New York-Presbyterian Hospital, Core Laboratory, 622 W 168th St, PH3-363, New York, NY 10032; e-mail:
Am J Clin Pathol. 2013 Nov;140(5):715-20. doi: 10.1309/AJCP7QB3QQIBZPEK.
To describe validation and performance of epoc, a blood gas analysis point-of-care system, in a live clinical setting.
Data were collected for 156 epoc systems over 12 months. Preimplementation precision and correlation studies and postimplementation quality assurance data were collected, including test card, reader, and personal data assistant (PDA) failure rates.
The coefficient of variation was clinically acceptable for all analytes. Correlation studies yielded an R(2) from 0.901 (for sodium) to 0.994 (for potassium) with the Nova analyzer and from 0.961 (sodium) to 0.991 (glucose) with the i-STAT. Average test card failure rate was 13%. Of the PDA/reader units, 55% needed repair within 1 year.
The analytical performance showed high precision and good correlation with the Nova and i-STAT platforms. Test card and instrument failure rates were higher than that of the i-STAT system.
描述 epoc 血气分析即时检测系统在实际临床环境中的验证和性能。
在 12 个月内收集了 156 个 epoc 系统的数据。收集了预实施精度和相关性研究以及实施后的质量保证数据,包括测试卡、读取器和个人数据助理 (PDA) 的故障率。
所有分析物的变异系数均具有临床可接受性。相关性研究产生了从 Nova 分析仪的 0.901(钠)到 0.994(钾)和 i-STAT 的 0.961(钠)到 0.991(葡萄糖)的 R²。平均测试卡故障率为 13%。在 PDA/读取器单元中,55%的单元在 1 年内需要维修。
分析性能显示出高精度和与 Nova 和 i-STAT 平台的良好相关性。测试卡和仪器的故障率高于 i-STAT 系统。