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目了:了解全国乙肝表面抗原(HBsAg)检测状况,提高检测水平和质量。方法:定期向全国各参评实验室发放已知样本,然后对其回报数据进行统计、分析和评价。结果:从1989-1996年,HBsAg测定获年度满分(10分)的实验室比例从17%上升到64%。方法学评价表明采用酶联免疫吸附试验(ELISA)实验室比例从1989年的77%上升到1996年的92%,同时灵敏度较差的反向间接血凝法(RPHA)则完全被淘汰。各厂家HBsAg测定试剂盒的临床使用评价表明,其随着质评工作的开展,质量也有大幅度的提高。结论:HBsAg测定全国室间质评系统的运行,有助于提高全国各级实验室的检侧水平以及各厂家HBsAg测定试剂盒的质量。
The purpose: to understand the national hepatitis B surface antigen (HBsAg) detection, improve the detection level and quality. Methods: Regularly distribute known samples to various participating laboratories throughout the country, and then make statistics, analysis and evaluation on the return data. Results: From 1989 to 1996, the proportion of laboratories achieving the full year (10 points) score for HBsAg rose from 17% to 64%. Methodological evaluation showed that the proportion of laboratories using ELISA increased from 77% in 1989 to 92% in 1996, while the less sensitive indirect hemagglutination (RPHA) was completely eliminated. The evaluation of the clinical use of the HBsAg assay kits by various manufacturers shows that with the development of quality assessment work, the quality has also been greatly improved. Conclusion: The operation of HBsAg in the evaluation of the national inter-laboratory quality assessment system helps to improve the level of laboratory testing and the quality of the HBsAg assay kits of various manufacturers.