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Screening Corneal Donors for Transmissible Disease: Title and subTitle BreakSafety, Resources, and Reason FREE

Susan Feigenbaum, PhD; Jay S. Pepose, MD, PhD
Arch Ophthalmol. 1991;109(7):941-943. doi:10.1001/archopht.1991.01080070053033
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The proliferation of newly discovered pathogens and screening tests poses a growing dilemma for the eye-banking community: which of the multitude of serologic tests should be required to screen donors? Are there guidelines that can be developed to facilitate systematic evaluation of future screening proposals according to standards of medical appropriateness and cost effectiveness? What are the scientific data requirements for a successful evaluation program? Are there instances in which one could expect such evaluation to yield divergent recommendations for the screening of corneal tissue vs other organs/tissues?

This issue was most clearly brought into focus with the onset of the acquired immunodeficiency syndrome (AIDS) epidemic in the United States in 19811 and later reports of AIDS transmission via blood transfusion.2 By 1985, a serologic enzyme-linked immunosorbent assay (ELISA) to detect human immunodeficiency virus (HIV) antibodies was developed and licensed by the Food and Drug Administration (FDA).

REFERENCES

Centers for Disease Control.  Pneumocystis pneumonia—Los Angeles . MMWR . 1981;;30:250.
Centers for Disease Control.  Possible transfusion-associated acquired immune deficiency syndrome (AIDS)—California . MMWR . 1982;;31:653-654.
 Provisional Public Health Service inter-agency recommendations for screening donated blood and plasma for antibody to the virus causing acquired immunodeficiency syndrome . MMWR . 1985;;34:1-5.
Pepose JS, MacKrae S, Quinn TC, Ward JW.  Studies of HIV infection of human corneas: serologic markers following the transplantation of corneas from donors infected with human immunodeficiency virus . Am J Ophthalmol . 1987;;103:798-801.
Salahuddin SZ, Palestine AG, Heck E, et al.  Isolation of human T-cell leukemia/lymphotropic virus type III from the cornea . Am J Ophthalmol . 1987;;101:149.
Doro S, Navia B, Kahn A, Pumarola-Sune T, Price RW.  Confirmation of HTLV-III virus in cornea . Am J Ophthalmol . 1986;;102:390-391.
Cantrill HL, Henry K, Jackson B, Erice A, Ussery FM, Balfour HH.  Recovery of human immunodeficiency virus from ocular tissues in patients with acquired immune deficiency syndrome . Ophthalmology . 1988;;95:1458-1462.
Ablashi DV, Sturzenegger S, Hunter EA, et al.  Presence of HTLV-III in tears and cells from the eyes of AIDS patients . J Exp Pathol . 1987;;3:693-703.
Pepose JS, Pardo FS, Kessler JS, Kline R, Donegan E, Quinn TC.  Screening cornea donors for antibodies against human immunodeficiency virus: efficacy of ELISA testing of cadaveric sera and aqueous humor . Ophthalmology . 1987;;94:95-100.
Backer V, Weinauer F, Gathof G, Eberle J.  HIV antigen screening in blood donors . Lancet . 1987;;2:1215.
Dodd RY, Barker LF.  Early markers of HIV-1 infection in plasma donors . JAMA . 1989;;202:92-93.
Hort RH, Pflugfelder SC, Ulman S, Forster RK, Polack FM, Schifl ER.  Clinical evidence for hepatitis B transmission resulting from corneal transplantation . Ophthalmology . 1988;;95( (suppl) ):162.
Choo QL, Kuo G, Weiner AJ, Overby LR, Bradley DW, Houghton M.  Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome . Science . 1989;;244:359-362.
Kuo G, Choo QL, Alter HJ, et al.  An assay for circulating antibodies to a major etiologic virus of human non-A, non-B hepatitis . Science . 1989;;244:362-364.
Gout O, Baulac M, Gessain A, et al.  Rapid development of myelopathy after HTLV-1 infection acquired by transfusion during cardiac transplantation . N Engl J Med . 1990;;322:383-388.
Williams AE, Fang CT, Slamon DJ, et al.  Seroprevalence and epidemiological correlates of HTLV-I infection in U.S. blood donors . Science . 1988;;240:643-646.
Van der Sluis JJ, ten Kate FJW, Vuzevski VD, Aciber GMN, Van Eijk RVW.  Transfusion syphilis, survival of Treponema pallidum in stored donor blood, II: dose dependence of experimentally determined survival time . Vox Sang . 1985;;49:390-399.
Posner R.  A theory of negligence . J Legal Studies . 1972;;1:29-54.
Weisbrod B.  Costs and benefits of medical research . J Political Economy . 1971;;79:527-544.

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Centers for Disease Control.  Pneumocystis pneumonia—Los Angeles . MMWR . 1981;;30:250.
Centers for Disease Control.  Possible transfusion-associated acquired immune deficiency syndrome (AIDS)—California . MMWR . 1982;;31:653-654.
 Provisional Public Health Service inter-agency recommendations for screening donated blood and plasma for antibody to the virus causing acquired immunodeficiency syndrome . MMWR . 1985;;34:1-5.
Pepose JS, MacKrae S, Quinn TC, Ward JW.  Studies of HIV infection of human corneas: serologic markers following the transplantation of corneas from donors infected with human immunodeficiency virus . Am J Ophthalmol . 1987;;103:798-801.
Salahuddin SZ, Palestine AG, Heck E, et al.  Isolation of human T-cell leukemia/lymphotropic virus type III from the cornea . Am J Ophthalmol . 1987;;101:149.
Doro S, Navia B, Kahn A, Pumarola-Sune T, Price RW.  Confirmation of HTLV-III virus in cornea . Am J Ophthalmol . 1986;;102:390-391.
Cantrill HL, Henry K, Jackson B, Erice A, Ussery FM, Balfour HH.  Recovery of human immunodeficiency virus from ocular tissues in patients with acquired immune deficiency syndrome . Ophthalmology . 1988;;95:1458-1462.
Ablashi DV, Sturzenegger S, Hunter EA, et al.  Presence of HTLV-III in tears and cells from the eyes of AIDS patients . J Exp Pathol . 1987;;3:693-703.
Pepose JS, Pardo FS, Kessler JS, Kline R, Donegan E, Quinn TC.  Screening cornea donors for antibodies against human immunodeficiency virus: efficacy of ELISA testing of cadaveric sera and aqueous humor . Ophthalmology . 1987;;94:95-100.
Backer V, Weinauer F, Gathof G, Eberle J.  HIV antigen screening in blood donors . Lancet . 1987;;2:1215.
Dodd RY, Barker LF.  Early markers of HIV-1 infection in plasma donors . JAMA . 1989;;202:92-93.
Hort RH, Pflugfelder SC, Ulman S, Forster RK, Polack FM, Schifl ER.  Clinical evidence for hepatitis B transmission resulting from corneal transplantation . Ophthalmology . 1988;;95( (suppl) ):162.
Choo QL, Kuo G, Weiner AJ, Overby LR, Bradley DW, Houghton M.  Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome . Science . 1989;;244:359-362.
Kuo G, Choo QL, Alter HJ, et al.  An assay for circulating antibodies to a major etiologic virus of human non-A, non-B hepatitis . Science . 1989;;244:362-364.
Gout O, Baulac M, Gessain A, et al.  Rapid development of myelopathy after HTLV-1 infection acquired by transfusion during cardiac transplantation . N Engl J Med . 1990;;322:383-388.
Williams AE, Fang CT, Slamon DJ, et al.  Seroprevalence and epidemiological correlates of HTLV-I infection in U.S. blood donors . Science . 1988;;240:643-646.
Van der Sluis JJ, ten Kate FJW, Vuzevski VD, Aciber GMN, Van Eijk RVW.  Transfusion syphilis, survival of Treponema pallidum in stored donor blood, II: dose dependence of experimentally determined survival time . Vox Sang . 1985;;49:390-399.
Posner R.  A theory of negligence . J Legal Studies . 1972;;1:29-54.
Weisbrod B.  Costs and benefits of medical research . J Political Economy . 1971;;79:527-544.

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