Hostname: page-component-586b7cd67f-vdxz6 Total loading time: 0 Render date: 2024-12-01T09:17:10.106Z Has data issue: false hasContentIssue false
  • English
  • Français

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 ,
Richard F. Louie ,
John H. Vy ,
Corbin M. Curtis ,
William J. Ferguson ,
Mandy Lam ,
Stephanie Sumner  and
Gerald J. Kost
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]).
Get access Rights & Permissions [Opens in a new window]

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
Information
Disaster Medicine and Public Health Preparedness , Volume 8 , Issue 1 , February 2014 , pp. 51 - 57
Copyright
Copyright © Society for Disaster Medicine and Public Health, Inc. 2014 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

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.Google Scholar
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.Google Scholar
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.Google Scholar
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.Google Scholar
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.Google Scholar
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.Google Scholar
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.Google Scholar
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.Google Scholar
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.Google Scholar
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.CrossRefGoogle ScholarPubMed
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.Google Scholar
12. Kline, DG. Inside and somewhat outside Charity. J Neurosurg. 2007;106:180-188.Google Scholar
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.Google Scholar
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.CrossRefGoogle ScholarPubMed
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.Google Scholar
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.Google Scholar
17. Hekal IM. Desiccant entrained polymer. US patent US 5,911,937. June 15, 1999.Google Scholar
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.Google Scholar
19. Eikmeier, H, Sacherer, K-D, Schreiber, J, etal. Storage system for test elements. US patent US 5,720,924. February 24, 1998.Google Scholar
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.Google Scholar
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.Google Scholar
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.Google Scholar