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Clinical and Vaccine Immunology, April 2009, p. 558-566, Vol. 16, No. 4
1071-412X/09/$08.00+0     doi:10.1128/CVI.00368-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

Qualification of the Hemagglutination Inhibition Assay in Support of Pandemic Influenza Vaccine Licensure{triangledown}

Diana L. Noah,1* Heather Hill,2 David Hines,3 E. Lucile White,1 and Mark C. Wolff2

Southern Research Institute, 2000 9th Avenue South, Birmingham, Alabama,1 EMMES Corporation, 401 North Washington St., Suite 700, Rockville, Maryland 20850,2 CBR International Corporation, 2905 Wilderness Place, Suite 202, Boulder, Colorado 803013

Received 9 October 2008/ Returned for modification 3 November 2008/ Accepted 6 February 2009

Continued outbreaks of highly pathogenic avian influenza over the past decade have spurred global efforts to develop antivirals and vaccines. As part of vaccine development, standard methods are needed for determining serum antibody titers in response to vaccination. Hemagglutination inhibition (HAI) assays are appropriate for assessing the immunogenicity of pandemic influenza vaccines in support of license approval. We demonstrate that a rigorous qualification of the HAI assay for H5N1 influenza virus, evaluating for precision, intermediate precision, linearity, range, specificity, and robustness, satisfies the intent of regulatory guidance for assay validation despite the lack of availability of specific reference standard antigens and antisera.

* Corresponding author. Mailing address: Southern Research Institute, 2000 9th Avenue South, Birmingham, AL 35205. Phone: (205) 581-2586. Fax: (205) 581-2093. E-mail: noah{at}sri.org

{triangledown} Published ahead of print on 18 February 2009.

Clinical and Vaccine Immunology, April 2009, p. 558-566, Vol. 16, No. 4
1071-412X/09/$08.00+0     doi:10.1128/CVI.00368-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.





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