title: A two-stage, multilevel quality control system for serological assays in anthrax vaccine clinical trials.
abstract: 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.
authors.affiliation: 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. ssoroka@cdc.gov
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Soroka
authors.forename: Jarad M
authors.initials: JM
authors.lastname: Schiffer
authors.forename: Vera A
authors.initials: VA
authors.lastname: Semenova
authors.forename: Han
authors.initials: H
authors.lastname: Li
authors.forename: Lydia
authors.initials: L
authors.lastname: Foster
authors.forename: Conrad P
authors.initials: CP
authors.lastname: Quinn
mesh_terms: D022122:Anthrax Vaccines / Q000008:administration & dosage / Q000276:immunology / Q000627:therapeutic use*; D000942:Antigens, Bacterial / Q000276:immunology; D001427:Bacterial Toxins / Q000276:immunology; D002487:Centers for Disease Control and Prevention, U.S.; D002986:Clinical Trials as Topic; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D009500:Neutralization Tests; D011786:Quality Control; D014481:United States
chemical_list: D022122:Anthrax Vaccines; D000942:Antigens, Bacterial; D001427:Bacterial Toxins; C030325:anthrax toxin