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FDA批准下呼吸道感染与脓毒症抗生素治疗检测试剂盒

FDA clears test to help manage antibiotic treatment for lower respiratory tract infections and sepsis
来源:FDA 2017-03-14 10:45点击次数:4160发表评论

美国FDA近日批准了Vidas Brahms PCT试剂盒的扩大适用范围,用于帮助医务人员确定下呼吸道感染(如社区获得性肺炎)患者是否开始或停止抗生素治疗以及脓毒症患者是否停止抗生素治疗。这是首款以降钙素原(PCT,一种与细菌感染后机体反应相关的蛋白)作为生物标志物,用于此类患者抗生素治疗决策的试剂盒。


The U.S. Food and Drug Administration today cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, such as community-acquired pneumonia, and stopped in patients with sepsis. This is the first test to use procalcitonin (PCT), a protein associated with the body’s response to a bacterial infection, as a biomarker to help make antibiotic management decisions in patients with these conditions.


FDA医疗器械与放射健康中心体外诊断试剂与放射健康办公室主任Alberto Gutierrez博士指出:“抗生素的不必要应用可导致抗生素耐药性感染增加。该试剂盒可帮助临床医师做出抗生素治疗决策。”


“Unnecessary antibiotic use may contribute to the rise in antibiotic-resistant infections,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “This test may help clinicians make antibiotic treatment decisions.”


该试剂盒的工作原理是测定PCT水平。高水平PCT提示细菌感染,而低水平PCT提示病毒感染或非感染病因。临床医师可通过PCT水平和其他信息暂缓或停止抗生素治疗。鉴于PCT可能预示各种细菌感染,因此它不能确定患者症状的具体原因。


The test works by measuring PCT. High levels of PCT suggest a bacterial infection, while low levels suggest a viral infection or non-infectious causes. Clinicians may be able to use PCT and other information to safely withhold or stop antibiotics. Because PCT may indicate the presence of a variety of bacterial infections, it does not detect the exact cause of a patient’s symptoms.


脓毒症是机体对感染的一种反应,可导致组织损伤、器官衰竭甚至死亡。下呼吸道感染包括社区获得性肺炎、急性支气管炎和慢性阻塞性肺疾病急性加重。细菌通常可导致脓毒症和下呼吸道感染,但病毒(特别是下呼吸道感染)及非感染性疾病也可能导致相似症状。


Sepsis can be part of the body’s response to an infection and can lead to tissue damage, organ failure, and death. Lower respiratory tract infections include community-acquired pneumonia, acute bronchitis, and acute exacerbations of chronic obstructive pulmonary disease (COPD). Bacteria often cause sepsis and lower respiratory tract infections, but viruses (particularly for lower respiratory tract infections) and non-infectious diseases can cause similar symptoms.


Vidas Brahms PCT试剂盒通过510(k)途径(用于与合法上市的参比医疗器械实质等同的医疗器械的批准途径)获得批准。FDA首次批准该试剂盒,旨在帮助临床医师更好地预测患者死亡或脓毒症致病风险。


The test was cleared through the 510(k) pathway, a regulatory pathway for certain medical devices that are substantially equivalent to a legally marketed predicate device. The FDA first cleared this test to help clinicians better predict a patient’s risk of dying or becoming sicker due to sepsis.


支持该试剂盒扩大应用的数据包括已发表的PCT指导治疗与标准治疗对照的临床研究资料。来自这些前瞻性随机研究数据显示,接受PCT指导治疗患者的抗生素应用显著下降,且未见明显的安全性影响。


Data supporting the test’s expanded use included clinical trial findings from published literature that compared PCT-guided therapy to standard therapy. Data from these prospective, randomized studies showed a significant decrease in antibiotic use for patients who had received PCT-guided therapy, without significantly affecting safety.


Vidas Brahms PCT试剂盒适用于医院或急诊室。与之相关的风险包括导致非必要抗生素治疗的假阳性结果,以及导致合理治疗延迟的假阴性结果。医务人员进行治疗决策时不应仅仅依据PCT的检测结果,还应结合患者的临床状态及其他实验室结果。医务人员和实验室人员应仔细阅读试剂盒说明书,了解有关试剂盒合理临床应用和检测操作的完整信息。


The Vidas Brahms test is intended to be used in the hospital or emergency room. Risks associated with use of the test may include false positive results, which may lead to unnecessary treatment with antibiotics, and false negative results, which may lead to a delay in the selection of appropriate therapy. Health care providers should not rely solely on PCT test results when making treatment decisions, but should interpret test results in the context of a patient’s clinical status and other laboratory results. Health care providers and laboratorians should review the test’s package insert for complete information regarding appropriate clinical use and test performance.


Vidas Brahms试剂盒由位于法国Marcy l'Etoile 的bioMérieux公司生产。


The Vidas Brahms test is manufactured by bioMérieux Inc. in Marcy l'Etoile, France.


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学科代码: 呼吸病学  感染病学  检验病学     关键词:Vidas Brahms PCT试剂盒 下呼吸道感染 脓毒症 FDA抗生素治疗 ,新闻 爱思唯尔医学网, Elseviermed
来源: FDA
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