【摘要】 目的:比较7种检测风疹IgG抗体试剂盒的效果。方法:7种试剂盒中2种为本室自制,其余5种为国外市售。取262例育龄妇女血清标本按照试剂盒说明书用酶联免疫吸附法完成测定。结果:7种试剂盒Kappa值和方法的可用度分别为0.21～1和24.1%～100%,检测世界卫生组织提供的风疹抗体标准品时,曲线有很好的相关性(γ>0.85);试剂盒检测血清样本时诊断敏感性和特异性范围分别为57.3%～93.3%,53.1%～96.1%。结论:7种试剂盒检测血清标本时有较大的差异,急需进行试剂盒的标准化研究,进一步提高检测的敏感性和特异性。更多还原

【Abstract】 Objective:To assess the reliability of 7 kits for detecting rubella virus(RV)specific immunoglobulin G(IgG)antibodies.Methods:The comparison of 7 different kits(2 from self-made and 5 from overseas purchasing)was conducted by standard indirect enzyme-linked immunosorbent assay in the serum samples of 262 women of reproductive age according to the instructions of the kits.Results:The Kappa value and availability of these seven kits ranged from 0.21 to 1.00 and 24.1% to 100%,respectively.The concentration had the good relevance to the optical density value when measuring the international standard for anti-rubella immunoglobulin substance provided by World Health Organization.The diagnostic sensitivity range and specificity range were 57.3-93.3 percent and 53.1-96.1 percent,respectively.Conclusion:The comparison results among 7 kits showed significant differences.The standardization of kits for detecting RV-IgG antibodies needs urgently to improve assay sensitivity and specificity.更多还原