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

Details

• Personal Author:
  Biagini, Raymond E. ; Bienek DR ; Charlton DG ; Robertson SA ; Sammons DL ; Smith JP
• Description:
  Currently, there is no routine monitoring of an immune response to the anthrax vaccine. Simple on-site tests are needed to evaluate the antibody response of anthrax-vaccinated individuals in the Armed Forces and others at high risk. Using a prototype lateral flow assay (LFA) (R. E. Biagini, D. L. Sammons, J. P. Smith, B. A. MacKenzie, C. A. F. Striley, J. E. Snawder, S. A. Robertson, and C. P. Quinn, Clin. Vaccine Immunol. 13:541-546, 2006), we investigated the agreement between a validated anthrax protective antigen (PA) immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) and the LFA for 335 unvaccinated and vaccinated subjects. We also investigated the performance of the LFA under the following conditions: thermal shock (i.e., thermal cycling between temperature extremes), high temperature/high relative humidity, high temperature/low relative humidity, and low temperature/low relative humidity. With the anti-PA ELISA used as a standard, the LFA was shown to be optimally diagnostic at 11 mu g/ml anti-PA-specific IgG. At this concentration, the LFA specificity and sensitivity were 98% (95% confidence interval [CI], 97% to 100%) and 92% (CI, 88% to 97%), respectively. Receiver operating characteristic curve analysis yielded an area under the curve value of 0.988 (CI, 0.976 to 1.00), suggesting that the LFA is an extremely accurate diagnostic test. For < or equal to 4 or > or equal to 50 mu g/ml PA-specific IgG, the LFA results for each environmental condition were identical to those obtained in the laboratory. These data indicate that this rapid point-of-care test would be a feasible tool in monitoring the serological antibody responses of individuals that have been vaccinated against anthrax. [Description provided by NIOSH]
• Subjects:
  Antibodies Antigens Diagnosis Immune System Occupational Health Safety Temperature
• Keywords:
  Antibody-response Diagnostic-techniques Immune-reaction Military-personnel Temperature-effects Vaccines
• ISSN:
  1556-6811
• Document Type:
  Text
• Genre:
  Journal Article
• Place as Subject:
  Illinois ; Maryland ; Ohio ; OSHA Region 3 ; OSHA Region 5
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Division:
  DART - Division of Applied Research and Technology
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Volume:
  15
• Issue:
  4
• NIOSHTIC Number:
  nn:20033667
• Citation:
  Clin Vaccin Immunol 2008 Apr; 15(4):644-649
• Contact Point Address:
  Diane R. Bienek, Naval Institute for Dental and Biomedical Research, 310A B Street, Bldg. 1-H, Great Lakes, IL 60088-5259
• Email:
  diane.bienek@med.navy.mil
• Federal Fiscal Year:
  2008
• NORA Priority Area:
  Healthcare and Social Assistance ; Manufacturing
• Peer Reviewed:
  True
• Source Full Name:
  Clinical and Vaccine Immunology
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:74ff3dc8e6787e541a711c5302c1cabf13d4d8ef8d573d9803920cf12966c7dd07726d364f4be022d69d6ca27a045eda4f36eab49365438ce1799cc995fd07fc
• Download URL:
  https://stacks.cdc.gov/view/cdc/189147/cdc_189147_DS1.pdf
• File Type:
  [PDF - 114.21 KB ]