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PLASMA 35,138
SERUM 212,668

Study Documents

PDF Data Dictionary (PDF - 547.1 KB)
PDF CA Recipient Protocol (PDF - 63.1 KB)
PDF CCD Protocol (PDF - 69.1 KB)
PDF CD (HIV) Protocol (PDF - 76.7 KB)
PDF Donor Catalog (PDF - 51.1 KB)
PDF Donor(HIV)-Recipient Protocol (PDF - 169.8 KB)
PDF Donor(HTLV-I)-Recipient Protocol (PDF - 101.1 KB)
PDF Donor(HTLV-III)-Recipient Protocol (PDF - 178.7 KB)
PDF Final Report (PDF - 243.5 KB)
PDF HTLV-I CD Protocol (PDF - 67.2 KB)
PDF Publications and Presentations (PDF - 140.1 KB)
PDF Sexual Transmission of HIV Protocol (PDF - 45.8 KB)
PDF Subject Catalog (PDF - 51.7 KB)

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Transfusion Safety Study (TSS)

Clinical Trials URL:
Study Type: Epidemiology Study
Prepared on February 8, 2010
Study Dates: 1984 - 1997
Consent: Unrestricted Consent
Commercial Use Restrictions: No
NHLBI Division: DBDR
Collection Type: Open BioLINCC Study - See bottom of this webpage for request information


To develop two donor-recipient repositories consisting of a serum repository from 200,000 donors in high AIDs prevalence areas of the United States and a plasma and cell repository from subjects consisting of blood donors, transfusion and other blood product recipients and control cohorts. The purpose was to be able to determine the outcome of the transfusion of blood components whose donors would be excluded when screening tests for anti-HIV-1 infection became available. A secondary consideration was to be able to determine the outcome of the transfusion of blood components from donors with positive tests for other viruses subsequently found to be of importance in transfusion medicine.


In the early 1980’s there were reports of AIDS in patients with hemophilia and in others receiving blood transfusions. The incidence of transfusion-acquired AIDS was so low as to preclude a general prospective study of transfusion recipients to determine the overall incidence of the disease. By focusing on patient groups that appeared to have a higher likelihood for developing AIDS because they required chronic, repeated transfusion therapy, information about the epidemiology of the disorder could be more readily obtained. Continuing medical evaluation of these patients from apparent high-risk groups in a prospective fashion allowed identification of significant emerging physiologic alterations and to follow the time-course of pathologic developments.


Donor Serum Repository Subjects for the donor repository were recruited from persons who presented to make blood donations at study sites. Blood service staff followed the established blood donation procedures in practice during the period of September 1984 through February 1985 to determine eligibility to donate blood. All potential donors were explained the objectives of TSS. Participants agreed to have an additional blood sample collected and stored from anti-HIV-1 testing, when it became available and to be contacted later if participation would be helpful to the conduct of the study.

Subject Repository The study cohorts included; HIV-infected donors and controls; HIV-exposed transfusion recipients and controls; sexual contact of HIV study recipients; HTLV-infected donor and controls; HTLV-exposed recipients and controls; household contacts of HTLV study donors and recipients; and persons with congenital clotting disorders or congenital anemias and their respective household and sexual contacts. A total of 4,084 subjects were enrolled and followed every six months.


Donor Serum Repository A serum repository for HIV testing was established and collected approximately 200,000 sera from blood donors in late 1984 and early 1985 in metropolitan areas of the US with the highest prevalence of AIDS. Blood donors were also asked for permission to contact them later if the results of such tests indicated that further observations would yield useful scientific information.

Subject Repository Subject recruitment began following testing of the donor repository specimens for antibodies to HIV. Subjects were entered in July 1985 through June 1989. Analysis continued through November 1997. At baseline, each subject received a physical examination, was questioned as to medical history, and gave blood samples for immunologic and other studies. Each subject returned at a specified interval for a repeat of studies specified in the protocol. Blood studies included complete blood cell count, characterization of immunologic cells such as T- and B-lymphocytes and natural killer-cells. Plasma (see Footnote 1 below) and Buffy coat cell suspensions were stored frozen. Alanine aminotransferase levels were determined. Serologic tests were performed for hepatitis, Epstein-Barr virus, and cytomegalovirus. Markers of immune status, including immune globulin levels were measured.


  1. Disclaimer statement on material type in TSS subject repository: Requestors of specimens from the TSS Subject Repository are hereby notified of a discrepancy in the documentation of this historical collection that the NHLBI Biological Specimen Repository is unable to resolve. A large proportion of the blood fluid specimens were recorded in the study database as plasma/serum. While TSS Subject study protocol specified collection of 5 mls of plasma in 2 aliquots, the NHLBI Biorepository cannot confirm the material type as plasma.


1. Diaz RS, Pardini R, Catroxo M, Operskalski EA, Mosley JW, Busch MP. HIV-1 superinfection is not a common event. J Clin Virol. 2005; 33(4):328-30. PMID: 16036183.

2. Grossman Z, Herberman RB, Vatnik N, Intrator N. Conservation of total T-cell counts during HIV infection: alternative hypotheses and implications. J Acquir Immune Defic Syndr Hum Retrovirol. 1998; 17(5):450-7. PMID: 9562048.

3. Operskalski EA, Stram DO, Busch MP, Huang W, Harris M, Dietrich SL, Schiff ER, Donegan E, Mosley JW. Role of viral load in heterosexual transmission of human immunodeficiency virus type 1 by blood transfusion recipients. Transfusion Safety Study Group. Am J Epidemiol. 1997; 146(8):655-61. PMID: 9345119.

4. Operskalski EA, Mosley JW, Busch MP, Stram DO. Influences of age, viral load, and CD4+ count on the rate of progression of HIV-1 infection to AIDS. Transfusion Safety Study Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1997; 15(3):243-4. PMID: 9257660.

5. Operskalski EA, Busch MP, Mosley JW, Stram DO. Comparative rates of disease progression among persons infected with the same or different HIV-1 strains. The Transfusion Safety Study Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1997; 15(2):145-50. PMID: 9241114.

6. Wong WY, Zhou Y, Operskalski EA, Hassett J, Powars DR, Mosley JW. Hematologic profile and lymphocyte subpopulations in hemoglobin SC disease: comparison with hemoglobin SS and black controls. The Transfusion Safety Study Group. Am J Hematol. 1996; 52(3):150-4. PMID: 8756079.

7. Busch MP, Operskalski EA, Mosley JW, Lee TH, Henrard D, Herman S, Sachs DH, Harris M, Huang W, Stram DO. Factors influencing human immunodeficiency virus type 1 transmission by blood transfusion. Transfusion Safety Study Group. J Infect Dis. 1996; 174(1):26-33. PMID: 8656010.

8. Operskalski EA, Stram DO, Lee H, Zhou Y, Donegan E, Busch MP, Stevens CE, Schiff ER, Dietrich SL, Mosley JW. Human immunodeficiency virus type 1 infection: relationship of risk group and age to rate of progression to AIDS. Transfusion Safety Study Group. J Infect Dis. 1995; 172(3):648-55. PMID: 7658055.

9. Diaz RS, Sabino EC, Mayer A, Mosley JW, Busch MP. Dual human immunodeficiency virus type 1 infection and recombination in a dually exposed transfusion recipient. The Transfusion Safety Study Group. J Virol. 1995; 69(6):3273-81. PMID: 7745674; PMCID: PMC189038.

10. Wong WY, Powars DR, Operskalski EA, Hassett J, Parker JW, Sarnaik S, Pegelow CH, Hilgartner MW, Johnson CS, Zhou Y, et al. Blood transfusions and immunophenotypic alterations of lymphocyte subsets in sickle cell anemia. The Transfusion Safety Study Group. Blood. 1995; 85(8):2091-7. PMID: 7718880.

11. Gjerset GF, Pike MC, Mosley JW, Hassett J, Fletcher MA, Donegan E, Parker JW, Counts RB, Zhou Y, Kasper CK, et al. Effect of low- and intermediate-purity clotting factor therapy on progression of human immunodeficiency virus infection in congenital clotting disorders. Transfusion Safety Study Group. Blood. 1994; 84(5):1666-71. PMID: 7915149.

12. Busch MP, Operskalski EA, Mosley JW, Stevens CE, Schiff ER, Kleinman SH, Lee H, Lee M, Harris M. Epidemiologic background and long-term course of disease in human immunodeficiency virus type 1-infected blood donors identified before routine laboratory screening. Transfusion Safety Study Group. Transfusion. 1994; 34(10):858-64. PMID: 7940656.

13. Mosley JW, Nowicki MJ, Kasper CK, Donegan E, Aledort LM, Hilgartner MW, Operskalski EA. Hepatitis A virus transmission by blood products in the United States. Transfusion Safety Study Group. Vox Sang. 1994;67 Suppl 1:24-8. PMID: 8091731.

14. Hilgartner M. Results of the transfusion safety study. Ann Hematol. 1994;68 Suppl 3:S59. PMID: 7910043.

15. Hilgartner MW. Changes in CD4 count relative to product usage: findings from the transfusion safety study. Semin Hematol. 1993; 30(4 Suppl 5):7-9. PMID: 7903481.

16. Hassett J, Gjerset GF, Mosley JW, Fletcher MA, Donegan E, Parker JW, Counts RB, Aledort LM, Lee H, Pike MC. Effect on lymphocyte subsets of clotting factor therapy in human immunodeficiency virus-1-negative congenital clotting disorders. The Transfusion Safety Study Group. Blood. 1993; 82(4):1351-7. PMID: 8353293.

17. Adams M, Lee TH, Busch MP, Heitman J, Marshall GJ, Gjerset GF, Mosley JW. Rapid freezing of whole blood or buffy coat samples for polymerase chain reaction and cell culture analysis: application to detection of human immunodeficiency virus in blood donor and recipient repositories. The Transfusion Safety Study Group. Transfusion. 1993; 33(6):504-8. PMID: 8516793.

18. Hilgartner MW, Buckley JD, Operskalski EA, Pike MC, Mosley JW. Purity of factor VIII concentrates and serial CD4 counts. The Transfusion Safety Study Group. Lancet. 1993; 341(8857):1373-4. PubMed PMID: 8098792.

19. Aledort LM, Operskalski EA, Dietrich SL, Koerper MA, Gjerset GF, Lusher JM, Lian EC, Mosley JW. Low CD4+ counts in a study of transfusion safety. The Transfusion Safety Study Group. N Engl J Med. 1993; 328(6):441-2. Erratum in: N Engl J Med 1993; 328(15):1128. PMID: 8093638.

20. Fletcher MA, Mosley JW, Hassett J, Gjerset GF, Kaplan J, Parker JW, Donegan E, Lusher JM, Lee H. Effect of age on human immunodeficiency virus type 1-induced changes in lymphocyte populations among persons with congenital clotting disorders. Transfusion Safety Study Group. Blood. 1992; 80(3):831-40. PMID: 1638032.

21. Aledort LM, Hilgartner MW, Pike MC, Gjerset GF, Koerper MA, Lian EY, Lusher JM, Mosley JW. Variability in serial CD4 counts and relation to progression of HIV-I infection to AIDS in haemophilic patients. Transfusion Safety Study Group. BMJ. 1992; 304(6821):212-6. PMID: 1346752; PMCID: PMC1881487.

22. Donegan E, Pell P, Lee H, Shaw GM, Mosley JW. Transmission of human T-lymphotropic virus type I by blood components from a donor lacking anti-p24: a case report. The Transfusion Safety Study Group. Transfusion. 1992 Jan;32(1):68-71. PMID: 1731439.

23. Busch MP, Henrard DR, Hewlett IK, Mehaffey WF, Epstein JS, Allain JP, Lee TH, Mosley JW. Poor sensitivity, specificity, and reproducibility of detection of HIV-1 DNA in serum by polymerase chain reaction. The Transfusion Safety Study Group. J Acquir Immune Defic Syndr. 1992; 5(9):872-7. PMID: 1512686.

24. Buckley JD, Pike MC, Mosley JW. Statistical approaches to evaluating prognostic indices in HIV infection. The Transfusion Safety Study Group. AIDS. 1991 Nov;5(11):1398. PMID: 1768396.

25. Odom-Maryon T, Langholz B, Niland J, Azen S. Generalization of normal discriminant analysis using Fourier series density estimators. Transfusion Safety Study Group. Stat Med. 1991; 10(3):473-85. PMID: 2028130.

26. Busch MP, Young MJ, Samson SM, Mosley JW, Ward JW, Perkins HA. Risk of human immunodeficiency virus (HIV) transmission by blood transfusions before the implementation of HIV-1 antibody screening. The Transfusion Safety Study Group. Transfusion. 1991; 31(1):4-11. PMID: 1986462.

27. Fletcher MA, Gjerset GF, Hassett J, Donegan E, Parker JW, Mosley JW. Lymphocyte immunophenotypes among anti-HTLV-I/II-positive blood donors and recipients. The Transfusion Safety Study Group. J Acquir Immune Defic Syndr. 1991;4(6):628-32. PMID: 1673714.

28. Parks WP, Lenes BA, Tomasulo PA, Schiff ER, Parks ES, Shaw GM, Lee H, Yan HQ, Lai S, Hollingsworth CG, et al. Human T-cell lymphotropic virus infection among blood donors in south Florida. The Transfusion Safety Study Group. J Acquir Immune Defic Syndr. 1991;4(1):89-96. PMID: 1670589.

29. Busch MP, Taylor PE, Lenes BA, Kleinman SH, Stuart M, Stevens CE, Tomasulo PA, Allain JP, Hollingsworth CG, Mosley JW. Screening of selected male blood donors for p24 antigen of human immunodeficiency virus type 1. The Transfusion Safety Study Group. N Engl J Med. 1990; 323(19):1308-12. PMID: 2120588.

30. Donegan E, Busch MP, Galleshaw JA, Shaw GM, Mosley JW. Transfusion of blood components from a donor with human T-lymphotropic virus type II (HTLV-II) infection. The Transfusion Safety Study Group. Ann Intern Med. 1990; 113(7):555-6. PMID: 2393211.

31. Busch MP, Donegan E, Stuart M, Mosley JW. Donor HIV-1 p24 antigenaemia and course of infection in recipients Transfusion Safety Study Group. Lancet. 1990; 335(8701):1342. PMID: 1971398.

32. Parker JW, Adelsberg B, Azen SP, Boone D, Fletcher MA, Gjerset GF, Hassett J, Kaplan J, Niland JC, Odom-Maryon T, et al. Leukocyte immunophenotyping by flow cytometry in a multisite study: standardization, quality control, and normal values in the Transfusion Safety Study. The Transfusion Safety Study Group. Clin Immunol Immunopathol. 1990; 55(2):187-220. PMID: 2182228.

33. Dietrich SL, Mosley JW, Lusher JM, Hilgartner MW, Operskalski EA, Habel L, Aledort LM, Gjerset GF, Koerper MA, Lewis BH, et al. Transmission of human immunodeficiency virus type 1 by dry-heated clotting factor concentrates. Transfusion Safety Study Group. Vox Sang. 1990; 59(3):129-35. PMID: 2124751.

34. Miller K, Donegan E, Curran P, Shelley TJ. Effects of counselling on knowledge about HIV-1 among transfusion recipients and their partners. Transfusion Safety Study Group. AIDS Care. 1990; 2(2):155-62. PMID: 2085537.

35. Operskalski EA, Schiff ER, Kleinman SH, Busch M, Taylor PE, Parks WP, Lee H, Tomasulo PA, Donegan E, Stuart M, et al. Epidemiologic background of blood donors with antibody to human T-cell lymphotropic virus. Transfusion Safety Study Group. Transfusion. 1989; 29(8):746-8. PMID: 2572078.

36. Kleinman SH, Niland JC, Azen SP, Operskalski EA, Barbosa LH, Chernoff AI, Edwards VM, Lenes BA, Marshall GJ, Nemo GJ, et al. Prevalence of antibodies to human immunodeficiency virus type 1 among blood donors prior to screening. The Transfusion Safety Study/NHLBI Donor Repository. Transfusion. 1989; 29(7):572-80. PMID: 2672433.

37. Fletcher MA, Azen SP, Adelsberg B, Gjerset G, Hassett J, Kaplan J, Niland JC, Odom-Maryon T, Parker JW, Stites DP, et al. Immunophenotyping in a multicenter study: the Transfusion Safety Study experience. Clin Immunol Immunopathol. 1989; 52(1):38-47. PMID: 2656018.

38. Edwards VM, Mosley JW. Reproducibility in quality control of protein (Western) immunoblot assay for antibodies to human immunodeficiency virus. Am J Clin Pathol. 1989; 91(1):75-8. PMID: 2910017.

39. Norman GL, Barker SS, Rasheed S. Immunoblot reactivity of a non-HIV protein with human sera. Transfusion Safety Study Group. J Clin Lab Anal. 1989;3(3):148-51. PMID: 2787852.

40. Lang DJ, Kovacs AA, Zaia JA, Doelkin G, Niland JC, Aledort L, Azen SP, Fletcher MA, Gauderman J, Gjerset GJ, et al. Seroepidemiologic studies of cytomegalovirus and Epstein-Barr virus infections in relation to human immunodeficiency virus type 1 infection in selected recipient populations. Transfusion Safety Study Group. J Acquir Immune Defic Syndr. 1989;2(6):540-9. PMID: 2555471.