炭疽疫苗临床试验中血清学检测的两阶段、多层次质量控制系统。
A two-stage, multilevel quality control system for serological assays in anthrax vaccine clinical trials.
作者信息
Soroka Stephen D, Schiffer Jarad M, Semenova Vera A, Li Han, Foster Lydia, Quinn Conrad P
机构信息
Microbial Pathogenesis and Immune Response Laboratory, Meningitis and Vaccine Preventable Diseases Branch, Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States.
出版信息
Biologicals. 2010 Nov;38(6):675-83. doi: 10.1016/j.biologicals.2010.09.001. Epub 2010 Sep 28.
A two-stage, multilevel assay quality control (QC) system was designed and implemented for two high stringency QC anthrax serological assays; a quantitative anti-PA IgG enzyme-linked immunosorbent assay (ELISA) and an anthrax lethal toxin neutralization activity (TNA) assay. The QC system and the assays were applied for the congressionally mandated Centers for Disease Control and Prevention (CDC) Phase 4 human clinical trial of anthrax vaccine adsorbed (AVA, BioThrax). A total of 57,284 human serum samples were evaluated by anti-PA enzyme-linked immunosorbent assay (ELISA) and 11,685 samples by anthrax lethal toxin neutralization activity (TNA) assay. The QC system demonstrated overall sample acceptance rates of 86% for ELISA and 90% for the TNA assays respectively. Monitoring of multiple assay and test sample variables showed no significant long term trends or degradation in any of the critical assay reagents or reportable values for both assays. Assay quality control data establish the functionality of the quality control system and demonstrates the reliability of the serological data generated using these assays.
针对两种高严格度的炭疽血清学检测方法，设计并实施了一个两阶段、多层次的检测质量控制（QC）系统；一种是定量抗保护性抗原（PA）IgG酶联免疫吸附测定（ELISA），另一种是炭疽致死毒素中和活性（TNA）测定。该质量控制系统和检测方法应用于美国疾病控制与预防中心（CDC）根据国会要求开展的吸附型炭疽疫苗（AVA，BioThrax）4期人体临床试验。通过抗PA酶联免疫吸附测定（ELISA）共评估了57284份人体血清样本，通过炭疽致死毒素中和活性（TNA）测定评估了11685份样本。质量控制系统显示，ELISA检测的总体样本接受率分别为86%，TNA检测为90%。对多种检测和测试样本变量的监测表明，两种检测方法的任何关键检测试剂或可报告值均无显著的长期趋势或降解情况。检测质量控制数据确立了质量控制系统的功能，并证明了使用这些检测方法所产生的血清学数据的可靠性。
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