Young Megan K, Bertolini Joseph, Kotharu Pushpa, Maher Darryl, Cripps Allan W
a School of Medicine and Menzies Health Institute Queensland , Griffith University , Gold Coast , Australia.
b CSL Behring (Australia) Pty Ltd , Broadmeadows , Australia.
Hum Vaccin Immunother. 2017 Aug 3;13(8):1952-1955. doi: 10.1080/21645515.2017.1327110. Epub 2017 Jun 12.
Rubella antibodies are not routinely measured in immunoglobulin products and there is a lack of information on the titer in Australian products. To facilitate future studies of the effectiveness of passive immunisation for preventing rubella and congenital rubella syndrome, this study measured the concentration of rubella-specific antibodies in Australian intramuscular (IM) and intravenous (IV) human immunoglobulin products suitable for post-exposure prophylaxis using a chemiluminescent immunoassay. The GMT ± GSD for the IM product was 19 ± 1.2 IU/mg (2980 ± 1.2 IU/mL). The GMT ± GSD for the IV product was 12 ± 1.5 IU/mg (729 ± 1.5 IU/mL). At present, Australian guidelines recommend offering non-immune pregnant women exposed to rubella 20 mL of intramuscular immunoglobulin within 72 hours of exposure. This equates to 42,160 IU of rubella antibodies if the lowest titer obtained for the Australian IM product is considered. The same dose would be delivered by 176 mL of the Australian IV product at the lowest measured rubella-specific antibody titer.
免疫球蛋白产品中通常不常规检测风疹抗体,并且缺乏关于澳大利亚产品效价的信息。为了促进未来关于被动免疫预防风疹和先天性风疹综合征有效性的研究,本研究使用化学发光免疫分析法测量了澳大利亚适合暴露后预防的肌内注射(IM)和静脉注射(IV)人免疫球蛋白产品中风疹特异性抗体的浓度。IM产品的几何平均滴度(GMT)±几何标准差(GSD)为19±1.2 IU/mg(2980±1.2 IU/mL)。IV产品的GMT±GSD为12±1.5 IU/mg(729±1.5 IU/mL)。目前,澳大利亚指南建议在暴露后72小时内为接触风疹的非免疫孕妇提供20 mL肌内免疫球蛋白。如果考虑澳大利亚IM产品获得的最低效价,这相当于42,160 IU的风疹抗体。以测量的最低风疹特异性抗体效价计算,相同剂量的澳大利亚IV产品需要176 mL。