TWI699703B - Detection system with recognition label compensation function - Google Patents

Detection system with recognition label compensation function Download PDF

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TWI699703B
TWI699703B TW108117918A TW108117918A TWI699703B TW I699703 B TWI699703 B TW I699703B TW 108117918 A TW108117918 A TW 108117918A TW 108117918 A TW108117918 A TW 108117918A TW I699703 B TWI699703 B TW I699703B
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test paper
test
screening test
detection system
read message
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TW202044116A (en
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葛均
田玉昇
林欣穎
楊宗翰
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保康特生物科技股份有限公司
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Abstract

一種具辨識標籤補償功能之檢測系統,包含一體外檢測器供一快篩試紙插入並拍攝影像,再傳輸到一電子裝置去作比對分析,其中該快篩試紙上所設的辨識標籤內容至少具有一第一讀取訊息,包括該快篩試紙其試紙種類、測試項目基本資料所對應的演算法,以及; 一第二讀取訊息,包括固定環境下的標準測試參數,供快篩試紙上控制線所呈現訊號進行量測校正。重點在使該快篩試紙的測量值,可與所設定在固定環境條件下之測量值比較,依據其差異以運算法對測試組之該測量值進行補償性修正,使受測項目產生一準確的檢測報告,不會受到外在不同環境的影響。A detection system with identification label compensation function includes an in vitro detector for inserting a quick screening test paper and shooting images, and then transmitting to an electronic device for comparison and analysis, wherein the identification label set on the quick screening test paper is at least It has a first reading message, including the type of the quick screening test paper, the algorithm corresponding to the basic data of the test item, and; a second reading message, including the standard test parameters in a fixed environment, for the quick screening test paper The signal presented by the control line is measured and corrected. The key point is to make the measured value of the quick screening test paper comparable with the measured value set under fixed environmental conditions, and use the algorithm to compensate the measured value of the test group according to the difference, so that the tested item will produce an accurate The test report will not be affected by different external environments.

Description

具辨識標籤補償功能之檢測系統Detection system with recognition label compensation function

本發明係有關體外檢測系統的技術領域,尤指一種具辨識標籤補償功能之檢測系統。 The present invention relates to the technical field of in-vitro detection systems, and particularly refers to a detection system with an identification tag compensation function.

隨著檢測技術不斷進步,市面上有許多可即時得知結果的快篩檢測裝置或快篩試紙,如驗孕棒或流感快篩試紙等,其雖然標榜操作簡單好用,但目前的快篩試紙依結果僅能簡單告知受測者陰性或陽性反應,不能反應精準分級的檢測結果,無法提供受測者更多資訊。尤其是檢測時,若待測物所含受檢之抗原/抗體濃度較低,導致受測後之快篩試紙結果不易被肉眼辨識,因而產生錯誤判斷及認知,提供給受測者錯誤的資訊,如此容易導致受測者及家人身心靈恐慌,或是造成不必要的醫療浪費。 With the continuous advancement of detection technology, there are many quick screening test devices or quick screening test papers that can know the results instantly, such as pregnancy test sticks or flu quick screening test papers. Although they claim to be simple and easy to use, the current quick screening The test paper can only tell the testee a negative or positive reaction based on the result. It cannot reflect the accurate grading test result and cannot provide more information about the testee. Especially during the test, if the test substance contains a low concentration of the tested antigen/antibody, the result of the quick screening test paper after the test is not easy to be recognized by the naked eye, resulting in wrong judgment and cognition, and providing the testee with wrong information , So it is easy to cause physical and mental panic of the subject and family members, or cause unnecessary medical waste.

雖然,目前可利用拍攝擷取該受測後快篩試紙之影像,再透過特定裝置進行分析來克服。譬如醫院內所設檢測專用的影像設備,但這種特殊設備龐大且所費不貲,非一般人能輕易購買或取得,且檢測時受測者需在醫院花費大量時間等待;另外,市面上也有一些可攜式電子裝置,可進行受測後快篩試紙之顯示影像擷取,再傳送至運算伺服器或相互搭配之設備如智慧型手機或電腦等以得到檢測結果;但其缺點是該 可攜式電子裝置應用時,操作麻煩必須另外搭設支架穩固,且是處於開放空間進行拍攝,其拍攝影像容易因環境之不同而有所差異,可能導致判讀上之誤差,再加上不同款式的可攜式電子裝置其畫素、對焦距離或感光度皆不同,拍攝出來的影像也會有所落差,容易導致判讀上亦產生誤差,造成許多不便。 Although, at present, it can be overcome by capturing the image of the quick screening test paper after the test, and then analyzing it through a specific device. For example, there are imaging equipment dedicated to testing in the hospital, but this special equipment is huge and expensive, and it can be easily purchased or obtained by non-ordinary people, and the testee needs to spend a lot of time in the hospital during testing; in addition, there are some on the market The portable electronic device can capture the displayed image of the quick screening test paper after the test, and then send it to a computing server or a compatible device such as a smart phone or computer to obtain the test result; but its disadvantage is that When using a portable electronic device, it’s troublesome to set up a stand for shooting, and it’s in an open space for shooting. The shot images are likely to vary depending on the environment, which may lead to errors in interpretation, plus different styles Portable electronic devices have different pixels, focusing distances, or sensitivity, and the captured images will also have gaps, which will easily lead to errors in interpretation and cause many inconveniences.

尤其,現有的快篩試紙都是一次性抛棄式用品,其每批內置試紙品質不同,容易受材質、製程差異影響,而造成批次生產間的差異,更是容易導致判讀結果時造成差異失去準確性。雖然現有的快篩試紙都具有一樣品區、一觀察區、以及一辨識標籤,但習式的快篩試紙其辨識標籤通常只是用來提供相關產品的名稱、序號、及製造日期等諸如此類的基本資訊而已,事實上並不能用來有效解決其試紙批次生產間差異上導致測試結果不同的問題。 In particular, the existing quick screening test strips are disposable disposable products. Each batch of built-in test strips is of different quality, which is easily affected by differences in materials and manufacturing processes, resulting in differences between batches, and it is easy to cause differences in the interpretation of results. accuracy. Although the existing quick screening test papers all have a sample area, an observation area, and an identification label, the identification label of the conventional quick screening test paper is usually only used to provide the name, serial number, and manufacturing date of the related product. Information is only, in fact, it cannot be used to effectively solve the problem of different test results caused by differences in test strip batch production.

更不能用來解決克服,習式快篩試紙因為快篩檢驗試劑是應用免疫分析檢驗技術及層析原理,在樣品區滴入檢體後,利用層析法將檢體擴散至測試組及對照組,對照組為Control Line,測試組為Test Line,而Control Line的反應作用如同與Test Line都是抗體與抗原的結合反應作用,同樣都會受作用時周遭環境的影響。其中當在不同環境條件下操作時(例如:溫度),即會使對照組Control Line反應受到影響,明顯造成測試結果不同失去準確性的使用上缺點。 It cannot be used to solve the problem. The traditional quick screening test paper is because the quick screening test reagent uses the immunoassay test technology and the principle of chromatography. After the sample is dropped into the sample area, the sample is diffused to the test group and the control by chromatography In the control group, the control group is the Control Line, and the test group is the Test Line. The reaction of the Control Line is the binding reaction of the antibody and the antigen as with the Test Line, and it will also be affected by the surrounding environment. Among them, when operating under different environmental conditions (for example: temperature), the control line reaction of the control group will be affected, which obviously causes the disadvantage of different test results and loss of accuracy.

為了解決上述之問題,故而開發出本發明之一種可隨身攜帶、即時知道反應結果,以及反應程度之具辨識標籤補償功能之檢測系統。 In order to solve the above-mentioned problems, a detection system with identification tag compensation function that can be carried around and knows the reaction result and the degree of reaction in real time is developed according to the present invention.

本發明之目的,在於提供一種具辨識標籤補償功能之檢測系統,包括:一體外檢測器、一快篩試紙、以及一電子裝置,其中該體外檢測器為一具有攝影功能的封閉環境,對外設有一檢體插入口,以供快篩試紙插入並拍攝影像,再傳輸到電子裝置去作比對分析,特徵在於:該快篩試紙,具有一樣品區、一觀察區、以及一辨識標籤,其中該觀察區至少具有一測試組與一對照組,而該辨識標籤的對應內容至少具有一第一讀取訊息、及一第二讀取訊息,其中該第一讀取訊息,至少包括該快篩試紙其試紙種類、測試項目基本資料所對應的演算法;該第二讀取訊息,至少包括該快篩試紙在固定環境下的標準測試參數,供快篩試紙上樣品區控制線(Control Line)所呈現訊號進行量測校正;藉此,使本發明應用時,透過該第一讀取訊息中傳達的試紙種類、測試項目基本資料,讓電子裝置內之分析軟體,對應產生一參數包與一判斷數據,然後將該判斷數據與由雲端所下載一對應的演算法及一資料參數供比對,以產生該測試組之一測量值;另外,更可透過該第二讀取訊息由該雲端所下載該運算法,將前述對照組之一測量值,與該系統所設定在固定環境條件下之測量值比較,依據其差異由該運算法產生對該測試組之該測量值之補償性修正;從而,讓受測者生理反應受測項目能產生一準確的檢測報告,不會受到外在環境不同而影響,以達成早期發現早期預防及規劃之功能。 The object of the present invention is to provide a detection system with recognition label compensation function, including: an in vitro detector, a quick screening test paper, and an electronic device, wherein the in vitro detector is a closed environment with a photography function, which is very useful for peripherals There is a specimen insertion port for inserting the quick screening test paper and shooting images, and then transmitting to the electronic device for comparison and analysis. The feature is that the quick screening test paper has a sample area, an observation area, and an identification label. The observation area has at least a test group and a control group, and the corresponding content of the identification tag has at least a first read message and a second read message, wherein the first read message includes at least the quick screen The algorithm corresponding to the type of the test paper and the basic data of the test item; the second read message includes at least the standard test parameters of the fast screening test paper in a fixed environment for the control line of the sample area on the fast screening test paper (Control Line) The presented signal is measured and calibrated; thereby, when the present invention is applied, the type of test paper and the basic data of the test item conveyed in the first read message are used to allow the analysis software in the electronic device to generate a parameter package and a corresponding Determine the data, and then compare the determination data with a corresponding algorithm and a data parameter downloaded from the cloud to generate a measurement value of the test group; in addition, the second read message can be read from the cloud The downloaded algorithm compares one of the measurement values of the aforementioned control group with the measurement value set by the system under fixed environmental conditions, and generates a compensatory correction for the measurement value of the test group based on the difference. ; Thus, the physiological response of the subject can be tested to produce an accurate test report, will not be affected by different external environments, in order to achieve the function of early detection, early prevention and planning.

為達上述目的,本發明之技術手段會在該雲端內設有一對照資料庫,該對照資料庫中根據辨識標籤的第一讀取訊息、及一第二讀取訊息所對應的內容,而具有多種不同程度之生理反應檢測影像結果,而該等檢測影像結果透過該雲端運算產生該資料參數,當使用者開啟該電子裝置內之分析軟體時,該分析軟體會自動下載該資料參數,並儲存於該分析軟體中;當檢測完成時,該電子裝置接收自該體外檢測器所傳輸之顯示影像,透過該分析軟體將分別產生一具有生理反應參數、顯示影像之參數包,以及一本次檢測結果之判斷數據,該分析軟體進一步會將該參數包傳送至該雲端,以進行數據之儲存及收集,同時該判斷數據與該資料參數將依檢測之類別進行反應程度之比對,進一步產生具有生理反應程度之該檢測報告。 In order to achieve the above-mentioned purpose, the technical means of the present invention will set up a comparison database in the cloud. The comparison database has content corresponding to the first read message of the identification tag and a second read message. A variety of different levels of physiological response detection image results, and the detection image results generate the data parameters through the cloud computing. When the user opens the analysis software in the electronic device, the analysis software will automatically download the data parameters and save them In the analysis software; when the detection is completed, the electronic device receives the display image transmitted from the in vitro detector, and through the analysis software, a parameter package with physiological response parameters, display images, and a current detection The result of the judgment data, the analysis software will further send the parameter package to the cloud for data storage and collection. At the same time, the judgment data and the data parameter will be compared with the degree of response according to the detection category, and further generate The test report of the degree of physiological reaction.

10:體外檢測器 10: In vitro detector

101:檢體插入口 101: Specimen insertion port

11:控制面板 11: Control Panel

111:電源鈕 111: Power button

112:影像擷取鈕 112: Image capture button

13:檢視面板 13: view panel

131:電源顯示燈 131: Power indicator

132:無線連接指示燈 132: Wireless connection indicator

133:檢體顯示燈 133: Specimen display light

134:傳輸顯示燈 134: Transmission indicator

14:USB連接槽 14: USB connection slot

15:檢體盒 15: Specimen box

151:感應器 151: Sensor

16:拍攝影像處理器 16: shooting image processor

17:傳輸介面控制處理器 17: Transmission interface control processor

18:電源單元 18: Power supply unit

20:快篩試紙 20: Quick screening test paper

21:樣品區 21: Sample area

22:觀察區 22: Observation area

221:測試組 221: Test Group

222:對照組 222: control group

23:辨識標籤 23: Identify tags

231:第一讀取訊息 231: First read message

232:第二讀取訊息 232: Second read message

30:電子裝置 30: Electronic device

31:分析軟體 31: Analysis software

40:雲端 40: Cloud

第1圖 為本發明系統的配置圖。 Figure 1 is a configuration diagram of the system of the present invention.

第2圖 為本發明快篩試紙的平面圖。 Figure 2 is a plan view of the quick screening test paper of the present invention.

第3圖 為本發明測試應用的流程圖。 Figure 3 is a flowchart of the test application of the present invention.

第4圖 為快篩試紙的反應圖。 Figure 4 is the reaction diagram of the quick screening test paper.

第5圖 為本發明體外檢測器的外觀圖。 Figure 5 is an external view of the in vitro detector of the present invention.

第6圖 為本發明體外檢測器的內部結構圖。 Figure 6 is the internal structure diagram of the in vitro detector of the present invention.

為便於 貴審查委員能對本發明之技術手段及運作過程有更進一步之認識與瞭解,茲舉例配合圖式,詳細說明如下。 In order to facilitate your reviewer to have a further understanding and understanding of the technical means and operation process of the present invention, an example is given in conjunction with the diagram, and the detailed description is as follows.

請參閱第1、2圖所示,本發明有關一種具辨識標籤補償功能之檢測系統,包含一體外檢測器10、一快篩試紙20、以及一電子裝置30,其中該體外檢測器10為一具有攝影功能的封閉環境,對外設有一檢體插入口101,以供快篩試紙20插入並拍攝影像,再傳輸到電子裝置30去作比對分析,其特徵在於:該快篩試紙20,具有一樣品區21、一觀察區22、以及一辨識標籤23,其中該觀察區22至少具有一測試組221與一對照組222,該辨識標籤23可為一維條碼或二維條碼,但實施時並不以此為限,且該辨識標籤23的對應內容至少具有一第一讀取訊息231、及一第二讀取訊息232,其中該第一讀取訊息231,至少包括該快篩試紙20其試紙種類、測試項目基本資料所對應的演算法;該第二讀取訊息232,至少包括該快篩試紙20在固定環境下的標準測試參數,供快篩試紙20上樣品區21的控制線Control Line所呈現訊號進行量測校正。 Please refer to Figures 1 and 2, the present invention relates to a detection system with recognition label compensation function, comprising an in vitro detector 10, a quick screening test paper 20, and an electronic device 30, wherein the in vitro detector 10 is an A closed environment with photography function is provided with a specimen insertion port 101 for the quick screening test paper 20 to insert and shoot images, which are then transmitted to the electronic device 30 for comparison and analysis. The feature is that the quick screening test paper 20 has A sample area 21, an observation area 22, and an identification label 23. The observation area 22 has at least a test group 221 and a control group 222. The identification label 23 can be a one-dimensional bar code or a two-dimensional bar code. It is not limited to this, and the corresponding content of the identification tag 23 has at least a first read message 231 and a second read message 232, wherein the first read message 231 includes at least the quick screening test paper 20 The type of test paper and the algorithm corresponding to the basic data of the test item; the second read message 232 includes at least the standard test parameters of the fast screening test paper 20 in a fixed environment, and is provided for the control line of the sample area 21 on the fast screening test paper 20 The signal presented by the Control Line is measured and corrected.

藉由以上的有效設計,使本發明測試應用時具有以下之優點: With the above effective design, the present invention has the following advantages when testing and applying:

第一,以該辨識標籤23的第一讀取訊息231,可供體外檢測器10讀取,而透過藍芽連線之手機APP至雲端40下載並套用第一讀取訊息231代表的演算法,進行快篩試紙20的判讀。 First, the first read message 231 of the identification tag 23 can be read by the in vitro detector 10, and the mobile phone APP connected via Bluetooth is downloaded to the cloud 40 and the algorithm represented by the first read message 231 is applied. , Interpretation of fast screening test paper 20.

應用說明:利用體外檢測器10拍攝掃描一待測的快篩試紙20上對照組222與辨識標籤23的影像,透過有線或無線的方式連接一電子裝置30,將影像擷取至電子裝置30之中。當體外檢測器10透過讀取快篩試紙20上的辨識標籤23,初步取得第一讀取訊息231時,可以清楚知道試紙種類、測試項目基本資料,即會從雲端40讀取並下載有關辨識標籤23其第一讀取訊息231對應的演算法至一電子體外檢測器10,以進行測試組221與對照組222之比對結果分析與儲存功能。 Application note: Use the in vitro detector 10 to capture and scan the images of the control group 222 and the identification tag 23 on a quick screening test paper 20 to be tested, connect an electronic device 30 through a wired or wireless way, and capture the image to the electronic device 30 in. When the in vitro detector 10 initially obtains the first reading message 231 by reading the identification label 23 on the quick screening test paper 20, it can clearly know the type of test paper and the basic data of the test item, and it will read and download the relevant identification from the cloud 40 The algorithm corresponding to the first read message 231 of the tag 23 is sent to an electronic in vitro detector 10 to perform the comparison result analysis and storage function of the test group 221 and the control group 222.

第二,以辨識標籤23的第二讀取訊息232,可供作快篩試紙20上樣品區21的控制線Control Line所呈現訊號進行量測校正。 Second, the second read message 232 of the identification tag 23 can be used as the signal presented by the Control Line of the sample area 21 on the quick screening test paper 20 for measurement and calibration.

應用說明:當快篩試紙20試劑應用時,在樣品區21滴入檢體後,利用層析法將檢體擴散至測試組221及對照組222,當在不同環境條件下操作時,譬如在熱帶國家與寒帶國家溫度不同的環境,造成使對照組222 Control Line反應受影響,此時即可用來與第二讀取訊息232已選定固定環境條件標準測試參數的Control Line反應訊號來做比較,以計算出在不同環境下對於量測影響造成之差異比,進而對測試組221的Test Line之分析結果進行補償性的修正,以得到更精確之分析數值。 Application note: When the quick screening test paper 20 reagent is used, after dropping the sample in the sample area 21, the sample is diffused to the test group 221 and the control group 222 by chromatography. When operating under different environmental conditions, such as The temperature difference between tropical countries and frigid countries affects the control line response of the control group 222. At this time, it can be used to compare with the control line response signal of the second reading message 232 that has selected the standard test parameters of the fixed environmental conditions. In order to calculate the difference ratio caused by the measurement effects under different environments, the analysis results of the Test Line of the test group 221 are compensated for correction to obtain more accurate analysis values.

第三,該辨識標籤23的第二讀取訊息231其對應內容,還可衍伸應用在降低試紙批間差異。 Third, the corresponding content of the second read message 231 of the identification tag 23 can also be extended to reduce the difference between test strips.

應用說明:主要是因為一般快篩試紙20的觀察區22之結果,可能受材質、製程差異影響,而造成批次生產間的差異,進而導致系統判讀結果時造成之差異,故此時即可利用讀取辨識標籤23的第二讀取訊息231以載入不同之運算參數,進而達到校正且校對觀察區22之結果。 Application note: Mainly because the results of the observation area 22 of the general quick screening test paper 20 may be affected by differences in materials and manufacturing processes, resulting in differences between batches, which will lead to differences in the system's interpretation of results, so it can be used at this time The second reading message 231 of the identification tag 23 is read to load different operation parameters, and then the result of calibration and proofreading of the observation area 22 is achieved.

第四,透過上述第二點辨識標籤23的第二讀取訊息231,還可衍伸至試紙的有效期限控管。 Fourth, the second read message 231 of the second point identification tag 23 can also be extended to control the validity period of the test paper.

應用說明:透過快篩試紙20之辨識標籤23可雲端40紀錄試紙的有效期限進而限制過期試紙之使用,避免可能的過期試紙產生的錯誤判讀混淆使用者的生理數值判讀。 Application note: Through the identification label 23 of the quick screening test paper 20, the expiration date of the test paper can be recorded in the cloud 40, thereby limiting the use of the expired test paper, and avoiding possible misinterpretation caused by the expired test paper to confuse the user's physiological value interpretation.

藉此,如第1圖至第4圖所示,使本系統實施執行具辨識標籤補償功能之檢測時,可用來判讀快篩試紙20是否仍在保存期限?若否,為過期電子裝置30不予判讀,若是,則進一步判讀待測快篩試紙20是否存在對照組222 Control Line,若該快篩試紙20的Control Line沒有出現,則電子裝置30會判定為失效反應(invalid),若是,則再比對該Control Line是否與固定環境條件下之對照組222 Control Line反應訊號相同,若否,則用參數包做對測試組221的Test Line的數據判讀;若是,則計算Control Line(C line)的差異比進而對Test Line(T line)的結果進行補償性的修正,以得到更精確之分析數值。 As a result, as shown in Figures 1 to 4, the system can be used to determine whether the quick screening test paper 20 is still in the shelf life when the system performs the detection with the recognition label compensation function? If not, the expired electronic device 30 will not be judged. If so, it will be further judged whether the quick screening test paper 20 to be tested has a control line 222. If the Control Line of the quick screening test paper 20 does not appear, the electronic device 30 will determine Invalid response (invalid), if it is, then compare whether the control line is the same as the control line 222 Control Line under fixed environmental conditions, if not, use the parameter package to interpret the test line data of the test group 221; If so, calculate the difference ratio of the Control Line (C line) and then make a compensatory correction to the result of the Test Line (T line) to obtain a more accurate analysis value.

更具體而言,以上所述之本發明系統可實現應用在各種方便易攜的體外檢測器10與不同種類快篩試紙20上,其中該體外檢測器10與該電子設備30可透過有線或無線的方式連接,該電子裝置30可為智慧型手機、平板電腦、桌上型電腦以及筆記型電腦等。 More specifically, the system of the present invention described above can be applied to various convenient and portable in vitro detectors 10 and different types of quick screening test papers 20, wherein the in vitro detector 10 and the electronic device 30 can be wired or wireless The electronic device 30 can be a smart phone, a tablet computer, a desktop computer, a notebook computer, and so on.

如第1圖及第5圖所示,其中本發明的該體外檢測器10機種造型可多樣化,其外觀實際並不以此為限,也可設計成其他不同造型。 As shown in Figs. 1 and 5, the shape of the in vitro detector 10 of the present invention can be diversified, and its appearance is not limited to this, and can also be designed in other different shapes.

以第5圖為例,該體外檢測器10之一面具有一控制面板11,該控制面板11上設有一電源鈕111以及一影像擷取鈕112,該體外檢測器 10上具有一檢體插入口101以及一USB連接槽14,該檢體插入口101以及該USB連接槽14分別設於不同面,於該體外檢測器10上具有一檢視面板13,該檢視面板13上設有一電源顯示燈131、一無線連接指示燈132、一檢體顯示燈133以及一傳輸顯示燈134等,用以提醒使用者該體外檢測器10是否有被啟動以及運作狀況。 Taking Figure 5 as an example, one of the external detectors 10 has a control panel 11, and the control panel 11 is provided with a power button 111 and an image capture button 112. The external detector 10 has a specimen insertion port 101 and a USB connection slot 14. The specimen insertion port 101 and the USB connection slot 14 are respectively provided on different sides, and the extracorporeal detector 10 has a viewing panel 13, the viewing panel A power indicator light 131, a wireless connection indicator light 132, a specimen indicator light 133, and a transmission indicator light 134 are provided on the 13 to remind the user whether the extracorporeal detector 10 is activated and operating conditions.

請參閱第5、6圖所示,該體外檢測器10內為一封閉環境,內設有一檢體盒15、一拍攝影像處理器16、一傳輸介面控制處理器17以及一電源單元18。其中,一受測後之快篩試紙20可自該檢體插入口101插入該檢體盒15內,當該受測後之快篩試紙20接觸到該檢體盒15一端所設有之一感應器151時,該檢視面板13之檢體顯示燈133會被啟動,如此使用者將知道該受測後之快篩試紙20有正確放入,且可以開始進行影像之擷取,該拍攝影像處理器16係設於該檢體盒15之一側與該影像擷取鈕112電性連接,透過該影像擷取鈕112控制該拍攝影像處理器16擷取該檢體盒15內之受測後之快篩試紙20之一顯示影像,並將該顯示影像傳送至該傳輸介面控制處理器17,該傳輸介面控制處理器17可為無線之藍芽傳輸或wifi傳輸,亦可透過與之電性連接之該USB連接槽14進行有線傳輸,直接藉由無線或有線的方式將該顯示影像輸出至該電子裝置30內進行分析,同時該檢視面板13之傳輸顯示燈134會被啟動。 As shown in FIGS. 5 and 6, the in vitro detector 10 is a closed environment with a specimen box 15, a shooting image processor 16, a transmission interface control processor 17, and a power supply unit 18. Among them, a quick screening test paper 20 after testing can be inserted into the sample box 15 from the sample insertion port 101, and when the quick screening test paper 20 after testing touches one of the ends of the sample box 15 When the sensor 151 is activated, the specimen display light 133 of the viewing panel 13 will be activated, so that the user will know that the quick screening test paper 20 after the test is correctly inserted, and can start the image capture, the captured image The processor 16 is arranged on one side of the specimen box 15 and is electrically connected to the image capturing button 112. Through the image capturing button 112, the shooting image processor 16 is controlled to capture the test in the specimen box 15 One of the subsequent quick screening test papers 20 displays an image, and transmits the displayed image to the transmission interface control processor 17. The transmission interface control processor 17 can be wireless Bluetooth transmission or wifi transmission, and can also be connected to it. The USB connection slot 14 of the sexual connection performs wired transmission, and the displayed image is directly output to the electronic device 30 for analysis by wireless or wired means, and the transmission indicator light 134 of the viewing panel 13 is activated.

請參閱第1、2圖所示,該電子裝置30內具有一分析軟體31,當檢測完成時,該電子裝置30接收該體外檢測器10所傳輸之顯示影像,該分析軟體31對該顯示影像影像進行去背、去雜訊以及清晰度處理後,分別產生一參數包以及一判斷數據,該參數包內包含該辨識標籤23之訊 號以及該測試組221之影像,並傳遞至本發明之雲端40,而該判斷數據為測試組221之影像所產生。 Please refer to Figures 1 and 2, the electronic device 30 has an analysis software 31. When the detection is completed, the electronic device 30 receives the display image transmitted by the in vitro detector 10, and the analysis software 31 displays the image After the image is processed for de-backing, de-noising and sharpness, a parameter package and a judgment data are generated respectively, and the parameter package contains the information of the identification tag 23 The number and the image of the test group 221 are transmitted to the cloud 40 of the present invention, and the judgment data is generated by the image of the test group 221.

該雲端40內設有一與該分析軟體31相對應之對照資料庫,該對照資料庫中根據辨識標籤23的第一讀取訊息231、及一第二讀取訊息232所對應的內容,而具有複數種不同程度之生理反應檢測之顯示影像,因生理反應程度不同,其檢體中欲檢測成分濃度會有所不同,所以呈現在該受測後之快篩試紙20之結果亦會有深淺不同之區分,當使用者在有線環境下打開該電子裝置30,該分析軟體31會自動自該雲端40下載最新之該資料參數,如此,當該電子裝置30處在無線情況下仍然可進行檢測結果之比對。 A comparison database corresponding to the analysis software 31 is provided in the cloud 40. The comparison database contains contents corresponding to the first read message 231 and a second read message 232 of the identification tag 23, and has The displayed images of multiple physiological response tests of different levels. Due to the different degrees of physiological response, the concentration of the components to be detected in the sample will be different, so the results of the quick screening test paper 20 presented after the test will also have different depths. When the user turns on the electronic device 30 in a wired environment, the analysis software 31 will automatically download the latest data parameters from the cloud 40, so that the detection result can still be performed when the electronic device 30 is wireless The comparison.

該雲端40接收自該分析軟體31傳送之參數包後,會依據該參數包內具有之生理反應參數以及該測試組221之影像進行數據之分類及歸檔,若所提供之影像為新的,該對照資料庫則會進行更新,使針對該快篩試紙20其上辨識標籤23一第一讀取訊息231、及一第二讀取訊息232所對應的內容,供該分析軟體31下載,使本發明應用時,透過該第一讀取訊息231中傳達的試紙種類、測試項目基本資料,讓電子裝置30內之分析軟體,對應產生一參數包與一判斷數據,然後將該判斷數據與由雲端40所下載之一資料參數比對,以產生該測試組221之一測量值;另外,更可透過該第二讀取訊息232由該雲端40所下載該運算法,將前述對照組222之一測量值,與該系統所設定在固定環境條件下之測量值比較,依據其差異由該運算法產生對該測試組221之該測量值之補償性修正。從而,讓受測者生理反應受測項目能產生一準確的檢測報 告,不會受到外在環境不同而影響,以達成早期發現早期預防及規劃之功能。 After the cloud 40 receives the parameter package sent from the analysis software 31, it classifies and archives the data according to the physiological response parameters contained in the parameter package and the image of the test group 221. If the provided image is new, the The control database will be updated so that the content corresponding to the first reading message 231 and the second reading message 232 of the identification tag 23 on the quick screening test paper 20 can be downloaded by the analysis software 31 to make the In the application of the invention, the analysis software in the electronic device 30 correspondingly generates a parameter package and a judgment data through the test paper type and basic data of the test item conveyed in the first read message 231, and then the judgment data is transferred to the cloud Compare a data parameter downloaded in 40 to generate a measurement value of the test group 221; in addition, the algorithm can be downloaded from the cloud 40 through the second read message 232 to compare one of the aforementioned control groups 222 The measured value is compared with the measured value set by the system under fixed environmental conditions, and the compensation correction for the measured value of the test group 221 is generated by the algorithm based on the difference. Thus, the subject’s physiological response to the tested item can produce an accurate test report. Report, will not be affected by the difference of the external environment, in order to achieve the function of early detection, early prevention and planning.

本發明之體外檢測系統透過該體外檢測器10於封閉環境中擷取該受測後之快篩試紙20之顯示影像,無須擔心因環境或拍攝設備之不同,而影響影像擷取之結果,因此使用者可將該體外檢測器10隨身攜帶,隨時隨地進行檢測;並將該顯示影像傳送至該電子裝置30進行結果之分析,可節省使用者自行上傳資料之程序;再者,該體外檢測系統透過該電子裝置30內之該分析軟體31會定時自該雲端40下載該資料參數,因此在有線或無線的情況下皆可進行該顯示影像之分析比對,除可得知生理反應知陰性/陽性外,亦可分析其生理反應程度並提供建議,達到早期發現早期預防及規劃之功能。 The in vitro detection system of the present invention captures the displayed image of the quick screening test paper 20 after the test through the in vitro detector 10 in a closed environment, and there is no need to worry about the difference in environment or shooting equipment that will affect the results of image capture. The user can carry the in vitro detector 10 with him for testing anytime and anywhere; and send the displayed image to the electronic device 30 for analysis of the results, which saves the user from uploading data by himself. Furthermore, the in vitro testing system The analysis software 31 in the electronic device 30 will periodically download the data parameters from the cloud 40. Therefore, the displayed image can be analyzed and compared under wired or wireless conditions, except that the physiological response is known to be negative/ In addition to positive, it can also analyze the degree of physiological reaction and provide suggestions to achieve the functions of early detection and early prevention and planning.

惟以上所述者,僅為本發明之較佳實施例而已,當不能以此限定本發明實施之範圍;故,凡依本發明申請專利範圍及發明說明書內容所作之簡單的等效變化與修飾,皆應仍屬本發明專利涵蓋之範圍內。 However, the above are only preferred embodiments of the present invention, and should not be used to limit the scope of implementation of the present invention; therefore, all simple equivalent changes and modifications made in accordance with the scope of the patent application of the present invention and the content of the description of the invention , Should still fall within the scope of the invention patent.

10:體外檢測器 10: In vitro detector

101:檢體插入口 101: Specimen insertion port

20:快篩試紙 20: Quick screening test paper

21:樣品區 21: Sample area

22:觀察區 22: Observation area

23:辨識標籤 23: Identify tags

231:第一讀取訊息 231: First read message

232:第二讀取訊息 232: Second read message

30:電子裝置 30: Electronic device

31:分析軟體 31: Analysis software

40:雲端 40: Cloud

Claims (8)

一種具辨識標籤補償功能之檢測系統,包括:一體外檢測器、一快篩試紙、以及一電子裝置,其中該體外檢測器,具有一封閉環境,以設有一檢體盒、一拍攝影像處理器、一傳輸介面控制處理器以及一電源單元,該檢體盒對外設有一檢體插入口,用以插入一受測之該快篩試紙;該快篩試紙,具有一樣品區、一觀察區、以及一辨識標籤,其中該觀察區至少具有一測試組與一對照組,而該辨識標籤的對應內容至少具有一第一讀取訊息、及一第二讀取訊息,其中該第一讀取訊息,至少包括該快篩試紙其試紙種類、測試項目基本資料所對應的演算法;該第二讀取訊息,至少包括該快篩試紙在固定環境下的標準測試參數,供該快篩試紙上樣品區控制線所呈現訊號進行量測校正;以及該電子裝置,其內具有一分析軟體,用以接收自該體外檢測器透過該拍攝影像處理器擷取該檢體盒,經該傳輸介面控制處理器所傳來之受測後之該快篩試紙之顯示影像,以產生一參數包與一判斷數據;藉此,透過該第一讀取訊息中傳達的試紙種類、測試項目基本資料,可將該判斷數據與由雲端所下載一對應的演算法及一資料參數供比對,以產生該測試組之一測量值;而透過該第二讀取訊息由該雲端所下載該運算法,將前述對照組之一測量值,與該系統所設定在固定環境條件下之測量值比較,依據其差異由該運算法產生對該測試組之該測量值之補償性修正,讓受測者生理反應受測項目能產生一準確的檢測報告。 A detection system with identification label compensation function, including: an in vitro detector, a quick screening test paper, and an electronic device, wherein the in vitro detector has a closed environment, and is provided with a specimen box and a shooting image processor , A transmission interface control processor and a power supply unit, the sample box is provided with a sample insertion port for inserting the quick screening test paper to be tested; the quick screening test paper has a sample area, an observation area, And an identification tag, wherein the observation area has at least a test group and a control group, and the corresponding content of the identification tag has at least a first read message and a second read message, wherein the first read message , Including at least the quick-screening test paper, the type of test paper, and the algorithm corresponding to the basic data of the test item; the second read message includes at least the standard test parameters of the quick-screening test paper in a fixed environment for the sample on the quick-screening test paper The signal presented by the area control line is measured and calibrated; and the electronic device has an analysis software in it, which is used to receive from the extracorporeal detector through the imaging processor to capture the specimen box, and control the processing through the transmission interface The display image of the quick screening test paper after the test from the device to generate a parameter package and a judgment data; thereby, through the test paper type and basic data of the test item conveyed in the first read message, The judgment data is compared with a corresponding algorithm and a data parameter downloaded from the cloud to generate a measurement value of the test set; and the algorithm downloaded by the cloud through the second read message is used to compare the aforementioned A measurement value of the control group is compared with the measurement value set by the system under fixed environmental conditions. The algorithm generates a compensatory correction for the measurement value of the test group based on the difference, so that the subject’s physiological response is affected. Test items can produce an accurate test report. 如申請專利範圍第1項所述之具辨識標籤補償功能之檢測系統,其中該雲端內建有一與該分析軟體相互對應之對照資料庫,該對照資料庫中係根據該辨識標籤的第一讀取訊息、及一第二讀取訊息所對應的內容,而具有複數種不同程度之生理反應檢測顯示影像,並將該等顯示影像透過運算、分類產生該資料參數。 For example, the detection system with recognition tag compensation function described in the first item of the patent application, wherein the cloud has a built-in comparison database corresponding to the analysis software, and the comparison database is based on the first reading of the recognition tag Obtain the content corresponding to the message and a second read message, detect and display images with a plurality of different degrees of physiological response, and generate the data parameters through calculation and classification of the displayed images. 如申請專利範圍第2項所述之具辨識標籤補償功能之檢測系統,其中該辨識標籤應的第二讀取訊息其對應內容進一步用在降低試紙批間差異,以提供不同之運算參數下載,達到校正且校對觀察區之結果。 For example, the detection system with identification label compensation function described in the second item of the scope of patent application, wherein the corresponding content of the second read message corresponding to the identification label is further used to reduce the difference between test strips and provide different calculation parameters for download. Reach the result of calibration and proofreading the observation area. 如申請專利範圍第3項所述之具辨識標籤補償功能之檢測系統,其中該辨識標籤的第二讀取訊息其對應內容進一步提供作為試紙的有效期限控管。 For example, the detection system with recognition label compensation function as described in item 3 of the scope of patent application, wherein the corresponding content of the second read message of the recognition label is further provided as the validity period control of the test paper. 如申請專利範圍第2項所述之具辨識標籤補償功能之檢測系統,其中該雲端會接收該參數包內具有檢測結果之生理反應參數以及該測試組之影像,並進行數據之儲存及收集。 For example, the detection system with identification tag compensation function described in the scope of patent application 2, wherein the cloud will receive the physiological response parameters with the detection results in the parameter package and the image of the test group, and store and collect the data. 如申請專利範圍第1項所述之具辨識標籤補償功能之檢測系統,其中該電子裝置可為智慧型手機、平板電腦、桌上型電腦以及筆記型電腦之其中一種。 For example, the detection system with identification tag compensation function described in the first item of the scope of patent application, wherein the electronic device can be one of a smart phone, a tablet computer, a desktop computer, and a notebook computer. 如申請專利範圍第1項所述之具辨識標籤補償功能之檢測系統,其中該傳輸介面控制處理器係可分別透過一USB連接槽進行有線傳輸,以及藍芽或WIFI進行無線傳輸。 For example, the detection system with recognition tag compensation function described in the first item of the patent application, wherein the transmission interface control processor can respectively perform wired transmission through a USB connection slot and wireless transmission through Bluetooth or WIFI. 如申請專利範圍第1項所述之具辨識標籤補償功能之檢測系統,其中該體外檢測器之一面具有一檢示面板,其上分別設有一電源顯示燈、一無線連接指示燈、一檢體顯示燈以及一傳輸顯示燈。 For example, the detection system with identification tag compensation function described in the first item of the scope of patent application, wherein one of the external detectors has a detection panel with a power indicator light, a wireless connection indicator light, and a specimen Indicator light and a transmission indicator light.
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