Vulnerability of point-of-care test reagents and instruments to environmental stresses: implications for health professionals and developers
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Richard F. Louie
,
William J. Ferguson
Abstract
Strategic integration of point-of-care (POC) diagnostic tools during crisis response can accelerate triage and improve management of victims. Timely differential diagnosis is essential wherever care is provided to rule out or rule in disease, expedite life-saving treatment, and improve utilization of limited resources. POC testing needs to be accurate in any environment in which it is used. Devices are exposed to potentially adverse storage and operating conditions, such as high/low temperature and humidity during emergencies and field rescues. Therefore, characterizing environmental conditions allows technology developers, operators, and responders to understand the broad operational requirements of test reagents, instruments, and equipment in order to improve the quality and delivery of care in complex emergencies, disasters, and austere environmental settings. This review aims to describe the effects of environmental stress on POC testing performance and its impact on decision-making, to describe how to study the effects, and to summarize ways to mitigate the effects of environmental stresses through good laboratory practice, development of robust reagents, and novel thermal packaging solutions.
We wish to thank Anh-Thu Truong for her critical review of the manuscript and assistance with the manuscript preparation. This work was supported by a grant from the National Institute of Biomedical Imaging and Bioengineering [NIBIB, NIH, U54EB007959, Dr. Gerald Kost, PI]. The content is solely the responsibility of the authors and does not necessarily represent the official views of NIBIB or the National Institutes of Health. Tables and figures provided courtesy and permission of Knowledge Optimization®, Davis, CA, USA.
Conflict of interest statement
Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research funding played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.
Research funding: Research grant from the National Institute of Biomedical Imaging and Bioengineering [NIBIB, NIH, U54EB007959, Dr. Gerald Kost, PI].
Employment or leadership: None declared.
Honorarium: None declared.
References
1. Kost GJ, Sakaguchi A, Curtis C, Tran NK, Katip P, Louie RF. Enhancing crisis standards of care using innovative point-of-care testing. Am J Disaster Med 2011;6:351–68.10.5055/ajdm.2011.0074Suche in Google Scholar PubMed PubMed Central
2. United Nations. United States of America – Disaster statistics. Natural disasters from 1980–2010. Available from: http://www.preventionweb.net/english/countries/statistics/?cid=185. Accessed 4 June, 2013.Suche in Google Scholar
3. Klein KR, Nagel NE. Mass medical evacuation: hurricane Katrina and nursing experiences at the New Orleans airport. Disaster Manag Response 2007;5:56–61.10.1016/j.dmr.2007.03.001Suche in Google Scholar PubMed
4. Kline DG. Inside and somewhat outside charity. J Neurosurg 2007;106:180–8.10.3171/jns.2007.106.1.180Suche in Google Scholar PubMed
5. Ferguson WJ, Louie RF, Tang CS, Paw KT, Kost GJ. Dynamic temperature and humidity environmental profiles: impact for future emergency and disaster preparedness and response. Prehosp Disaster Med 2013, in press.10.1017/S1049023X13009199Suche in Google Scholar PubMed
6. Lippi G, Favaloro EJ, Plebani M. Laboratory medicine and natural disasters: are we ready for the challenge? Clin Chem Lab Med 2010;48:573–5.10.1515/CCLM.2010.148Suche in Google Scholar PubMed
7. Tirimacco R, Koumantakis G, Erasmus R, Mosca A, Sandberg S, Watson ID, et al. Glucose meters – fit for clinical purpose. Clin Chem Lab Med 2013;51:943–52.10.1515/cclm-2013-0011Suche in Google Scholar PubMed
8. Curtis CM, Louie RF, Vy JH, Ferguson WJ, Lam M, Truong AT, et al. Innovations in point-of-care testing for enhanced United States disaster caches. Am J Disaster Med 2013, in press.Suche in Google Scholar
9. Taylor J. Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products. Pharma J 2001;267:128–31.Suche in 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;126:513–20.10.1309/NWU5E6T0L4PFCBD9Suche in Google Scholar PubMed
11. Vanholder R, Borniche D, Claus S, Correa-Rotter R, Crestani R, Ferir MC, et al. When the earth trembles in the Americas: the experience of Haiti and Chile 2010. Nephron Clin Pract 2011;117:c184–97.10.1159/000320200Suche in Google Scholar PubMed
12. Rust MJ, Carlson NA, Nichols JH. A thermo-modulating container for transport and storage of glucose meters in a cold weather environment. Point Care 2012;11:157–60.10.1097/POC.0b013e318265f3bbSuche in Google Scholar
13. Kost GJ, Katip P, Curtis CM. Strategic point-of-care requirements of hospitals and public health for preparedness in regions at risk. Point Care 2012;11:114–8.10.1097/POC.0b013e31825a2442Suche in Google Scholar PubMed PubMed Central
14. 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;6:232–40.10.1001/dmp.2012.42Suche in Google Scholar PubMed
15. Ferguson WJ, Louie RF, Curtis CM, Vy JH, Tang CS, Kost GJ. Effects of environmental stress on point-of-care cardiac biomarker test results during simulated emergency/disaster rescue. 2012 AACC Annual Meeting, Los Angeles, CA, July 15–19, 2012. Abstract D-36;A157. Available from: http://www.aacc.org/events/annualmtgdirectory/Documents/AACC_12_Abstracts_D31-D75.pdf. Accessed 4 June, 2013.Suche in Google Scholar
16. MIL-STD-810G, Department of Defense Test Method Standard: Environmental Engineering Considerations and Laboratory Tests. October 31, 2008. Available from: http://www.everyspec.com/MIL-STD/MIL-STD-0800-0899/MIL-STD-810G_12306/. Accessed 4 June, 2013.Suche in Google Scholar
17. Bernhardt P. FDA evaluation of point of care blood glucose meters. Available from: http://www.pointofcare.net/virginia/FDA_8-11-11.pdf. Accessed 4 June, 2013.Suche in Google Scholar
18. Tang CS, Ferguson WJ, Louie RF, Vy JH, Sumner SL, Kost GJ. Ensuring quality control of point-of-care technologies: effects of dynamic temperature and humidity stresses on Glucose quality control solutions. Point Care 2012;11:147–51.10.1097/POC.0b013e318265f38aSuche in Google Scholar
19. 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, in press.Suche in Google Scholar
20. Ferguson WJ, Vy JH, Louie RF, Zhou M, Curtis CM, Tang CS, et al. Preliminary evaluation of a point-of-care blood gas–electrolyte analyzer potentially robust in cold during emergencies and disasters: evidence from evaluation of reagents in stress testing chambers. Point Care 2012;11:152–6.10.1097/POC.0b013e318265f3a3Suche in Google Scholar
21. King JM, Eigenmann CA, Colagiuri S. Effect of ambient temperature and humidity on performance of blood glucose meters. Diabet Med 1995;12:337–40.10.1111/j.1464-5491.1995.tb00488.xSuche in Google Scholar PubMed
22. Nawawi H, Sazali BS, Kamuruzaman BH, Yazid TN, Jemain AA, Ismail F, et al. Effect of ambient temperature on analytical and clinical performance of a blood glucose monitoring system: Omnitest Sensor glucose meter. Ann Clin Biochem 2001;38:676–83.10.1258/0004563011901091Suche in Google Scholar PubMed
23. Fink KS, Christensen DB, Ellsworth A. Effect of high altitude on blood glucose meter performance. Diabetes Technol Ther 2002;5:627–35.10.1089/152091502320798259Suche in Google Scholar PubMed
24. Bamberg R. Schulman K, Mackenzie M, Moore J, Olchesky S. Effect of adverse storage conditions on performance of glucose meter test strips. Clin Lab Sci 2005;18:203–9.Suche in Google Scholar
25. 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; 9:1–9.10.1089/dia.2006.0051Suche in Google Scholar PubMed
26. 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;3:13–7.10.1097/DMP.0b013e3181979a06Suche in Google Scholar PubMed PubMed Central
27. Moore K, Vizzard N, Coleman C, McMahon J, Hayes R, Thompson CJ. Extreme altitude mountaineering and type 1 diabetes; the Diabetes Federation of Ireland Kilimanjaro Expedition. Diabet Med 2001;18:749–55.10.1046/j.0742-3071.2001.00568.xSuche in Google Scholar PubMed
28. Nerhus K, Rustad P, Sandberg S. Effect of ambient temperature on analytical performance of self-monitoring blood glucose systems. Diabetes Technol Ther 2011;13:883–92.10.1089/dia.2010.0255Suche in Google Scholar PubMed
29. Cembrowski GC, Smith B, O’Malley EM. Increases in whole blood glucose measurements using optically based self-monitoring of blood glucose analyzers due to extreme Canadian winters. J Diabetes Sci Technol 2009;3:661–7.10.1177/193229680900300407Suche in Google Scholar PubMed PubMed Central
30. O’Malley JJ, Ulmer RW. Thermal stability of glucose oxidase and its ad-mixtures with synthetic polymers. Biotechnol Bioeng 1973;15:917–25.10.1002/bit.260150509Suche in Google Scholar PubMed
31. Gouda MD, Singh SA, Rao AG, Thakur MS, Karanth NG. Thermal inactivation of glucose oxidase. Mechanism and stabilization using additives. J Biol Chem 2003;278:24324–33.10.1074/jbc.M208711200Suche in Google Scholar PubMed
32. Karan R, Capes MD, DasSarma S. Function and biotechnology of extremophilic enzymes in low water activity. Aquat Biosyst 2012;8:4.10.1186/2046-9063-8-4Suche in Google Scholar PubMed PubMed Central
33. Stavelin A, Meijer P, Kitchen D, Sandberg S. External quality assessment of point-of-care international normalized ratio (INR) testing in Europe. Clin Chem Lab Med 2012;50: 81–8.10.1515/cclm.2011.719Suche in Google Scholar
34. Wang G, He X, Wang L, Gu A, Huang Y, Fang B, et al. Non-enzymatic electrochemical sensing of glucose. Microchim Acta 2013;180:161–86.10.1007/s00604-012-0923-1Suche in Google Scholar
35. Park S, Boo H, Chung TD. Electrochemical non-enzymatic glucose sensors. Anal Chim Acta 2006;556:46–57.10.1016/j.aca.2005.05.080Suche in Google Scholar PubMed
©2014 by Walter de Gruyter Berlin Boston
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Artikel in diesem Heft
- Masthead
- Masthead
- Editorial
- Point of care testing: evolving scenarios and innovative perspectives
- Review
- Point-of-care testing: where is the evidence? A systematic survey
- Mini Review
- Vulnerability of point-of-care test reagents and instruments to environmental stresses: implications for health professionals and developers
- Opinion Paper
- Twenty-five years of idiopathic calcium nephrolithiasis: has anything changed?
- Genetics and Molecular Diagnostics
- Optimizing the purification and analysis of miRNAs from urinary exosomes
- General Clinical Chemistry and Laboratory Medicine
- Extensive study of human insulin immunoassays: promises and pitfalls for insulin analogue detection and quantification
- Absorptive chemistry based extraction for LC-MS/MS analysis of small molecule analytes from biological fluids – an application for 25-hydroxyvitamin D
- Evaluation of 3-epi-25-hydroxyvitamin D3 cross-reactivity in the Roche Elecsys Vitamin D Total protein binding assay
- Quantification of linezolid in serum by LC-MS/MS using semi-automated sample preparation and isotope dilution internal standardization
- Comparison of two immunoassays for measurement of faecal calprotectin in detection of inflammatory bowel disease: (pre)-analytical and diagnostic performance characteristics
- Reference Values and Biological Variations
- Reference change values to assess changes in concentrations of biomarkers of exposure in individuals participating in a cigarette-switching study
- Reference values of fetal serum β2-microglobulin in the Chinese: evaluation of its clinical usefulness
- Cancer Diagnostics
- Gut neuroendocrine tumor blood qPCR fingerprint assay: characteristics and reproducibility
- Androgen deprivation decreases prostate specific antigen in the absence of tumor: implications for interpretation of PSA results
- Radioimmunoassay of free plasma metanephrines for the diagnosis of catecholamine-producing tumors
- Infectious Diseases
- Plasma endothelial cell-specific molecule-1 (ESM-1) in management of community-acquired pneumonia
- A soluble form of the macrophage-related mannose receptor (MR/CD206) is present in human serum and elevated in critical illness
- Letters to the Editor
- Evaluation of a JAK2 V617F quantitative PCR to monitor residual disease post-allogeneic hematopoietic stem cell transplantation for myeloproliferative neoplasms
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- Evaluating the inappropriateness of repeated laboratory testing in a teaching hospital of South Italy
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