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Evaluation of Imprecision Bias and Total Error of Clinical Chemistry Analysers

机译:临床化学分析仪的不精确度偏差和总误差的评估

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摘要

Context Two Biosystems analysers are used in our laboratory, a fully automated A25 and a semi-automated BTS-350. Internal quality control is done for both but external quality control only for A25. As BTS-350 is used for backup, it is important that the results of both analysers are not just comparable but also within predefined limits of systematic, random and total error (TE). Aim To evaluate the imprecision, bias and TE of the two Biosystem analysers. Materials and Methods Biosystems level-1 quality control sera lot number 70A was run in duplicate for 32 days on both the analysers. Between day imprecision (measured by the coefficient of variation), bias and TE were calculated for ten analytes and were checked to see whether they are within the acceptable minimum limits, desirable limits and optimum limits of allowable error based on specifications on Westgard’s website updated in 2014. Results On both the analysers, all the analytes except alkaline phosphatase were within the acceptable minimum limits of TE and most analytes were within the desirable limits of TE. Only TG on A25 was within the optimum limit of TE. Conclusion The two Biosystem analysers performed comparably with errors within acceptable limits for most analytes. BTS-350 was found to be a suitable and ready backup analyser for A25.
机译:背景我们实验室使用了两台Biosystems分析仪,即全自动A25和半自动化BTS-350。两者均进行内部质量控制,但仅对A25进行外部质量控制。由于BTS-350用于备份,因此两个分析仪的结果不仅要具有可比性,而且还要在系统,随机和总误差(TE)的预定范围内,这一点很重要。目的评估两个生物系统分析仪的不精确度,偏倚和TE。材料和方法Biosystems一级质量控制血清批次70A在两个分析仪上一式两份运行了32天。在一天的不精确度之间(通过变化系数测量),针对十种分析物计算了偏差和TE,并根据Westgard网站上更新的规范(根据更新),检查它们是否在可接受的最小限度,理想限度和允许误差的最佳限度内。 2014.结果在两种分析仪上,除碱性磷酸酶外,所有分析物均在TE的可接受最低限度内,而大多数分析物均在TE的理想限度内。仅A25上的TG在TE的最佳范围内。结论两种生物系统分析仪的性能在大多数分析物可接受的范围内具有可比性。发现BTS-350是适合A25的现成备用分析仪。

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