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针对 architect i1000SR 免疫分析系统的适用性评估。

Fit-for-purpose evaluation of architect i1000SR immunoassay analyzer.

机构信息

Ped-pulmonary Basic Research, Indiana University, 420 University Blvd. Indianapolis, IN 46202, USA.

出版信息

Clin Chim Acta. 2010 Jun 3;411(11-12):798-801. doi: 10.1016/j.cca.2010.02.061. Epub 2010 Feb 24.

DOI:10.1016/j.cca.2010.02.061
PMID:20188084
Abstract

BACKGROUND

Last year Abbott Laboratories introduced the Architect i1000SR modular chemiluminescent immunoassay analyzer for laboratories performing <200 test/day. The analyzer has a diverse menu of most routinely tested assays for the low to mid volume hospital laboratory. We evaluated the analytical performance, productivity and efficiency of this system for a 1-y period.

METHOD

The analytical performance was ascertained by i) determining functional sensitivity in serum matrix for cTnI and measuring precision for other assays. ii) Accuracy was determined by performing patient correlations for TSH, cTnI and FT4 assays. iii) Analyzer productivity and efficiency were evaluated by determining the expected annual throughput and impact of routine workload on STAT TATs, respectively.

RESULTS

Coefficient of variation ranging from 3.6 to 8.2% was achieved for all assays evaluated. Functional sensitivity for cTnI was found to be 0.05 ng/ml. Patient correlation gave regression coefficients ranging from 0.875-0.998. An average hourly throughput ranged from 41-48 tests per hour (tph).

CONCLUSIONS

We find the Architect i1000SR random access immunoassay analyzer met all of the requirements desired in a low to mid volume instrument. Stat turn around times (TAT) are maintained to <20 min.

摘要

背景

去年,雅培实验室推出了 Architect i1000SR 模块化化学发光免疫分析仪,适用于每天检测量<200 次的实验室。该分析仪提供了大多数低到中量医院实验室常规检测项目的多样化检测菜单。我们评估了该系统在过去一年的分析性能、生产效率和效率。

方法

通过以下方式确定分析性能:i)确定血清基质中 cTnI 的功能灵敏度,并测量其他检测的精密度。ii)通过对 TSH、cTnI 和 FT4 检测进行患者相关性分析来确定准确性。iii)通过确定预期的年吞吐量和常规工作量对 STAT TAT 的影响,分别评估分析仪的生产效率和效率。

结果

所有评估的检测项目的变异系数均在 3.6%至 8.2%之间。cTnI 的功能灵敏度为 0.05ng/ml。患者相关性分析得出的回归系数范围为 0.875-0.998。平均每小时吞吐量范围为每小时 41-48 次检测(tph)。

结论

我们发现 Architect i1000SR 随机访问免疫分析仪满足了低到中量仪器的所有要求。STAT 周转时间(TAT)保持在<20 分钟内。

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