Application of recovery tests in the validation of immunoassays for assessing the immunogenicity of B. anthracis PA vaccine

G Halperin, H Marcus - PDA Journal of Pharmaceutical Science …, 2001 - journal.pda.org
In the quantitative assessment of polyclonal serum antibodies, the complex composition and
characteristics of the analyte population (serum antibodies) restricts the capability of …

Validation of an anti-PA-ELISA for the potency testing of anthrax vaccine in mice

M Pombo, I Berthold, E Gingrich, M Jaramillo, M Leef… - Biologicals, 2004 - Elsevier
The potency test for the anthrax vaccine currently licensed for human use in the United
States (Anthrax Vaccine Adsorbed) involves the protection of actively immunized guinea …

Validation and long term performance characteristics of a quantitative enzyme linked immunosorbent assay (ELISA) for human anti-PA IgG

VA Semenova, J Schiffer, E Steward-Clark… - Journal of …, 2012 - Elsevier
Accurate, reliable and standardized quantification of anti-protective antigen (PA) IgG
antibody levels is essential for comparative analyses of anti-toxin immune responses in …

Development of an in vitro-based potency assay for anthrax vaccine

SF Little, WM Webster, BE Ivins, PF Fellows, SL Norris… - Vaccine, 2004 - Elsevier
The potency assay currently used to evaluate consistency of manufacture for the anthrax
vaccine is contingent upon meeting specified parameters after statistical analysis of the …

Development and validation of serological methods for human vaccine potency testing: case study of an anthrax vaccine

JL Arciniega, RI Domínguez-Castillo - Procedia in Vaccinology, 2011 - Elsevier
Only one anthrax vaccine (Anthrax Vaccine Adsorbed, AVA) is licensed in the US to date,
although new vaccines are under development. Logistic difficulties with the potency testing …

A two-stage, multilevel quality control system for serological assays in anthrax vaccine clinical trials

SD Soroka, JM Schiffer, VA Semenova, H Li, L Foster… - Biologicals, 2010 - Elsevier
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 …

Validation of high throughput screening of human sera for detection of anti-PA IgG by Enzyme-Linked Immunosorbent Assay (ELISA) as an emergency response to an …

VA Semenova, E Steward-Clark, P Maniatis… - Biologicals, 2017 - Elsevier
To improve surge testing capability for a response to a release of Bacillus anthracis, the
CDC anti-Protective Antigen (PA) IgG Enzyme-Linked Immunosorbent Assay (ELISA) was re …

Evaluation of an anti-rPA IgG ELISA for measuring the antibody response in mice

SF Little, WM Webster, SLW Norris, GP Andrews - Biologicals, 2004 - Elsevier
A recombinant protective antigen (rPA)-based enzyme-linked immunosorbent assay (ELISA)
was developed to measure the serological response of female A/J mice after inoculation …

Mass value assignment of total and subclass immunoglobulin G in a human standard anthrax reference serum

VA Semenova, E Steward-Clark… - Clinical and Vaccine …, 2004 - Am Soc Microbiol
ABSTRACT An anti-Anthrax Vaccine Adsorbed (anti-AVA) standard human reference serum
pool, AVR414, has been prepared, and the total and protective antigen (PA)-specific …

Agar-gel precipitin technique in anthrax antibody determinations

JG Ray Jr, PJ Kadull - Applied Microbiology, 1964 - Am Soc Microbiol
A modification of the agar-gel precipitation inhibition technique of Thorne and Belton for
detecting anthrax antibodies reduces inconsistency of visually determined end points on the …