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Effects of Humidity on Foil and Vial Packaging to Preserve Glucose and Lactate Test Strips for Disaster Readiness

Published online by Cambridge University Press:  04 March 2014

Anh-Thu Truong
Affiliation:
Point-of-Care Testing Center for Teaching and Research, Pathology and Laboratory Medicine, University of California, Davis, California
Richard F. Louie*
Affiliation:
Point-of-Care Testing Center for Teaching and Research, Pathology and Laboratory Medicine, University of California, Davis, California
John H. Vy
Affiliation:
Point-of-Care Testing Center for Teaching and Research, Pathology and Laboratory Medicine, University of California, Davis, California
Corbin M. Curtis
Affiliation:
Point-of-Care Testing Center for Teaching and Research, Pathology and Laboratory Medicine, University of California, Davis, California
William J. Ferguson
Affiliation:
Point-of-Care Testing Center for Teaching and Research, Pathology and Laboratory Medicine, University of California, Davis, California
Mandy Lam
Affiliation:
Point-of-Care Testing Center for Teaching and Research, Pathology and Laboratory Medicine, University of California, Davis, California
Stephanie Sumner
Affiliation:
Point-of-Care Testing Center for Teaching and Research, Pathology and Laboratory Medicine, University of California, Davis, California
Gerald J. Kost
Affiliation:
Point-of-Care Testing Center for Teaching and Research, Pathology and Laboratory Medicine, University of California, Davis, California
*
Correspondence and reprint requests to Richard F. Louie, PhD, University of California, Davis Point-of-Care Testing Center for Teaching and Research, Pathology and Laboratory Medicine, University of California, Davis, 1 Shields Ave, 3455 Tupper Hall, Davis, CA 95616 (e-mail [email protected]).

Abstract

Objective

Efficient emergency and disaster response is challenged by environmental conditions exceeding test reagent storage and operating specifications. We assessed the effectiveness of vial and foil packaging in preserving point-of-care (POC) glucose and lactate test strip performance in humid conditions.

Methods

Glucose and lactate test strips in both packaging were exposed to mean relative humidity of 97.0 ± 1.1% in an environmental chamber for up to 168 hours. At defined time points, stressed strips were removed and tested in pairs with unstressed strips using whole blood samples spiked to glucose concentrations of 60, 100, and 250 mg/dL (n = 20 paired measurements per level). A Wilcoxon signed rank test was used to compare stressed and unstressed test strip measurements.

Results

Stressed glucose and lactate test strip measurements differed significantly from unstressed strips, and were inconsistent between experimental trials. Median glucose paired difference was as high as 12.5 mg/dL at the high glucose test concentration. Median lactate bias was −0.2 mmol/L. Stressed strips from vial (3) and foil (7) packaging failed to produce results.

Conclusions

Both packaging designs appeared to protect glucose and lactate test strips for at least 1 week of high humidity stress. Documented strip failures revealed the need for improved manufacturing process. (Disaster Med Public Health Preparedness. 2014;0:1–7)

Type
Original Research
Copyright
Copyright © Society for Disaster Medicine and Public Health, Inc. 2014 

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