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Rapid, sensitive, and specific lateral-flow immunochromatographic device to measure anti-anthrax protective antigen immunoglobulin G in serum and whole blood.

Biagini-RE; Sammons-DL; Smith-JP; MacKenzie-BA; Striley-CAF; Snawder-JE; Robertson-SR; Quinn-CP
Clin Vaccin Immunol 2006 May; 13(5):541-546
Evidence from animals suggests that anti-anthrax protective antigen (PA) immunoglobulin G (IgG) from vaccination with anthrax vaccine adsorbed (AVA) is protective against Bacillus anthracis infection. Measurement of anti-PA IgG in human sera can be performed using either enzyme-linked immunosorbent assay or fluorescent covalent microsphere immunoassay (ELISA) (R. E. Biagini, D. L. Sammons, J. P. Smith, B. A. MacKenzie, C. A. Striley, V. Semenova, E. Steward-Clark, K. Stamey, A. E. Freeman, C. P. Quinn, and J. E. Snawder, Clin. Diagn. Lab. Immunol. 11:50-55, 2004). Both these methods are laboratory based. We describe the development of a rapid lateral-flow immunochromatographic assay (LFIA) test kit for the measurement of anti-PA IgG in serum or whole-blood samples (30-l samples) using colloidal gold nanoparticles as the detection reagent and an internal control. Using sera from 19 anthrax AVA vaccinees (anti-PA IgG range, 2.4 to 340 g/ml) and 10 controls and PA-supplemented whole-blood samples, we demonstrated that the LFIA had a sensitivity of approximately 3 g/ml anti-PA IgG in serum and 14 g/ml anti-PA IgG in whole blood. Preabsorption of sera with PA yielded negative anti-PA LFIAs. The diagnostic sensitivity and specificity of the assay were 100% using ELISA-measured anti-PA IgG as the standard. This kit has utility in determining anti-PA antibody reactivity in the sera of individuals vaccinated with AVA or individuals with clinical anthrax.
Toxicology; Risk-analysis; Biological-warfare-agents; Biological-weapons; Decontamination; Analytical-processes; Analytical-chemistry; Nanotechnology
Division of Applied Research and Technology, Biomonitoring and Health Assessment Branch, Biological Monitoring Research Team, CDC/NIOSH MS C-26, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, OH 45226
Publication Date
Document Type
Interagency Agreement; Journal Article
Email Address
Funding Type
Interagency Agreement
Fiscal Year
NTIS Accession No.
NTIS Price
Issue of Publication
NIOSH Division
Source Name
Clinical and Vaccine Immunology