Network Laboratory
Under the leadership of Susan Eshleman of Johns Hopkins University, the NL is responsible for collecting, testing and reporting results from biological samples; assisting in the development and quality assurance assessment of local laboratory capacity at the Clinical Trials Units (CTUs) participating in HPTN clinical trials; and identifying and implementing state-of-the-art assays and technologies to advance the scientific agenda of the Network.
- Network Laboratory Objectives
- CTU Laboratory Expectations
- Primary Network Lab (PNL) Assignments
- Quality Assurance Measurements
- Network Laboratory News
- Network Laboratory Resources
- Network Laboratory Staff and Affiliates
Network Laboratory Objectives
- Participate in management of the HPTN and establishment of the HPTN Scientific Agenda.
- Provide laboratory-based scientific leadership and consultation to the HPTN.
- Participate in HPTN protocol development and review.
- Collaborate with other National Institutes of Health (NIH)-sponsored HIV clinical trials networks to harmonize laboratory methods and maximize the efficiency of protocol development, implementation and analysis.
- Provide processing, storage and retrieval guidelines for domestic and international HPTN trial specimens.
- Provide QA for specimen processing, assay performance and specimen-related data transmission for testing performed at CTU laboratories.
- Provide training and infrastructure support in laboratory QA, assay performance and specimen shipping procedures at CTU laboratories.
- Provide continued opportunities for technology transfer, particularly to international HPTN laboratories.
- Perform novel and routine immunologic, virologic, pharmacologic and other testing for HPTN protocols.
- Evaluate and validate new assays for clinical trials of HIV prevention, with particular emphasis on assays that can be used in HPTN trials.
- Coordinate procedures for transmission of laboratory data to the HPTN SDMC
- Work with the Managing Partners and Cross Network Committees to harmonize laboratory procedures across DAIDS-sponsored networks.
- Develop QA/QC and training tools and materials for use in domestic and international laboratories across DAIDS-sponsored networks.
- Publish findings of assay development/evaluation and pathogenesis-based studies.
CTU Laboratory Expectations
CTU Laboratories are expected to do the following:
- Routine safety laboratory assays including hematology and chemistry
- HIV antibody testing
- CD4/CD8 cell counts
- HIV RNA PCR testing (preferably Roche AMPLICOR version 1.5)
- have adequate monitored specimen storage equipment and backup
- Meet IATA regulations for shipment of specimens
- Adhere to good clinical laboratory practices in performance of assays for HPTN trials
- Participate in proficiency testing panels and maintain adequate proficiency in protocol related testing
- Use the Laboratory Data Management System (LDMS) for specimen storage, tracking and shipping
Quality Assurance Measurements
The Quality Assurance (QA) staff at the Network Lab will measure the following parameters on an ongoing basis:
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Validation of assay runs
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Retesting
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Turn Around Time (TAT)
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Proficiency Testing
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Integrity and security of specimen repository
Network Laboratory News
- New! Specimen Management Training VIdeo
- New Cross Network PBMC Processing SOP Now Available!
- New Shipping Label
Requirement
Effective January 1, 2007, all UN3373 labels need to be changed to include "Biological Substance Category B" - learn more - New Online Western Blot Training
Network Laboratory Resources
- CTU Laboratory Support (MS Word) (PDF)
- HPTN-MTN Lab Manual
- LDMS Barcoding Documentation for the HPTN and MTN Networks
- LDMS Operational Plan
- Wet Mount Proficiency Test
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PBMC Cryopreservation Training
- CD4 Flow Cytometry Q&A
- CD4 Enumeration E-Learning Course
- HIV Antibody Testing Algorithm
- Laboratory Shipping Label Notice
- VQA HIV RNA Proficiency Testing
- Western Blot Proficiency Testing
Network Laboratory Staff & Affiliates
Yaw Agyei get info
Robert C. Bollinger get info
Marcelo Cardona get info
Karen Carroll get info
William Clarke get info
Tynia Conley get info
Vanessa Cummings get info
Susan Eshleman get info
Charlotte A. Gaydos get info
Lisa Heid get info
Craig Hendrix get info
Danielle Heyl get info
Sarah Hudelson get info
LeTanya Johnson-Lewis get info
Danielle Jones get info
Lebah Lugalia get info
Joseph Margolick get info
Terry Parsons get info
Estelle Piwowar-Manning get info
Paul Richardson get info
Theresa Shapiro get info
Alexandra Valsamakis get info
Michelle Xing get info
