Ferguson Morag, Heath Alan, Johnes Suzanne, Pagliusi Sonia, Dillner Joakim
Division of Virology, National Institute for Biological Standards and Control, South Mimms, United Kingdom.
Int J Cancer. 2006 Mar 15;118(6):1508-14. doi: 10.1002/ijc.21515.
Detection of genotype-specific human papillomavirus (HPV) capsid antibody in serum suggests past HPV infection. Also, these antibodies appear to correlate with vaccine-induced protection against infection, at least in animal models. However, each laboratory defines a reactive result differently and there is no agreed definition of what level of response indicates sero-reactivity. Standardization of assays for HPV capsid antibody will therefore assist with HPV vaccine development and epidemiology. This study was undertaken to investigate the specificity and sensitivity of assays in current use for measuring antibody to the major viral capsid protein L1 of HPV. Ten laboratories from 8 countries each analyzed 12 coded serum samples, which were derived from an uninfected woman, from naturally infected women and from individuals immunized with different vaccine candidates currently under clinical development. Study samples were assayed by methods in routine use in the participating laboratories. Nine assays were based on virus-like particles (VLPs) of 1 or more HPV genotypes. One laboratory used bacterially expressed major capsid protein L1 of HPV genotypes as antigen. There was considerable interlaboratory variation in estimated antibody levels. However, ranking of the potency of HPV 16 reactivity across the 12 test sera was consistent for all 10 laboratories. Expression of HPV 16 antibody levels relative to that of a single serum sample from an HPV16-infected woman considerably improved the interlaboratory assay comparability. Establishment of an International Standard for antibodies to HPV 16 would therefore facilitate the comparison of HPV antibody measurements between laboratories and assays.
血清中基因型特异性人乳头瘤病毒（HPV）衣壳抗体的检测表明既往有HPV感染。此外，这些抗体似乎与疫苗诱导的抗感染保护作用相关，至少在动物模型中如此。然而，每个实验室对反应性结果的定义不同，对于何种反应水平表明血清反应性也没有一致认可的定义。因此，HPV衣壳抗体检测方法的标准化将有助于HPV疫苗的研发和流行病学研究。本研究旨在调查当前用于检测HPV主要病毒衣壳蛋白L1抗体的检测方法的特异性和敏感性。来自8个国家的10个实验室分别分析了12份编码血清样本，这些样本来自一名未感染的女性、自然感染的女性以及接种了目前正在临床开发的不同候选疫苗的个体。研究样本采用参与实验室常规使用的方法进行检测。9种检测方法基于1种或多种HPV基因型的病毒样颗粒（VLP）。1个实验室使用细菌表达的HPV基因型主要衣壳蛋白L1作为抗原。各实验室估计的抗体水平存在相当大的差异。然而，所有10个实验室对12份检测血清中HPV 16反应性强度的排序是一致的。将HPV 16抗体水平相对于一名HPV16感染女性的单一血清样本进行表达，可显著提高实验室间检测的可比性。因此，建立HPV 16抗体国际标准将有助于实验室和检测方法之间HPV抗体测量结果的比较。
