Abstract

The Division of AIDS, NIAID, NIH intends to award a contract for a Virology Quality Assurance Program to ensure the integrity and comparability of virologic laboratory data obtained from multi-center AIDS clinical trials sponsored by the Division of AIDS. To that end, the Contractor will obtain, characterize and store quality control materials, such as whole blood from HIV positive and negative donors, viral lysates with varying concentrations of HIV p24 antigen, HIV proviral DNA copy number standards, and other HIV and its associated co-pathogens viral probes and reagents. These materials will be shipped periodically to 60 - lOO designated laboratories for the purpose of monitoring virologic assay performance through a program of proficiency testing and real-time assay validation. In addition, the Contractor will facilitate the field testing of virologic assays prior to their implementation in clinical trials; evaluate and compare assay methodologies and commercial assay kits/reagents; and apply existing or novel statistical models for evaluation, interpretation and display of virologic assay test results. These activities will be supported by a computerized database and analysis systems.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research and Development Contracts (N01)
Project #
N01AI035172-004
Application #
2295856
Study Section
Project Start
1993-09-01
Project End
1998-08-31
Budget Start
1994-09-23
Budget End
1995-11-30
Support Year
Fiscal Year
1994
Total Cost
Indirect Cost

  Institution

Name
Rush University Medical Center
Department
Type
DUNS #
City
Chicago
State
IL
Country
United States
Zip Code
60612

  Publications

Caliendo, Angela M; Valsamakis, Alexander; Bremer, James W et al. (2011) Multilaboratory evaluation of real-time PCR tests for hepatitis B virus DNA quantification. J Clin Microbiol 49:2854-8
Caliendo, Angela M; Ingersoll, Jessica; Fox-Canale, Andrea M et al. (2007) Evaluation of real-time PCR laboratory-developed tests using analyte-specific reagents for cytomegalovirus quantification. J Clin Microbiol 45:1723-7
Caliendo, A M; Valsamakis, A; Zhou, Y et al. (2006) Multilaboratory comparison of hepatitis C virus viral load assays. J Clin Microbiol 44:1726-32
McSharry, J M; Lurain, N S; Drusano, G L et al. (1998) Flow cytometric determination of ganciclovir susceptibilities of human cytomegalovirus clinical isolates. J Clin Microbiol 36:958-64
Holodniy, M; Anderson, D; Wright, D et al. (1998) HIV quantitation in spiked vaginocervical secretions: lack of non-specific inhibitory factors. DATRI 005 Study Team. Division of AIDS Treatment Research Initiative. J Virol Methods 72:185-95