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Clinical and Vaccine Immunology, May 2006, p. 541-546, Vol. 13, No. 5
1071-412X/06/$08.00+0     doi:10.1128/CVI.13.5.541-546.2006

Rapid, Sensitive, and Specific Lateral-Flow Immunochromatographic Device To Measure Anti-Anthrax Protective Antigen Immunoglobulin G in Serum and Whole Blood

Raymond E. Biagini,1* Deborah L. Sammons,1 Jerome P. Smith,1 Barbara A. MacKenzie,1 Cynthia A. F. Striley,1 John E. Snawder,1 Shirley A. Robertson,1 and Conrad P. Quinn2

Biological Monitoring Laboratory Section, Biomonitoring and Health Assessment Branch, National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Cincinnati, Ohio,1 Microbial Pathogenesis and Immune Response (MPIR) Laboratory, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia2

Received 26 January 2006/ Returned for modification 1 March 2006/ Accepted 13 March 2006

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-µl 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 µg/ml) and 10 controls and PA-supplemented whole-blood samples, we demonstrated that the LFIA had a sensitivity of approximately 3 µg/ml anti-PA IgG in serum and ~14 µg/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.

* Corresponding author. Mailing address: 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. Phone: (513) 533-8196. Fax: (513) 533-8494. E-mail: rbiagini{at}cdc.gov.

Clinical and Vaccine Immunology, May 2006, p. 541-546, Vol. 13, No. 5
1071-412X/06/$08.00+0     doi:10.1128/CVI.13.5.541-546.2006




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  • Bienek, D. R., Biagini, R. E., Charlton, D. G., Smith, J. P., Sammons, D. L., Robertson, S. A. (2008). Rapid Point-of-Care Test To Detect Broad Ranges of Protective Antigen-Specific Immunoglobulin G Concentrations in Recipients of the U.S.-Licensed Anthrax Vaccine. CVI 15: 644-649 [Abstract] [Full Text]  


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