泌尿道感染（Urinary Tract Infections, UTIs）是全球常見的感染性疾病之一，每年影響超過 1.5 億人，其中約半數女性在一生中至少經歷一次感染。傳統 UTIs診斷多依賴細菌培養，不僅耗時超過三天，還需專業儀器與技術，導致無法即時提供診斷與治療，易延誤病情控制。
導致 UTIs 的主要病原為泌尿道致病性大腸桿菌（Uropathogenic Escherichia coli, UPEC），其致病能力主要來自多種毒性因子的協同作用。其中，細胞壞死毒素 1（Cytotoxic Necrotizing Factor 1, CNF1）是 UPEC 的重要毒力蛋白，能透過活化宿主細胞的 Rho GTPase，誘導細胞骨架重組、影響細胞訊息傳遞並促進細胞壞死與發炎反應。研究指出， CNF1 與膀胱炎、腎盂腎炎等臨床症狀高度相關，亦與感染嚴重程度及復發率有顯著關聯。因此，針對 CNF1 進行早期檢測，有助於辨識具高致病性之菌株，提升臨床診斷的精準性。
本研究結合微流體技術與即時檢測系統，開發一款用於檢測尿液中 CNF1 毒素之晶片式檢測裝置。使用者僅需添加少量樣品至微流體晶片中，即可進行ELISA 免疫分析，反應完成後搭配機台中的微型光譜儀進行分析，即可得知尿液內是否具有大腸桿菌細胞壞死毒素 1。為確認本研究之可行性，此晶片透過不同濃度下大腸桿菌之 CNF1 進行測試，實驗結果與實際濃度的相關係數為 0.9972，且在 35 例人工尿液盲測中，獲得 98.33%的平均回收率，得知該系統可準確辨識UPEC 所產生之 CNF1 毒素，有助於早期發現感染風險、提升診療效率與治療精準性。
本研究建立之微流體檢測平台，提供準確且低耗材的新型 UTIs 檢測工具，未來可應用於居家健康監測、遠距診療及臨床輔助診斷，對泌尿道感染之預防與治療具有重要實用價值。

Urinary tract infections (UTIs) are among the most common infections globally, affecting over 150 million people each year. Nearly half of all women experience at least one UTI in their lifetime. Traditional diagnostic methods rely on bacterial culture, which is time-consuming and requires specialized equipment, delaying treatment and worsening clinical outcomes. Uropathogenic Escherichia coli (UPEC) is the main pathogen responsible for UTIs, with Cytotoxic Necrotizing Factor 1 (CNF1) being a key virulence factor. CNF1 promotes infection by activating host Rho GTPases, causing cytoskeletal changes, cellular disruption, and inflammation. It is closely linked to severe UTI symptoms and recurrence. Early detection of CNF1 can improve diagnosis by identifying highly virulent UPEC strains.
In this study, we developed a microfluidic diagnostic platform for real-time detection of CNF1 in urine. The system uses a microfluidic chip and enzyme-linked immunosorbent assay (ELISA), followed by signal analysis via a miniaturized spectrometer. Testing with various CNF1 concentrations showed a strong correlation (R² = 0.9972) between measured and actual values. In a blind test of 35 artificial urine samples, the system achieved a recovery rate of 98.33%, demonstrating high accuracy and potential for rapid UTI diagnosis.
In summary, the microfluidic detection system established in this study provides a precise and low-consumption alternative for UTI diagnosis. It holds great potential for applications in home health monitoring, telemedicine, and clinical diagnostics, offering a practical and efficient solution for the prevention, early detection, and management of urinary tract infections.

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