Clinical Laboratory Sciences, GSK, Rixensart.
R&D Center, GSK Vaccines, Wavre, Belgium.
J Infect Dis. 2019 Sep 26;220(9):1462-1468. doi: 10.1093/infdis/jiz345.
The plaque reduction neutralization test (PRNT), which measures a subset of immunoglobulin antibodies (functional neutralizing antibodies), and the enzyme-linked immunosorbent assay (ELISA), which measures total immunoglobulin (neutralizing and nonneutralizing antibodies), characterize different aspects of the anti-mumps virus antibody response after vaccination.
Data from a recent phase 3 clinical trial (NCT01681992) of 2 measles-mumps-rubella vaccines were used to compare anti-mumps antibody responses measured using an unenhanced PRNT (GSK; seropositivity cutoff and threshold, 2.5 and 4 times the 50% end-point dilution, respectively) with those estimated using an ELISA (thresholds, 5 and 10 ELISA units/mL, respectively).
Of 3990 initially seronegative samples, 3284 (82.3%) were seropositive after vaccination for anti-mumps antibodies in both assays. The Pearson correlation coefficient for double-positive samples was 0.57, indicative of a moderate correlation. Receiver operating characteristic curve analysis showed that an ELISA threshold of 51.7 ELISA units/mL best corresponded to the PRNT seroresponse threshold. There was no obvious vaccine brand effect on the correlation between assays.
The moderate correlation between the anti-mumps antibody measurements obtained with PRNT and ELISA reflects different aspects of the serological response. In the absence of a well-defined protective serological threshold, PRNT provides complementary information on the antibody response, whereas ELISA remains a critically useful measurement of vaccine immunogenicity.
微量中和试验(PRNT)测量了免疫球蛋白抗体的一个亚群(功能中和抗体),酶联免疫吸附试验(ELISA)则测量了总免疫球蛋白(中和和非中和抗体),这两种方法分别从不同方面描述了疫苗接种后的抗腮腺炎病毒抗体反应。
使用最近一项关于两种麻疹-腮腺炎-风疹联合疫苗的 3 期临床试验(NCT01681992)的数据,对使用未经增强的 PRNT(GSK;血清阳性临界值和阈值分别为 2.5 和 4 倍 50%终点稀释度)和 ELISA(阈值分别为 5 和 10 ELISA 单位/mL)测量的抗腮腺炎抗体反应进行了比较。
在最初的 3990 份血清阴性样本中,有 3284 份(82.3%)在两种检测方法中均对腮腺炎抗体呈血清阳性。双阳性样本的 Pearson 相关系数为 0.57,表明相关性适中。受试者工作特征曲线分析表明,ELISA 阈值为 51.7 ELISA 单位/mL 时与 PRNT 血清反应阈值最匹配。两种检测方法之间没有明显的疫苗品牌效应。
PRNT 和 ELISA 获得的抗腮腺炎抗体测量之间的中度相关性反映了血清反应的不同方面。在缺乏明确的保护性血清学阈值的情况下,PRNT 提供了抗体反应的补充信息,而 ELISA 仍然是疫苗免疫原性的重要测量方法。