Research · Clinical Validation研究・臨床驗證

Clinical validation臨床驗證

What is licensed, what has been measured in the field, and what remains to be proven. GFUSIP is a screening aid, not a diagnosis; this page is written to be read by clinicians and regulators.哪些已取得許可、哪些已在現場量測、哪些還有待證明。GFUSIP 是篩檢輔助而非診斷;本頁是寫給臨床醫師與主管機關看的。

Regulatory status法規狀態

Licensed medical hardware and reagents.具許可證的醫療硬體與試劑。

Taiwan FDA medical-device licence No. 010471台灣 TFDA 醫療器材許可證第 010471 號

UROBOT R/K/M series, Class I (2025). The licence covers the device as placed on the market; it is not a manufacturing licence and does not constitute endorsement.UROBOT R/K/M 系列,第一等級(2025 年)。許可證涵蓋上市之器材本身;不是製造許可,也不代表任何背書。

Quality management system品質管理系統

QMS certification held by the manufacturer, IMPRESSIVE CARE CO., LTD (2025).製造商英普瑞斯股份有限公司持有 QMS 認證(2025 年)。

Test strips試紙

Medical-grade urinalysis strips licensed in Taiwan are used for the chemical check.化學檢測使用台灣已取得許可的醫療級尿液試紙。

Methods檢測方法

Three measurements from one sample.一份樣本,三種量測。

01

Physical物理

Colour, clarity and density — hydration, signs of infection, crystal/stone risk.顏色、清澈度與比重——水分狀態、感染徵象、結晶/結石風險。

02

Chemical化學

Strip chemistry: protein, glucose, blood, pH, leukocytes, nitrite, bilirubin and more — early signs of kidney disease, diabetes, UTI and liver trouble.試紙化學:蛋白質、葡萄糖、潛血、pH、白血球、亞硝酸鹽、膽紅素等——腎病、糖尿病、泌尿道感染與肝臟問題的早期徵象。

03

Uroflowmetry尿流速

Flow rate and curve shape for the lower urinary tract — the first module validated in the field (Tainan, 2025–26).尿流速與流速曲線,評估下泌尿道——第一個在現場驗證的模組(台南,2025–26)。

Together the methods read 16–39 markers depending on the model. See the programme page for the plain-language version.三種方法合計依機型可讀取 16–39 項指標。白話版本請見計劃內容

Validated so far目前已驗證

What the first site has shown.首站已經證明的事。

Feasibility of unstaffed operation. A fully automated uroflowmetry unit ran in an existing public toilet at the Tainan City Public Health Bureau from March 2025, with venue, utilities and cleaning provided from existing non-clinical staff at no new public cost. Over 3,000 uses were recorded by August 2026 (as of 31 July 2026: over 3,000 uses and over 300 consented records).無人值守營運的可行性。全自動尿流速裝置自 2025 年 3 月起在台南市衛生局既有公廁運作,場地、水電與清潔由既有非臨床人力提供,未新增公共支出。截至 2026 年 8 月已逾 3,000 人次(以 2026/7/31 為基準日:逾 3,000 人次、逾 300 筆同意留存紀錄)。

Reach. 71 % of consenting users were aged 50 or under — close to the inverse of the age profile of clinic-based lower-urinary-tract care in national claims data, where only 21 % were under 50.觸及對象。同意留存的使用者中 71% 在 50 歲以下——幾乎是全國健保下泌尿道就醫人口(50 歲以下僅 21%)的反轉。

Signal. Among 221 interpretable records (voided volume ≥ 150 mL), maximum flow was below 15 mL/s in 41–47 % of men in every age band. This is a screening signal in an unselected population, not a prevalence estimate: the threshold was designed for symptomatic men in clinics, and single uncontrolled measurements inevitably yield high abnormal rates.訊號。221 筆可判讀紀錄(排尿量 ≥ 150 mL)中,各年齡層均有 41–47% 的男性最大尿流速低於 15 mL/s。這是未經篩選人群中的篩檢訊號,不是盛行率估計:該門檻原為診所中有症狀的男性設計,單次、非受控的量測本來就會出現偏高的異常率。

Limitations we state openly. Nine tenths of users did not complete the optional form; the design cannot distinguish no phone, unfamiliarity with scanning or unwillingness. The consented subsample favours smartphone users. Anonymity prevented follow-up. Full detail is in the GHF 2026 abstract.我們公開承認的限制。九成使用者未填寫選填表單;設計上無法區分沒有手機、不熟悉掃碼或不願意。同意留存的子樣本偏向智慧型手機使用者。匿名使追蹤不可行。完整內容見 GHF 2026 摘要

Validation programme驗證計畫

What the next sites are designed to prove.下一批站點要證明什麼。

1

Lower the data barrier降低資料門檻

Thermal-printer reports (proposed by the Tainan host) and a seated unit at Linkou to test whether consent rates rise without a smartphone.熱感紙報告(台南主辦單位建議)與林口的坐式機型,測試不靠智慧型手機時同意率是否提升。

2

Close the loop完成追蹤迴圈

Partner with a host authority that holds subsequent health records, so flagged users can be followed to a clinical outcome.與持有後續健康紀錄的主辦機關合作,讓被標記的使用者能追蹤到臨床結果。

3

Extend the modules擴充檢測模組

Women’s station and kidney-related chemistry (e.g. proteinuria) on the same unstaffed, consented infrastructure — subject to device licensing for each module.在同一套無人值守、經同意的基礎設施上,新增女性站與腎臟相關化學檢測(如蛋白尿)——各模組需先取得器材許可。

Partner on validation參與驗證合作