Department of Pathology and Laboratory Medicine, Children's Hospital Los Angeles, Los Angeles, California, USA
Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
J Clin Microbiol. 2018 Mar 26;56(4). doi: 10.1128/JCM.00018-18. Print 2018 Apr.
INTRODUCTIONSyndromic panels were first FDA cleared for detection of respiratory pathogens in 2008. Since then, other panels have been approved by the FDA, and most recently, the FilmArray meningitis/encephalitis panel (BioFire, Salt Lake City, UT) has become available. This assay detects 14 targets within 1 h and includes pathogens that typically cause different manifestations of infection, although they infect the same organ system. Several studies have reported both false-positive and false-negative results with this test, and all agree that the cost is significant. As with other panels, health care systems have adopted different strategies for offering this assay. Some have implemented strategies to limit the use of the test to certain patient populations, others have elected not to offer the test, and others have elected not to offer the test and instead request that providers order specific PCRs for the pathogens that best fit the patient's symptoms. In this Point-Counterpoint, Jennifer Dien Bard of the Department of Pathology and Laboratory Medicine, Children's Hospital Los Angeles, and of the Keck School of Medicine at the University of Southern California explains why laboratories should offer these assays without restriction. Kevin Alby of the University of Pennsylvania explains the concerns about the use of these assays as first-line tests and why some limitations on their use might be appropriate.
引言
2008 年,首个针对呼吸道病原体的综合征检测试剂盒获得了 FDA 的批准。此后,FDA 又批准了其他一些试剂盒,最近,FilmArray 脑膜炎/脑炎检测试剂盒(BioFire,盐湖城,犹他州)也已上市。该检测可在 1 小时内检测 14 个靶点,涵盖了可引起同一器官系统感染但临床表现不同的病原体。多项研究报道了该检测存在假阳性和假阴性结果,所有研究均认为该检测费用高昂。与其他检测试剂盒一样,医疗机构采用了不同的策略来提供这种检测。一些机构采取了策略,将该检测限制用于特定的患者群体,另一些机构则选择不提供该检测,还有一些机构选择不提供该检测,而是要求医生根据患者症状选择最适合的病原体进行特定的 PCR 检测。在这篇观点对立方中,洛杉矶儿童医院病理学和检验科的 Jennifer Dien Bard 博士以及南加州大学凯克医学院的 Jennifer Dien Bard 博士解释了实验室为何应无限制地提供这些检测。宾夕法尼亚大学的 Kevin Alby 博士则解释了为何将这些检测作为一线检测存在一些顾虑,以及对其使用加以限制可能是合适的。