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全血细胞计数能力验证测试计划的制定与评估

Formation and Evaluation of Complete Blood Count Proficiency Testing Program.

作者信息

Vu Huy Quang, Le Oanh Hoang, Truong Duan Cong, Nguyen Dung Ngoc, Van Triet Hy, Le Van Thi Kieu, Vang Linh Thi Truc

机构信息

Faculty of Nursing and Medical Technology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City 748010, Vietnam.

Quality Control Center for Medical Laboratory, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City 748010, Vietnam.

出版信息

Hematol Rep. 2022 Mar 25;14(2):73-84. doi: 10.3390/hematolrep14020012.

Abstract

: The haematology external quality assessment (EQA) scheme is the most commonly used service of quality assurance. The provision of complete blood count (CBC) materials must meet the quality requirements at a reasonable cost. These requirements are the most significant challenges for EQA organisers in Vietnam. This study's objective was to evaluate the homogeneity, long-term stability, and peer-group performance of 10-parameter stabilised CBC EQA samples. : The CBC EQA material was prepared using the following steps, including (1) adjusting levels of stabilised erythrocyte, leukocyte, and platelet samples, (2) mixing those cells into batches at three levels, and (3) dispensing and storing them at 2-6 °C. A set of 10 and 30 specimens were randomly chosen from each batch to study the homogeneity and long-term stability following ISO 13528:2015. In total, 166 samples at two levels were randomly distributed to 40 participants, which reported 83 automatic cell counters among six automated analyser models in the CBC EQA program. : The 10-parameter stabilised CBC EQA materials at three levels became homogeneous and stable in 12 weeks when preserved at 2-6 °C. Meanwhile, for five parameters (RBC, Hb, MCH, MCV, and MPV), this process was prolonged for up to 16 weeks in stock condition. In terms of peer-group performance, the CV (%) values increased at the low concentration for almost all parameters, especially in platelet counts. : The stabilised CBC EQA samples prepared using the partial fixation method with aldehyde and gutaraldehyde in this study meet the ISO 13528:2015 requirements of homogeneity and long-term stability for the CBC EQA scheme. Analytical performance evaluation should categorise participant methods into peer groups.

摘要

血液学外部质量评估(EQA)计划是最常用的质量保证服务。提供全血细胞计数(CBC)材料必须以合理成本满足质量要求。这些要求是越南EQA组织者面临的最重大挑战。本研究的目的是评估10参数稳定化CBC EQA样本的均匀性、长期稳定性和同组性能。:CBC EQA材料通过以下步骤制备,包括(1)调整稳定化红细胞、白细胞和血小板样本的水平,(2)将这些细胞按三个水平混合成批次,(3)在2-6°C下分装和储存。从每个批次中随机选取一组10个和30个标本,按照ISO 13528:2015研究均匀性和长期稳定性。总共将两个水平的166个样本随机分发给40名参与者,这些参与者在CBC EQA计划中报告了六种自动分析仪型号中的83台自动血细胞计数器。:三个水平的10参数稳定化CBC EQA材料在2-6°C保存时,12周内变得均匀且稳定。同时,对于五个参数(红细胞、血红蛋白、平均红细胞血红蛋白含量、平均红细胞体积和平均血小板体积),在库存条件下这个过程延长至16周。在同组性能方面,几乎所有参数在低浓度时变异系数(CV)值增加,尤其是血小板计数。:本研究中使用醛和戊二醛的部分固定方法制备的稳定化CBC EQA样本符合CBC EQA计划的ISO 13528:2015均匀性和长期稳定性要求。分析性能评估应将参与者的方法分类为同组。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ad04/9036311/1548627d9154/hematolrep-14-00012-g001.jpg

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