets.
前述的机动型扫描分析装置，其中所述的扫描分析装置可应用于急性心肌梗塞的检验。The aforementioned mobile scanning analysis device, wherein said scanning analysis device can be applied to the examination of acute myocardial infarction.
前述的机动型扫描分析装置，其中所述的扫描分析装置可应用于违禁药物的检验。The aforementioned mobile scanning analysis device, wherein the scanning analysis device can be applied to the inspection of prohibited drugs.
前述的机动型扫描分析装置，其中所述的扫描分析装置可应用于肝炎分型与测定。The aforementioned mobile scanning analysis device, wherein said scanning analysis device can be applied to hepatitis typing and determination.
前述的机动型扫描分析装置，其中所述的扫描分析装置可应用于传染性疾病的检测。The aforementioned mobile scanning analysis device, wherein the scanning analysis device can be applied to the detection of infectious diseases.
本发明与现有技术相比具有明显的优点和有益效果。由以上技术方案可知，为了达到前述发明目的，本发明提出一种机动型扫描分析装置，主要是使用组合式扫描器探头进行扫描工作。其中，该组合式扫描器探头是以阵列式发光二极管光源与阵列式光电二极管侦测器组合而成。当试纸与检体反应后，可利用扫描装置对试纸进行扫描，并得到对应于该检体的检验信号；此外，进行扫描的同时，扫描装置可将检验信号馈入信号放大器中，将检验信号放大后输出至类比/数位转换器，对检验信号执行类比/数位转换后输出至计算机主机处加以分析，以得知客观的检验结果。再者，计算机主机可与控制装置耦接，并藉由控制装置控制一启动装置，使扫描装置可进行试纸的扫描工作。Compared with the prior art, the present invention has obvious advantages and beneficial effects. It can be seen from the above technical solutions that in order to achieve the above-mentioned purpose of the invention, the present invention proposes a mobile scanning analysis device, which mainly uses a combined scanner probe to perform scanning work. Wherein, the combined scanner probe is composed of an arrayed light emitting diode light source and an arrayed photodiode detector. After the test paper reacts with the sample, the scanning device can be used to scan the test paper and obtain the test signal corresponding to the sample; in addition, while scanning, the scanning device can feed the test signal into the signal amplifier to convert the test signal After amplification, it is output to an analog/digital converter, and after analog/digital conversion is performed on the test signal, it is output to the host computer for analysis, so as to obtain objective test results. Furthermore, the host computer can be coupled with the control device, and the control device can control an activation device, so that the scanning device can scan the test paper.
本发明机动型扫描分析装置，可在救护车上或是其它紧急现场进行检体的检验工作，并将检验结果分析后通知院方进行医疗准备，而可缩短治疗前的准备时间，争取病患就医时机。该机动型检体扫描分析装置中，当试纸与检体反应后，可经由扫描装置驱使光机组合对试纸进行扫描，并得到对应于该检体的检验信号；此外，进行扫描的同时，扫描装置可将检验信号馈入信号放大器中，将检验信号放大后输出至类比/数位转换器，对检验信号执行类比/数位转换后输出至计算机主机处加以分析，以得知客观的检验结果。再者，计算机主机可与控制装置耦接，并藉由控制装置控制一启动装置，用以驱动扫描装置进行试纸的扫描工作。The mobile scanning analysis device of the present invention can carry out the inspection work of the specimen on the ambulance or other emergency sites, and notify the hospital to prepare for medical treatment after analyzing the inspection results, so that the preparation time before treatment can be shortened, and patients can be saved. When to seek medical attention. In the mobile specimen scanning and analyzing device, after the test paper reacts with the specimen, the scanning device can drive the optical-mechanical combination to scan the test paper, and obtain the test signal corresponding to the specimen; in addition, while scanning, the scanning The device can feed the inspection signal into the signal amplifier, amplify the inspection signal and output it to the analog/digital converter, perform analog/digital conversion on the inspection signal and output it to the host computer for analysis, so as to obtain objective inspection results. Furthermore, the host computer can be coupled with the control device, and the control device controls an activation device to drive the scanning device to scan the test paper.
本发明所提供的机动型扫描分析装置，至少具有以下优点：The motorized scanning analysis device provided by the present invention has at least the following advantages:
一、本发明所提供的机动型扫描分析装置，可配合所使用阵列式的组合式扫描器探头，而使整体系统微小化而便于携带，由于装置微小化便于携带，能够在不同场合快速进行检测，可机动进行检体的检验工作，以争取病患的最佳就医时机，从而更加适于实用。1. The mobile scanning analysis device provided by the present invention can cooperate with the array-type combined scanner probe to make the overall system miniaturized and easy to carry. Because the device is miniaturized and easy to carry, it can quickly detect in different occasions , can carry out the inspection work of the sample flexibly, so as to strive for the best time for the patient to see a doctor, so that it is more suitable for practical use.
二、本发明所提供的机动型扫描分析装置，可在现场机动快速检测，并由计算机分析检验结果，而使病情的判读更加准确客观。2. The motorized scanning analysis device provided by the present invention can be used for mobile and fast detection on the spot, and the computer can analyze the test results, so that the interpretation of the disease can be more accurate and objective.
三、本发明所提供的机动型扫描分析装置，可经由试纸作定量分析，且检验程序快速简单，而可充分发挥免疫试纸及其它固相呈色反应测试的简便特性。3. The mobile scanning analysis device provided by the present invention can perform quantitative analysis through the test paper, and the test procedure is fast and simple, and can give full play to the convenient characteristics of the immunological test paper and other solid-phase chromogenic reaction tests.
综上所述，本发明特殊的机动型扫描分析装置，具有上述诸多的优点及实用价值，并在同类产品中未见有类似的结构设计公开发表或使用而确属创新，其不论在结构上或功能上皆有较大的改进，在技术上有较大的进步，并产生了好用及实用的效果，且较现有的机动型扫描分析装置具有增进的多项功效，从而更加适于实用，而具有产业的广泛利用价值，诚为一新颖、进步、实用的新设计。In summary, the special mobile scanning analysis device of the present invention has the above-mentioned many advantages and practical value, and there is no similar structural design published or used in similar products, so it is indeed innovative, regardless of its structure Or the function has been greatly improved, the technology has made great progress, and has produced easy-to-use and practical effects, and has a number of enhanced functions compared with the existing mobile scanning analysis device, so it is more suitable for It is practical, and has wide application value in the industry. It is a novel, progressive and practical new design.
上述说明仅是本发明技术方案的概述，为了能够更清楚了解本发明的技术手段，并可依照说明书的内容予以实施，以下以本发明的较佳实施例并配合附图详细说明如后。The above description is only an overview of the technical solutions of the present invention. In order to understand the technical means of the present invention more clearly and implement them according to the contents of the description, the preferred embodiments of the present invention and accompanying drawings are described in detail below.
附图说明Description of drawings
图1是依照本发明一较佳实施例的一种机动型扫描分析装置的方块图。FIG. 1 is a block diagram of a mobile scanning analysis device according to a preferred embodiment of the present invention.
图2是依照本发明一较佳实施例的一种整合式探头的时序图。FIG. 2 is a timing diagram of an integrated probe according to a preferred embodiment of the present invention.
图3是一种检体内肌红蛋白、肌钙蛋白与肌酸激浓度随时间的变化情形示意图。Fig. 3 is a schematic diagram of the change of concentration of myoglobin, troponin and creatine in a sample with time.
12： 控制信号 14： 驱动信号12: Control signal 14: Driving signal
16： 检验信号 100：光机组合16: Inspection signal 100: Optical-mechanical combination
110：扫描装置 120：信号放大器110: Scanning device 120: Signal amplifier
130：驱动装置130: drive device
140：类比/数位转换器(模拟/数字转换器)140: Analog/Digital Converter (Analog/Digital Converter)
150：串列介面(串列介面) 160：控制装置150: serial interface (serial interface) 160: control device
170：计算机主机170: computer host
具体实施方式Detailed ways
以下结合附图及较佳实施例，对依据本发明提出的机动型扫描分析装置其具体实施方式、结构、特征及其功效，详细说明如后。The specific implementation, structure, features and functions of the mobile scanning analysis device according to the present invention will be described in detail below in conjunction with the accompanying drawings and preferred embodiments.
依照本发明原理所设计出来的机动型扫描分析装置，由于装置微小化与检测使用程序简易，而成为就地医护检测(point of care testing，POCT)的有利工具，得以在各种紧急现场发挥功用，甚或做为自我监测的日常医疗器具。The mobile scanning analysis device designed according to the principle of the present invention becomes a favorable tool for point of care testing (POCT) due to the miniaturization of the device and the simplicity of the testing procedures, and can be used in various emergency sites , or even as a daily medical device for self-monitoring.
一般而言，进行扫瞄分析之前，会先将要检测的检体(内含至少一种或多种被测物)，置于检测试纸之上，再以例如插入或其它方式将试纸送入扫瞄分析装置中。接着，请参阅图1所示，是依照本发明一较佳实施例的一种机动型扫描分析装置的方块图。首先，试纸与检体反应后的试纸通过如试纸槽或插槽而送入光机组合100中的试纸座101，而扫描装置110对试纸进行扫描，则得到对应于该检体的一检验信号16。Generally speaking, before performing scanning analysis, the sample to be detected (containing at least one or more analytes) will be placed on the detection test paper, and then the test paper will be sent into the scanning device by inserting or other methods. in the analyzer. Next, please refer to FIG. 1 , which is a block diagram of a mobile scanning analysis device according to a preferred embodiment of the present invention. First, the test paper after the reaction between the test paper and the sample is sent into the test paper seat 101 in the optical-mechanical combination 100 through the test paper slot or slot, and the scanning device 110 scans the test paper to obtain a test signal corresponding to the sample. 16.
光机组合100可经由启动装置130驱动，进行试纸的扫描工作，并将扫瞄所得的检验信号16输出。在进行扫描的同时，光机组合100的扫描装置110可将检验信号16馈入信号放大器120中，将检验信号15放大后输出至类比/数位转换器140，对检验信号16执行类比/数位(模拟/数字)转换的工作。转换完毕后，即可将数字化的检验信号16馈入计算机主机170并加以分析，以得知客观的检验结果。The optical-mechanical combination 100 can be driven by the activation device 130 to scan the test paper and output the inspection signal 16 obtained from the scanning. While scanning, the scanning device 110 of the optical-mechanical combination 100 can feed the inspection signal 16 into the signal amplifier 120, amplify the inspection signal 15 and output it to the analog/digital converter 140, and perform analog/digital ( analog/digital) conversion work. After conversion, the digitized test signal 16 can be fed into the computer host 170 for analysis to obtain an objective test result.
另一方面，计算机主机170可接收一使用者的命令输入或其它条件设定刺激(如一试纸插入讯号)，而产生一控制信号12。计算机主机170可藉由串列介面150与控制装置160耦接，串列介面(串行接口)150介于计算机主机170与该控制装置160间，以作为控制信号12的传输介面(接口)。再者，控制装置160可依据由计算机主机170所传来的控制信号12，产生启动信号14而馈入启动装置130中，并藉由启动装置130而驱动扫描装置110进行扫描工作。其中，串列介面150可以是符合RS-232规格的介面或其它可达到此类似功能的元件。On the other hand, the host computer 170 can receive a user's command input or other condition setting stimulus (such as a test strip insertion signal), and generate a control signal 12 . The host computer 170 can be coupled to the control device 160 through the serial interface 150 , and the serial interface (serial interface) 150 is interposed between the host computer 170 and the control device 160 to serve as a transmission interface (interface) for the control signal 12 . Moreover, the control device 160 can generate an activation signal 14 according to the control signal 12 sent from the computer host 170 and feed it into the activation device 130 , and drive the scanning device 110 to perform scanning through the activation device 130 . Wherein, the serial interface 150 may be an interface conforming to the RS-232 standard or other components capable of achieving this similar function.
其中，为增进该机动型扫描分析装置的机动性，可设计使用电池做为电源，以便于携带使用，但亦可使用其它充电机制以帮助紧急运作。Among them, in order to enhance the mobility of the mobile scanning analysis device, a battery can be designed to be used as a power source for easy portability, but other charging mechanisms can also be used to help emergency operations.
其中本发明的特征之一是光机组合中扫瞄装置是采用阵列式发光二极管(Light Emitting Diode，LED)光源与阵列式光电二极管(Photodiode))侦测器的组合式扫描器探头。本发明光机组合的光源部份，是使用阵列式LED激光光源，照射光度较强，且可经由如使用绿光、红光与白光等三微型LED阵列作为光源，而有黄绿光、红光与合成白光的各种选择。其光源的选择经与被测物抗体染色的搭配，可进一步提升检体中多重被测物，单一扫描定量的灵敏度。本发明光机组合的侦测器部份，是使用阵列式光电二极管，提高灵敏度。而依照本发明的另一较佳实施例，本发明光机组合的阵列式光电二极管与阵列式LED激光光源配置于一个匣式扫描器内，相互以呈约90度的方式配置。One of the features of the present invention is that the scanning device in the light-machine combination is a combined scanner probe using an arrayed light emitting diode (Light Emitting Diode, LED) light source and an arrayed photodiode (Photodiode) detector. The light source part of the light-machine combination of the present invention uses an array type LED laser light source, and the irradiation luminosity is relatively strong, and it can have yellow-green light, red light and white light by using three micro-LED arrays as light sources Various options for synthetic white light. The selection of the light source and the combination of the antibody staining of the analyte can further improve the sensitivity of multiple analytes in the sample and single-scan quantification. The detector part of the optical-mechanical combination of the present invention uses an array photodiode to improve sensitivity. According to another preferred embodiment of the present invention, the arrayed photodiodes and the arrayed LED laser light sources of the optical-mechanical combination of the present invention are arranged in a cassette scanner, and arranged at about 90 degrees to each other.
以下举例说明本发明的整合式探头的操作相关规格细节：
并请参阅图2所示，其为上例中整合式探头的时序图。由图2中可见，若时脉频率为1.0MHz时，其取样时间(ts)可短至10-9秒范围。故本发明的光机组合，其光源有高达600DPI高解析度及光源阵列幅宽长达5.42cm，且其中的所用的光电二极管侦测器，有低杂讯(dark current)输出及10-9秒范围的暖机与取讯号时间特性。And please refer to Figure 2, which is the timing diagram of the integrated probe in the above example. It can be seen from FIG. 2 that if the clock frequency is 1.0 MHz, the sampling time (ts) can be as short as 10 −9 seconds. Therefore, in the optical-mechanical combination of the present invention, the light source has a high resolution of up to 600DPI and the width of the light source array is as long as 5.42cm, and the photodiode detector used therein has a low noise (dark current) output and 10 -9 Warm-up and signal-taking time characteristics in the second range.
上述的光机组合的激光LED阵列光源与光电二极管阵列侦测器整合式探头，因光源与侦测器均是采用阵列(LED阵列与光电二极管阵列)的关系，故该光机组合因少数个LED光源或光电二极管失效而影响整体运作的可能性极小，因此该光机组合对讯号的撷取极为稳定。且本发明的整合式探头的解析度可达六百PSI，灵敏度亦远较一般探头为高。The laser LED array light source and photodiode array detector integrated probe of the above-mentioned optical-mechanical combination, because the light source and detector both use the relationship of the array (LED array and photodiode array), so the optical-mechanical combination is due to a small number of The possibility of LED light source or photodiode failure affecting the overall operation is extremely small, so the optical-mechanical combination is extremely stable for signal acquisition. Moreover, the resolution of the integrated probe of the present invention can reach 600 PSI, and the sensitivity is far higher than that of common probes.
但是，本实施例并非限制本发明的机动型扫描分析装置必须配合前述的规格的组合式探头。反之，针对不同的被测物与不同检测场所、检测时间与检测分析数据等条件，本发明可以配合其它目前已知或可轻易预知的方法机制，来调整光机组合与其它装置的细节。However, this embodiment does not limit the motorized scanning analysis device of the present invention to be compatible with the aforementioned combination probe. Conversely, the present invention can cooperate with other currently known or easily predictable methods and mechanisms to adjust the details of the optical-mechanical combination and other devices for different tested objects, different testing locations, testing time, and testing and analysis data.
如前所述，由于激光LED光源与光电二极管阵列整合为一体，而使本发明的机动型扫描分析装置能够小型化，而有不同机型以因应不同场合与不同使用者的需求，包括“桌上型”、“触控型”及“手携型”等。As mentioned above, due to the integration of the laser LED light source and the photodiode array, the mobile scanning analysis device of the present invention can be miniaturized, and there are different models to meet the needs of different occasions and different users, including "table On-type", "touch-type" and "hand-held type", etc.
而本发明中与扫瞄装置及控制装置耦合的启动装置，至少包括有具驱动程序的一芯片或一中央处理器(central processing unit，CPU)，该启动装置接收到驱动信号后会经软件驱动扫瞄装置，带动光机组合的整合式探头对试纸结构进行幅宽达5.42cm的扫瞄。实际上，由于光机组合的整合式探头，因光源与侦测器均是采用阵列的关系，激光LED阵列光源与光电二极管阵列侦测器均可相互依照扫瞄装置的设定，以一列列或一行行的方式依序启动而达到扫瞄的目的；当然亦可依照试纸结构、测试样品种类数量等检测需求，调整扫瞄的方式，例如以一区块或一带状或其它形式来进行扫瞄。And the starting device coupled with the scanning device and the control device in the present invention at least includes a chip or a central processing unit (central processing unit, CPU) with a driver, and the starting device will be driven by software after receiving the driving signal. The scanning device drives the integrated probe of the optical-mechanical combination to scan the structure of the test paper with a width of up to 5.42cm. In fact, due to the integrated probe of the optical-mechanical combination, the relationship between the light source and the detector is an array, and the laser LED array light source and the photodiode array detector can be arranged in rows according to the settings of the scanning device. or line by line to achieve the purpose of scanning; of course, the scanning method can also be adjusted according to the detection requirements such as the structure of the test paper and the number of test samples, such as a block or a strip or other forms. scan.
由于本发明的装置是采用扫瞄方式取讯，故试纸结构上可用于检测试验的有效区间可大幅增加，而不必像现有习知技术以定位读取时只有极有限的区间可用于检测。试纸结构上有效区间可以依照有多少种被测物而划分，以例如一条不到1mm细线区间呈色一种被测物，故试纸结构上可同时承载许多被测物，而以一次式扫瞄定量分析所有被测物。本发明利用软件启动扫瞄装置，而使光机组合的整合式探头对试纸进行全试纸宽幅扫描，而执行扫描式快速检验分析，进而可使检测效率大幅增加。Since the device of the present invention adopts the scanning method to obtain information, the effective interval of the test paper structure that can be used for the detection test can be greatly increased, and there is no need for only a very limited interval for detection when positioning and reading in the prior art. The effective interval of the test paper structure can be divided according to the number of tested objects. For example, a thin line of less than 1mm can be used to represent one tested object. Therefore, the test paper structure can carry many tested objects at the same time, and one-time scanning Aim for quantitative analysis of all analytes. The invention uses software to activate the scanning device, so that the optical-mechanical integrated probe scans the test paper with a wide width, and performs scanning-type rapid inspection and analysis, thereby greatly increasing the detection efficiency.
此外，本发明中光机组合可视设计需要而定，其更包括一步进马达，通过启动装置的芯片或中央处理器，其更包括有具有步进马达驱动程序，而驱动步进马达带动试纸或带动光机组合，而使试纸与光机组合处于一适当的扫瞄位置，以便光机组合的整合式探头对试纸结构进行扫瞄。In addition, the light-machine combination in the present invention can be determined according to the design requirements, and it further includes a stepping motor, which further includes a stepping motor driver through a chip or a central processing unit of the starting device, and drives the stepping motor to drive The test paper may drive the optical-mechanical combination, so that the test paper and the optical-mechanical combination are in an appropriate scanning position, so that the integrated probe of the optical-mechanical combination scans the structure of the test paper.
针对本发明的机动型扫描分析装置，依照本发明的又一较佳实施例，建议配合使用本发明人所发明的另一项选择染色性技术于试纸结构上，而得以更加提高检测的灵敏度与准确度。该项技术(已申请包括中国在内的十数余国专利，并已获得台湾专利证书发明第一六四三三一号)是利用反应性染料选择性染色蛋白质，而使抗体或抗原可以与纺织工业用的反应性染料经由共价键结合而染色。详细细节请参阅中国专利申请号01110355.8。For the mobile scanning analysis device of the present invention, according to another preferred embodiment of the present invention, it is suggested to use another selective dyeing technology invented by the inventor on the test paper structure, so as to further improve the detection sensitivity and Accuracy. This technology (has applied for patents in more than a dozen countries including China, and has obtained Taiwan Patent Certificate Invention No. 164331) uses reactive dyes to selectively stain proteins, so that antibodies or antigens can be combined with Reactive dyes used in the textile industry dye through covalent bonding. Please refer to Chinese Patent Application No. 01110355.8 for details.
本发明可利用该项染色技术，配合检测仪器的光源，视被测物的不同种类，染成各种颜色，而应用于各种多重被测物临床分析应用中。利用将不同种类被测物染上各种不同颜色，即可有所区别地针对检体中多重被测物，进行一次式全试纸扫描且同时准确地定量监测各种不同被测物。The present invention can use the dyeing technology to cooperate with the light source of the detection instrument to dye various colors depending on the different types of the measured objects, and to be applied to various clinical analysis applications of multiple measured objects. By dyeing different types of analytes with different colors, multiple analytes in the sample can be differentiated, one-time full test paper scanning and various different analytes can be accurately and quantitatively monitored at the same time.
一般而言，若只使用单一种颜色染色被测物如抗体时，对同一检体中，浓度相差达105～106倍的不同种类被测物，就有因浓度极高无法兼顾，因为若灵敏度要调到能测出低浓度被测物，则可能就测不到高浓度被测物浓度的变化，反之亦然。Generally speaking, if only a single color is used to stain the analyte, such as an antibody, for the same sample, the concentration of different analytes with a difference of 10 5 to 10 6 times cannot be taken into consideration due to the extremely high concentration, because If the sensitivity is adjusted to detect the analyte at low concentration, the concentration change of the analyte at high concentration may not be detected, and vice versa.
举例来说：在泌尿系统发炎患者血液中，摄护腺癌与摄护腺良性肥大的C活性蛋白(C-reactive protein，CRP)的浓度为10-3g(milligram)/ml范围，而游离摄护腺特殊抗原(free-prostate specific antigen，PSA-free)的浓度为10-10g(sub-nanogram)/ml范围，浓度相差107倍左右。故单用胶体金的深紫红色染色PSA-free抗体，进行检量线构筑，则染上相同颜色的CRP抗体，会因为检体中CRP浓度太高，而导致颜色太深，对被测物浓度的变化不显著而致无法构建检量线。但若CRP抗体经染上对光源(激光LED阵列光源)较不灵敏的染料颜色，而仍然将PSA-free与错合摄护腺特殊抗原(PSA-complex)的抗体，染上较灵敏的胶体金颜色，则可经由一次扫瞄式，同时顺利完成患者检体中PSA-complex、PSA-free与CRP的浓度定量，达到现场POCT检测，而达到直接辅助治疗的目的。For example: in the blood of patients with urinary system inflammation, the concentration of C-reactive protein (C-reactive protein, CRP) in prostate cancer and benign hypertrophy of the prostate is in the range of 10 -3 g (milligram)/ml, while free The concentration of prostate specific antigen (free-prostate specific antigen, PSA-free) is in the range of 10 -10 g (sub-nanogram)/ml, with a difference of about 10 7 times. Therefore, if the PSA-free antibody is stained with deep purple colloidal gold alone, and the calibration line is constructed, the CRP antibody stained with the same color will cause the color to be too dark because the CRP concentration in the specimen is too high, which is harmful to the analyte. The change in concentration is not significant so that the calibration curve cannot be constructed. However, if the CRP antibody is stained with a dye color that is less sensitive to the light source (laser LED array light source), and the PSA-free and complex prostate specific antigen (PSA-complex) antibody is still stained with a more sensitive colloid The gold color can successfully complete the concentration quantification of PSA-complex, PSA-free and CRP in the patient's sample at the same time through a single scan to achieve on-site POCT detection and achieve the purpose of direct adjuvant therapy.
因而，本发明的机动型扫描分析装置，若针对检体中多重被测物却具极高浓度差异的状况，则可配合上述利用反应性染料选择性染色蛋白质，让本发明的机动快速检测分析仪对不同被测物均保有适当的灵敏度，增加本系统实用性。本发明可使用前述染色技术于试纸结构上，而达到执行检体内高浓度差、多重被测物的单一次扫瞄侦测，且因此方法的定量线性范围较广，而同时得到可靠有效的定量检测结果，并可解决现有习知仪器均无力解决的问题。但是，该较佳实施例并非限制本发明的机动型扫描分析装置必须配合前述的染色方法。反之，针对不同的被测物与不同检测场所、检测时间与检测分析数据等条件，本发明可以配合其它目前已知或可轻易预知的方法机制，来调整试纸结构的显色与改变其它有助于增进检测的因素。Therefore, if the mobile scanning analysis device of the present invention is aimed at the situation that multiple analytes in the specimen have extremely high concentration differences, it can cooperate with the above-mentioned selective staining of proteins with reactive dyes to make the mobile rapid detection and analysis of the present invention The instrument maintains appropriate sensitivity to different measured objects, which increases the practicability of the system. The present invention can use the above-mentioned dyeing technology on the test paper structure to achieve a single scan detection of high concentration difference and multiple analytes in the specimen, and therefore the quantitative linear range of the method is wide, and at the same time reliable and effective quantitative Test results, and can solve problems that existing conventional instruments are unable to solve. However, this preferred embodiment does not limit the mobile scanning analysis device of the present invention to cooperate with the aforementioned staining method. Conversely, for different tested objects and different testing places, testing time and testing and analysis data and other conditions, the present invention can cooperate with other currently known or easily predictable method mechanisms to adjust the color development of the test paper structure and change other helpful features. factors to enhance detection.
与现有技术相较，本发明的光机组合，因为光源与侦测器均采取列陈方式整合为一体，不但解析度高，暖机、取样时间短，而且讯号远较非列阵、光源分离式稳定。Compared with the prior art, the optical-mechanical combination of the present invention, because the light source and the detector are integrated in an array, not only has high resolution, but also has a short warm-up and sampling time, and the signal is much lower than that of non-array and light source. Separate and stable.
又因本发明扫瞄头陈列幅宽极大，可同时扫瞄检体内十个以上被测物(如B型肝炎各种标志物测定)，并具有同时进行定量运算的潜能。In addition, because the scanning head of the present invention has a very large display width, it can simultaneously scan more than ten analytes in the specimen (such as the determination of various markers of hepatitis B), and has the potential to perform quantitative calculations at the same time.
因此，此等机动型扫描分析装置可针对现有习知检体检测工作的缺点加以突破，可机动进行检体检测，并以计算机判读检测结果，提高免疫试纸的效能。该等机动型检体扫描分析装置可使免疫试纸确实发挥简单、便利、可靠等优点，使其能适用于加护病房、居家照护、门诊、急诊、救护车及毒品检测等工作项目上。在检体采取后，待试纸与其反应完毕，放入此装置后即可实时获得检验结果，以采取必要的医疗措施。尤其是传染性疾病或某些心血管疾病，更需快速得到结果，以避免延误病情，并避免病疫情扩大。此外，在毒品检验方面，更需就地检验，取得客观结果作判断，以避免样品被动手脚，并免除了样品保存等问题。Therefore, these mobile scanning analysis devices can overcome the shortcomings of the existing conventional sample testing work, and can perform sample testing on a mobile basis, and use computers to interpret the test results to improve the efficiency of the immune test strips. These mobile specimen scanning and analysis devices can make the immunological test strips really play the advantages of simplicity, convenience, and reliability, making them suitable for work items such as intensive care units, home care, outpatient clinics, emergency departments, ambulances, and drug testing. After the sample is taken, after the reaction between the test paper and it is completed, the test result can be obtained in real time after being placed in the device, so that necessary medical measures can be taken. Especially for infectious diseases or certain cardiovascular diseases, it is even more necessary to get results quickly to avoid delays in treatment and avoid the spread of disease outbreaks. In addition, in terms of drug testing, it is even more necessary to conduct on-site testing and obtain objective results for judgment, so as to prevent samples from being tampered with and avoid problems such as sample storage.
由于此等机动型扫描分析装置可将微弱的检验信号放大并交由计算机做分析，因此，使用者可自行设定分析参数，使检验的适用范围扩增；除此之外，使用者亦可设定作定性或定量等判读，并可同时执行单项或多项的检测工作。请参阅图3所示，是一种检体内肌红蛋白、肌钙蛋白与肌酸激Since these mobile scanning analysis devices can amplify weak test signals and send them to the computer for analysis, users can set analysis parameters by themselves to expand the scope of application of the test; in addition, users can also Set for qualitative or quantitative interpretation, and can perform single or multiple detection tasks at the same time. Please refer to Figure 3, which is a sample of myoglobin, troponin and creatine
浓度随时间的变化情形示意图。以此图为例，当病人疑似心肌梗塞时，需设定为定量判读，同时对肌红蛋白、肌钙蛋白与肌酸激的浓度作检测，或择其二或其一加以检验。其中，此三者参数各有其临床意义，当心肌梗塞发生后，肌钙蛋白在血液中高于正常浓度的时间比其它两者维持得更久(如图3所示)，基于此项特点，即有利于医师对病情作正确的判断，以免延误就医。Schematic diagram of the change of concentration with time. Taking this picture as an example, when the patient is suspected of myocardial infarction, it needs to be set to quantitative interpretation, and the concentration of myoglobin, troponin and creatine hormone should be detected at the same time, or the two or one of them should be tested. Among them, these three parameters have their own clinical significance. After myocardial infarction, the time of troponin in the blood higher than normal concentration is longer than the other two (as shown in Figure 3). Based on this characteristic, That is to say, it is beneficial for doctors to make correct judgments on the condition, so as to avoid delays in seeking medical treatment.
本发明的装置可以用于测试如摄护腺癌、急性心肌梗塞、小儿川崎氏症、SARS感染等的筛检，以及毒品或违禁药物现场查验上。本发明的装置亦将适用于肝炎分型与测定、治疗药物监测、性传染性疾病与成孕机会的检测上。The device of the present invention can be used for screening such as prostate cancer, acute myocardial infarction, children's Kawasaki's disease, SARS infection, and on-site inspection of drugs or illegal drugs. The device of the present invention will also be applicable to the typing and determination of hepatitis, the monitoring of therapeutic drugs, the detection of sexually transmitted diseases and the chance of pregnancy.
以上所述，仅是本发明的较佳实施例而已，并非对本发明作任何形式上的限制，虽然本发明已以较佳实施例揭露如上，然而并非用以限定本发明，任何熟悉本专业的技术人员，在不脱离本发明技术方案范围内，当可利用上述揭示的技术内容作出些许更动或修饰为等同变化的等效实施例，但凡是未脱离本发明技术方案的内容，依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与修饰，均仍属于本发明技术方案的范围内。The above description is only a preferred embodiment of the present invention, and does not limit the present invention in any form. Although the present invention has been disclosed as above with preferred embodiments, it is not intended to limit the present invention. Anyone familiar with this field Those skilled in the art, without departing from the scope of the technical solution of the present invention, can use the technical content disclosed above to make some changes or modify equivalent embodiments with equivalent changes, but all the content that does not depart from the technical solution of the present invention, according to the present invention Any simple modifications, equivalent changes and modifications made to the above embodiments by the technical essence still belong to the scope of the technical solution of the present invention.
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| EP1775577A1 (en) * | 2005-10-12 | 2007-04-18 | Taiwan Unison Biotech Inc. | Portable, scanning and analyzing apparatus |
| CN101598599B (en) * | 2009-07-20 | 2011-06-22 | 中国检验检疫科学研究院 | A multi-channel portable colloidal gold test strip rapid testing device |
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| EP1775577A1 (en) * | 2005-10-12 | 2007-04-18 | Taiwan Unison Biotech Inc. | Portable, scanning and analyzing apparatus |
| RU2358257C2 (en) * | 2005-10-12 | 2009-06-10 | Тайвен Юнизн Биотек Инк. | Portable scanning and analysing device |
| CN101598599B (en) * | 2009-07-20 | 2011-06-22 | 中国检验检疫科学研究院 | A multi-channel portable colloidal gold test strip rapid testing device |
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