Buttarello Mauro
Servizio di Medicina di Laboratorio, Azienda Ospedaliera, via Giustiniani 2, 35128, Padova, Italy.
Clin Chim Acta. 2004 Aug 2;346(1):45-54. doi: 10.1016/j.cccn.2004.02.038.
Quality specifications for automated blood cell counts include topics that go beyond the traditional analytic stage (imprecision, inaccuracy, quality control) and extend to pre- and post-analytic phases.
In this review pre-analytic aspects concerning the choice of anticoagulants, maximum conservation times and differences between storage at room temperature or at 4 degrees C are considered. For the analytic phase, goals for imprecision and bias obtained with various approaches (ratio to biologic variation, state of the art, specific clinical situations) are evaluated. For the post-analytic phase, medical review criteria (algorithm, decision limit and delta check) and the structure of the report (general part and comments), which constitutes the formal act through which a laboratory communicates with clinicians, are considered.
K2EDTA is considered the anticoagulant of choice for automated cell counts. Regarding storage, specimens should be analyzed as soon as possible. Storage at 4 degrees C may stabilize specimens from 24 to 72 h when complete blood count (CBC) and differential leucocyte count (DLC) is performed. For precision, analytical goals based on the state of the art are acceptable while for bias this is satisfactory only for some parameters.
In haematology quality specifications for pre- and analytical phases are important, but the review criteria and the quality of the report play a central role in assuring a definite clinical value.
自动血细胞计数的质量规范所涵盖的主题超出了传统分析阶段（不精密度、不准确、质量控制），并延伸至分析前和分析后阶段。
在本综述中，考虑了分析前阶段有关抗凝剂的选择、最长保存时间以及室温或4℃保存之间差异等方面。对于分析阶段，评估了通过各种方法（与生物学变异的比值、现有技术水平、特定临床情况）获得的不精密度和偏差目标。对于分析后阶段，考虑了医学审核标准（算法、决策限和差值检查）以及报告结构（一般部分和注释），报告结构构成了实验室与临床医生沟通的正式行为。
K2EDTA被认为是自动血细胞计数的首选抗凝剂。关于保存，标本应尽快进行分析。当进行全血细胞计数（CBC）和白细胞分类计数（DLC）时，4℃保存可使标本稳定24至72小时。对于精密度，基于现有技术水平的分析目标是可接受的，而对于偏差，仅对某些参数而言是令人满意的。
在血液学中，分析前和分析阶段的质量规范很重要，但审核标准和报告质量在确保明确的临床价值方面起着核心作用。
