Biological Variations of Hematologic Parameters Determined by UniCel DxH 800 Hematology Analyzer
Biological Variations of Hematologic Parameters Determined by UniCel DxH 800 Hematology Analyzer
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DOI：
10.5858/arpa.2012-0377-oa
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发表时间：
2013-08-01
影响因子：
4.6
通讯作者：
Xu, Dongsheng
中科院分区：
文献类型：
--
作者：
Zhang, Pianhong;Tang, Huqiang;Xu, Dongsheng
背景-库尔特DxH800血细胞分析仪可以确定常规的血液学参数。它还提供了许多新的血液学参数，其中一些具有潜在的临床实用价值。目的：首次研究新血液学参数的生物变异，并使用最新的库尔特血液学分析仪重新研究常规血液学参数的生物变异。设计-纳入40名成年志愿者(21名女性和19名男性)。所有参与者都保持了正常的生活方式。血液样本由一名经验丰富的抽血员抽取一式两份，并在2小时内使用单一分析仪进行分析。在每次批次分析前，使用相同批次的试剂进行仪器质量控制。结果：常规血液学参数的受试者内和受试者之间的生物变异与公布的数据一致。DxH800对这些参数的解析变化似乎较小。所有参数的个体性指数(受试者内部与受试者之间的生物变异比率)都很低。此外，大多数研究参数的日内和日间生物变化在受检人群中相当稳定。结论-这些观察结果具有临床价值。关于受试者内生物变异和分析精密度的数据可用于生成用于质量管理的客观增量校验值。通过比较研究对象内和研究对象之间在新参数上的生物学差异，我们可以决定传统的基于人群的参考范围的效用。此外，记录新参数的生物学变化是未来任何临床应用发展的基本前提。
Context.-The Coulter DxH 800 hematology analyzer can determine conventional hematologic parameters. It also provides many new hematologic parameters, some of which show potential clinical utility.Objective.-To study, for the first time, the biological variations of new hematologic parameters and reinvestigate the biological variations of conventional hematologic parameters using the newest Coulter hematology analyzer.Design.-Forty adult volunteers (21 women and 19 men) were included. All participants maintained their normal lifestyles. Blood samples were drawn in duplicate by a single experienced phlebotomist and analyzed within 2 hours using a single analyzer. Before each batch analysis, the instrument quality controls were performed using the same lots of reagents.Results.-Within-subject and between-subject biological variations for the conventional hematologic parameters were compatible with published data. The analytic variation of the DxH 800 for these parameters appeared smaller. Index of individuality (ratio of within-subject to between-subject biological variation) for all parameters was low. In addition, intraday and interday biological variations of most parameters studied are fairly constant among the population examined.Conclusions.-These observations are clinically valuable. Data on within-subject biological variation and analytic precision may be used to generate objective delta-check values for use in quality management. Comparing within-subject and between-subject biological variation on new parameters may allow us to decide the utility of traditional population-based reference ranges. Furthermore, documentation of biological variations of new parameters is an essential prerequisite in the development of any clinical application in the future.