Ashley E Kita1, Daniel W Bradbury2, Zachary D Taylor2,3,4, Daniel T Kamei2, Maie A St John1,3,5. 1. 1 Department of Head and Neck Surgery, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA. 2. 2 Department of Bioengineering, Henry Samueli School of Engineering and Applied Sciences, University of California Los Angeles, Los Angeles, California, USA. 3. 3 UCLA Head and Neck Cancer Program, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA. 4. 4 Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA. 5. 5 Jonsson Comprehensive Cancer Center, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
Abstract
OBJECTIVE: A cerebrospinal fluid leak is one of the most serious complications in otolaryngology. It may occur as a result of injury to the skull base, typically traumatic or iatrogenic. While the presence of a leak is often discerned in the emergent setting, distinguishing normal secretions from those containing cerebrospinal fluid can be difficult during postoperative visits in the clinic. As most current laboratory-based assays are labor intensive and require several days to result, we aim to develop a more user-friendly and rapid point-of-care cerebrospinal fluid detection device. STUDY DESIGN: Our laboratory developed a barcode-style lateral-flow immunoassay utilizing antibodies for beta-trace protein, a protein abundant in and specific for cerebrospinal fluid, with a concentration of 1.3 mg/L delineating a positive result. SETTING: Tertiary medical center. SUBJECTS AND METHODS: Tests with known concentrations of resuspended beta-trace protein and the contents of discarded lumbar drains (presumed to contain cerebrospinal fluid) were performed to validate our novel device. RESULTS: Our results demonstrate the ability of our device to semiquantitatively identify concentrations of beta-trace protein from 0.3-90 mg/L, which is within the required range to diagnose a leak, thus making beta-trace protein an excellent target for rapid clinical detection. CONCLUSION: Herein we detail the creation and initial validation of the first point-of-care cerebrospinal fluid detection device. This device is a feasible method to more efficiently and cost-effectively identify cerebrospinal fluid leaks, minimize costs, and improve patient outcomes.
OBJECTIVE: A cerebrospinal fluid leak is one of the most serious complications in otolaryngology. It may occur as a result of injury to the skull base, typically traumatic or iatrogenic. While the presence of a leak is often discerned in the emergent setting, distinguishing normal secretions from those containing cerebrospinal fluid can be difficult during postoperative visits in the clinic. As most current laboratory-based assays are labor intensive and require several days to result, we aim to develop a more user-friendly and rapid point-of-care cerebrospinal fluid detection device. STUDY DESIGN: Our laboratory developed a barcode-style lateral-flow immunoassay utilizing antibodies for beta-trace protein, a protein abundant in and specific for cerebrospinal fluid, with a concentration of 1.3 mg/L delineating a positive result. SETTING: Tertiary medical center. SUBJECTS AND METHODS: Tests with known concentrations of resuspended beta-trace protein and the contents of discarded lumbar drains (presumed to contain cerebrospinal fluid) were performed to validate our novel device. RESULTS: Our results demonstrate the ability of our device to semiquantitatively identify concentrations of beta-trace protein from 0.3-90 mg/L, which is within the required range to diagnose a leak, thus making beta-trace protein an excellent target for rapid clinical detection. CONCLUSION: Herein we detail the creation and initial validation of the first point-of-care cerebrospinal fluid detection device. This device is a feasible method to more efficiently and cost-effectively identify cerebrospinal fluid leaks, minimize costs, and improve patient outcomes.
Entities:
Keywords:
beta-trace protein; cerebrospinal fluid leak; diagnostic; lateral-flow immunoassay; otolaryngology; point of care; semiquantitative