Department of Bioengineering, Henry Samueli School of Engineering and Applied Sciences, University of California Los Angeles, Los Angeles, CA, USA.
Department of Head and Neck Surgery, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.
SLAS Technol. 2020 Feb;25(1):67-74. doi: 10.1177/2472630319877377. Epub 2019 Sep 22.
Cerebrospinal fluid (CSF) leaks can occur when there is communication between the intracranial cavities and the external environment. They are a common and serious complication of numerous procedures in otolaryngology, and if not treated, persistent leaks can increase a patient's risk of developing life-threatening complications such as meningitis. As it is not uncommon for patients to exhibit increased secretions postoperatively, distinguishing normal secretions from those containing CSF can be difficult. Currently, there are no proven, available tests that allow a medical provider concerned about a CSF leak to inexpensively, rapidly, and noninvasively rule out the presence of a leak. The gold standard laboratory-based test requires that a sample be sent to a tertiary site for analysis, where days to weeks may pass before results return. To address this, our group recently developed a semiquantitative, barcode-style lateral-flow immunoassay (LFA) for the quantification of the beta-trace protein, which has been reported to be an indicator of the presence of CSF leaks. In the work presented here, we created a rapid diagnostic test kit composed of our LFA, a collection swab, dilution buffers, disposable pipettes, and instructions. Validation studies demonstrated excellent predictive capabilities of this kit in distinguishing between clinical specimens containing CSF and those that did not. Our diagnostic kit for CSF leak detection can be operated by an untrained user, does not require any external equipment, and can be performed in approximately 20 min, making it well suited for use at the point of care. This kit has the potential to transform patient outcomes.
脑脊液 (CSF) 泄漏可发生于颅内腔隙与外部环境之间出现沟通时。它们是耳鼻喉科众多手术中常见且严重的并发症，如果不加以治疗，持续性泄漏可能会增加患者罹患危及生命的并发症（如脑膜炎）的风险。由于患者术后分泌物增加并不罕见，因此区分正常分泌物和含有 CSF 的分泌物可能具有一定难度。目前，尚无经证实、可利用的测试方法，可帮助关注 CSF 泄漏的医务人员以经济、快速且非侵入性的方式排除泄漏的存在。基于实验室的黄金标准测试要求将样本送到三级站点进行分析，可能需要数天到数周才能得到结果。为了解决这一问题，我们小组最近开发了一种用于定量检测β-痕迹蛋白的半定量、条码式侧向流动免疫分析 (LFA)，据报道，β-痕迹蛋白是 CSF 泄漏存在的一个指标。在目前呈现的工作中，我们创建了一个快速诊断试剂盒，由我们的 LFA、采集拭子、稀释缓冲液、一次性移液管和说明组成。验证研究表明，该试剂盒在区分含有 CSF 的临床样本和不含 CSF 的样本方面具有出色的预测能力。我们的 CSF 泄漏检测诊断试剂盒可由未经培训的用户操作，不需要任何外部设备，大约可在 20 分钟内完成操作，非常适合在护理点使用。该试剂盒有可能改善患者的预后。
