TWM652658U - System using number of immune cells to interpret disease information of tested living thing - Google Patents

System using number of immune cells to interpret disease information of tested living thing Download PDF

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TWM652658U
TWM652658U TW112211258U TW112211258U TWM652658U TW M652658 U TWM652658 U TW M652658U TW 112211258 U TW112211258 U TW 112211258U TW 112211258 U TW112211258 U TW 112211258U TW M652658 U TWM652658 U TW M652658U
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顏肇宏
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杏創生物科技股份有限公司
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Abstract

一種利用免疫細胞數量判讀受測生物疾病資訊之系統,包括用以輸出受測檢體之免疫細胞數量數據的免疫細胞檢測裝置以及與其通訊連接的數據分析工作站,數據分析工作站包括中央處理器以及與其信號連接之比對細胞數據庫、演算模組及回歸校正模組;該演算模組讀取該免疫細胞數量數據並據以演算獲得風險預測數據;該回歸校正模組內設有基於該比對細胞數據庫建立之回歸模型,該回歸校正模組讀取該風險預測數據以根據該比對細胞數據庫回歸校正獲得風險預測校正數據。藉此,獲得更精準、有效的免疫細胞疾病風險預測結果。A system that uses immune cell numbers to interpret tested biological disease information, including an immune cell detection device for outputting immune cell number data of a tested subject and a data analysis workstation that is communicatively connected to it. The data analysis workstation includes a central processor and its The signal connects the comparison cell database, the calculation module and the regression correction module; the calculation module reads the immune cell quantity data and calculates the risk prediction data based on it; the regression correction module has a function based on the comparison cells The regression model established by the database, the regression correction module reads the risk prediction data to obtain the risk prediction correction data according to the regression correction of the comparison cell database. In this way, more accurate and effective immune cell disease risk prediction results can be obtained.

Description

利用免疫細胞數量判讀受測生物疾病資訊之系統A system that uses the number of immune cells to interpret tested biological disease information

本新型係與免疫細胞數量檢測有關,特別是指利用免疫細胞數量判讀受測生物疾病資訊之系統。This new type of system is related to the detection of immune cell numbers, and particularly refers to a system that uses immune cell numbers to interpret disease information of tested organisms.

在醫療領域中,免疫細胞數量被認為是一個與疾病風險相關的重要指標。當免疫細胞的數量出現異常時,代表受測生物體內的健康狀態可能受到某些疾病相關的影響,例如感染性疾病、癌症、過敏和自體免疫性疾病等。In the medical field, the number of immune cells is considered an important indicator related to disease risk. When the number of immune cells is abnormal, it means that the health status of the tested organism may be affected by certain diseases, such as infectious diseases, cancer, allergies, and autoimmune diseases.

隨著科技的進步,目前可以透過多種方式來測定免疫細胞數量,以獲得受測生物的疾病風險資訊。當前測定免疫細胞數量的技術主要包括血液常規檢查和酶聯免疫吸附測定(Enzyme-linked immunosorbent assay,ELISA)。然而,這些現有的測定技術都有其局限性。例如,血液常規檢查雖然操作簡單,但其結果容易受到多種因素的影響,如樣本的質量和患者的健康狀態等。ELISA技術雖然可以提供更精確的免疫細胞數量數據,但其通常需要專門的設備和操作技能,且成本較高。此外,這些技術需要對細胞或血清進行特殊處理,這可能會影響測試結果的準確性。With the advancement of technology, the number of immune cells can now be measured in a variety of ways to obtain disease risk information of the tested organism. Current technologies for measuring the number of immune cells mainly include routine blood tests and enzyme-linked immunosorbent assay (ELISA). However, these existing assay techniques have their limitations. For example, although routine blood tests are simple to operate, their results are easily affected by many factors, such as the quality of the sample and the patient's health status. Although ELISA technology can provide more accurate immune cell quantity data, it usually requires specialized equipment and operating skills, and is costly. Additionally, these techniques require special processing of cells or serum, which may affect the accuracy of test results.

值得注意的是,流式細胞儀(Flow cytometry)具有明顯的優勢。流式細胞儀不僅能夠實時地測量血液中多種免疫細胞的數量和功能,還能對單個細胞進行分析,提供更多層次和更高解析度的資料。然而,流式細胞儀在測定免疫細胞數量方面仍存在一定的挑戰,例如對染料和試劑的選擇,以及高度專門化的操作要求。It is worth noting that flow cytometry has obvious advantages. Flow cytometry can not only measure the number and function of various immune cells in the blood in real time, but also analyze individual cells, providing more levels and higher resolution data. However, flow cytometry still presents certain challenges in determining immune cell numbers, such as the selection of dyes and reagents, as well as highly specialized operational requirements.

據上,雖然目前已有多種技術可用於測定免疫細胞數量以評估疾病風險,但這些方法仍存在諸多局限。流式細胞儀作為一種先進的技術,有潛力解決這些問題,但仍需要進一步的優化和研究。According to reports, although there are currently a variety of technologies that can be used to measure immune cell numbers to assess disease risk, these methods still have many limitations. As an advanced technology, flow cytometry has the potential to solve these problems, but further optimization and research are still needed.

本新型的目的係在於提供一種利用免疫細胞數量判讀受測生物疾病資訊之系統,透過以流式細胞儀作為免疫細胞檢測裝置,將獲得之免疫細胞數量數據進行演算獲得免疫細胞疾病的風險預測數據,再基於比對細胞數據庫對該風險預測數據進行回歸校正,以獲得更精準、有效的受測生物免疫細胞疾病風險預測結果。The purpose of this new model is to provide a system that uses the number of immune cells to interpret tested biological disease information. By using a flow cytometer as an immune cell detection device, the obtained immune cell number data is calculated to obtain risk prediction data for immune cell diseases. , and then perform regression correction on the risk prediction data based on the comparison cell database to obtain more accurate and effective immune cell disease risk prediction results for the tested organisms.

為達前述目的,本新型提供一種利用免疫細胞數量判讀受測生物疾病資訊之系統,其包括:一免疫細胞檢測裝置,為一流式細胞儀,用以輸出一受測檢體的一免疫細胞數量數據;一數據分析工作站,與該免疫細胞檢測裝置通訊連接,該數據分析工作站包括一中央處理器以及與其信號連接之一比對細胞數據庫、一演算模組及一回歸校正模組;該演算模組透過該中央處理器讀取該免疫細胞數量數據並據以演算獲得一風險預測數據;該回歸校正模組內設有基於該比對細胞數據庫建立之回歸模型,該回歸校正模組透過該中央處理器讀取該風險預測數據以根據該比對細胞數據庫回歸校正獲得一風險預測校正數據。In order to achieve the aforementioned purpose, the present invention provides a system for interpreting biological disease information by using the number of immune cells, which includes: an immune cell detection device, which is a first-flow cytometer, and is used to output the number of immune cells of a subject under test. Data; a data analysis workstation, communicatively connected with the immune cell detection device, the data analysis workstation includes a central processor and a comparison cell database, a calculation module and a regression correction module signally connected to it; the calculation module The team reads the immune cell quantity data through the central processor and calculates it to obtain a risk prediction data; the regression correction module is equipped with a regression model based on the comparison cell database, and the regression correction module uses the central processing unit The processor reads the risk prediction data to obtain a risk prediction correction data based on the comparison cell database regression correction.

可選地,於本新型實施例中,該免疫細胞檢測裝置包含另一個中央處理器及與其信號連接之一檢測模組;該檢測模組用於輸出該受測檢體之一細胞螢光數值數據至該中央處理器,供一免疫細胞數量數據轉換單元讀取並轉換該細胞螢光數值數據形成該免疫細胞數量數據。Optionally, in this novel embodiment, the immune cell detection device includes another central processor and a detection module signal connected thereto; the detection module is used to output a cell fluorescence value of the tested sample The data is sent to the central processing unit for an immune cell quantity data conversion unit to read and convert the cell fluorescence numerical data to form the immune cell quantity data.

可選地,於本新型實施例中,該細胞螢光數值數據包含一同種型抗體螢光數值及一特異型抗體螢光數值。Optionally, in this novel embodiment, the cell fluorescence value data includes the fluorescence value of an antibody of the same isotype and the fluorescence value of a specific type of antibody.

可選地,於本新型實施例中,該免疫細胞檢測裝置還包括一分析圖表輸出單元與該中央處理器信號連接,供讀取該免疫細胞數量數據,並據以輸出一檢體細胞分析圖表至該數據分析工作站。Optionally, in this novel embodiment, the immune cell detection device further includes an analysis chart output unit connected to the central processor via a signal for reading the immune cell quantity data and outputting a sample cell analysis chart accordingly. to the data analysis workstation.

可選地,於本新型實施例中,該數據分析工作站還包括一檢驗報告產出單元與該中央處理器信號連接,該檢驗報告產出單元讀取該風險預測校正數據及該檢體細胞分析圖表並據以輸出一免疫細胞疾病風險預測報告。Optionally, in the new embodiment of the present invention, the data analysis workstation further includes a test report output unit connected to the central processor signal, and the test report output unit reads the risk prediction correction data and the sample cell analysis The chart is used to output an immune cell disease risk prediction report.

可選地,於本新型實施例中,該免疫細胞檢測裝置另設有一人機介面模組及一儲存模組與該中央處理器信號連接。Optionally, in this novel embodiment, the immune cell detection device is further provided with a human-machine interface module and a storage module that are signally connected to the central processor.

可選地,於本新型實施例中,該數據分析工作站另設有一人機介面模組及一儲存模組與該中央處理器信號連接。Optionally, in the new embodiment of the present invention, the data analysis workstation is further provided with a human-machine interface module and a storage module signally connected to the central processor.

可選地,於本新型實施例中,該免疫細胞檢測裝置與該數據分析工作站分別設有一通訊模組,該免疫細胞檢測裝置與該數據分析工作站透過該通訊模組進行數據的通訊傳輸。Optionally, in this novel embodiment, the immune cell detection device and the data analysis workstation are each provided with a communication module, and the immune cell detection device and the data analysis workstation communicate and transmit data through the communication module.

可選地,於本新型實施例中,該比對細胞數據庫為基於特定人類遺傳特徵之細胞數據建立的資料庫。Optionally, in this novel embodiment, the comparison cell database is a database established based on cell data of specific human genetic characteristics.

可選地,於本新型實施例中,該比對細胞數據庫為基於特定動物細胞數據建立之資料庫。Optionally, in this novel embodiment, the comparison cell database is a database established based on specific animal cell data.

綜上所述,本新型的利用免疫細胞數量判讀受測生物疾病資訊之系統可以採用流式細胞儀作為免疫細胞檢測裝置,解決了血液常規檢查和ELISA測定免疫細胞數量等技術所存在的技術問題,不僅檢測方便、檢測成本降低,更可以快速且精準地獲得更精準的受測生物免疫細胞數量,從而提供準確、有效的受測生物疾病資訊判斷結果。To sum up, this new system that uses the number of immune cells to interpret tested biological disease information can use flow cytometry as the immune cell detection device, solving the technical problems existing in routine blood tests and ELISA to measure the number of immune cells. , not only is the detection convenient and the detection cost is reduced, but also a more accurate number of immune cells of the tested organism can be obtained quickly and accurately, thereby providing accurate and effective information and judgment results of the tested organism's disease information.

有關於本新型為達成上述目的,所採用之技術、手段及其他功效,茲舉較佳可行實施例並配合圖式詳細說明如後。Regarding the technologies, means and other effects adopted by the present invention to achieve the above objectives, the best feasible embodiments are described in detail below along with the drawings.

為利於對本新型的瞭解,以下結合實施例進行說明。In order to facilitate the understanding of the present invention, the following description is given in conjunction with the embodiments.

如圖1所示,本新型提供的利用免疫細胞數量判讀受測生物疾病資訊之系統主要包括一免疫細胞檢測裝置10及一數據分析工作站20。其中,該免疫細胞檢測裝置10可為一流式細胞儀,該數據分析工作站20可為設於本地的計算機設備或伺服器,亦可為設於雲端的數據分析系統或伺服器。As shown in Figure 1, the system provided by the present invention for using the number of immune cells to interpret tested biological disease information mainly includes an immune cell detection device 10 and a data analysis workstation 20. The immune cell detection device 10 can be a first-flow cytometer, and the data analysis workstation 20 can be a local computer device or server, or a data analysis system or server in the cloud.

於本新型實施例中,如圖1,該免疫細胞檢測裝置10可包含中央處理器11以及與其信號連接的檢測模組12、免疫細胞數量數據轉換單元13、人機介面模組14、儲存模組15、分析圖表輸出單元16及通訊模組17。該數據分析工作站20具體可包含中央處理器21以及與其信號連接的比對細胞數據庫22、演算模組23、回歸校正模組24、人機介面模組25、儲存模組26、通訊模組27及檢驗報告產出單元28。其中,該免疫細胞檢測裝置10與該數據分析工作站20可透過該通訊模組17、27實現有線或無線的數據傳輸或通訊。In this novel embodiment, as shown in Figure 1 , the immune cell detection device 10 may include a central processor 11 and a detection module 12 signal-connected thereto, an immune cell quantity data conversion unit 13, a human-machine interface module 14, and a storage module. Group 15, analysis chart output unit 16 and communication module 17. The data analysis workstation 20 may specifically include a central processor 21 and a comparison cell database 22 connected to the signal, a calculation module 23, a regression correction module 24, a human-machine interface module 25, a storage module 26, and a communication module 27 and the inspection report output unit 28. Among them, the immune cell detection device 10 and the data analysis workstation 20 can realize wired or wireless data transmission or communication through the communication modules 17 and 27.

如圖1,該演算模組23透過該中央處理器21讀取該免疫細胞數量數據並據以演算獲得一風險預測數據;該回歸校正模組24內設有基於該比對細胞數據庫22建立之回歸模型,該回歸校正模組24透過該中央處理器21讀取該風險預測數據以根據該比對細胞數據庫22回歸校正獲得一風險預測校正數據。As shown in Figure 1, the calculation module 23 reads the immune cell quantity data through the central processor 21 and calculates it to obtain a risk prediction data; the regression correction module 24 is provided with a risk prediction method based on the comparison cell database 22. Regression model, the regression correction module 24 reads the risk prediction data through the central processor 21 to perform regression correction based on the comparison cell database 22 to obtain a risk prediction correction data.

於本新型實施例中,本新型系統主要用於檢驗並預測包括腫瘤風險、過敏免疫風險、自體免疫風險、免疫低落風險、感染風險等免疫細胞疾病風險,但不限於此。是以,如圖2所示,該數據分析工作站20的演算模組23中進一步包含腫瘤風險評估單元231、過敏免疫風險險評估單元232、自體免疫風險評估單元233、免疫低落風險評估單元234及感染風險評估單元235等免疫細胞疾病風險評估單元;各該風險評估單元中根據所要評估之免疫細胞疾病設有相應的演算法公式,藉此,該比對細胞數據庫22在讀取該免疫細胞數量數據後,篩選出影響待測風險之疾病的免疫細胞數量數據,並將篩選後的數據導入相應的風險評估單元中,以利用該演算法公式計算獲得該風險預測數據。In the embodiment of the present invention, the new system is mainly used to detect and predict immune cell disease risks including tumor risk, allergic immunity risk, autoimmune risk, immune depression risk, infection risk, etc., but is not limited thereto. Therefore, as shown in Figure 2, the calculation module 23 of the data analysis workstation 20 further includes a tumor risk assessment unit 231, an allergy immune risk assessment unit 232, an autoimmune risk assessment unit 233, and an immune hyporisk assessment unit 234. and infection risk assessment unit 235 and other immune cell disease risk assessment units; each risk assessment unit is provided with a corresponding algorithm formula according to the immune cell disease to be assessed, whereby the comparison cell database 22 reads the immune cell disease After collecting the quantitative data, filter out the immune cell quantity data that affects the disease to be tested, and import the filtered data into the corresponding risk assessment unit to calculate and obtain the risk prediction data using the algorithm formula.

免疫細胞在受測生物體內的作用在於防禦體內異常或外來威脅以維護生物個體健康。免疫細胞包含T細胞、B細胞和NK細胞等,其具有識別和排除病原體或異常細胞的能力;因此,能夠藉由免疫細胞數量變化獲得受測生物體內健康狀態的重要資訊。例如,在腫瘤監控方向,免疫細胞(如NK細胞和T細胞)數量下降,體內對異常細胞的清除能力可能降低,增加腫瘤發展的風險;在過敏免疫部分,免疫細胞的異常激活或數量變化可導致過度對外部抗原(如花粉或食物)的反應,形成過敏症狀;有些免疫細胞若過度活躍或數量過多,則可能增加自體免疫疾病的風險;總體免疫細胞數量降低(如T細胞、B細胞)可能削弱對病原體的防禦能力;以及,免疫細胞(如巨噬細胞、中性粒細胞)數量減少可能使體內對抗感染的能力降低,增加感染風險。承上可知,免疫細胞數量變化可被視為疾病風險的一個指標,亦可反映出疾病進展和治療反應,故通過檢測及詳細分析免疫細胞的變化,能夠作出更精準的健康狀態評估和疾病風險預測,或為未來的治療方針提供方向。The role of immune cells in the tested organism is to defend against abnormalities or external threats in the body to maintain the health of the individual organism. Immune cells include T cells, B cells, and NK cells, which have the ability to identify and eliminate pathogens or abnormal cells; therefore, important information on the health status of the tested organism can be obtained through changes in the number of immune cells. For example, in the direction of tumor monitoring, the number of immune cells (such as NK cells and T cells) decreases, and the body's ability to clear abnormal cells may decrease, increasing the risk of tumor development; in the part of allergic immunity, abnormal activation or changes in the number of immune cells may Causes excessive reaction to external antigens (such as pollen or food), forming allergic symptoms; if some immune cells are overactive or excessive in number, they may increase the risk of autoimmune diseases; the number of overall immune cells decreases (such as T cells, B cells ) may weaken the defense against pathogens; and, the reduced number of immune cells (such as macrophages, neutrophils) may reduce the body's ability to fight infection and increase the risk of infection. From the above, it can be seen that changes in the number of immune cells can be regarded as an indicator of disease risk, and can also reflect disease progression and treatment response. Therefore, by detecting and analyzing changes in immune cells in detail, a more accurate assessment of health status and disease risk can be made. Predict or provide direction for future treatment strategies.

進一步地,由於現有流式細胞儀中的細胞數據主要來自於西方人種,因此應用於非西方人種的免疫細胞疾病風險預測時存在不可避免的偏差;是以,該數據分析工作站20的回歸校正模組24用以將前述演算模組23輸出的風險預測數據進行回歸校正,以獲得相較於該風險預測數據更為準確、有效的風險預測校正數據。具體地,如圖3所示,該回歸校正模組24主要對應該演算模組23的各該風險評估單元設有腫瘤風險回歸校正模組241、過敏免疫風險回歸校正模組242、自體免疫風險回歸校正模組243、免疫低落風險回歸校正模組244及感染風險回歸校正模組245;各該風險回歸校正模組內設有基於該比對細胞數據庫22建立之回歸模型。Furthermore, since cell data in existing flow cytometers mainly come from Western populations, there are inevitable biases when applied to immune cell disease risk prediction for non-Western populations; therefore, the regression of the data analysis workstation 20 The correction module 24 is used to perform regression correction on the risk prediction data output by the aforementioned calculation module 23 to obtain risk prediction correction data that is more accurate and effective than the risk prediction data. Specifically, as shown in Figure 3, the regression correction module 24 mainly includes a tumor risk regression correction module 241, an allergic immunity risk regression correction module 242, and an autoimmune risk assessment unit corresponding to each risk assessment unit of the calculation module 23. Risk regression correction module 243, immunocompromised risk regression correction module 244 and infection risk regression correction module 245; each risk regression correction module is equipped with a regression model established based on the comparison cell database 22.

於本新型實施例中,該比對細胞數據庫22可為基於人類細胞數據建立之資料庫;所述人類細胞可根據特定遺傳特徵篩分後建立形成該比對細胞數據庫22,以提高具有該些特定遺傳特徵之人群的粒線體檢測準確度,並增加判讀受測生物生理資訊的有效性;於實際應用中,所述特定遺傳特徵可限定為華人(英語:Ethnic Chinese),即廣義上中華民族的後裔,或以地域區分可為東亞地區的民族後裔,藉此降低流式細胞儀提供之免疫細胞數量數據係基於西方人種細胞數據進行分析造成的數據偏差。In this novel embodiment, the comparison cell database 22 can be a database established based on human cell data; the human cells can be screened according to specific genetic characteristics and then established to form the comparison cell database 22, in order to improve the number of cells with these characteristics. The accuracy of mitochondrial testing for people with specific genetic characteristics can increase the effectiveness of interpreting the physiological information of the tested organisms; in practical applications, the specific genetic characteristics can be limited to ethnic Chinese (English: Ethnic Chinese), that is, Chinese in a broad sense. Descendants of ethnic groups, or by region, can be ethnic descendants of East Asia, thereby reducing the data bias caused by the analysis of immune cell number data provided by flow cytometry based on Western ethnic cell data.

於本新型實施例中,該比對細胞數據庫22可為基於特定動物細胞數據建立之資料庫;所述特定動物細胞可以依據物種分類後建立形成該比對細胞數據庫22;於實際應用中,所述特定物種可為常見之寵物物種(如犬類、貓類)或培育中瀕危物種等,藉此提高受測物種之免疫細胞數量檢測準確度,增加判讀受測物種生理資訊的有效性。In the embodiment of the present invention, the comparison cell database 22 can be a database established based on specific animal cell data; the specific animal cells can be established according to species classification to form the comparison cell database 22; in practical applications, so The specific species can be common pet species (such as dogs, cats) or endangered species in cultivation, etc., thereby improving the accuracy of detecting the number of immune cells of the tested species and increasing the effectiveness of interpreting the physiological information of the tested species.

如圖1,該免疫細胞檢測裝置10的檢測模組12用於輸出該受測檢體之一細胞螢光數值數據至該中央處理器11,令該免疫細胞數量數據轉換單元13透過該中央處理器11讀取並轉換該細胞螢光數值數據形成該免疫細胞數量數據。其中,該細胞螢光數值數據包含一同種型抗體螢光數值及一特異型抗體螢光數值。As shown in FIG. 1 , the detection module 12 of the immune cell detection device 10 is used to output cell fluorescence numerical data of the tested sample to the central processing unit 11 , so that the immune cell quantity data conversion unit 13 passes through the central processing unit 11 . The device 11 reads and converts the cell fluorescence numerical data to form the immune cell quantity data. Wherein, the cell fluorescence value data includes the fluorescence value of an antibody of the same isotype and the fluorescence value of a specific type of antibody.

如圖1,該分析圖表輸出單元16透過該中央處理器11讀取該免疫細胞數量數據,並據以分析後輸出一檢體細胞分析圖表;該檢體細胞分析圖表回傳至該中央處理器11後,經該通訊模組17、27傳輸至該數據分析工作站20。藉此,該數據分析工作站20的檢驗報告產出單元28即可透過該中央處理器21讀取該風險預測校正數據及該檢體細胞分析圖表,並據以整合輸出一免疫細胞疾病風險預測報告。As shown in Figure 1, the analysis chart output unit 16 reads the immune cell quantity data through the central processor 11, analyzes it and outputs a specimen cell analysis chart; the specimen cell analysis chart is sent back to the central processor. 11, and then transmitted to the data analysis workstation 20 through the communication modules 17 and 27. Thereby, the test report output unit 28 of the data analysis workstation 20 can read the risk prediction correction data and the specimen cell analysis chart through the central processor 21, and integrate and output an immune cell disease risk prediction report accordingly. .

於本新型實施例中,該人機介面模組14供人員控制操作該免疫細胞檢測裝置10進行檢測及操作該免疫細胞檢測裝置10的內建分析軟體,該儲存模組15供儲存檢測獲得數據以及與該免疫細胞檢測裝置10內建分析軟體相匹配的細胞數據庫。In this novel embodiment, the human-machine interface module 14 is used by personnel to control and operate the immune cell detection device 10 to perform detection and operate the built-in analysis software of the immune cell detection device 10 , and the storage module 15 is used to store the data obtained during the detection. and a cell database matching the built-in analysis software of the immune cell detection device 10 .

於本新型實施例中,該人機介面模組25供人員控制操作該數據分析工作站20進行數據分析及檢視和產出檢測報告;該儲存模組26供儲存受試者資料、實驗數據、檢測及分析後獲得的數據以及報告等資訊。In this novel embodiment, the human-machine interface module 25 is used for personnel to control and operate the data analysis workstation 20 to perform data analysis and review and produce test reports; the storage module 26 is used to store subject information, experimental data, and test reports. and the data and reports obtained after analysis.

以上說明了本新型系統的具體結構及數據傳輸關係,以下說明本新型系統的檢測流程。以下檢測流程是以受測生物為人類來進行舉例,但本新型不以此為限制。以受測生物為人類為例的檢測流程之步驟包括:The specific structure and data transmission relationship of the new system are explained above. The detection process of the new system is explained below. The following detection process is based on the example that the tested organism is a human being, but the present invention is not limited to this. Taking the tested organism as a human being as an example, the steps of the testing process include:

採集血液檢體:抽取靜脈血8ml,加入抗凝劑Heparin。Collect blood samples: 8ml of venous blood is drawn, and the anticoagulant Heparin is added.

分離單核細胞(PBMC):從檢體中取6ml全血,加入PBS(Phosphate buffered saline;磷酸鹽緩衝生理鹽水)稀釋;接著,先取一離心管(SepMateTM),加入淋巴細胞分離液(LymphoprepTM)3.5ml,再把前述PBS稀釋全血移加至該離心管中;於該離心管內再加入適量PBS後將離心管及其內容物進行離心;之後計算檢體中的PBMC活細胞數量,獲得PBMC檢體。Isolate mononuclear cells (PBMC): Take 6ml of whole blood from the specimen, add PBS (Phosphate buffered saline; phosphate buffered saline) to dilute; then, take a centrifuge tube (SepMateTM) and add lymphocyte separation solution (LymphoprepTM) 3.5ml, and then add the aforementioned PBS diluted whole blood to the centrifuge tube; add an appropriate amount of PBS into the centrifuge tube and centrifuge the centrifuge tube and its contents; then count the number of PBMC viable cells in the specimen to obtain PBMC specimen.

細胞表面抗原-螢光抗體反應:取兩管前述PBMC檢體(每管的細胞含量為1×10 6);其中一管PBMC檢體加入同種型抗體(Isotype antibody)以作為對照例;另一管前述PBMC檢體加入特異性抗體(Specific antibody)以作為反應例(特異性抗體的種類可為2種或2種以上至12種,具體選擇如下表1所示)。將前述對照例檢體及反應例檢體分別進行避光反應10-15分鐘後,加入PBS洗滌細胞。 Cell surface antigen-fluorescent antibody reaction: Take two tubes of the aforementioned PBMC specimens (the cell content of each tube is 1×10 6 ); add an isotype antibody (Isotype antibody) to one of the PBMC specimens as a control example; the other tube Add specific antibodies to the aforementioned PBMC samples as a reaction example (the types of specific antibodies can be 2 or more than 12 types, the specific selection is shown in Table 1 below). After the aforementioned control sample and reaction sample were reacted in the dark for 10-15 minutes, PBS was added to wash the cells.

儀器檢測:以流式細胞儀(美國BD公司)分析獲得該對照例檢體及該反應例檢體的細胞螢光數值數據。於該儀器檢測步驟中,針對不同疾病的檢測,設計不同免疫細胞表面抗原的抗體Panel。Instrumental detection: Use a flow cytometer (BD Company, USA) to analyze and obtain the cell fluorescence numerical data of the control sample and the reaction sample. In the detection step of this instrument, antibody panels for different immune cell surface antigens are designed for the detection of different diseases.

數值轉換及分析:使用流式細胞儀對前述細胞螢光數值進行轉換,以獲得相應的免疫細胞數量數據,其中含有特定免疫細胞群的數量比例(以百分比表示)。Numerical conversion and analysis: Use a flow cytometer to convert the aforementioned cell fluorescence values to obtain corresponding immune cell number data, which contains the number ratio of a specific immune cell group (expressed as a percentage).

數值分析:使用流式細胞儀對該免疫細胞數量數據進行分析並輸出檢體細胞分析圖表至該數據分析工作站20。Numerical analysis: Use a flow cytometer to analyze the immune cell quantity data and output the sample cell analysis chart to the data analysis workstation 20 .

風險判讀:使用數據分析工作站20對前述免疫細胞數量數據進行特定疾病或生理狀態的風險預測。於該風險判讀步驟中,該數據分析工作站20可透過該演算模組23讀取並演算而獲得該風險預測數據,再透過該回歸校正模組24將該風險預測數據回歸校正形成該預測風險校正數據。Risk assessment: The data analysis workstation 20 is used to predict the risk of a specific disease or physiological state based on the aforementioned immune cell quantity data. In the risk assessment step, the data analysis workstation 20 can read and calculate the risk prediction data through the calculation module 23, and then regress and correct the risk prediction data through the regression correction module 24 to form the predicted risk correction data.

製作檢驗報告:根據前述風險預測數據或預測風險校正數據以及該檢體細胞分析圖表,產出免疫細胞疾病風險預測報告,該報告中包含:(1)腫瘤風險、(2)過敏免疫風險、(3)自體免疫風險、(4)免疫低落風險、(5)感染風險等風險評估結果。Produce an inspection report: Based on the aforementioned risk prediction data or predicted risk correction data and the specimen cell analysis chart, produce an immune cell disease risk prediction report, which includes: (1) tumor risk, (2) allergic immunity risk, ( Risk assessment results such as 3) autoimmune risk, (4) immunocompromised risk, and (5) infection risk.

表1:可用於本新型系統檢測免疫細胞數量的特異性抗體列表資料。其中,本新型利用表1中2種或2種以上特異性的細胞表面標記,於流式細胞儀中來標定出特定免疫細胞族群。如:用CD3 +/CD56 -標定T細胞、用CD3 -/CD19 +標定B細胞和用CD3 -/CD56 +標定NK細胞等。 BD公司 材料編號 抗體克隆 名稱 螢光染劑 細胞表面 標記 (特異性) 滴度 (µl) 第一混合液 559866 G46-6 APC HLA-DR 3.5 566752 2-L1-A BV711 CCR7 5 560675 HI100 PE-Cy7 CD45RA 4 564488 B159 BB515 CD56 4 563877 SK3 BV786 CD4 4 561417 UCHT1 V500 CD3 4 560717 3G8 PerCP-Cy5.5 CD16 3 564054 M5E2 BV605 CD14 3 565935 EH12.1 BV421 PD-1 3 567056 RPA-T8 R718 CD8 2.5 560177 SJ25C1 APC-H7 CD19 3 566919 6H6 PE CD123 4 565909 Clone 3.9 PE CD11c 4 第二混合液 555531 FN50 PE CD69 20 564771 1B5 APC CCR10 5 740737 RF8B2 BV711 CXCR5 5 560225 M-A251 APC-H7 CD25 5 563877 SK3 BV786 CD4 4 566533 1C6 BB700 CXCR3 4 562724 11A9 BV605 CCR6 4 562576 2D7 BV421 CCR5 4 560675 HI100 PE-Cy7 CD45RA 4 564488 B159 BB515 CD56 4 561417 UCHT1 V500 CD3 4 567056 RPA-T8 R718 CD8 2.5 Table 1: List of specific antibodies that can be used in this new system to detect the number of immune cells. Among them, the present invention uses two or more specific cell surface markers in Table 1 to identify specific immune cell populations in a flow cytometer. For example: use CD3 + /CD56 - to calibrate T cells, use CD3 - /CD19 + to calibrate B cells, use CD3 - /CD56 + to calibrate NK cells, etc. BD company material number Antibody clone name Fluorescent dye Cell surface markers (specific) Titer(µl) first mixture 559866 G46-6 APC HLA-DR 3.5 566752 2-L1-A BV711 CCR7 5 560675 HI100 PE-Cy7 CD45RA 4 564488 B159 BB515 CD56 4 563877 SK3 BV786 CD4 4 561417 UCHT1 V500 CD3 4 560717 3G8 PerCP-Cy5.5 CD16 3 564054 M5E2 BV605 CD14 3 565935 EH12.1 BV421 PD-1 3 567056 RPA-T8 R718 CD8 2.5 560177 SJ25C1 APC-H7 CD19 3 566919 6H6 PE CD123 4 565909 Clone 3.9 PE CD11c 4 Second mixture 555531 FN50 PE CD69 20 564771 1B5 APC CCR10 5 740737 RF8B2 BV711 CXCR5 5 560225 M-A251 APC-H7 CD25 5 563877 SK3 BV786 CD4 4 566533 1C6 BB700 CXCR3 4 562724 11A9 BV605 CCR6 4 562576 2D7 BV421 CCR5 4 560675 HI100 PE-Cy7 CD45RA 4 564488 B159 BB515 CD56 4 561417 UCHT1 V500 CD3 4 567056 RPA-T8 R718 CD8 2.5

以上檢測流程是以受測生物為人類來進行舉例,但本新型不以此為限制。舉例來說,針對動物,檢體可以採用動物細胞放入培養液的檢體,且添加劑可能是其他類型的抗凝劑或其他藥劑,且添加的稀釋液也不一定是PBS,甚至螢光染劑可能上述之外的其他螢光染劑。The above detection process is based on the example that the tested organism is a human being, but the present invention is not limited to this. For example, for animals, the specimen can be a specimen in which animal cells are placed in a culture medium, and the additives may be other types of anticoagulants or other agents, and the added diluent is not necessarily PBS, or even fluorescent stains. Fluorescent dyes other than those listed above may be used.

綜上所述,本新型利用免疫細胞數量判讀受測生物疾病資訊之系統可精確檢測具有特定遺傳特徵之物種的免疫細胞數量,並據以判讀出準確的受測生物免疫細胞疾病風險,從而達到提供有效促進生理健康之建議。In summary, this new system that uses the number of immune cells to interpret disease information of tested organisms can accurately detect the number of immune cells of species with specific genetic characteristics, and based on this, accurately interpret the risk of immune cell diseases of the tested organisms, thereby achieving Provide effective suggestions for promoting physical health.

10:免疫細胞檢測裝置 11:中央處理器 12:檢測模組 13:免疫細胞數量數據轉換單元 14:人機介面模組 15:儲存模組 16:分析圖表輸出單元 17:通訊模組 20:數據分析工作站 21:中央處理器 22:比對細胞數據庫 23:演算模組 231:腫瘤風險評估單元 232:過敏免疫風險險評估單元 233:自體免疫風險評估單元 234:免疫低落風險評估單元 235:感染風險評估單元 24:回歸校正模組 241:腫瘤風險回歸校正模組 242:過敏免疫風險回歸校正模組 243:自體免疫風險回歸校正模組 244:免疫低落風險回歸校正模組 245:感染風險回歸校正模組 25:人機介面模組 26:儲存模組 27:通訊模組 28:檢驗報告產出單元10: Immune cell detection device 11:Central processing unit 12:Detection module 13: Immune cell number data conversion unit 14: Human-machine interface module 15:Storage module 16: Analysis chart output unit 17:Communication module 20:Data analysis workstation 21:Central processing unit 22: Compare cell database 23: Calculation module 231:Oncology Risk Assessment Unit 232: Allergy Immunity Risk Insurance Assessment Unit 233: Autoimmune Risk Assessment Unit 234: Immunocompromised Risk Assessment Unit 235: Infection Risk Assessment Unit 24: Regression correction module 241: Tumor risk regression correction module 242: Allergy immune risk regression correction module 243:Autoimmune risk regression correction module 244: Immunity low risk regression correction module 245: Infection risk regression correction module 25: Human-machine interface module 26:Storage module 27:Communication module 28: Inspection report output unit

圖1是本新型利用免疫細胞數量判讀受測生物疾病資訊之系統的架構示意圖; 圖2是本新型數據分析工作站的演算模組架構示意圖; 圖3是本新型數據分析工作站的回歸校正模組架構示意圖。 Figure 1 is a schematic diagram of the architecture of this new system that uses the number of immune cells to interpret tested biological disease information; Figure 2 is a schematic diagram of the calculation module architecture of this new data analysis workstation; Figure 3 is a schematic diagram of the regression correction module architecture of this new data analysis workstation.

10:免疫細胞檢測裝置 10: Immune cell detection device

11:中央處理器 11:Central processing unit

12:檢測模組 12: Detection module

13:免疫細胞數量數據轉換單元 13: Immune cell number data conversion unit

14:人機介面模組 14: Human-machine interface module

15:儲存模組 15:Storage module

16:分析圖表輸出單元 16: Analysis chart output unit

17:通訊模組 17:Communication module

20:數據分析工作站 20:Data analysis workstation

21:中央處理器 21:Central processing unit

22:比對細胞數據庫 22: Compare cell database

23:演算模組 23: Calculation module

24:回歸校正模組 24: Regression correction module

25:人機介面模組 25: Human-machine interface module

26:儲存模組 26:Storage module

27:通訊模組 27:Communication module

28:檢驗報告產出單元 28: Inspection report output unit

Claims (10)

一種利用免疫細胞數量判讀受測生物疾病資訊之系統,包括: 一免疫細胞檢測裝置,為一流式細胞儀,用以輸出一受測檢體的一免疫細胞數量數據; 一數據分析工作站,與該免疫細胞檢測裝置通訊連接,該數據分析工作站包括一中央處理器以及與其信號連接之一比對細胞數據庫、一演算模組及一回歸校正模組; 該演算模組透過該中央處理器讀取該免疫細胞數量數據並據以演算獲得一風險預測數據; 該回歸校正模組內設有基於該比對細胞數據庫建立之回歸模型,該回歸校正模組透過該中央處理器讀取該風險預測數據以根據該比對細胞數據庫回歸校正獲得一風險預測校正數據。 A system that uses the number of immune cells to interpret tested biological disease information, including: An immune cell detection device, which is a flow cytometer, is used to output data on the number of immune cells of a subject; A data analysis workstation is communicatively connected to the immune cell detection device. The data analysis workstation includes a central processor and a comparison cell database, a calculation module and a regression correction module signally connected to the central processor; The calculation module reads the immune cell quantity data through the central processor and calculates it to obtain a risk prediction data; The regression correction module is equipped with a regression model based on the comparison cell database. The regression correction module reads the risk prediction data through the central processor to obtain a risk prediction correction data based on the regression correction of the comparison cell database. . 如請求項1所述之利用免疫細胞數量判讀受測生物疾病資訊之系統,其中,該免疫細胞檢測裝置包含一中央處理器及與其信號連接之一檢測模組;該檢測模組用於輸出該受測檢體之一細胞螢光數值數據至該中央處理器,供一免疫細胞數量數據轉換單元讀取並轉換該細胞螢光數值數據形成該免疫細胞數量數據。The system for interpreting tested biological disease information by using the number of immune cells as described in claim 1, wherein the immune cell detection device includes a central processor and a detection module connected to its signal; the detection module is used to output the The cell fluorescence value data of the subject is sent to the central processing unit for an immune cell quantity data conversion unit to read and convert the cell fluorescence value data to form the immune cell quantity data. 如請求項2所述之利用免疫細胞數量判讀受測生物疾病資訊之系統,其中,該細胞螢光數值數據包含一同種型抗體螢光數值及一特異型抗體螢光數值。As claimed in claim 2, the system for interpreting tested biological disease information using the number of immune cells, wherein the cell fluorescence value data includes an isotype antibody fluorescence value and a specific type antibody fluorescence value. 如請求項1所述之利用免疫細胞數量判讀受測生物疾病資訊之系統,其中,該免疫細胞檢測裝置還包括一分析圖表輸出單元與該中央處理器信號連接,供讀取該免疫細胞數量數據,並據以輸出一檢體細胞分析圖表至該數據分析工作站。The system for interpreting tested biological disease information by using the number of immune cells as described in claim 1, wherein the immune cell detection device further includes an analysis chart output unit connected to the central processor via a signal for reading the immune cell number data. , and accordingly output a sample cell analysis chart to the data analysis workstation. 如請求項4所述之利用免疫細胞數量判讀受測生物疾病資訊之系統,其中,該數據分析工作站還包括一檢驗報告產出單元與該中央處理器信號連接,該檢驗報告產出單元讀取該風險預測校正數據及該檢體細胞分析圖表並據以輸出一免疫細胞疾病風險預測報告。As described in claim 4, the system for interpreting tested biological disease information using the number of immune cells, wherein the data analysis workstation also includes a test report output unit connected to the central processor signal, and the test report output unit reads The risk prediction correction data and the sample cell analysis chart are used to output an immune cell disease risk prediction report. 如請求項2所述之利用免疫細胞數量判讀受測生物疾病資訊之系統,其中,該免疫細胞檢測裝置另設有一人機介面模組及一儲存模組與該中央處理器信號連接。As claimed in claim 2, the system for interpreting tested biological disease information by using the number of immune cells, wherein the immune cell detection device is further provided with a human-machine interface module and a storage module that are signally connected to the central processor. 如請求項1所述之利用免疫細胞數量判讀受測生物疾病資訊之系統,其中,該數據分析工作站另設有一人機介面模組及一儲存模組與該中央處理器信號連接。The system for interpreting tested biological disease information by using the number of immune cells as described in claim 1, wherein the data analysis workstation is also provided with a human-machine interface module and a storage module connected to the central processor signal. 如請求項1所述之利用免疫細胞數量判讀受測生物疾病資訊之系統,其中,該免疫細胞檢測裝置與該數據分析工作站分別設有一通訊模組,該免疫細胞檢測裝置與該數據分析工作站透過該通訊模組進行數據的通訊傳輸。The system for interpreting tested biological disease information by using the number of immune cells as described in claim 1, wherein the immune cell detection device and the data analysis workstation are respectively provided with a communication module, and the immune cell detection device and the data analysis workstation communicate through The communication module performs data communication and transmission. 如請求項1所述之利用免疫細胞數量判讀受測生物疾病資訊之系統,其中,該比對細胞數據庫為基於特定人類遺傳特徵之細胞數據建立的資料庫。The system for interpreting tested biological disease information by using the number of immune cells as described in claim 1, wherein the comparison cell database is a database established based on cell data of specific human genetic characteristics. 如請求項1所述之利用免疫細胞數量判讀受測生物疾病資訊之系統,其中,該比對細胞數據庫為基於特定動物細胞數據建立之資料庫。The system for interpreting tested biological disease information by using the number of immune cells as described in claim 1, wherein the comparison cell database is a database established based on specific animal cell data.
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