Objective To analyze the detection status in primary medical institutions, so to evaluate the quality and development trend of Hepatitis B and related tests, and provide objective basis for improving the detection quality and formulating management plan for primary medical institutions.Methods We randomly selected county-level maternal and child medical institutions with number of 345 ± 107 for 6 consecutive years.HBsAg, HBsAb, HBeAg, HBeAb and HBcAb were detected by blind detection method with five levels per item.The feedback data were collected, classified, sorted, analyzed and summarized.Results The detection methods of HBsAg, HBsAb, HBeAg, HBeAb and HBcAb include: ELISA method, gold standard method, chemiluminescence immunoassay, latex method, time-resolved fluoroimmunoassay, enzymatic method and others.We further analyzed the use status of different methods in 2011-2016.During this period of time,the external quality assessment passing rate of hepatitis B five tests were significantly improved, especially HBcAb.The passing rate from 43% in 2011 was raised to 92% in 2016.The HBsAg, HBsAb, HBeAg, HBeAb passing rates were close to 100%.Conclusion With the development of the quality evaluation activities, the accuracy of primary medical institutions was increased and the service quality was improved remarkably.%目的 通过分析基层医疗机构乙肝五项检验现状,了解基层检验质量及发展趋势,为切实提高基层检验质量、制定相应管理方案提供客观依据.方法 连续6年随机抽取我国县级妇幼医疗机构345±107家,应用盲样检测方法进行HBsAg、HBsAb、HBeAg、HBeAb和HBcAb检测,每个项目5个水平,对回馈的数据进行分类、核对、整理、分析与总结.结果HBsAg、HBsAb、HBeAg、HBeAb和HBcAb的检测方法主要有ELISA法、金标法、化学发光法、乳胶法、时间分辨法、酶法和其他未填写的方法等,并对各方法在2011年至2016年间的使用情况进行分析.6年间,乙肝五项各项目的室间质评及格率明显提升,尤其是HBcAb,由2011年第一次的43%提高到2016年的92%, HBsAg、HBsAb、HBeAg、HBeAb的室间质评及格率接近100%.结论 随着全国临床检验室间质量评价活动的开展和积极推进,基层医疗机构乙肝五项检验结果的准确性提高,服务机构的检验水平显著提升.
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