两种检测HAV-IgM 试剂的敏感性评价

Sensitivity of two immunoassays for detection of Hepatitis A Virus immunoglobulin M

摘要:

目的 对国内市场上应用较广的两种甲型肝炎病毒抗体（HAV-IgM）检测试剂进行敏感性评价。 方法 收集疑似HAV 感染者的血清标本，以美国雅培公司的HAV-IgM 试剂检测结果作为金标准，评价北京万 泰生物药业股份有限公司和北京现代高达生物技术有限责任公司两种检测HAV-IgM 试剂的敏感性；比较两 种HAV-IgM 试剂样本值/ 临界值（S/CO）的相关性；评价两种检测HAV-IgM 试剂的一致性。结果 万泰 HAV-IgM 检测试剂和高达HAV-IgM 检测试剂的敏感性分别为94.3%、97.1%，特异性分别为85.2%、91.3% ；万 泰、高达与雅培HAV-IgM 检测试剂S/CO 值有相关（r =0.597 和0.541，均P =0.000）；万泰、高达与雅培 HAV-IgM 检测试剂结果均高度一致（K =0.648 和0.772，均P =0.000）。结论 万泰、高达试剂均有很好的检 测性能，为临床检测和人群血清流行病学调查参考试剂选择提供重要参考依据。

Abstract:

Objective To evaluate the sensitivity of two immunoassay kits for anti-Hepatitis A Virus (HAV) IgM. Method On the gold standard confirmed by assay-Abbott HAV-IgM, the sensitivity of the two kits for testing HAVIgM in China were evaluated. The correlation of S/CO value of the two kits with Abbott HAV-IgM were estimated. Results HAV IgM had a sensitivity and specificity of 94.3% and 85.2% respectively with Wantai test, while 97.1% and 91.3% respectively with Gaoda test. HAV-IgM (Abbott) showed a correlation of S/CO valuewith HAV-IgM (Wantai) test and HAV-IgM (Gaoda) test, respectively (r = 0.597 and 0.541, all P = 0.000). HAV-IgM (Wantai) test and HAV-IgM (Gaoda) test showed good consistency with HAV-IgM (Abbott) test, with a k-coefficients of 0.648 and 0.772, respectively. Conclusion HAV-IgM (Wantai) and HAV-IgM (Gaoda) have good detection performances, which provides important reference for clinical detection and seroepidemiology statistics.