UC Davis-LLNL POC Technologies Center, Point-of-Care Testing Center for Teaching and Research (POCT-CTR), Pathology and Laboratory Medicine, School of Medicine, University of California-Davis, CA 95616, USA.
Disaster Med Public Health Prep. 2012 Oct;6(3):232-40. doi: 10.1001/dmp.2012.42.
To characterize the performance of glucose meter test strips using simulated dynamic temperature and humidity disaster conditions.
Glucose oxidase- and glucose dehydrogenase-based test strips were dynamically stressed for up to 680 hours using an environmental chamber to simulate conditions during Hurricane Katrina. Paired measurements vs control were obtained using 3 aqueous reagent levels for GMS1 and 2 for GMS2.
Stress affected the performance of GMS1 at level 1 (P < .01); and GMS2 at both levels (P < .001), lowering GMS1 results but elevating GMS2 results. Glucose median-paired differences were elevated at both levels on GMS2 after 72 hours. Median-paired differences (stress minus control) were as much as -10 mg/dL (range, -65 to 33) at level 3 with GMS1, with errors as large as 21.9%. Glucose median-paired differences were as high as 5 mg/dL (range, -1 to 10) for level 1 on GMS2, with absolute errors up to 24.4%.
The duration of dynamic stress affected the performance of both GMS1 and GMS2 glucose test strips. Therefore, proper monitoring, handling, and storage of point-of-care (POC) reagents are needed to ensure their integrity and quality of actionable results, thereby minimizing treatment errors in emergency and disaster settings.
描述使用模拟动态温度和湿度灾害条件的血糖仪测试条的性能。
使用环境室对基于葡萄糖氧化酶和葡萄糖脱氢酶的测试条进行长达 680 小时的动态压力测试,以模拟卡特里娜飓风期间的条件。使用 3 种水试剂水平对 GMS1 和 2 种水试剂水平对 GMS2 进行配对测量与对照。
压力对 GMS1 水平 1(P<.01)和 GMS2 两个水平(P<.001)的性能产生影响,降低了 GMS1 的结果,但提高了 GMS2 的结果。在 GMS2 上,72 小时后,两个水平的葡萄糖中位数配对差异均升高。GMS1 水平 3 的中位数配对差异(压力减去对照)高达-10 毫克/分升(范围,-65 至 33),误差高达 21.9%。GMS2 水平 1 的葡萄糖中位数配对差异高达 5 毫克/分升(范围,-1 至 10),绝对误差高达 24.4%。
动态压力的持续时间影响了 GMS1 和 GMS2 葡萄糖测试条的性能。因此,需要对即时护理(POC)试剂进行适当的监测、处理和储存,以确保其完整性和可操作结果的质量,从而最大限度地减少紧急和灾害环境中的治疗错误。