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工業技術研究院

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技術名稱: 急性心肌梗塞檢測試劑

技術簡介

所開發之急性心肌梗塞檢測試劑依據臨床需求定義出預期使用目的與規格要求。在美國與台灣皆屬於第二等級醫療器材,在產品開發階段遵守相對應之法規與品質系統要求,並建立了設計歷史檔(DHF)。

Abstract

The developed acute myocardial infarction diagnostic kit met current clinical needs. Intended use and product specifications are defined. The developed product is classified as Class II medical device in both USFDA and TFDA. Regulations and quality system requirements of Class II IVD products have been followed during product development. Design history files have been established.

技術規格

干擾物影響:< 10% 專一性影響:< 0.01% 最低偵測濃度:TnI:10pg/ml CK-MB:<0.2ng/ml 偵測範圍:TnI:0-0.7ng/ml CK-MB:0-150ng/ml 精密度:Repeatability CV< 10% Within-laboratory precision CV<15%

Technical Specification

Interference :< 10% Specificity:< 0.01% LOD:TnI:10pg/ml CK-MB:<0.2ng/ml Dynamic Range:TnI:0-0.7ng/ml CK-MB:0-150ng/ml Precision:Repeatability CV< 10% Within-laboratory precision CV<15%

技術特色

1. 使用自有抗體,自行掌握關鍵原物料。 2. 使用磁珠載體,易與其他平台結合。 3. 高靈敏度。

應用範圍

心肌梗塞定點照護檢測。

接受技術者具備基礎建議(設備)

P1實驗室、微孔盤光學分析儀

接受技術者具備基礎建議(專業)

技術分類 分子診斷

聯絡資訊

聯絡人:陳廷碩 精準醫療指引診斷技術組(0N000)

電話:03-5912143 或 Email:CTS@itri.org.tw

客服專線:+886-800-45-8899

傳真:03-5912444

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