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

  • Anh-Thu Truong (a1), Richard F. Louie (a1), John H. Vy (a1), Corbin M. Curtis (a1), William J. Ferguson (a1), Mandy Lam (a1), Stephanie Sumner (a1) and Gerald J. Kost (a1)...

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)

Copyright

Corresponding author

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 rflouie@ucdavis.edu).

References

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1. Louie, RF, Sumner, SL, Belcher, S, Mathew, R, Tran, NK, Kost, GJ. Thermal stress and point-of-care testing performance: suitability of glucose test strips and blood gas cartridges for disaster response. Disaster Med Public Health Prep. 2009;3:13-17.
2. Ferguson, WJ. Dynamic temperature and humidity environmental profiles: impact for future emergency and disaster preparedness and response. Prehosp Disaster Med. 2014;2:1-8.
3. Tang, CS, Ferguson, WJ, Louie, RF, Vy, JH, Sumner, SL, Kost, GJ. Ensuring quality control of point-of-care technologies. Point of Care. 2012;11:147-151.
4. Louie, RF, Ferguson, WJ, Curtis, CM, Vy, JH, Kost, GJ. Vulnerability of point-of-care test reagents and instruments to environmental stresses: implications for health professionals and developers. Clin Chem Lab Med. 2014;52:325-335.
5. Louie, RF, Ferguson, WJ, Curtis, CM, Vy, JH, Tang, CS, Kost, GJ. Effects of environmental conditions on point-of-care cardiac biomarker test performance during a simulated rescue: implications for emergency and disaster response. Am J Disaster Med. 2013;8:205-212.
6. Ferguson, WJ, Vy, JH, Louie, RF, etal. Preliminary evaluation of a point-of-care blood gas-electrolyte analyzer potentially robust in cold during emergencies and disasters. Point of Care. 2012;11:152-156.
7. Louie, RF, Lau, MJ, Lee, JH, Tang, Z, Kost, GJ. Multicenter study of the prevalence of blood contamination on point-of-care glucose meters and recommendations for controlling contamination. Point of Care. 2005;4:158-163.
8. King, JM, Eigenmann, CA, Colagiuri, S. Effect of ambient temperature and humidity on performance of blood glucose meters. Diabet Med. 1995;12:337-340.
9. Vanholder, R, Borniche, D, Claus, S, etal. When the earth trembles in the Americas: the experience of Haiti and Chile 2010. Nephron Clin Pract. 2011;117(3):c184-c197.
10. Kost, GJ, Tran, NK, Tuntideelert, M, Kulrattanamaneeporn, S, Peungposop, N. Katrina, the tsunami, and point-of-care testing: optimizing rapid response diagnosis in disasters. Am J Clin Pathol. 2006;126:513-520.
11. Klein, KR, Nagel, NE. Mass medical evacuation: Hurricane Katrina and nursing experiences at the New Orleans airport. Disaster Manag Response. 2007;5(2):56-61.
12. Kline, DG. Inside and somewhat outside Charity. J Neurosurg. 2007;106:180-188.
13. Louie, RF, Ferguson, WJ, Sumner, SL, Yu, JN, Curtis, CM, Kost, GJ. Effects of dynamic temperature and humidity stresses on point-of-care glucose testing for disaster care. Disaster Med Public Health Prep. 2012;6:232-240.
14. Tonyushkina, K, Nichols, JH. Glucose meters: a review of technical challenges to obtaining accurate results. J Diabetes Sci Technol. 2009;3(4):971-980.
15. Fleming, DR. Accuracy of blood glucose monitoring for patients: what it is and how to achieve it. Diabetes Educ. 1994;20(6):495-500.
16. Abrams, RS, Garren, RT. Process and apparatus for making a leak proof cap and body assembly. US patent US 5,723,085. March 3, 1998.
17. Hekal IM. Desiccant entrained polymer. US patent US 5,911,937. June 15, 1999.
18. Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities: Approved Guideline, 3rd ed. Wayne, PA: Clinical and Laboratory Standards Institute; 2013; CLSI document POCT12-A3.
19. Eikmeier, H, Sacherer, K-D, Schreiber, J, etal. Storage system for test elements. US patent US 5,720,924. February 24, 1998.
20. Bamberg, R, Schulman, K, MacKenzie, M, Moore, J, Olchesky, S. Effect of adverse storage conditions on performance of glucometer test strips. Clin Lab Sci. 2005;18:203-209.
21. Nerhus, K, Rustad, P, Sandberg, S. Effect of ambient temperature on analytical performance of self-monitoring blood glucose systems. Diabetes Technol Ther. 2011;13(9):883-892.
22. Haller, MJ, Shuster, JJ, Schatz, D, Melker, RJ. Adverse impact of temperature and humidity on blood glucose monitoring reliability: a pilot study. Diabetes Technol Ther. 2007;9(1):1-9.

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

  • Anh-Thu Truong (a1), Richard F. Louie (a1), John H. Vy (a1), Corbin M. Curtis (a1), William J. Ferguson (a1), Mandy Lam (a1), Stephanie Sumner (a1) and Gerald J. Kost (a1)...

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