Ensuring quality control of point-of-care technologies: Effects of dynamic temperature and humidity stresses on glucose quality control solutions

Chloe S. Tang, William J. Ferguson, Richard F. Louie, John Tuan H Vy, Stephanie L. Sumner, Gerald J Kost

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

OBJECTIVE: The objective of this study was to characterize the effects of dynamic temperature and humidity stresses on quality control (QC) reagents used for 2 glucose meter systems. METHODS: Quality control solutions tested on glucose meter systems GMS1 (StatStrip; Nova Biomedical, Waltham, Mass) and GMS2 (Accu-Chek; Roche Diagnostics, Indianapolis, Ind) were stressed for up to 4 weeks using temperature and humidity profiles simulating conditions (maximum, minimum temperature: 45°C [113°F], 20°C [68°F]; humidity: 31%, 100%) during Hurricane Katrina. Paired measurements were obtained at each time point using 3 QC levels for GMS1 and 2 for GMS2. RESULTS: Solutions stressed for durations of 24, 72, 168 (1 week), 336 (2 weeks), and 672 (4 weeks) hours were evaluated at an actual temperature of 23°C and humidity of 90.6%. Those stressed for durations of 8, 32, 80, 172, 344, and 680 hours were evaluated at a temperature of 45°C and humidity of 31.0%. For GMS1, glucose median paired differences (stressed - control) decreased for QC levels 1 and 3 after 8 hours (P < 0.05) and increased for level 1 after 336 (P < 0.01) and 344 hours (P < 0.05). For solutions tested on GMS2, median paired differences in QC reagents were decreased for both levels at each time point tested at 45°C (P < 0.01). CONCLUSIONS: Dynamic stresses affected the performance of QC solutions and, consequently, results given by GMS1 and GMS2. To protect the efficacy and accuracy of POC technologies in emergency and disaster settings, proper monitoring, handling, and storage of QC reagents must be ensured.

Original languageEnglish (US)
Pages (from-to)147-151
Number of pages5
JournalPoint of Care
Volume11
Issue number3
DOIs
StatePublished - Sep 2012

Fingerprint

Point-of-Care Systems
Humidity
Quality Control
Glucose
Temperature
Cyclonic Storms
Disasters
Emergencies
Technology

Keywords

  • austere environments and quality assurance
  • disaster preparedness
  • hurricane Katrina
  • medical errors

ASJC Scopus subject areas

  • Nursing(all)

Cite this

Ensuring quality control of point-of-care technologies : Effects of dynamic temperature and humidity stresses on glucose quality control solutions. / Tang, Chloe S.; Ferguson, William J.; Louie, Richard F.; Vy, John Tuan H; Sumner, Stephanie L.; Kost, Gerald J.

In: Point of Care, Vol. 11, No. 3, 09.2012, p. 147-151.

Research output: Contribution to journalArticle

Tang, Chloe S. ; Ferguson, William J. ; Louie, Richard F. ; Vy, John Tuan H ; Sumner, Stephanie L. ; Kost, Gerald J. / Ensuring quality control of point-of-care technologies : Effects of dynamic temperature and humidity stresses on glucose quality control solutions. In: Point of Care. 2012 ; Vol. 11, No. 3. pp. 147-151.
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AB - OBJECTIVE: The objective of this study was to characterize the effects of dynamic temperature and humidity stresses on quality control (QC) reagents used for 2 glucose meter systems. METHODS: Quality control solutions tested on glucose meter systems GMS1 (StatStrip; Nova Biomedical, Waltham, Mass) and GMS2 (Accu-Chek; Roche Diagnostics, Indianapolis, Ind) were stressed for up to 4 weeks using temperature and humidity profiles simulating conditions (maximum, minimum temperature: 45°C [113°F], 20°C [68°F]; humidity: 31%, 100%) during Hurricane Katrina. Paired measurements were obtained at each time point using 3 QC levels for GMS1 and 2 for GMS2. RESULTS: Solutions stressed for durations of 24, 72, 168 (1 week), 336 (2 weeks), and 672 (4 weeks) hours were evaluated at an actual temperature of 23°C and humidity of 90.6%. Those stressed for durations of 8, 32, 80, 172, 344, and 680 hours were evaluated at a temperature of 45°C and humidity of 31.0%. For GMS1, glucose median paired differences (stressed - control) decreased for QC levels 1 and 3 after 8 hours (P < 0.05) and increased for level 1 after 336 (P < 0.01) and 344 hours (P < 0.05). For solutions tested on GMS2, median paired differences in QC reagents were decreased for both levels at each time point tested at 45°C (P < 0.01). CONCLUSIONS: Dynamic stresses affected the performance of QC solutions and, consequently, results given by GMS1 and GMS2. To protect the efficacy and accuracy of POC technologies in emergency and disaster settings, proper monitoring, handling, and storage of QC reagents must be ensured.

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KW - medical errors

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