Objective: To study biological variation (BV) and analytical performance specifications (APS) of 15 erythrocyte and related parameters. Methods: Sixty healthy participants from Beijing Hospital were prospectively recruited for the study, from July to December, 2023, including 30 males [aged (41.3±11.9) years] and 30 females [aged (40.3±12.4) years]. The study was designed based on the Biological Variation Data Critical Appraisal Checklist and the characteristics of erythrocyte detection. Whole blood samples were collected 10 times at 2-week intervals during 20 weeks. All samples were tested in duplicate using Mindray BC-7500 hematology analyzer and its accompanying reagents. Within-subject biological variation (CVI) and between-subject biological variation (CVG) were estimated by the nested ANOVA method. The BV data in this study were compared with the BV data of the European Database of Biological Variation. APS, reference change value (RCV) and index of individuality (II) were calculated. Results: The CVI for 15 parameters ranged from 0.49% to 86.46%, and the CVI data for red cell distribution width (RDW)-CV, RDW-SD, reticulocyte (RET) percentage, RET count, reticulocyte hemoglobin content (RHE), medium fluorescence reticulocyte (MFR) and high fluorescence reticulocyte (HFR) were significantly higher in females than in males (all P<0.05). The CVG ranged from 1.27% to 100.79%, and the CVG data for HFR were significantly different between genders (P<0.05). The CVI data for red blood cell (RBC), hemoglobin (Hb), mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC) and RHE in this study were lower than those recommended by the European database. The derived indicators of most parameters were influenced by gender. The II values for all parameters were<1.4, where the II values of MCHC and HFR were between 0.6 and 1.4; the II values for the remaining 13 parameters were<0.6. Conclusions: A BV study protocol for erythrocyte parameters is designed. When the reference intervals differ between genders, BV data should be calculated separately and the lower BV data are recommended for calculating APS; the RCV should be set separately for each gender.
目的： 研究15项红细胞检测相关参数的生物学变异（BV）及分析性能指标。 方法： 前瞻性纳入2023年7至12月北京医院健康成年志愿者60名，其中男30名，年龄（41.3±11.9）岁；女30名，年龄（40.3±12.4）岁。按照欧洲生物学变异关键评估清单的要求，结合红细胞检测的特点，制定BV研究方案。间隔2周采集1次全血标本，连续采集10次，研究周期为20周；采用Mindray BC-7500血细胞分析仪及配套试剂对标本进行2次重复检测。采用巢式方差分析计算个体内生物学变异（CVI）和个体间生物学变异（CVG），将研究数据与欧洲BV数据库发布数据进行比较；计算检测参数的分析性能指标和个体指数（II）及参考变化值（RCV）。 结果： 15项红细胞检测相关参数的CVI分布范围为0.49%~86.46%，红细胞分布宽度（RDW）的变异系数（RDW-CV）、RDW的标准差（RDW-SD）、网织红细胞（RET）百分比、RET绝对计数、网织红细胞血红蛋白含量（RHE）、中荧光强度网织红细胞百分比（MFR）和高荧光强度网织红细胞百分比（HFR）共7个参数的CVI数据女性高于男性（均P<0.05）；CVG的分布范围为1.27%~100.79%，其中HFR的CVG数据在性别间差异有统计学意义（P<0.05）。红细胞（RBC）、血红蛋白（Hb）、平均红细胞体积（MCV）、平均红细胞血红蛋白浓度（MCHC）和RHE共5个检测参数的CVI低于欧洲数据库发布的数据。多数参数的分析性能指标和RCV受性别因素影响较大。所有参数的II值均<1.4，其中MCHC、HFR的II值在0.6~1.4之间；其余13个参数的II值<0.6。 结论： 本研究制定并实施了红细胞检测相关参数BV研究方案；当检测参数的参考区间存在性别间差异时，宜按性别分别计算BV，选择其中较小的BV数据设定分析性能指标，按性别分别设置RCV。.