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泰国使用冻干血红蛋白质控物进行血红蛋白 E、A2 和 F 分析的能力验证计划。

Proficiency testing program for hemoglobin E, A2 and F analysis in Thailand using lyophilized hemoglobin control materials.

机构信息

Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai 50200, Thailand.

Associated Medical Sciences Clinical Service Center, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.

出版信息

Clin Chem Lab Med. 2018 Mar 28;56(4):602-608. doi: 10.1515/cclm-2017-0581.

Abstract

BACKGROUND

There is no external quality assessment (EQA) program for hemoglobin analysis that uses lyophilized hemoglobin control materials with HbA2/E in levels as high as those found in people with the β-thalassemia trait, HbE trait, β-thalassemia/HbE disease or homozygous HbE; these are all found frequently in the southeast Asian population. The aim of this study was to evaluate the efficiency of the control materials used in the established proficiency testing (PT) program at the Associated Medical Sciences-Clinical Service Center (AMC-CSC), Chiang Mai University, Chiang Mai, Thailand.

METHODS

The PT program for Hb analysis and the thalassemia interpretation was established in compliance with ISO/IEC17043:2010. Three cycles per year were performed in 2015 and 2016. In each cycle, three different types of control material were provided to the participants. Each participant analyzed the control materials in the same manner as in their routine practices. Hb analysis results and their thalassemia interpretation codes were entered into the report form and sent back to AMC-CSC.

RESULTS

The number of participants increased from 63 in 2015 to 76 in 2016. In addition, the number of participants who took part in all three cycles increased from 95.2% (60/63) in 2015 to 100% (76/76) in 2016. All participants reported the correct Hb measurement and type; however, misinterpretations in thalassemia diagnosis were noted.

CONCLUSIONS

The lyophilized hemoglobin control materials prepared at AMC-CSC were used successfully in our PT program. However, the study results indicate the need for further improvement in thalassemia interpretation skills for laboratory staff.

摘要

背景

目前尚无针对血红蛋白分析的外部质量评估(EQA)计划,该计划使用的冻干血红蛋白控制材料中 HbA2/E 的水平与β-地中海贫血特征、HbE 特征、β-地中海贫血/HbE 疾病或纯合子 HbE 患者体内的水平一样高;这些在东南亚人群中都很常见。本研究旨在评估泰国清迈大学医学科学附属临床服务中心(AMC-CSC)建立的血红蛋白分析能力验证(PT)计划中使用的控制材料的效率。

方法

Hb 分析和地中海贫血解读的 PT 计划是按照 ISO/IEC17043:2010 建立的。2015 年和 2016 年每年进行三个周期。每个周期向参与者提供三种不同类型的控制材料。每个参与者都以与常规实践相同的方式分析控制材料。Hb 分析结果及其地中海贫血解读代码被输入到报告表中,并发送回 AMC-CSC。

结果

参与者人数从 2015 年的 63 人增加到 2016 年的 76 人。此外,参加所有三个周期的参与者人数从 2015 年的 95.2%(60/63)增加到 2016 年的 100%(76/76)。所有参与者都报告了正确的 Hb 测量值和类型;然而,地中海贫血诊断存在错误解读。

结论

AMC-CSC 制备的冻干血红蛋白控制材料在我们的 PT 计划中成功使用。然而,研究结果表明,实验室工作人员需要进一步提高地中海贫血解读技能。

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