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 April  14, 2009
 Influenza Options: HAI and Beyond

Speaker for this event:

Keith A. Gottlieb, PhD, Principal Scientist, Clinical Trials Department, Focus Diagnostics, Inc.  Learn More


Influenza Options: HAI and Beyond


This webinar will feature an examination of the current status of the hemagglutination inhibition assay (HAI) as a surrogate test for evaluating serological status to influenza, both vaccines and natural infection.  This program will include guidelines for the assay and describe some of the technical aspects and known shortcomings, such as the variability of this technique both within a single laboratory (validation) and in comparison to other laboratories.  Also included in this discussion will be the current status of the HAI assay for H5N1 vaccine response evaluations.

The presentation help the audience understand some of the known disadvantages of the HAI assay, other assays currently being used in the influenza field will be discussed, including the influenza microneutralization test, single-radial hemolysis, enzyme-linked immunosorbent assay (ELISA), and neuraminidase inhibition.  In addition, a brief mention of some of newer techniques being used to evaluate influenza vaccines, including ELISPOT, will be discussed.

Finally, there will be a brief discussion of the assays Focus has available for influenza vaccine analyses, as well as some of the new tests Focus has developed specifically for this purpose as an example of the portfolio of assays often used in evaluating new influenza vaccine candidates.


Influenza Vaccine Manufacturers and Developers, including individuals who are responsible for outsourcing and determining which tests need to be performed for influenza vaccine candidates (clinical research or clinical immunology) 

  • VP, Director or Manager of Clinical Development or Clinical Operations
  • VP, Director or Manager of Product Development
  • Senior Clinical Research Manager or Director
  • Serology Manager
  • Clinical Affairs  Manager
  • Director of Clinical Immunology
  • Director of Outsourcing


Keith A. Gottlieb, PhD, Principal Scientist, Clinical Trials Department, Focus Diagnostics, Inc. 

Dr. Gottlieb has been the lead scientist responsible for developing numerous assays for the Clinical Trials department at Focus Diagnostics for the last 5 years, including writing over 200 validations, qualifications, and SOPs for analyses of numerous vaccine candidates, including influenza, vaccinia, flaviviruses, poliovirus, and RSV.  He has validated over 25 antigens for HAI and developed ELISA, Luminex, and microneutralization assays for influenza.  He received his undergraduate degree in biology and chemistry at the Johns Hopkins University.  He received his graduate degree in virology from the University of California, Irvine, where he studied the natural infection of polyomavirus in mice.  He then went on to study hantavirus in wild mice in the deserts of New Mexico at the University of New Mexico School of Medicine in Albuquerque, again focusing on the natural infection with particular interest in understanding the transmission, persistence, and reactivation of the virus.


Focus Diagnostics Clinical Trials Program provides highly specialized laboratory services to support the development and commercialization of all types of vaccines. Our clients include researchers and manufacturers of vaccines for influenza, flaviviruses, pneumococcus and other viral and bacterial vaccines. Our expertise is in performing high volume testing of complex methods including viral neutralization, hemagglutination inhibition and other serological and molecular assays.

Pharmaceutical companies choose Focus Diagnostics’ expertise in vaccine and immunological testing with the knowl­edge that Focus will work without compromise to meet budget and schedule requirements, while providing the highest quality testing services. For our clients, this means smoother trials and faster commercialization.


Focus Diagnostics is a Quest Diagnostics company, and when a broader scope of testing is needed, our team can provide our partners with access to Quest Diagnostics’ extensive global capabilities for clinical trials testing.


For more information:  www.focusdx.com


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