Specimen Requests

WIHS Specimen Requests and Repository Information

Investigators with an EC-approved concept sheet are able to request access to WIHS specimens. The WIHS collects and stores a variety of biological specimens, including plasma, viable cells, and DNA.

WIHS Repositories

  • Precision Bioservices (Frederick, MD)
    • WIHS central repository
    • WDMAC coordinates/completes repository requests
    • Specimen types available (most commonly used):
      • Serum
      • Plasma
      • Viable cells (PBMCs)
      • Dry cell pellets
      • Urine (whole and supernatant)
      • CVL (whole)
      • Cervical swabs
      • Stimulated saliva
  • Local Repositories
    • Site coordinates/completes repository requests
    • Site maintains specimen inventory
    • Requests to use local repository specimens go through site directly
  • WIHS DNA Repository (New York, NY)
    • Managed by NYU under the advisement of Dr. Bradley Aouizerat
    • Requests for DNA are submitted to WDMAC
    • Site coordinates/completes all DNA repository requests
    • Site maintains DNA inventory
  • Fisher Bioservices (Rockville, MD)
    • Bacterial Vaginosis (BV) slides
      • WDMAC coordinates/completes all BV requests
      • Slides stored for testing from V12 –V38
    • Immortalized B-cell lines
      • Program ended July 2004
      • 60% of WIHS participants have established B-cell lines
      • Per program, each participant would have four vials of viable B-cells and six vials of cell pellets
      • Only cell pellets can be distributed to investigators

Before Submitting Request

  • Make sure you have:
    • Funding
    • Freezer space
    • Personnel and materials necessary for testing
    • IRB approval to receive specimens

How to Request Specimens: Choosing ID-VISITS

  • Method One: WDMAC Selects
    • Investigator has EC-approved concept sheet
    • Investigator provides WDMAC Project Director (PD) with (submit to JHSPH.wdmac@jhu.edu):
    • WDMAC PD approves and assigns a WDMAC programmer
    • WDMAC programmer works with investigator to select final list of id-visits
    • Final list of id-visits is given to WDMAC coordinator for processing
  • Method Two: Investigator Selects
    • Investigator has EC-approved concept sheet
    • Investigator selects final list of id-visits based on criteria in concept sheet
    • Investigator provides WDMAC PD with (submit to JHSPH.wdmac@jhu.edu):
      • Excel spreadsheet, SAS data file, or ASCII file of id-visits
      • WIHS Central Repository Checklist
    • WDMAC PD approves
    • Final list of id-visits is given to WDMAC coordinator for processing

By submitting a WIHS Central Repository Checklist to WDMAC, you are indicating that you are ready to receive specimens.

WIHS Specimen Allocation Committee (WSAC) Review

  • WDMAC checks all requests for VIP specimens (see table below)
  • If VIP id-visits included in request:
    • WSAC completes one-week review
    • WSAC will approve as is, approve with modification, or will not approve VIP id-visits.
  • If no VIP id-visits, specimen request moves forward without WSAC review
VIP – High Value Event Definition Restricted Visits
HIV Seroconverters All women who have become HIV+ during the study 3 last negative visits and all post-seroconversion visits
Incident Cancer Confirmed incident cancers while in the WIHS Up to 4 pre-cancer visits and 1st reported cancer visit
ART-Naïve HAART Initiators ART-naïve HAART initiator; Cannot occur at baseline visit 1 visit prior and 3 visits after HAART initiation
Long-Term Non-Progressors CD4 >500 for 5+ years; No ART; A single CD4 measurement between 350-500 is allowed during that time period All
Elite Controllers HIV RNAAll
Pre-HAART Deaths HIV+; Died prior to 9/30/97 with at least two years of follow-up All

Specimen Selection/Submittal

  • Specimens are requested using final list of id-visits
  • WDMAC works with investigator regarding:
    • Vial warnings
    • Alternate id-visits (if no specimens remain)
    • Volume concerns
  • Specimen selection takes approximately 1-2 weeks
  • Once complete, WDMAC provides investigator with:
    • Requisition number for request
    • Excel spreadsheet of final id-visits requested
    • List of any id-visits dropped or replaced
    • List of any transfer id-visits in request
  • Discrepancy reports
    • WDMAC handles all discrepancy reports
    • In some cases:
      • Alternate id-visits may be selected
      • Id-visits may need to be dropped

Specimens will be received within 10 business days from submittal of request by WDMAC.

Unused Material

Once specimens have left the repository, been thawed, and/or used for testing, they cannot be returned to the repository. Left-over materials cannot be used for other studies not described in the EC-approved concept sheet.

Repository Files

  • Following central edits and data freeze:
    • WDMAC Data Manager (DM) requests inventory dump of repository database contents
    • DM checks file for correct wihsid numbers, transfer ids, visit numbers, and visit dates
    • DM works with WDMAC coordinator to correct any inconsistencies in repository database
    • Data files are created by specimen type (according to S-code and/or material modifiers)
    • Data files are available to investigators by request

Restrictions on Samples

  • Use of last vial for any id-visit:
    • WDMAC asks investigator to select alternate id-visit
    • If no alternates exist, investigator can:
      • Contact local repositories to obtain specimens
      • Petition the EC for approval to use the last vial
    • VIP specimens:
      • Use of VIP specimens must be approved by WSAC

DNA is available from approximately 3,000 participants enrolled at Bronx, Brooklyn, DC, Los Angeles, San Francisco, and Chicago WIHS sites. DNA is not currently available from Atlanta, UNC, Miami, or UAB-MS WIHS sites.

Transfer of Results

The WIHS releases specimens to investigators with the understanding that the WIHS is entering into a full collaboration with the study investigator. All data generated from testing of WIHS specimens must be submitted to WDMAC following the acceptance of the first publication using the WIHS data.

Results should be sent to the WDMAC DM with the following information (in Excel or ASCII):

  • Brief synopsis of project and type of testing performed
  • Codebook detailing result ranges and full test names
  • Include (at the very least): wihsid, visit, specimen collection date, test(s) result(s)