重庆市2013-2016年免疫定性项目结果互认新鲜血标本比对与分析

Comparison and analysis of fresh blood samples in immune qualitative items results mutual recognition in Chongqing City during 2013-2016

目的分析2013-2016年重庆市部分三级医院和二级医院检验科免疫定性项目结果的可比性,为实现检验结果互认奠定基础。方法通过问卷调查和现场督查的方式进行基本情况调研。2013-2016年连续对乙型肝炎(简称"乙肝")标志物和自身抗体项目进行新鲜血标本比对和分析,回报和统计检测结果。通过调研指导和分阶段新鲜血比对,发现问题,持续改进检验质量。结果调研分析发现,重庆市医院检验科免疫亚专业组发展不平衡,资源配置差别较大,定性项目室内质控覆盖率亟待提高。2013-2016年新鲜血标本比对中,乙肝病毒表面抗原(HBsAg)和乙肝病毒表面抗体(HBsAb)项目一致性较好,其次为乙肝病毒e抗原(HBeAg)。2013-2016年项目通过率分别为HBsAg:99.23%、100.00%、96.40%、98.72%;HBsAb:100.00%、99.30%、97.00%、98.46%;HBeAg:98.50%、92.40%、92.70%、97.69%。乙肝病毒e抗体(HBeAb)和乙肝病毒核心抗体(HBcAb)由于试剂、仪器和方法学差异较大,结果一致性差于前三项。自身抗体项目比对核型和阴阳性符合率为100.00%,但开展实验室较少(<15家)。结论三级医院实验室免疫互认检验项目质量较好,二级医院实验室部分项目检验质量尚需进一步提高;通过免疫专业调研分析和新鲜血标本比对,规范室内质控和室间质量评价,可以提高医院间检验结果互认的可比性和准确性,为推进分级诊疗奠定技术基础。

Objective To analyze the comparability of immune qualitative items results in the clinical laboratory department of partial tertiary hospital and second-class hospitals of Chongqing City during 2013-2016 to lay the foundation for realizing the results mutual recognition of immune qualitative items.Methods The basic situation survey and inquiry were conducted by the questionnaire survey and spot-supervision modes.The comparison and analysis of fresh blood samples for hepatitis B immune markers and autoantibody items were continuously performed from 2013 to 2016.The problems were found by the investigation guidance and fresh blood samples comparison by stages,and then continuously improving the test quality was performed.Results The investigation and analysis found that the development in immune sub-professional group of hospital clinical laboratory department in Chongqing City was imbalance,the resource allocation had large difference and the coverage rate of internal quality items urgently needed to be increased.In the comparison of fresh blood samples during 2013-2016,the items of HBsAg and HBsAb had good consistency,followed by HBeAg.The average scores of item passing rate during 2013-2016 were 99.23%,100.00%,96.40% and 98.72%for HBsAg;100.00%,99.30%,97.00% and 98.46%for anti-HBs;98.50%,92.40%,92.70% and 97.69%for HBeAg.The results consistency of HBeAb and HBcAb was poorer than that of the former 3 items due to large difference in the reagent,instrument and methodology.The consistency rate in the comparison the karyotype,negative and positive in the autoantibody items was 100.00%,but there was few laboratories carrying out this items(<15).Conclusion The quality of immune mutual recognition items of tertiary hospital laboratories is good,and the test quality of partial items in the second-class hospital laboratory still needs to be further increased;through the immune professional investigation and analysis,and the comparison of fresh blood samples,standardizing the internal quality control and external quality assessment can increase the comparability and accuracy of inter-hospital test results mutual recognition to lay the foundation for promoting the hierarchical diagnosis and treatment.