Interlaboratory Comparison of Three Multiplexed Bead-Based Immunoassays for Measuring Serum Antibodies to Pneumococcal Polysaccharides

Details

• Personal Author:
  Biagini, Raymond E. ; Borrow RB ; Carlone GM ; Laher G ; Martinez J ; Plikaytis B ; Romero-Steiner S ; Rose C ; Sammons DL ; Smith JP ; Snawder, John E. ; Whaley MJ
• Description:
  Serotype-specific IgG, as quantified by a standardized WHO enzyme-linked immunosorbent assay (ELISA), is a serologic end point used to evaluate pneumococcal polysaccharide-based vaccine immunogenicity. Antibodies to each vaccine polysaccharide in licensed multivalent vaccines are quantified separately; this is laborious and consumes serum. We compared three bead-based immunoassays: a commercial assay (xMAP Pneumo14; Luminex) and two in-house assays (of the Health Protection Agency [HPA] and Centers for Disease Control and Prevention [CDC]), using the WHO-recommended standard reference and reference sera (n /=/11) from vaccinated adults. Multiple comparisons of the IgG concentrations for seven conjugate vaccine serotypes were performed by sample (percent error), serotype (equivalency testing), and laboratory (concordance correlation coefficient [CCC]). When comparing concentrations by sample, bead-based immunoassays generally yielded higher antibody concentrations than the ELISA and had higher variability for serotypes 6B, 18C, and 23F. None of the three assays met the current WHO recommendation of 75% of sera falling within 40% of the assigned antibody concentrations for all seven serotypes. When compared by serotype, the CDC and HPA tests were equivalent for five of seven serotypes, whereas the Luminex assay was equivalent for four of seven serotypes. When overall mean IgG concentrations were compared by laboratory, a higher level of agreement (CCC close to 1) was found among bead-based immunoassays than between the assays and WHO assignments. When compared to WHO assignments, the HPA assay outperformed the other assays (r /=/ 0.920; CCC /=/ 0.894; coefficient of accuracy /=/ 0.972). Additional testing with sera from immunogenicity studies should demonstrate the applicability of this methodology for vaccine evaluation. [Description provided by NIOSH]
• Subjects:
  Antibodies Antigens Diagnosis Immune System Laboratories Occupational Health Safety
• Keywords:
  Antibody-response Diagnostic-techniques Immune-reaction Immunology Laboratory-techniques Laboratory-testing Standards Statistical-analysis Vaccines
• ISSN:
  1556-6811
• Document Type:
  Text
• Genre:
  Journal Article
• Place as Subject:
  Georgia ; Ohio ; OSHA Region 4 ; 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:
  17
• Issue:
  5
• NIOSHTIC Number:
  nn:20036795
• Citation:
  Clin Vaccin Immunol 2010 May; 17(5):862-869
• Contact Point Address:
  Sandra Romero-Steiner, Vaccinology Laboratories, MVPD, DBD, Centers for Disease Control and Prevention, 1600 Clifton Road, Building 18, Room B-105, MS A-36, Atlanta, GA 30333
• Email:
  Ssteiner@cdc.gov
• Federal Fiscal Year:
  2010
• 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:fb0dcd73303bd18530184cc9a652db88f8b490a4b88264efd60c071d18e6b9c869ae8be82068c0e3d99154720ddd57688cd1ca2d57feb0813b19519bb14133f0
• Download URL:
  https://stacks.cdc.gov/view/cdc/188068/cdc_188068_DS1.pdf
• File Type:
  [PDF - 675.25 KB ]