Long-term biological variation estimates of 13 hematological parameters in healthy Chinese subjects
Long-term biological variation estimates of 13 hematological parameters in healthy Chinese subjects
复制标题
中国健康受试者13个血液学参数的长期生物学变异估计
DOI：
10.1515/cclm-2019-1141
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发表时间：
2020-02
影响因子：
6.8
通讯作者：
Zhou Wenbin
中科院分区：
文献类型：
--
作者：
Li Chenbin;Peng Mingting;Wu Ji;Du Zhongli;Lu Hong;Zhou Wenbin
摘要背景全血细胞计数（CBC）是一项基本的检查，作为医生对患者进行初步诊断的一部分。为了确保CBC的安全临床应用，需要可靠的生物变异（BV）数据来建立分析性能质量标准。我们的目的是使用严格的方案来定义CBC参数的BV，该方案符合欧洲临床化学和实验室医学联合会提供的生物变异数据关键评估清单（BIVAC）。方法采用ABX Pentra 80全自动生化分析仪对41例健康体检者（男22例，女19例;年龄23-59岁）连续6个月每月1次的外周血进行分析。仪器经过精确校准。对所有样本的13个CBC参数进行一式两份分析。在嵌套ANOVA之前，评估数据的离群值、正态性和方差齐性。计算性别分层的受试者内（CVI）和受试者间（CVG）BV估计值。结果剔除离群值后，每例受试者的剩余数据数为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个参数的平均值在性别之间存在显著差异，从而导致CVG数据在性别之间的划分。大多数BV估计值和最近发表的代表Europid人群的估计值之间没有显着差异。结论：BIVAC依从性研究中的大多数BV估计值相似。在CBC BV研究中应考虑血细胞的周转时间和受试者的年龄分布。我们的研究将有助于全球BV估计和未来的研究。
Abstract 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.
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作者：
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通讯作者：
D. Lacher;J. Barletta;Jeffery P. Hughes
影响因子：
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