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Consensus Laboratory Assay Protocols -- Virology

DAIDS and collaborating investigators have developed consensus assay methodologies for implementation in multi-site investigations. These methodologies have been collated into the Virology Manual for HIV Laboratories . This manual includes assay protocols for viral load detection, virus quantitation, and assessment of HIV (and CMV) virus drug susceptibility, addresses laboratory biosafety issues, and provides recommendations for specimen processing, storage and shipping.

Virology Quality Assessment Program

To enhance the integrity and comparability of virological laboratory evaluations performed on samples from patients enrolled in multi-site HIV/AIDS investigations, the Virology Quality Assessment Program (VQAP) was established to assist DAIDS-sponsored and collaborating investigators by:

• Providing proficiency testing programs to assess the ability of laboratories to perform HIV RNA, quantitative micrococulture, DNA PCR, and ICD p24 antigen assays
  
• Providing controls and standards for real-time validation of assays performed on patient specimens
  
• Supporting the adaptation, standardization and quality assessment of novel virological assays for implementation in multi-site investigations
  
• Providing statistical support for proficiency testing and assay development efforts

Please contact Dr. Joe Fitzgibbon (phone: 301-451-2738; email: jfitzgibbon@niaid.nih.gov) or Dr. Michael Ussery (phone: 301-402-0134; email: mussery@niaid.nih.gov ) for additional information regarding this program.

Other Virology Performance Evaluation Programs

• The College of American Pathologist offers Proficiency Testing for HIV-1 p24 antigen, DNA PCR, and RNA quantitation. For more information please call 800-323-4040 (select option 3) or fax 800-289-1815.
  
• The Centers for Disease Control and Prevention offer Performance Evaluation/Proficiency Testing Programs for determinations of HIV p24 antigen and HIV RNA copy number in blood.
  
• The European Network for the Virological Evaluation of International Trials for New Anti-HIV Therapies (ENVA) provides proficiency panels for RNA quantitation and genotypic assessment of drug resistance. This service is administered from Virology Networks B.V. in the Netherlands (phone: 31-30-230-7140; fax: 31-30-236-8025; e-mail: Wessel.Kok@vironet.com).

Sample Publications on Performance Evaluation and Assay Development

• H. Lin, et al. 1994. Multicenter evaluation of methods for the quantitation of plasma HIV-1 RNA. J. Infect. Dis. 170:553-562.
  
• B. Yen-Leiberman, et al. 1996. Preliminary evaluation of a quality assurance program (QAP) for detection of Human Immunodeficiency Virus Type-1 plasma RNA by the AIDS Clinical Trials Group (ACTG). J. Clin. Micro. 43:2695-2701.
  
• P. Reichelderfer, et al. 1994. Quality assurance and the use of PCR in clinical trials. PCR Methods and Applications 4:S141-S149.
  
• A. Japour, et al. 1995. Prevalence and clinical significance of zidovudine resistance mutations in human immunodeficiency virus isolated from patients following long-term zidovudine treatment. J. Infect. Dis. 171:1172-1179.
  
• For a more complete list of publications arranged by assay type please click here.