International Bordetella pertussis assay standardization and harmonization meeting report. Centers for Disease Control and Prevention, Atlanta, Georgia, United States, 19–20 July 2007

Anna Giammanco, Messonnier, Han, Tondella, Morris, Burns, Xing, Hueston, Mink, Lynn, Hildreth, Wirsing Von König, Carlone, Poolman, Meade, Guiso, Hewlett, Quinn, Cherry, EdwardsRobbins, Powell

Risultato della ricerca: Articlepeer review

34 Citazioni (Scopus)

Abstract

An international meeting on Bordetella pertussis assay standardization and harmonizationwas held at the Centers for Disease Control and Prevention (CDC), Atlanta, GA, 19–20 July 2007. The goal of the meeting was to harmonize the mmunoassays used for pertussis diagnostics and vaccine evaluation, as agreed upon by academic and government researchers, regulatory authorities, vaccine manufacturers, and theWorld Health Organization (WHO).The primary objectives were (1) to provide epidemiologic, laboratory, and statistical background forsupport of global harmonization; (2) to overview the current status of global epidemiology, pathogenesisand immunology of pertussis; (3) to develop a consensus opinion on existing gaps in understandingstandardization of pertussis assays used for serodiagnosis and vaccine evaluation; and (4) to search for amulticenter process for addressing these priority gaps. Presentations and discussions by content expertsaddressed these objectives. A prioritized list of action items to improve standardization and harmonizationof pertussis assayswas identified during a group discussion at the end of the meeting. Themajor itemsincluded: (1) to identify a group that will organize, prepare, maintain, and distribute proficiency panelsand key reagents such as reference and control sera; (2) to encourage the development and identificationof one or more reference laboratories that can serve as an anchor and resource for other laboratories;(3) to define a performance-based assay method that can serve as a reference point for evaluating laboratorydifferences; (4) to develop guidance on quality of other reagents, e.g., pertussis toxin and otherantigens, and methods to demonstrate their suitability; (5) to establish an international working groupto harmonize the criteria to evaluate the results obtained on reference and proficiency panel sera; (6) tocreate an inventory to determine the amount of appropriate andwell-characterized sera that are availableglobally to be used as bridging reagents for vaccine licensure; and (7) to seek specific guidance from regulatoryauthorities regarding the expectations and requirements for the licensure of new multicomponentpertussis vaccines
Lingua originaleEnglish
pagine (da-a)803-814.
Numero di pagine11
RivistaVaccine
Volume27
Stato di pubblicazionePublished - 2009

All Science Journal Classification (ASJC) codes

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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