Kim Seung Youn, Kim Yun Kyung, Eun Byung Wook, Kim Nam Hee, Kang Eun Kyeong, Lee Byong Sop, Lim Jung Sub, Lee Jun Ah, Kim Dong Ho
Department of Pediatrics, Korean Cancer Center Hospital, Seoul, Korea.
Korean J Pediatr. 2012 Dec;55(12):474-80. doi: 10.3345/kjp.2012.55.12.474. Epub 2012 Dec 20.
For evaluating the immunogenicity of an influenza vaccine, the microneutralization (MN) test has a higher sensitivity and specificity as compared to the hemagglutination inhibition (HI) test. However, the MN test is more time consuming and is difficult to standardize. We performed the MN test to determine its usefulness as an alternative or complementary test to the HI test for evaluating the immunogenicity of influenza vaccines.
We compared the MN test with the HI test using 50 paired samples taken from a previous clinical study (2008-2009) in Korean children under 18 years of age.
The linear correlation coefficients of the 2 tests for H3N2, H1N1, and influenza B were 0.69, 0.70, and 0.66, respectively. We identified a high index of coincidence between the 2 tests. For an influenza vaccine, the postvaccination seroprotection rates and seroconversion rates determined by the MN test were 78.0% and 96.0%, 90% and 42.0%, and 42.0% and 48.0% for H3N2, H1N1, and influenza B, respectively. Geometric mean titer fold increases of H3N2, H1N1, and influenza B were 2.89, 5.04, and 4.29, respectively, and were 2.5-fold higher. We obtained good results in the evaluation of the immunogenicity of the 2008-2009 seasonal influenza vaccines.
We found that the MN test was as effective as the HI test. Therefore, we suggest that the MN test can be used as an alternative or complementary test to the HI test for evaluating the immunogenicity of influenza vaccines.
为评估流感疫苗的免疫原性,与血凝抑制(HI)试验相比,微量中和(MN)试验具有更高的敏感性和特异性。然而,MN试验耗时更长且难以标准化。我们进行MN试验以确定其作为评估流感疫苗免疫原性的HI试验的替代或补充试验的实用性。
我们使用从之前一项针对18岁以下韩国儿童的临床研究(2008 - 2009年)中获取的50对样本,将MN试验与HI试验进行比较。
针对H3N2、H1N1和乙型流感,两种试验的线性相关系数分别为0.69、0.70和0.66。我们发现两种试验之间的符合率较高。对于流感疫苗,通过MN试验确定的接种后血清保护率和血清转化率,H3N2分别为78.0%和96.0%,H1N1分别为90%和42.0%,乙型流感分别为42.0%和48.0%。H3N2、H1N1和乙型流感的几何平均滴度倍数增加分别为2.89、5.04和4.29,且高出2.5倍。我们在评估2008 - 2009年季节性流感疫苗的免疫原性方面取得了良好结果。
我们发现MN试验与HI试验同样有效。因此,我们建议MN试验可作为评估流感疫苗免疫原性的HI试验的替代或补充试验。