Qiu Dekui, Liu Yue, Wang Zhiping, Zhang Zhigang, Nie Meifeng, Xia Ningshao, Li Shaowei, Zhao Qinjian
State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Xiamen University, Xiamen, Fujian 361102, PR China; School of Public Health, Xiamen University, Xiamen, Fujian 361102, PR China.
State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Xiamen University, Xiamen, Fujian 361102, PR China; School of Life Sciences, Xiamen University, Xiamen, Fujian 361102, PR China.
J Virol Methods. 2023 Jun;316:114716. doi: 10.1016/j.jviromet.2023.114716. Epub 2023 Mar 23.
Cervical cancer, the second leading cause of cancer-related deaths among women, is caused by human papillomavirus (HPV), a sexually transmitted virus. Vaccination is an effective preventive measure against viral infections and subsequent development of cervical cancer. Enzyme-linked immunosorbent assay (ELISA) is commonly used to measure specific binding antibody titers and assess the immunogenicity of test vaccines in preclinical models or clinical volunteers. Two methods of deriving titers, the endpoint titer (ET) and the effective dilution producing a median maximal effective fold of dilution (ED) with a cut-off value, are widely used. For HPV, a pseudovirion-based neutralization assay (PBNA) is used to measure functional antibody titers. The ELISA binding titers and functional PBNA titers were found to be well-correlated for all nine HPV types tested in the vaccine, consistent with previous studies on HPV 16/18. Comparing the PBNA results with the two titration methods, the ED method showed higher precision and a closer correlation with PBNA results, both for individual types and pooled data analysis for all nine types. When comparing the titration results of the ET method based on a cut-off value with the ED method using all the data points across the dilution series, the ED method demonstrated better precision and a stronger correlation with PBNA results.
宫颈癌是女性癌症相关死亡的第二大主要原因，由人乳头瘤病毒（HPV）引起，这是一种性传播病毒。接种疫苗是预防病毒感染及后续宫颈癌发展的有效措施。酶联免疫吸附测定（ELISA）通常用于测量特异性结合抗体滴度，并在临床前模型或临床志愿者中评估测试疫苗的免疫原性。两种推导滴度的方法，即终点滴度（ET）和产生具有截止值的中位最大有效稀释倍数（ED）的有效稀释度，被广泛使用。对于HPV，基于假病毒颗粒的中和试验（PBNA）用于测量功能性抗体滴度。在该疫苗中测试的所有九种HPV类型中，ELISA结合滴度和功能性PBNA滴度均显示出良好的相关性，这与先前关于HPV 16/18的研究一致。将PBNA结果与两种滴定方法进行比较，无论是对于单个类型还是对所有九种类型的汇总数据分析，ED方法均显示出更高的精度以及与PBNA结果更紧密的相关性。当将基于截止值的ET方法的滴定结果与使用稀释系列中的所有数据点的ED方法进行比较时，ED方法显示出更好的精度以及与PBNA结果更强的相关性。
