为了评价本实验室建立的快速全血凝集法检测HBsAg的效果,检测了河北省不同人群534份全血样品,得到了满意结果.来自不同人群的369份样品(其中62份来自乙肝患者,180份来自献血者,127份来自正常人群),经快速全血凝集法和国家认证的市售ELISA试剂盒平行检测后,总符合率为96.7%,灵敏度为90.99%,特异性为98.7%.乙肝患者、献血者和正常人群中阳性率分别为52.6%,4.3%和8.9%.实验结果说明快速全血凝集法不仅简单快速、不需要特殊设备,而且具有高的敏感性和特异性,因此它可以广泛应用于基层卫生机构和临床HBsAg的检测,尤其适用于病人的床边诊断.
In order to evaluate the efficacy of rapid whole-blood agglutination assay(RWBA) established in our laboratory,we tested 534 samples of whole-blood for HBsAg detection from different populatons in Hebei Province of China,and obtained satisfactory results.We detected HBsAg with whold-blood samples from different populations by RWBA,and compared with the results tested by commercial ELISA kit.The parallelled 369 samples from different populations were detected by both RWBA and commercial ELISA kit.Among them,there were 62 clinical patients with hepatitis B,180 cases of blood donors and 127 cases normal population.The total coincident index is 96.7%,the sensibility was 90.9%,and the specificity was 98.7%.The positive rate of population with clinical hepatitis,blood donors,and common population was 52.6%,4.3% and 8.9% respectively.The results indicated that RWBA was not only simpler and faster,need no special instruments,but also had higher sensiblity and specificity.It can be widely used in grass-roots health units and bedsides diagnosis for HBsAg detection.
[1] 陈淑芬, 于秋丽, 牛建章, 孟宗达, 康铁军, 朱会宾, 崔泽, Chen Shufen, Yu Qiuli, Niu Jianzhang, Meng Zongda, Kang Tiejun, Zhu Huibin, Cui Ze. 抗人红细胞血型糖蛋白A非凝集性单克隆抗体的研制及其生物特性研究 [J]. 河北医科大学学报 1999.doi:10.3969/j.issn.1007-3205.1999.02.004
[2] Tiollais P, POURCEL C, DEJEAN A. The hepatitis B virus [J]. Nature 1985, 317.
[3] Beasley R P, HWANG L Y. Viral hepatitis and liver disease [M]. New York:Grune & Stratton 1984.
[4] PENG W W. Viral hepatitis study [M]. Guangzhou:Guangdong Scientific Technique Publishing House 1998.
[5] Kang T J, NIU J Z, Lu H Y. Using chemical cross-link technology to prepare bispecific antibody, which can detect HBsAg by rapid whole-blood agglutination assay [J]. American Journal of Comprehensive Medicine 1999, 11.
[6] NIU J Z, LU H Y, Chen S F. Application and evaluation of rapid whold-blood agglutination assay kit in Chinese [J]. Chinese Journal of Public Health 1998, 14(07).
[7] Russo C, CALLEGARO L, LANZA E. Purification of IgG monoclonal antibody by caprylic acid precipitation [J]. Journal of Immunological Methods 1983, 65(1-2).
[8] Parham P. On the fragmentation of monoclonal IgGl, IgG2a, Igg2b from BALB/c mice [J]. Journal of Immunology 1983, 131.
[9] Brennan M, DAVISON P F, PAULUS H. Preparation of bispecific antibodies by chemical recombination of monoclonal immunoglobulin G1 fragments [J]. Science 1985, 229.
[10] BIGBEE W L, VANDERLAAN M, FONG S N. Monoclonal antibodies specific for the M- and N-froms of human glycophorin A [J]. Molecular Immunology 1983, 20(12).
