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Proceedings Paper

Oximetry system performance assessment with POM (acetal) phantoms incorporating hemoglobin calibration standards and customized saturation levels
Author(s): Hyounguk Jang; Karam Singh; Hsing-Wen Wang; T. Joshua Pfefer; Yu Chen
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Paper Abstract

Standardized approaches for performance assessment of biophotonic devices have the potential to facilitate system development and intercomparison, clinical trial standardization, recalibration, manufacturing quality control and quality assurance during clinical use. Evaluation of devices based on near-infrared spectroscopy (NIRS) for detection of hemoglobin (Hb) content and oxygenation have often involved tissue-simulating phantoms incorporating artificial dyes or flow systems. Towards the development of simple, effective techniques for objective, quantitative evaluation of basic NIRS system performance, we have developed and evaluated two test methods. These methods are based on cuvette inserts in solid turbid phantoms for measuring commercially-available Hb oximetry standards and custom-formulated oxy/deoxy-Hb solutions. Both approaches incorporate solid acetal, or polyoxymethylene (POM), as a tissue-simulating matrix material. First, inverse-adding-doubling (IAD) based on measurements with a spectrophotometer and an integrating sphere was used to measure POM optical properties and their stability over time. Second, two fiberopticprobe- based NIRS systems were used to measure concentration change of oxy- and deoxy-Hb in standard Hb solutions and customized Hb solutions by adding yeast. Differences in system performance were likely due to differences in light source outputs and fiberoptic probe design. Our preliminary results indicate that simple phantom-based approaches based on commercially available polymers and inclusions containing Hb standards, or controlled oxygenation levels may be useful for benchtop assessment of NIRS device quality for a variety of biophotonic devices.

Paper Details

Date Published: 11 March 2015
PDF: 7 pages
Proc. SPIE 9315, Design and Quality for Biomedical Technologies VIII, 931503 (11 March 2015); doi: 10.1117/12.2087095
Show Author Affiliations
Hyounguk Jang, Univ. of Maryland, College Park (United States)
U.S. Food and Drug Administration (United States)
Karam Singh, Univ. of Maryland, College Park (United States)
Hsing-Wen Wang, Univ. of Maryland, College Park (United States)
T. Joshua Pfefer, U.S. Food and Drug Administration (United States)
Yu Chen, Univ. of Maryland, College Park (United States)

Published in SPIE Proceedings Vol. 9315:
Design and Quality for Biomedical Technologies VIII
Ramesh Raghavachari; Rongguang Liang, Editor(s)

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