Development of a novel potential difference probe with bedside validation simulator for potential difference testing.

Area of Science:

• Pulmonary Medicine
• Biomedical Engineering
• Medical Diagnostics

Background:

• Cystic fibrosis (CF) arises from CFTR protein dysfunction, causing airway dehydration and mucus issues.
• Transepithelial potential difference (PD) measurement is a sensitive indicator of CFTR activity.
• Conventional PD measurement methods are cumbersome and prone to errors, especially for endobronchial applications.

Purpose of the Study:

• To develop and validate a novel, portable probe system for enhanced accuracy and sensitivity in CFTR functional testing.
• To adapt the probe system for endobronchial PD measurements.
• To establish proof of principle for the new device in a pilot study.

Main Methods:

• Development of a novel portable probe with integrated gas removal and optical coherence tomography (OCT) for visual guidance.
• Utilized a bedside electrocell simulator for probe performance validation.
• Conducted a pilot nasal PD study comparing the new probe in CF subjects and non-CF controls (n=10).

Main Results:

• The novel probe system demonstrated feasibility and enabled discrimination between CF and non-CF groups in nasal PD measurements.
• Deming regression showed a consistent linear relationship, and Somers' D indicated moderate rank ordering concordance.
• While Bland-Altman analysis suggested limited agreement, the results establish proof of principle for the new device.

Conclusions:

• The novel probe system offers improved accuracy and sensitivity for CFTR functional testing, particularly for endobronchial PD measurements.
• The device is validated through external electrocell simulation and pilot clinical studies.
• Further validation in larger cohorts is warranted to confirm the clinical utility of this advanced diagnostic tool.