现代检验医学杂志2012，Vol.27Issue(3)：125-127,3.DOI:10.3969/j.issn.1671-7414.2012.03.043
HBsAg两步法酶免国产试剂与进口试剂检测结果对比分析
Comparative Analysis of Detection by Domestic and Import HBsAg ELISA Reagents
钟小强 1吴正林 1徐韵靖 1何涛君 1肖桂初 1陆学东1
作者信息
- 1. 深圳市第四人民医院检验医学部,广东深圳 518033
- 折叠
摘要
Abstract
Objective To evaluate domestic HBsAg two-steps-ELISA reagents objectively. Methods 550 serums samples were tested by American BIO-RAD MONOLISA HBsAg ULTRA ELISA reagent and divided to MONOLISA HBsAg positive group (68samples) and MONOLISA HBsAg negative group (482samples). Then six domestic HBsAg two-steps-ELISA reagents were used to test the samples in two groups in order to compare the sensitivity and specificity of the six reagents. Additionally 2IU/ml HBsAg standard material was diluted according to 1 : 2 for 5 series dilutions. The series dilutions were test by MONOLISA HBsAg ULTRA ELISA reagent and the six domestic HBsAg reagents. Results For 68 samples in MONOLISA HBsAg positive group,three domestic reagents A,B and E got the same result as MONOLISA HBsAg ULTRA ELISA reagent;two domestic reagents C and D missed one sample as false negative (χ2 =0- 015, P>0. 05). For 482 samples in MONOLISA HBsAg negative group, the domestic reagents A missed 1 sample as false positive (χ2 =0. 002, P> 0. 05),the domestic reagents B,E missed 3 samples as false positive(χ2 =0. 002, P>0. 05),the domestic reagents C and D missed 4 sample as false positive (χ2 =0. 002, P>0. 05) ; another domestic reagent F failed several times because of high OD of negative control. Conclusion Most of the domestic HBsAg two-steps-ELISA reagents can meet the need of clinical lab, but import reagent is still better. Some domestic reagents from un-well-known tiny factory have a bad performance in clinical application.关键词
乙型肝炎病毒/乙肝表面抗原/酶联免疫吸附试验Key words
HBV/ HBsAg/ ELISA分类
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钟小强,吴正林,徐韵靖,何涛君,肖桂初,陆学东..HBsAg两步法酶免国产试剂与进口试剂检测结果对比分析[J].现代检验医学杂志,2012,27(3):125-127,3.
