Busadee Pratumvinit1, Nattakom Charoenkoop2, Soamsiri Niwattisaiwong2, Gerald J Kost3, Panutsaya Tientadakul2. 1. Department of Clinical Pathology, Faculty of Medicine Siriraj hospital, Mahidol University, Bangkok, Thailand busadee.pra@mahidol.ac.th. 2. Department of Clinical Pathology, Faculty of Medicine Siriraj hospital, Mahidol University, Bangkok, Thailand. 3. Point-of-Care Testing Center for Teaching and Research, School of Medicine, University of California and Knowledge Optimization®, Davis, CA, USA.
Abstract
BACKGROUND: Hospitals in tropical countries experience conditions that exceed manufacturer temperature and humidity limits for point-of-care (POC) glucose reagents. Our goal was to assess the effects of out-of-limits storage temperature, operating temperature, and operating humidity on POC glucose measurement reliability. METHODS: Quality control measurements were performed monthly using glucose test strips stored under controlled conditions and in inpatient wards under ambient conditions. Glucose test strips were evaluated in groups organized by operating temperatures of 24-25 (group 1), 28-29 (group 2), and 33-34°C (group 3), and relative humidity (RH) of ≤70 (group A), ~80 (group B), and ~90% (group C). RESULTS: Glucose results for different storage conditions were inconsistent. Measurements at higher operating temperatures had lower values with mean differences of -2.4 (P < .001) and -36.5 (P < .001) mg/dL (28-29 vs 24-25°C), and -3.6 (P < .001) and -37.4 (P < .001) mg/dL (33-34 vs 24-25°C) for low and high control levels, respectively. Measurements at higher RH had lower values with mean differences of -4.0 (P < .001) and -13.2 (P < .001) mg/dL (~80 vs ≤70% RH), and -5.8 (P < .001) and -16.6 (P < .001) mg/dL (~90 vs ≤70% RH) for low and high levels, respectively. CONCLUSIONS: High temperature and high RH decreased glucose concentrations for the POC oxidase-based system we evaluated. We recommend that individual hospitals perform stress testing, then determine if maximum absolute differences, which represent highest risk for patients, are clinically significant for decision making by using error grid analysis.
BACKGROUND: Hospitals in tropical countries experience conditions that exceed manufacturer temperature and humidity limits for point-of-care (POC) glucose reagents. Our goal was to assess the effects of out-of-limits storage temperature, operating temperature, and operating humidity on POC glucose measurement reliability. METHODS: Quality control measurements were performed monthly using glucose test strips stored under controlled conditions and in inpatient wards under ambient conditions. Glucose test strips were evaluated in groups organized by operating temperatures of 24-25 (group 1), 28-29 (group 2), and 33-34°C (group 3), and relative humidity (RH) of ≤70 (group A), ~80 (group B), and ~90% (group C). RESULTS:Glucose results for different storage conditions were inconsistent. Measurements at higher operating temperatures had lower values with mean differences of -2.4 (P < .001) and -36.5 (P < .001) mg/dL (28-29 vs 24-25°C), and -3.6 (P < .001) and -37.4 (P < .001) mg/dL (33-34 vs 24-25°C) for low and high control levels, respectively. Measurements at higher RH had lower values with mean differences of -4.0 (P < .001) and -13.2 (P < .001) mg/dL (~80 vs ≤70% RH), and -5.8 (P < .001) and -16.6 (P < .001) mg/dL (~90 vs ≤70% RH) for low and high levels, respectively. CONCLUSIONS: High temperature and high RH decreased glucose concentrations for the POC oxidase-based system we evaluated. We recommend that individual hospitals perform stress testing, then determine if maximum absolute differences, which represent highest risk for patients, are clinically significant for decision making by using error grid analysis.
Authors: Boris P Kovatchev; Christian A Wakeman; Marc D Breton; Gerald J Kost; Richard F Louie; Nam K Tran; David C Klonoff Journal: J Diabetes Sci Technol Date: 2014-06-13
Authors: David C Klonoff; Courtney Lias; Robert Vigersky; William Clarke; Joan Lee Parkes; David B Sacks; M Sue Kirkman; Boris Kovatchev Journal: J Diabetes Sci Technol Date: 2014-06-13
Authors: Dawn E Corl; Tom S Yin; Andrew N Hoofnagle; Joanne D Whitney; Irl B Hirsch; Brent E Wisse Journal: J Healthc Qual Date: 2012 Jul-Aug Impact factor: 1.095
Authors: Anh-Thu Truong; Richard F Louie; John H Vy; Corbin M Curtis; William J Ferguson; Mandy Lam; Stephanie Sumner; Gerald J Kost Journal: Disaster Med Public Health Prep Date: 2014-03-04 Impact factor: 1.385
Authors: Richard F Louie; Stephanie L Sumner; Shaunyé Belcher; Ron Mathew; Nam K Tran; Gerald J Kost Journal: Disaster Med Public Health Prep Date: 2009-03 Impact factor: 1.385
Authors: Mandy Lam; Richard F Louie; Corbin M Curtis; William J Ferguson; John H Vy; Anh-Thu Truong; Stephanie L Sumner; Gerald J Kost Journal: J Diabetes Sci Technol Date: 2014-01-01
Authors: Shijia Li; Liliana Ramona Demenescu; Catherine M Sweeney-Reed; Anna Linda Krause; Coraline D Metzger; Martin Walter Journal: Hum Brain Mapp Date: 2017-05-17 Impact factor: 5.038
Authors: Antonio Bernabé-Ortiz; Jessica H Zafra-Tanaka; Miguel Moscoso-Porras; Rangarajan Sampath; Beatrice Vetter; J Jaime Miranda; David Beran Journal: Global Health Date: 2021-03-09 Impact factor: 4.185