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研究生: 趙子齊
Zhao, Zi-Qi
論文名稱: 檢測設備研製與人絨毛膜促性腺激素試劑濃度偵測最佳化
The Fabrication of Inspection Equipment and Optimization of Concentration Detection for Human Chorionic Gonadotropin Strip
指導教授: 林裕城
Lin, Yu-Cheng
學位類別: 碩士
Master
系所名稱: 工學院 - 工程科學系
Department of Engineering Science
論文出版年: 2013
畢業學年度: 101
語文別: 中文
論文頁數: 148
中文關鍵詞: 影像判讀免疫呈色檢測系統最佳化田口方法
外文關鍵詞: Image interpretation, Immunochromatographic inspection equipment, Optimization, Taguchi method
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  • 本研究成功地自行製作出具有高精準度之快速免疫呈色檢測系統,利用免疫反應的呈色機制做為檢測對象,順利地突破傳統定性或半定量上的判定,使免疫呈色反應往定量方向踏出一步,此舉不僅減少了傳統對照的麻煩,更可免除人為誤差的存在。藉由使用壓克力配合雷射雕刻機與不同的感光元件自製出影像判讀儀,再搭配實驗室虛擬儀器工程平台(Laboratory Virtual Instrumentation Engineering Workbench, LabVIEWTM)撰寫出一套具有人機介面的呈色判讀程式,並且成功地將兩者整合成免疫試劑檢測系統,完成研製過程,最後再利用田口式品質工程分析方法進行最佳化調整,使其能夠對顏色達到最佳線性度及縮小判讀誤差藉以提升S/N達最大化,同時也實際應用於人類絨毛膜促性腺激素(Human chorionic gonadotropin, hCG)免疫試劑上,測試本研究所開發之免疫呈色檢測系統極限與誤差。最後由實驗結果發現,本研究所採用的網路攝影機與數位顯微鏡兩感光元件,在各自之最佳化參數組合下,數位顯微鏡之檢測極限可達3.125 mIU/mL,而其誤差僅有0.3803 mIU/mL之差,成功地突破傳統閾值25 mIU/ mL的判定。

    This study successfully fabricated a system of rapid inspection equipment with high accuracy for Immunochromatograpic. The system detected the gray from RGB colors of Immunochromatograpic and break through the traditional qualitative or semi-quantitative determination. The results not only reduced the hassle of traditional method, but also avoided the eliminating error from human. Inspection equipment design using Polymethylmethacrylate (PMMA) and Laser carving machine to made hardware of the system and then software of this system was compiled by Laboratory Virtual Instrumentation Engineering Workbench (LabVIEWTM). The study optimized this system by Taguchi method to achieve the best linearity of gray and lessen the error in order to enhance the S/N to maximization. Finally, this research also applied to Human chorionic gonadotropin (hCG) immunological reagents and then the experimental results showed that first and second inspection systems in their best parameter. The second inspection system detection limit of up to 3.125 mIU/mL, and the error just 0.3803 mIU/mL difference, succeeded in breaking through the traditional threshold 25 mIU / mL.

    摘要 I Abstract III 致謝 V 目錄 VI 圖目錄 XII 表目錄 XVI 第一章 緒論 1 1-1 研究背景 1 1-2 免疫分析法 4 1-2-1 免疫分析基本理論 5 1-2-2 抗原與抗體定義 5 1-2-3 抗原與抗體的結合力 7 1-2-4 免疫分析檢測種類 8 1-2-5 免疫分析偵測方法 9 1-3 文獻回顧 13 1-3-1 人類絨毛膜促性腺激素 13 1-3-1-1 人類絨毛膜促性腺激素之來由 13 1-3-1-2 人類絨毛膜促性腺激素之結構 15 1-3-1-3 人類絨毛膜促性腺激素於人體之來源與作用 16 1-3-1-4 人類絨毛膜促性腺激素於妊娠檢測之應用 18 1-3-1-5 人類絨毛膜促性腺激素於腫瘤標記之應用 19 1-3-1-6 人類絨毛膜促性腺激素驗孕免疫反應檢測試劑 19 1-3-2 影像判讀簡介 22 1-3-2-1 影像判讀之發展 24 1-3-3 田口方法簡介 29 1-4 研究動機與目的 31 1-5 研究架構 32 第二章 影像判讀儀系統之設計與製作 34 2-1 影像判讀儀之載具與外觀製作 34 2-1-1 影像判讀儀之PMMA載具設計 34 2-1-2 影像判讀儀之PMMA外觀設計 36 2-1-3 影像判讀儀之PMMA載台與外觀製作 38 2-2 LabVIEW程式設計 46 2-2-1 LabVIEW與CMOS感光元件之信號流程 46 2-2-2 LabVIEW程式流程之設計 49 2-2-3 LabVIEW程式設計之實現 50 2-3 影像判讀儀系統之組裝 57 第三章 實驗與研究方法 58 3-1 實驗儀器與設備 58 3-1-1 筆記型電腦 58 3-1-2 感光元件 59 3-1-2-1 第一代判讀系統之感光元件 59 3-1-2-2 第二代判讀系統之感光元件 60 3-2 實驗藥品 61 3-3 田口方法 63 3-3-1 理想機能與S/N 64 3-3-2 直交表 65 3-3-3 控制因子 67 3-4 實驗方法 69 3-4-1 高度 69 3-4-2 色度 70 3-4-2-1 色階試紙 70 3-4-2-2 hCG濃度呈色 72 3-4-3 灰階值與hCG濃度之轉換函數建立 73 第四章 結果與討論 74 4-1 感光元件之高度對於影像擷取之探討 74 4-2 第一代判讀系統之最佳化分析 75 4-2-1 篩選實驗 75 4-2-1-1 控制因子及水準 75 4-2-1-2 L12(211)直交表 76 4-2-1-3 S/N因子反應 77 4-2-1-4 S/N變異分析 80 4-2-1-5 預測值與確認實驗 82 4-2-1-6 信賴區間與確認實驗 84 4-2-2 1st交互作用檢測實驗 86 4-2-2-1 直交表選擇與點線圖 87 4-2-2-2 控制因子 89 4-2-2-3 L8(27)直交表 89 4-2-2-4 S/N因子反應交互作用圖表 90 4-2-3 2nd交互作用檢測實驗 94 4-2-3-1 直交表選擇與點線圖 94 4-2-3-2 控制因子 96 4-2-3-3 L4(23)直交表 96 4-2-3-4 S/N因子反應交互作用圖表 97 4-2-4 品質損失計算 99 4-3 第一代最佳判讀系統之實測 100 4-3-1 hCG濃度呈色 100 4-3-2 灰階值與hCG濃度之轉換函數建立 102 4-3-3 檢測確認 103 4-4 第二代判讀系統之最佳化分析 104 4-4-1 篩選實驗 104 4-4-1-1 控制因子及水準 104 4-4-1-2 L12(211)直交表 105 4-4-1-3 S/N因子反應 106 4-4-1-4 S/N變異分析 109 4-4-1-5 預測值與確認實驗 111 4-4-1-6 信賴區間與確認實驗 112 4-4-2 交互作用檢測實驗 114 4-4-2-1 直交表選擇與點線圖 114 4-4-2-2 控制因子 116 4-4-2-3 L4(23)直交表 116 4-4-2-4 S/N因子反應交互作用圖表 117 4-4-3 品質損失計算 120 4-5 第二代最佳判讀系統之實測 120 4-5-1 hCG濃度呈色 121 4-5-2 灰階值與hCG濃度之轉換函數建立 122 4-5-3 檢測確認 123 4-5-4 檢測極限 124 第五章 結論與建議 128 5-1 結論 128 5-2 建議 131 參考文獻 133 附錄一 142 附錄二 145 附錄三 146 附錄四 147 附錄五 148

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