De Keijzer M H, Perkins S, Motta V, Morelli D, Cristol J P, Dupuy A M, Hong Y, Watanabe S, Waerdt C, Grunewald R W
Laboratorium en Trombosedienst, Ziekenhuis Rivierenland, Tiel, Netherlands.
Clin Lab. 2009;55(9-10):363-70.
A new automated immunoassay low-mid volume (< or = 250 immunoassays/day) chemiluminescent analyzer, Abbott Architect i1000sR, was evaluated by seven laboratories around the world (4 in Europe, one each in Canada, Japan, and the U.S.A.) to demonstrate equivalent performance for key operating characteristics (e.g., precision, turn around time, limit of detection, functional sensitivity, and linearity).
The laboratories followed standard protocols to assess precision, limit of detection (LoD), functional sensitivity, assay linearity, method comparison, and sample carryover. Turn around time for three stat assays (beta-hCG, BNP, and CK-MB) and the time required to complete workloads of 50 and 100 tests with a mixture of 75% routine tests and 25% stat tests was also evaluated.
Total precision was typically < 5% CV for nine immunoassays. Analytical performance met design goals and demonstrated equivalency to package insert data for assays on market and in use for an existing high volume immunoassay system. Stat turn around times were consistent with the fixed analytical time of 15.6 minutes and met the expectations of the laboratories. Measured test throughput ranged from 47 - 54 tests per hour and demonstrated that the analyzer was fit for the intended purpose of supporting a laboratory that performs < or = 250 immunoassays per day.
A multisite, international analyzer familiarization study is a practical means of confirming that a new instrument meets both a manufacturer's design specifications and users' real world expectations and provides a pragmatic test for the system. The experience of investigators at seven sites around the world indicates that a new fully automated chemiluminescent system is suitable for use.
一种新型自动化免疫分析低中通量（≤250次免疫分析/天）化学发光分析仪，即雅培Architect i1000sR，由全球七个实验室（欧洲4个，加拿大、日本和美国各1个）进行评估，以证明其在关键操作特性（如精密度、周转时间、检测限、功能灵敏度和线性）方面具有等效性能。
各实验室遵循标准方案评估精密度、检测限（LoD）、功能灵敏度、分析线性、方法比较和样品携带污染。还评估了三项急诊检测项目（β-人绒毛膜促性腺激素、脑钠肽和肌酸激酶同工酶）的周转时间，以及完成由75%常规检测和25%急诊检测组成的50次和100次检测工作量所需的时间。
九种免疫分析的总精密度通常CV<5%。分析性能达到设计目标，并证明与市场上现有高通量免疫分析系统正在使用的包装说明书数据等效。急诊周转时间与固定分析时间15.6分钟一致，符合实验室预期。实测检测通量为每小时47 - 54次检测，表明该分析仪适合支持每天进行≤250次免疫分析的实验室的预期用途。
多中心国际分析仪熟悉度研究是确认新仪器符合制造商设计规格和用户实际期望的实用方法，也是对系统的务实测试。全球七个地点的研究人员的经验表明，一种新型全自动化学发光系统适合使用。
