一种HIV抗体化学发光诊断试剂的临床评价

Field Evaluation of HIV Antibody Chemiluminescent Immunoassay Kit

目的临床评价北京科美东雅生物技术有限公司HIV抗体化学发光诊断试剂。方法用HIV抗体化学发光诊断试剂对既往已知经确证检测结果为HIV-1抗体阳性者标本500份和用酶联免疫吸附(ELISA)试剂检测为HIV-1/2抗体阴性者标本1500份的血清样品进行检测,并对检测结果进行比较。结果HIV抗体化学发光诊断试剂盒的敏感性、特异性和功效率均为100%。结论HIV抗体化学发光诊断试剂盒具有良好的应用价值。

Objective To evaluate the HIV antibody chemiluminescence immunoassay kit produced by Beijing Chemclin Biotech Co. Ltd. Metbod Totally 500 HIV-1 antibody positive samples identified by the western blot testing and 1,500 HIV negative samples identified by ELISA testing were retested with HIV antibody chemiluminescence immunoassay Kit. The sensitivity, specificity and efficiency were calculated. Result The sensitivity, specificity and efficiency were all 100%. Conclusion This kit can be used to test HIV antibody.