摘要
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。
Aim: To investigate and improve the quality of HBsAg immunoassay in China. Methods: The definiled serum samples for HBsAg immunoassay were distributed to all laboratories participating the ex- temal quality assessment (EQA ) scheme. Then. the retumed data from the laboratories were analyzed statistically. Results: From 1989 to 1996, the rate of the participating laboratories obtaining annual quality score 10 in HBsAg detection increased from 17% to 64%. The assessment of methods used by the labora- tories showed that the rate of the laboratories using ELISA for HBsAg assay has increased from 77% in 1989 to 92% in 1996. meanwhile, RPHA with low sensitivity has not been usad by the laboratories in 1996. The clinical assessment on HBsAg assay kits showed that the quality of the kits was markedly improved as the EQA scheme had been carried out. Conclusion : The application of the EQA scheme for HBsAg immunoassay in China is useful to the improvement of performance of HBsAg detection in clinical laboratories and the quality of HBsAg assay kits.
出处
《中华肝脏病杂志》
CAS
CSCD
1997年第2期106-107,117,共3页
Chinese Journal of Hepatology
关键词
乙肝表面抗原
免疫测定
质量评价
乙型肝炎
Hepatitis B surface antigen lmmunoassay External quality assessment
