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Accelerate Diagnostics Announces FDA Clearance Of Its Accelerate Arc System, An Automated Platform Designed To Fight Against Sepsis And Antimicrobial Resistance

Accelerate Diagnostics Announces FDA Clearance Of Its Accelerate Arc System, An Automated Platform Designed To Fight Against Sepsis And Antimicrobial Resistance

accelerate diagnostics宣佈其accelerate Arc系統獲得FDA許可,這是一個自動化平台,旨在對抗敗血症和抗菌耐藥性
Benzinga ·  09/30 21:16

An automated platform designed to fight against Sepsis and Antimicrobial Resistance (AMR)

一個旨在對抗敗血症和抗微生物藥物耐藥性(AMR)的自動化平台

Enables rapid, automated microbial identification on the Bruker MALDI Biotyper CA System directly from positive blood culture samples

從陽性血培養樣本直接在Bruker MALDI Biotyper CA系統上進行快速自動微生物鑑定

TUCSON, Ariz., Sept. 30, 2024 /PRNewswire/ -- Accelerate Diagnostics, Inc. (NASDAQ:AXDX), an innovator of rapid in vitro diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the Accelerate Arc system and BC kit, an innovative, automated positive blood culture sample preparation platform, for use with Bruker's MALDI Biotyper CA System (MBT-CA System) and MBT-CA Sepsityper software extension.

亞利桑那州圖森,2024年9月30日 / PRNewswire / - Accelerate Diagnostics, Inc. (納斯達克: AXDX),快速體外診斷創新者,宣佈美國食品和藥物管理局(FDA)已批准Accelerate Arc系統和BC試劑盒,這是一種創新的自動化陽性血培養樣本製備平台,用於Bruker的MALDI Biotyper CA系統(MBt-CA系統)和MBt-CA敗血症鑑定軟件擴展。

Designed for clinical laboratories, the Accelerate Arc system has a simple workflow that automates positive blood culture sample preparation for direct downstream microbial identification (ID) using Bruker's MBT-CA system. This eliminates the need for overnight culture methods, reducing the wait time for microbial ID results, which is critical in the fight against sepsis.

專爲臨床實驗室設計,Accelerate Arc系統擁有一個簡單的工作流程,可自動化對抗Bruker的MBt-CA系統使用的陽性血培養樣本進行下游微生物鑑定(ID)。這消除了過夜培養方法的需要,縮短了微生物鑑定結果的等待時間,在對抗敗血症時至關重要。

The Accelerate Arc system is designed to leverage the breadth of the Bruker MBT-CA reference library to provide rapid ID. This, in conjunction with our future rapid phenotypic antibiotic susceptibility testing (AST) innovation, the Accelerate WAVE system1, can enable same shift reporting to Antimicrobial Stewardship teams and clinicians alike. By providing clinicians with rapid ID and AST results, clinicians can get the patient on the optimal antibiotic therapy many hours sooner, which has been shown to improve patient outcomes with Sepsis, reduce antimicrobial resistance rates and hospital costs.

Accelerate Arc系統旨在利用Bruker MBt-CA參考庫的廣度提供快速鑑定。結合我們未來的快速表型抗生素敏感性測試(AST)創新,Accelerate WAVE系統1,可以實現向抗微生物藥物管理團隊和臨床醫生進行同班次報告。通過爲臨床醫生提供快速鑑定和AST結果,醫生可以更早地開始患者接受最佳抗生素治療,這已被證明可改善敗血症患者預後,降低抗微生物藥物耐藥率和醫院成本。

譯文內容由第三人軟體翻譯。


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