中文摘要：

目的 了解国内实验室凝血因子Ⅷ、Ⅸ检测现状及存在的问题,为实施凝血因子Ⅷ、Ⅸ检测规范化及质量改进提供依据.方法 调查性研究.对76家实验室进行问卷调查研究,对54家实验室进行质控物活性检测调查研究.对调查问卷的回报信息进行统计分析,将质控物的检测结果按照检测试剂分为3组后进行分级评价.结果 72％（52/72）的实验室检测标本量少于30份/月.各实验室的定标频率不同,33％（24/72）的实验室未在每批样本检测前进行定标.39％（28/72）的实验室未开展室内质控,21％ （15/72）的实验室仅检测正常浓度水平质控物,个别实验室室内质控累积变异系数（CV）较大,超过30％.正常浓度水平质控物FⅧ、FⅨ检测结果的CV范围分别为11.3％ ～18.2％及11.3％ ～ 17.9％;异常浓度水平质控物FⅧ、FⅨ检测结果的CV范围分别为15.3％ ～20.3％及19.5％ ～21％.按照检测试剂分为3组,3组FⅧ检测结果不及格的实验室分别占18％、24％及22％;FⅨ检测结果不及格的实验室分别占20％、24％及28％.结论 国内凝血因子检测质量控制关键环节的要求有待明确和实施,部分实验室检测结果的重复性和可比性较差.拟通过制订凝血因子Ⅷ、Ⅸ检测规范化的技术要求,组织相关培训,建立全国室间质量评价计划等方式实施质量改进.

英文摘要：

Objective To investigate current status and problems of coagulation factor Ⅷ and Ⅸ assay in domestic laboratories so as to provide the reference for implementing the standardization and quality improvement.Methods A questionnaire survey was carried out in 76 laboratories,and quality control materials were distributed to 54 laboratories for activity assay.The questionnaire information was analyzed statistically.Test results of quality control materials were classified into three groups according to the reagents and the ranked grading analysis were used to evaluate the performance.Results This research was investigative study.The amount of sample was less than 30 per month in 72% （52/72）of laboratories.The frequencies of calibration were different,and 33% （24/72） of laboratories did not perform calibration in a different assay batch.39% （28/72）of laboratories did not run internal quality control,and about 21% （15/ 72） of laboratories just performed the normal level quality control.Individual laboratories showed a high cumulative CV （〉 30%） of intemal quality control.For normal FⅧ and FⅨ control materials,the CV of results were 11.3%-18.2% and 11.3%-17.9% respectively as well as 15.3%-20.3% and 19.5%-21% for abnormal.Of the three groups,the proportions of laboratories which the FⅧ test results out with consensus were18%,24% and 22% as well as 20%,24% and 28% for FⅨ.Conclusions The key requirements for quality control of coagulation factors active assay remain to be addressed and implemented.The repeatability and comparability in some laboratories are not satisfactory to meet the clinical needs.With the purpose of promoting quality improvement,we need to develop guidelines,organize related training and establish a national external quality assessment scheme.