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在泰国建立即时国际标准化比值的外部质量评估计划。

Establishing an external quality assessment scheme for point-of-care international normalized ratio in Thailand.

作者信息

Tientadakul P, Chuntarut A

机构信息

Department of Clinical Pathology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.

出版信息

Int J Lab Hematol. 2015 Aug;37(4):509-14. doi: 10.1111/ijlh.12321. Epub 2014 Dec 20.

DOI:10.1111/ijlh.12321
PMID:25529559
Abstract

INTRODUCTION

Effective warfarin therapy management has gained national interest, resulting in the increased use of point-of-care testing (POCT) for international normalized ratio (INR). External quality assessment (EQA) is recommended to ensure quality of the testing. CoaguChek XS and CoaguChek XS Plus are the only commonly available POCT INR monitors in Thailand. Therefore, Thailand NEQAS for Blood Coagulation initiated the scheme for POCT INR in 2013, including only hospitals using these devices.

METHODS

Questionnaires were sent to the hospitals, enquiring about their interest in EQA participation. Two surveys were distributed; each included five certified European Concerted Action on Anticoagulation (ECAA) INR plasma sets. Unsatisfactory performance was indicated by a 15% deviation from the certified mean INR value.

RESULTS

There were 156 hospitals using the devices. Thirty-five hospitals responded to the questionnaires. Medical personnel undertaking POCT INR were limited to laboratory staff in 29 (83%) of these centers, and 31 hospitals actually participated. The medians of results from participants were the same or nearly the same as the certified mean INRs.

CONCLUSION

External quality assessment for POCT INR in Thailand is feasible using the ECAA plasmas as control materials. The results therefore appear encouraging to other developing countries to establish their own EQA schemes.

摘要

引言

有效的华法林治疗管理已引起全国关注,导致即时检验(POCT)在国际标准化比值(INR)检测中的使用增加。建议进行外部质量评估(EQA)以确保检测质量。CoaguChek XS和CoaguChek XS Plus是泰国仅有的常用POCT INR监测仪。因此,泰国血液凝固国家外部质量评估计划于2013年启动了POCT INR计划,仅包括使用这些设备的医院。

方法

向医院发送问卷,询问其参与EQA的意愿。共发放了两份调查问卷;每份问卷包含五套经认证的欧洲抗凝协作行动(ECAA)INR血浆样本。若与认证的INR均值偏差达到15%,则表明检测结果不理想。

结果

有156家医院使用这些设备。35家医院回复了问卷。在这些中心中,有29家(83%)进行POCT INR检测的医务人员仅限于实验室工作人员,31家医院实际参与了调查。参与者的检测结果中位数与认证的INR均值相同或几乎相同。

结论

使用ECAA血浆作为对照材料对泰国POCT INR进行外部质量评估是可行的。因此,该结果对于其他发展中国家建立自己的EQA计划似乎具有鼓舞作用。

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