Rapid Diagnostic Test Kit for Point-of-Care Cerebrospinal Fluid Leak Detection

Author:

Bradbury Daniel W.1,Kita Ashley E.2,Hirota Kensuke1,St. John Maie A.1234,Kamei Daniel T.1

Affiliation:

1. Department of Bioengineering, Henry Samueli School of Engineering and Applied Sciences, University of California Los Angeles, Los Angeles, CA, USA

2. Department of Head and Neck Surgery, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA

3. Jonsson Comprehensive Cancer Center, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA

4. UCLA Head and Neck Cancer Program, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA

Abstract

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.

Funder

National Institute of Neurological Disorders and Stroke

American Academy of Otolaryngology-Head and Neck Surgery

Publisher

Elsevier BV

Subject

Medical Laboratory Technology,Computer Science Applications

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