​HANC coordinates 13 cross-Network laboratory working groups and committees.

Lab Principal Investigator (PI)/Manager Committee

The Lab PI/Manager Committee is comprised of PIs and managers of the Network Laboratories, who are responsible for the oversight of all laboratory activities within their Networks. This committee also includes representatives of DAIDS, representatives of the statistical and data management centers (SDMC)quality assurance contractors and laboratory technologists. As a group, these top-level laboratory representatives identify and address laboratory training, operations, and support issues that apply across networks.

The Lab PI/Manager Committee sometimes creates ad hoc working groups to complete specific projects. For example, the ad hoc Brazil Panel Shipping Working Group developed a centralized shipping scheme for safety proficiency testing panels in Brazil.

The ACTG/IMPAACT LTC serves as an online forum for the development and publication of the ACTG/IMPAACT Laboratory Manual. The ACTG/IMPAACT Laboratory Manual is an online resource for all ACTG and IMPAACT laboratories that provides guidelines for laboratory practice, specimen processing, shipping, immunologic methods and virologic methods. HANC also coordinates other projects for the LTC on an ad-hoc basis.

The CPQA program ensures that the testing of various pharmacologic substances, such as therapeutic anti-retroviral drugs, is performed accurately in network laboratories.
The CPQA Advisory Board serves as a forum for the networks to share which pharmacologic substances require quality assurance for their studies, provides oversight for the CPQA programs, and determines many of the processes and procedures for the CPQA’s proficiency testing program.

The CPQA Cross-Network Laboratory Group is composed of technical representatives (supervisors, technicians) from each network pharmacology laboratory and facilitates communications between the CPQA program and pharmacology laboratories.  Group members discuss key information about each program area’s activity and the laboratories’ anticipated participation in the activity. The laboratories provide feedback regarding pharmacology quality assurance activities and needs. 

The CPQA Steering Committee consists of operational representatives from the CPQA and subcontractor(s), such as Frontier Science & Technology Research Foundation (FSTRF) and RTI International.  It meets quarterly to receive direction and provide feedback regarding operating status of the program areas.  The CPQA Steering Committee operates the following areas of the CPQA program:

• Biannual and unique proficiency testing rounds
• Assay development, validation and implementation assignments
• Training
• Data management
• Communications and website activities/functions

The IQA CD4 Working Group addresses CD4 proficiency testing issues identified by the IQA and the United Kingdom National External Quality Assessment Service (UK NEQAS) at international network laboratories. CD4+ T-cells are the cells attacked by HIV, and the number of CD4 cells a person has is used to diagnose and track the progression of AIDS. Therefore, a laboratory's ability to accurately and reliability determine a person's level of CD4 cells is critical for appropriate clinical care and analysis of clinical trials data.

ICAG is establishing a robust PBMC cryopreservation external quality assurance program in collaboration with the IQA. The purpose of this program is to ensure that laboratories that cryopreserve PBMC for network studies can effectively do so in a manner that preserves the integrity and usefulness of the samples.

The LFG does much of the detailed background work, document development, and follow-up work to complete projects and tasks identified by the Lab PI/Manager Committee. The LFG has recently developed a HANC Laboratory Database for use by Networks and contractors and developed an HIV Diagnosis Algorithm for use by Network Laboratories in clinical trials. It is currently updating a Total Quality Management document to guide quality management in immunology, pharmacology, virology, safety, and PBMC cryopreservation, considering options for tracking laboratory-related training, and developing a comprehensive plan for utilizing back-up laboratories.

LFG-DCLOT serves as a forum for discussion of various laboratory matters that require input from all the networks and DAIDS.

The PBMC SOP Working Group is charged with developing, publishing and annually reviewing a cross-Network PBMC Processing SOP for all Network-affiliated labs that process PBMC.

The Malaria Laboratory Working Group held its first call in May, 2010. A preliminary group of goals includes:

• Determine the needs for sensitivity for nucleic acid tests
• Provide a range of standardized tools for assaying at various levels of sensitivity
• Oversee malaria laboratory readiness for participation in network protocols with malaria diagnostics endpoints
• Provide guidelines for standardized preparation of samples and diagnosis
• Develop a standard process for validating novel assays, point-of-care and rapid tests
• Develop lists of resources, references and reagents
• Serve as a resource for protocols teams as they develop protocols with malaria endpoints
• Survey current network laboratories for malaria diagnostics capabilities

The TBLDWG identifies, evaluates and prepares international site labs with the capacity for TB laboratory diagnostic testing for participation in network clinical trials that require the identification of people will both TB and HIV. These sites might also become regional teaching centers. The TBLDWG works with Patient Safety Monitoring and International Laboratory Evaluation (pSMILE) to conduct evaluation site visits to these laboratories.

In addition, the TBLDWG pursues a coordinated international approach to TB diagnostics and quality assessment. It explores opportunities for collaboration with other organizations that are developing new TB diagnostics techniques, and the use of network laboratories for the validation of new point-of-care diagnostic technologies in pediatric and adult, HIV-positive and HIV-negative populations.

The VQAAB addresses virology proficiency testing issues identified by the Virology Quality Assurance (VQA) to ensure that laboratories conducting viral load assays are doing so effectively. VQA resources and VQAAB records are available here on the HANC website. The VQAAB is also reviewing reports from the VQA of viral load assay validation at Network-affiliated laboratories.

Viral load assays measure the number of HIV virions or “particles” in a blood or other bodily fluid sample, and so are an important indicator of a person's health and prophylactic and therapeutic efficacy. As new techniques for measuring viral load become available, they must be validated to ensure that the results obtained from the new assays are comparable to those obtained with the older assays. Furthermore, each laboratory that conducts viral load assays must show that it can effectively use the new technology.