Abstract

Purpose: To evaluate stability of CBC parameters in samples containing K₃-EDTA in Hema&Tube brand evacuated tubes stored at 4 °C and room temperature in upright, horizontal and upside-down transport positions for up to 240 min by comparing with different stability criteria. Methods: A total of 450 outpatient samples, 75 for each condition, were stored for 240 min. Blood samples were analyzed at baseline, 60th, 120th and 240th min of storage time using Sysmex® XT-4000i hematology analyzer. CBC results were compared according to the paired samples t-test, one CV% change, CVI, BV DES 2014, RCPA, IQMH, EFLM Biological Variation 2019, ESfEQAand CLIA stability criteria. Results: In all transport conditions, almost all CBC parameters were unstable according to the paired samples t-test. Based on one CV % change RBC, hemoglobin, hematocrit, RDW-CV, neutrophils, platelets, MPV, PDW and plateletcrit were unstable in some transport conditions. However, most parameters were stable at all conditions, except especially for MCH, MPV, PDW and plateletcrit, while just MPV and PDW were unstable at RT in all transport conditions according to the lower and higher CVI, respectively. Conclusions: Paired samples t-test and one CV% change stability criteria are not suitable for decision. Clinical laboratories should establish the impact of storage time, storage temperature and transport positions for each CBC parameter while paying attention to the brand of evacuated tube according to the lower CVI of biological variation data stability criteria since it is more related to the impact of analysis deviation on clinical decisions to prevent misdiagnosis.

摘要

目的：通过与不同的稳定性标准进行比较，评估含有 K ₃ -EDTA 的样品在 Hema&Tube 品牌真空管中的 CBC 参数稳定性，该真空管在 4 °C 和室温下以直立、水平和倒置运输位置储存长达 240 分钟。方法：总共 450 个门诊样本，每种条件 75 个，储存 240 分钟。使用 Sysmex® XT-4000i 血液分析仪在基线、第 60 分钟、第 120 分钟和第 240 分钟的存储时间对血液样本进行分析。CBC 结果根据配对样本t检验、一个 CV% 变化、CVI、BV DES 2014、RCPA、IQMH、EFLM Biological Variation 2019、ESfEQA 和 CLIA 稳定性标准进行比较。结果：在所有运输条件下，根据配对样本t检验，几乎所有 CBC 参数都不稳定。基于一个 CV % 变化，RBC、血红蛋白、血细胞比容、RDW-CV、中性粒细胞、血小板、MPV、PDW 和血小板比容在某些运输条件下不稳定。然而，大多数参数在所有条件下都是稳定的，尤其是 MCH、MPV、PDW 和血小板比容，而根据较低和较高的 CVI，只有 MPV 和 PDW 在所有运输条件下在 RT 下都不稳定。结论：配对样本t-test 和一个 CV% 变化稳定性标准不适合决策。临床实验室应根据生物变异数据稳定性标准较低的CVI，建立每个CBC参数的储存时间、储存温度和运输位置的影响，同时注意真空管的品牌，因为它与分析偏差的影响更相关防止误诊的临床决策。