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含树脂的 BacT/ALERT® Plus 血培养瓶对 Accelerate Diagnostics Pheno 系统的性能。

Performance of the Accelerate Diagnostics Pheno system with resin-containing BacT/ALERT® Plus blood culture bottles.

机构信息

Clinical Microbiology Laboratory, Department of Pathology, Duke University Health System.

Clinical Microbiology Laboratory, Department of Pathology, Duke University Health System.

出版信息

Diagn Microbiol Infect Dis. 2019 Jun;94(2):122-128. doi: 10.1016/j.diagmicrobio.2019.01.002. Epub 2019 Jan 16.

Abstract

Bacteremia and septicemia require rapid identification (ID) and antimicrobial susceptibility testing (AST) to start targeted, appropriate therapy. To answer this need, Accelerate Diagnostics, Inc., developed the Accelerate Pheno™ system (AXDX), a fast ID and phenotypic AST platform. Performance of a pre-FDA clearance version of AXDX was evaluated using 261 positive BacT/ALERT® Plus bottles and compared with standard of care (SOC). Average time to ID was reduced by 24.9±6.9 h and AST by 36.7±18.9 h compared with SOC. AXDX reports ID and AST of blood pathogens in 1.9 and 7.1 h. Positive percent agreement and negative percent agreement of AXDX ID were 94.5% and 98.9%, respectively. AXDX AST had an essential agreement of 96.5% and categorical agreement of 94.6% with 4 major errors and 7 very major errors. AXDX performance was acceptable for all 3 bottle types. Rapid ID and AST with AXDX could impact patient care and antimicrobial stewardship.

摘要

菌血症和败血症需要快速鉴定(ID)和抗菌药物敏感性检测(AST),以启动针对性的适当治疗。为了满足这一需求,Accelerate Diagnostics, Inc. 开发了 Accelerate Pheno™ 系统(AXDX),这是一种快速 ID 和表型 AST 平台。使用 261 个阳性 BacT/ALERT® Plus 瓶评估了 AXDX 的预 FDA 清除版本的性能,并与标准护理(SOC)进行了比较。与 SOC 相比,ID 的平均时间减少了 24.9±6.9 小时,AST 减少了 36.7±18.9 小时。AXDX 报告血液病原体的 ID 和 AST 时间分别为 1.9 和 7.1 小时。AXDX ID 的阳性百分比一致率和阴性百分比一致率分别为 94.5%和 98.9%。AXDX AST 与 4 个主要错误和 7 个非常大的错误相比,具有 96.5%的基本一致性和 94.6%的分类一致性。AXDX 的性能对于所有 3 种瓶型都是可以接受的。AXDX 的快速 ID 和 AST 可能会影响患者的护理和抗菌药物管理。

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