Retrovirus Epidemiology Donor Study (REDS): Special Repository (SR) Collections

Objectives

The objective REDS-I was to develop a major multicenter epidemiologic study of the human retroviruses HIV-1, HIV-2, HTLV-I, and HTLV-II in volunteer U.S. blood donors. Blood samples collected at the time of donation and/or in follow-up visits, were submitted to special repositories. Criteria for submission to these special repository collections were the status of HTLV and HIV testing.

Background

REDS completed the collection of a large inventory of blood specimens from donors with specific test results for epidemiological and/or laboratory investigations of particular subpopulations of donors as the need arises. These eight special repositories (SRs) consist of specimens from donors who tested positive on routine screening assays, such as HTLV and HIV. Because of the unique linkage to demographic data and donation test results collected in the study database, investigations using these samples can be targeted to particular subsets of the blood donor population.

REDS blood centers that contributed to these repositories include:

• American Red Cross - Greater Chesapeake and Potomac Region, Baltimore, MD;
• American Red Cross - Southeastern Michigan Region, Detroit, MI;
• American Red Cross - Southern California Region, Los Angeles, CA;
• Blood Centers of the Pacific - San Francisco, CA; and
• Oklahoma Blood Institute - Oklahoma City, OK.

Descriptions of SR Collections

Special Repository Collection #1: HTLV I/II Antibody Reactive Donations

This collection was established in late 1990 and closed in 2002. It consists of 11,148 blood samples, obtained from 10,685 donations in the contributing REDS blood centers, found to be repeatedly reactive for HTLV-I/II antibodies by routine EIA screening. Available specimen types include whole blood and plasma. Serum was also collected from subjects in the period of 1990-1994 and whole blood was stored with and without DMSO beginning in late 1994.

Biospecimens from this collection have been used to validate new test methodologies including PCR and peptide tests that serologically distinguish HTLV-I from HTLV-II infection (see Publication #1 below). Additionally, samples from this repository were used to investigate over 400 HTLV indeterminate donors for the presence of occult HTLV infection using PCR assays (see Publication #2 below).

Special Repository Collection #3: HIV-1 Antibody Indeterminate Donations

This collection contains 523 follow-up samples from blood donors who tested HIV-1/2 antibody EIA repeat reactive and Western Blot indeterminate at the time of initial blood donation. This repository was established in 1991 and ended in August of 1995 after a study showed that none of the donors with HIV indeterminate test results were infected with HIV-1 (see Publication #3 below). Available specimen types include whole blood and plasma. Serum was also collected from subjects in the period of 1991-1994 and whole blood was stored with and without DMSO beginning in late 1994.

Special Repository Collection #4: HIV-2 Antibody Reactive, HIV-1 Antibody NonReactive Donations

This collection consists of follow-up samples obtained from 13 blood donors that did not test positive for HIV-1 but did test HIV-2 repeat reactive. This collection was opened in 1994 and discontinued in December 1996. Available specimen types include whole blood and plasma. Serum was also collected from subjects in 1994 and whole blood was stored with and without DMSO in 1995-1996.

Special Repository Collection #5: HIV 1/2 Antibody Reactive, HIV P24 Antigen Nonreactive Donations

This collection, comprised of 5,808 samples representing 5,665 donations, was initiated in late 1994 to capture all HIV antibody repeat reactive donations in the contributing REDS blood centers. These specimens can be used for studies of donors truly infected with HIV and for investigations of donors with false positive screening results. Whole blood with and without DMSO and plasma were collected.

Special Repository Collection #6: HIV p24 Antigen Reactive, HIV Antibody Nonreactive Donations

This collection was initiated on March 1996 after implementation of HIV-1 p24 antigen testing at the REDS blood centers. Donation components from donors who tested HIV-1 p24 antigen repeat reactive and HIV antibody nonreactive were eligible for this repository. These samples were used for HIV RNA PCR testing (see Publication #4 below). There are 2,220 samples in this repository representing 2,007 donations. Whole blood with and without DMSO and plasma were collected.

Special Repository Collection #5/6: HIV Antibody & Antigen Reactive Donations

This is a collection of 27 samples, representing 25 donations, that were repeat reactive for both HIV antibody and antigen. The specimens were collected between March 1996 and December 2002. Whole blood with and without DMSO and plasma were collected.

Special Repository Collection #7: HIV p24 Antigen Reactive Serum

This collection consists of 252 serum samples representing 240 donations and was also initiated in March 1996 with implementation of HIV-1 p24 antigen testing. It closed in November 1997. Samples for the Special Repository Collections were normally obtained from the donation collection bags of whole blood, packed red blood cells and fresh frozen plasma. However, due to the long lag time for completion of HIV antigen testing, an alternative source was used such as a retention or pilot tube. Most samples in SR#7 have a sample in SR#6 from the same donation.

Special Repository Collection #9: HIV-1 Antibody Positive Donations

This collection of plasma specimens was established in collaboration with American Red Cross (ARC)-National Reference Laboratory for Infectious Disease and includes 3,520 confirmed HIV-1 antibody positive samples collected by REDS blood centers as well as all ARC centers between 1992 and 1999. These samples of residual volume have been used to perform the HIV-1 antibody LS-EIA assay (the sensitive/less sensitive assay) that helped identify donors with recently acquired HIV infection. It was shown that when the samples are tested with current routine screening procedures and then again with the lower sensitivity assay it is possible to distinguish between recent and older infection.

Publications

1. Kleinman S, Kaplan J, Khabbaz R, Calabro M, Thomson R, Busch M, and the REDS Study Group. Evaluation of a p21e-spiked Western blot (Immunblot) in confirming human T-cell lymphotropic virus type I or II infection in volunteer blood donors. J Clin Microbiol. 1994; 32: 603-607.

2. Busch M, Laycock M, Kleinman S, Wages J Jr, Kaplan J, Khabbaz R, Hollingsworth C, and the REDS Study Group. Accuracy of supplementary serologic testing for human T-lymphotropic virus types I and II in US blood donors. Blood. 1994;83:1143-1148.

3. Busch M, Kleinman S, Williams A, Smith J, Ownby H, Laycock M, Lee L, Pau C, Schreiber G. and the REDS Group. Frequency of human immunodeficiency virus (HIV) infection among contemporary anti-HIV-1 and anti-HIV-2 supplemental test-indeterminate blood donors. Transfusion. 1996;36:37-144.

4. Kleinman S, Busch M, Ownby H, Williams A, Gilcher R. HIV p24 antigen (Ag) indeterminate (Ind) donors are not infected with HIV (abstract). Transfusion. 1997; 37S:98S.

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