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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.

 

The HPTN Network laboratory has developed a brief presentation as our way of introducing the HPTN  NL to new sites and as an update to those sites we have worked with previously.

 

View Network Lab Intro video 

• 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

1. Participate in management of the HPTN and establishment of the HPTN Scientific Agenda.

2. Provide laboratory-based scientific leadership and consultation to the HPTN.

3. Participate in HPTN protocol development and review.

4. 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.

5. Provide processing, storage and retrieval guidelines for domestic and international HPTN trial specimens.

6. Provide QA for specimen processing, assay performance and specimen-related data transmission for testing performed at CTU laboratories.

7. Provide training and infrastructure support in laboratory QA, assay performance and specimen shipping procedures at CTU laboratories.

8. Provide continued opportunities for technology transfer, particularly to international HPTN laboratories.

9. Perform novel and routine immunologic, virologic, pharmacologic and other testing for HPTN protocols.

10. Evaluate and validate new assays for clinical trials of HIV prevention, with particular emphasis on assays that can be used in HPTN trials.

11. Coordinate procedures for transmission of laboratory data to the HPTN SDMC

12. Work with the Managing Partners and Cross Network Committees to harmonize laboratory procedures across DAIDS-sponsored networks.

13. Develop QA/QC and training tools and materials for use in domestic and international laboratories across DAIDS-sponsored networks.

14. Publish findings of assay development/evaluation and pathogenesis-based studies.

CTU Laboratory Expectations

CTU Laboratories are expected to do the following:

1. Routine safety laboratory assays including hematology and chemistry

2. HIV antibody testing

3. CD4/CD8 cell counts

4. HIV RNA PCR testing (preferably Roche AMPLICOR version 1.5)

5. have adequate monitored specimen storage equipment and backup

6. Meet IATA regulations for shipment of specimens

7. Adhere to good clinical laboratory practices in performance of assays for HPTN trials

8. Participate in proficiency testing panels and maintain adequate proficiency in protocol related testing

9. 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:

1. Validation of assay runs

2. Retesting

3. Turn Around Time (TAT)

4. Proficiency Testing

5. Integrity and security of specimen repository

Network Laboratory News

• Updated PBMC Training Video

• Memo regarding PBMC SOP version 4

• GCLP Standards version 2.0 posted - PDF files of the GCLP Standards are available in the following languages: Chinese, English, French, Khmer, Portuguese, Spanish and Thai.  (Please read the note on submitting comments regarding translations.)

• Specimen Management Training Video

• Cross Network PBMC Processing SOP Version 4

• New Shipping Label Requirement
  Effective January 1, 2007, all UN3373 labels need to be changed to include
  "Biological Substance Category B" - learn more

• Online Western Blot Training

Network Laboratory Resources

• CTU Laboratory Support   (MS Word)    (PDF)

• LDMS Barcoding Documentation for the HPTN and MTN Networks

• LDMS Operational Plan

• Wet Mount Proficiency Test

• 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

Namandje Bumpus get info

Karen Carroll get info

William Clarke get info

Tynia Conley get info

Vanessa Cummings get info

Barbara Debevec 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