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健康受试者红细胞和网织红细胞参数的短期和中期生物学变异估计。

Short- and medium-term biological variation estimates of red blood cell and reticulocyte parameters in healthy subjects.

机构信息

Clinical Chemistry Laboratory, Papa Giovanni XXIII Hospital, Piazza OMS, 1 - 24127 Bergamo, Italy, Phone: (+039) 0352674550, Fax: (+039) 0352674939.

Medical Laboratory Service, San Raffaele Hospital, Milan, Italy.

出版信息

Clin Chem Lab Med. 2018 May 24;56(6):954-963. doi: 10.1515/cclm-2017-0902.

Abstract

BACKGROUND

The integrated evaluation of traditional and innovative red blood cell (RBC) and reticulocyte parameters is a rapid, inexpensive and non-invasive diagnostic tools for differential diagnosis and follow-up of anemia and other pathological conditions needing bone marrow erythropoiesis assessment. Therefore, estimating the biological variation (BV) of these parameters is essential for evaluating the analytical performance of hematological analyzers, and for enabling accurate data interpretation and appropriate clinical management. This study aims to define short- and medium-term BV estimates and reference change value (RCV) of RBC and reticulocyte parameters.

METHODS

Twenty-one healthy volunteers participated in the assessment of medium-term BV (blood sampling once/week, five consecutive weeks) and 22 volunteers in the assessment of short-term BV (blood sampling once/day, five consecutive days) using Sysmex XN. Outlier analysis was performed before CV-ANOVA, to determine BV estimates with confidence intervals (CI).

RESULTS

Medium- and short-term within-subject BV were between 0.3% and 16.4% and 0.2%-10.4% (MCH and IRF), respectively, whereas medium and short-term between-subjects BV ranged between 0.9% and 66.6% (MCHC and Micro-R) and 1.4%-43.6% (MCHC and IRF), respectively. The RCVs were similar for all parameters in both arms of the study, except for hemoglobin, RDW-CV and MCV.

CONCLUSIONS

This study allowed for estimating the BV of many RBC and reticulocyte parameters, some of which have not been currently explored. For RBC, hemoglobin, RDW-CV and MCV it seems advisable to use RCV calculated according to monitoring time and/or differentiated by sex. As regards analytical goals, we suggest using the most stringent targets found in the short-term arm of this study.

摘要

背景

传统和创新的红细胞(RBC)和网织红细胞参数的综合评估是一种快速、廉价且非侵入性的诊断工具,可用于鉴别诊断和监测贫血及其他需要骨髓红细胞生成评估的病理状况。因此,评估这些参数的生物学变异(BV)对于评估血液分析仪的分析性能以及实现准确的数据解释和适当的临床管理至关重要。本研究旨在确定 RBC 和网织红细胞参数的短期和中期 BV 估计值和参考变化值(RCV)。

方法

21 名健康志愿者参与了中期 BV(每周采血一次,连续 5 周)的评估,22 名志愿者参与了短期 BV(每天采血一次,连续 5 天)的评估,使用 Sysmex XN 进行。在 CV-ANOVA 之前进行离群值分析,以确定具有置信区间(CI)的 BV 估计值。

结果

个体内的中期和短期 BV 分别为 0.3%至 16.4%和 0.2%至 10.4%(MCH 和 IRF),而个体间的中期和短期 BV 分别为 0.9%至 66.6%(MCHC 和 Micro-R)和 1.4%至 43.6%(MCHC 和 IRF)。除血红蛋白、RDW-CV 和 MCV 外,研究的两个手臂中所有参数的 RCV 均相似。

结论

本研究允许评估许多 RBC 和网织红细胞参数的 BV,其中一些参数尚未得到当前的探索。对于 RBC,血红蛋白、RDW-CV 和 MCV,根据监测时间和/或性别进行区分,使用计算出的 RCV 似乎是明智的。就分析目标而言,我们建议使用本研究短期臂中发现的最严格的目标。

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