Li Chenbin, Peng Mingting, Wu Ji, Du Zhongli, Lu Hong, Zhou Wenbin
National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing Engineering Research Center of Laboratory Medicine, Beijing, P.R. China.
Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, P.R. China.
Clin Chem Lab Med. 2020 Jul 28;58(8):1282-1290. doi: 10.1515/cclm-2019-1141.
Background The complete blood count (CBC) is a basic test routinely ordered by physicians as a part of initial diagnostic work-up on their patients. To ensure safe clinical application of the CBC, reliable biological variation (BV) data are needed to establish analytical performance specifications. Our aim was to define the BV of CBC parameters using a rigorous protocol that is compliant with the Biological Variation Data Critical Appraisal Checklist (BIVAC) provided by the European Federation of Clinical Chemistry and Laboratory Medicine. Methods Blood samples drawn from 41 healthy Chinese subjects (22 females and 19 males; 23-59 years of age) once monthly for 6 consecutive months were analyzed using an ABX Pentra 80 instrument. The instrument was precisely calibrated. All samples were analyzed in duplicate for 13 CBC parameters. The data were assessed for outliers, normality, and variance homogeneity prior to nested ANOVA. Gender-stratified within-subject (CVI) and between-subject (CVG) BV estimates were calculated. Results The number of remaining data for each subject was 442-484 after removing outliers. No significant differences existed between female/male CVI estimates. Except for leukocytes, neutrophils, and lymphocytes, the mean values of 10 parameters differed significantly between genders, rendering partitioning of CVG data between genders. No significant differences were detected between most BV estimates and recently published estimates representing a Europid population. Conclusions Most BV estimates in BIVAC-compliant studies are similar. The turnover time of blood cells and age distribution of participants should be considered in a CBC BV study. Our study will contribute to global BV estimates and future studies.
背景 全血细胞计数（CBC）是医生常规开具的一项基本检查，作为对患者进行初始诊断检查的一部分。为确保CBC在临床中的安全应用，需要可靠的生物学变异（BV）数据来确定分析性能规范。我们的目的是使用符合欧洲临床化学和检验医学联合会提供的《生物学变异数据关键评估清单》（BIVAC）的严格方案来定义CBC参数的BV。方法 对41名健康中国受试者（22名女性和19名男性；年龄23 - 59岁）连续6个月每月采集一次血样，使用ABX Pentra 80仪器进行分析。仪器经过精确校准。对所有样本的13项CBC参数进行双份检测。在进行嵌套方差分析之前，对数据进行异常值、正态性和方差齐性评估。计算了按性别分层的受试者内（CVI）和受试者间（CVG）BV估计值。结果 去除异常值后，每个受试者剩余的数据量为442 - 484。女性/男性CVI估计值之间无显著差异。除白细胞、中性粒细胞和淋巴细胞外，10项参数的平均值在性别之间存在显著差异，使得CVG数据在性别之间进行划分。大多数BV估计值与最近发表的代表欧洲人群的估计值之间未检测到显著差异。结论 在符合BIVAC的研究中，大多数BV估计值相似。在CBC BV研究中应考虑血细胞的周转时间和参与者的年龄分布。我们的研究将有助于全球BV估计和未来的研究。
