Overview of Laboratory of Molecular Virology

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Overview of Laboratory of Molecular Virology

• Indira Hewlett, Ph.D
• Laboratory Chief

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CBER-OBRR DIVISION OF EMERGING TRANSFUSION TRANSM
ITTED DISEASES
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LMV - History

• Created during CBER reorganization of 1992
• Responsible for all HIV tests based on synthetic
  peptides, rDNA and molecular probes
• Acquired responsibility for all HIV and HTLV
  products in 1999
• WNV, Vaccinia virus and software added since 2001

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Laboratory of Molecular Virology Indira Hewlett,
Chief
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LMV mission- Regulatory

• Review and license applications for
• a) in vitro tests (donor screening and
  diagnostic) for HIV, HTLV and other retroviruses
  in blood, plasma and other body fluids e.g. oral
  fluid
• b) WNV donor screening assays since 2003
• c) consult reviews for Smallpox submissions
• d) software and instrument reviews for DETTD

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LMV mission- Regulatory (cont)

• Conventional Ab, Ag and NAT assays, rapid tests
  for diagnosis, patient monitoring, genotyping,
  drug resistance, and home use
• Perform inspections of test kit manufacturing
  facilities
• Develop guidelines, review criteria and standards
  for validation of tests
• Develop policies related to their use through
  interagency/industry and BPAC discussions

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LMV mission Research

• Perform research on HIV-1, HIV-2, HTLV, WNV and
  Vaccinia
• Conduct laboratory investigations of disease
  transmission and pathogenesis
• Develop and evaluate new technologies and methods
  to ensure blood safety from transmission of HIV,
  WNV and Vaccinia
• Develop laboratory standards/panels for
  standardization and lot release of HIV and WNV
  assays

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Research programs

• Hewlett HIV diagnosis and pathogenesis
• -Genetic diversity, diagnostic significance
  and pathogenesis of HIV variants
• -Reference reagents for HIV NAT assays
• Srinivasan Vaccinia virus as a model for
  Smallpox
• -Viremia in vaccinated individuals
• -Molecular basis for myocarditis

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Summary

• LMV has maintained product responsibility for HIV
  tests for over a decade
• New product responsibilities including WNV,
  Vaccinia, software/instruments
• LMV has maintained and initiated new research
  programs to support its regulatory function