Clinical Chemistry Laboratory, Papa Giovanni XXIII Hospital, Bergamo, Italy.
Medical Laboratory Service, San Raffaele Hospital, Milan, Italy.
Clin Chim Acta. 2017 Oct;473:147-156. doi: 10.1016/j.cca.2017.07.009. Epub 2017 Jul 10.
Recent studies showed that some cell population data (CPD) parameters of neutrophils may be useful for diagnosing myelodysplastic syndromes and sepsis, for the differential diagnosis of acute promyelocytic leukemia, and some CPD parameters of lymphocytes may be a valuable tool for preliminary screening of B cell lymphoproliferative disease. Notwithstanding the knowledge, no information has been made available about their analytical quality specification. This study was aimed to define short- and medium-term biological variation (BV) estimates and reference change value (RCV) of leukocyte count, extended leukocyte differential and CPD.
The study population consisted of 43 healthy volunteers, who participated in the assessment of medium-term (21 volunteers; blood sampling once a week for 5 consecutive weeks) and short-term (22 volunteers; blood sampling once a day for 5 consecutive days) BV, using Sysmex XN. Outlier analysis was carried out before CV-ANOVA, to determine BV estimates and their confidence intervals.
The medium-term and short-term within-subject BV (CV) was comprised between 0.6-19.7% and 0.2-21.9%, whereas the medium-term and short-term between-subjects BV (CV) was comprised between 1.2-61.5% and 1.1-58.5%. The RCVs were found to be similar for all the parameters, in both arms of the study, except for some CPD parameters.
This study allowed accurately estimating the BV of many leukocyte parameters, some of which have not been currently explored. The kinetics of some leukocyte turnover suggests the use of short-term BV data for calculating analytical goals and RCV.
最近的研究表明，中性粒细胞的某些细胞群体数据（CPD）参数可能有助于诊断骨髓增生异常综合征和脓毒症，用于急性早幼粒细胞白血病的鉴别诊断，以及淋巴细胞的某些 CPD 参数可能是 B 细胞淋巴增生性疾病初步筛查的有价值工具。尽管有这些知识，但尚未提供有关其分析质量规范的信息。本研究旨在定义白细胞计数、扩展白细胞分类和 CPD 的短期和中期生物学变异（BV）估计值和参考变化值（RCV）。
研究人群由 43 名健康志愿者组成，他们参与了中期（21 名志愿者；每周采血一次，连续 5 周）和短期（22 名志愿者；每天采血一次，连续 5 天）BV 的评估，使用 Sysmex XN。在 CV-ANOVA 之前进行离群值分析，以确定 BV 估计值及其置信区间。
中期和短期个体内 BV（CV）分别为 0.6-19.7%和 0.2-21.9%，而中期和短期个体间 BV（CV）分别为 1.2-61.5%和 1.1-58.5%。在研究的两个臂中，所有参数的 RCV 均发现相似，除了一些 CPD 参数。
本研究准确估计了许多白细胞参数的 BV，其中一些参数尚未得到当前探索。一些白细胞周转的动力学表明，使用短期 BV 数据来计算分析目标和 RCV。
