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工業技術研究院

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技術名稱: 自動校正血球容積比之血糖試片

技術簡介

人體血液之血球容積比具有個體性差異,血球容積比常會干 擾血糖機試片量測血糖的結果。本技術為一可自動校正血球 容積比的血糖試片,可藉由試片的獨特設計自動偵測血球容 積比的多寡,並根據精準的血球容積比數值,自資料庫中比 對,校正得出正確的血糖值。

Abstract

The hematocrit (Hct) of human blood varies by individuals, and its level is known to interfere with blood glucose measurement by glucose meters. We innovated a blood glucose strip that can automatically calibrate according to the Hct level. Through the strip’s unique design, it precisely measure the Hct level, calibrate according a database of hematocrit values and report an accurate glucose measurement. Presently marketed blood glucose meters either do not have an automatic calibration to Hct or can only calibrate a restricted Hct range of 35% to 50% and thereby limiting its clinical application. Traditional methods to account for the Hct effect would require an additional blood draw for clinical lab testing. This demands not only additional sample volume but also longer time to result. This product is a significant improvement over traditional methods and will allow use of blood glucose meters for a much wider range of Hct levels.

技術規格

1.所需血液量與一般市售血糖機相同,約0.8μl 2.可校正之血球容積比範圍為10%~65% 3.血糖量測範圍20mg/dl~600mg/dl 4.校正後之血糖量測準確度符合ISO15179

Technical Specification

1.Only one drop of blood will be needed to simultaneously measure Hct and blood glucose. 2.0.8μl of blood is sufficient for measurement. 3.Acceptable range of sample Hct : 20~70%. 4.Accuracy of corrected blood glucose complies with ISO15179.

技術特色

一滴血,同時檢測血球容積比與血糖數值 美國/歐洲/中國/台灣專利申請中,可技術授權

應用範圍

居家使用之血糖檢測 新生兒血糖檢測(婦產科/月子中心) 腎臟病患者血糖檢測(養老中心/洗腎中心) 貧血或大出血患者血糖檢測(醫療院所) 脫水患者(如燙傷、外傷、手術)或水腫患者血糖檢測(醫療院所)

接受技術者具備基礎建議(設備)

GMP等級血糖試片製造廠,已獲品質系統認證者為佳,未具備 者可輔導建廠已及協助取得認證

接受技術者具備基礎建議(專業)

須具備醫療產品研發與品管QC基本能力者或具有生化/生醫/ 醫電/醫工類基礎背景者

技術分類 醫療電子

聯絡資訊

聯絡人:謝文彬 精準醫療指引診斷技術組(0N000)

電話:+886-3-5913730 或 Email:Rupert@itri.org.tw

客服專線:+886-800-45-8899

傳真:+886-3-5910096

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