Screening for HIV Infection: Risks,Benefits,and the Burden of Proof

Gallo RC , Frequent detection and isolation of cytopathic retroviruses (HTLV-III) from patients with AIDS and at risk for AIDS, Science 1984, 214: 500–503; Fauci AS , The acquired immunodeficiency syndrome: An update, Annals of Internal Medicine 1985, 102: 800–813; Case K , Nomenclature: Human immunodeficiency virus, Annals of Internal Medicine 1986, 105: 135.

Curran JW , The epidemiology and prevention of the acquired immunodeficiency syndrome, Annals of Internal Medicine 1985, 103: 657–62; Sivak SL Wormser GP , How common is HTLV-III infection in the United States? (letter), New England Journal of Medicine 1985, 313: 1352.

Screening for AIDS, The Medical Letter 1985, 27: 29–30; Council on Scientific Affairs, American Medical Association, Status report on the acquired immunodeficiency syndrome, Journal of the American Medical Association 1985, 254: 1342–45.

Haynes RB , Increased absenteeism from work after detection and labeling of hypertensive patients, New England Journal of Medicine 1978, 299: 741–44.

Bayer R Levine C Wolf SM , HIV antibody screening: An ethical framework for evaluating proposed programs, Journal of the American Medical Association 1986, 256: 1768–74; Gostin L , Acquired immune deficiency syndrome: A review of science, health policy, and law, AIDS: Science, Policy, and Law 1986, 4: 3–13.

Burger H , Transmission of lymphadenopathyassociated virus/human T-lymphotropic virus type III in sexual partners: Seropositivity does not predict infectivity in all cases, American Journal of Medicine 1986, 81: 5–10.

Burger H , Transientantibody to lymphadenopathyassociated virus/human T-lymphotropic virus type III and T-lymphocyte abnormalities in the wife of a man who developed the acquired immunodeficiency syndrome, Annals of Internal Medicine 1985, 103: 545–47.

Francis DP , The natural history of infection with the lymphadenopathy-associated virus human T-lymphotropic virus type III, Annals of Internal Medicine 1985, 103:719–22.

Carlson JR , AIDS serology testing in low and high-risk groups, Journal of the American Medical Association 1985, 253: 3405–8.

Food and Drug Administration, Summary of basis for approval: VirgoTM HTLV-III ELISA, FDA Freedom of Information Staff, HFV-35, Rockville, Md., Reference Nos. 84–574 and 85–024; Food and Drug Administration, Summary of basis for approval: Abbott HTLV-III EIA, FDA Freedom of Information Staff, HFV-35, Rockville, Md., Reference Nos. 84–580 and 85–019; Food and Drug Administration, Summary of basis for approval: HTLV-III Bio-EnzaBeadTM Test Kit, FDA Freedom of Information Staff, HFV-35, Rockville, Md., Reference Nos. 84–587 and 85–588.

Weinstein MC Fineberg HV , Clinical decision analysis, Philadelphia: Saunders, 1980.

Safai B , Seroepidemiological studies of human T-lymphotropic retrovirus type III in acquired immunodeficiency syndrome, Lancet 1984, i: 1438–39; Essex M , Antigens of human T-lymphotropic virus type III/lymphadenopathy-associated virus, Annals of Internal Medicine 1985, 103: 700–703; Gershoni JM Palade GE , Protein blotting: Principles and applications, Analytical Biochemistry 1983, 131: 1–15.

Screening for AIDS, supra note 3; Mortimer PP Parry JV Mortimer JY , Which anti-HTLV-III/LAV assays for screening and confirmatory testing?, Lancet 1985, ii: 873–77; Burke DS Redfield RR , False-positive Western blot tests for antibodies to HTLV-III (letter), Journal of the American Medical Association 1986, 256: 347.

Sandstrom EG , Detection of human anti-HTLV-III antibodies by indirect immunofluorescence using fixed cells, Transfusion 1985, 25: 308–12; Mortimer PP , Prevalence of antibody to human T-lymphotropic virus type III by risk group and area, United Kingdom 1978–1984, British Medical Journal 1985, 190: 1176–78.

Gallo , supra note 1; Francis , supra note 8.

Nicholson JK , Exposure to human T-lymphotropic virus type III/lymphadenopathy-associated virus and immunologic abnormalities in asymptomatic homosexual men, Annals of Internal Medicine 1985, 103: 37–42.

Pinching AJ , Studies of cellular immunity in male homosexuals in London, Lancet 1983, ii: 126–30.

Redfield RR Wright DC Tramont EC , The Walter Reed staging classification for HTLV-III/LAV infection, New England Journal of Medicine 1986, 314: 131–32; Centers for Disease Control, Classification system for human T-lymphotropic virus type III/lymphadenopathy-associated virus infections, Annals of Internal Medicine 1986, 105: 234–37.

Stevens CE , Human T-cell lymphotropic virus type III infection in a cohort of homosexual men in New York City, Journal of the American Medical Association 1986, 255: 2167–72.

Id.; Francis , supra note 8; Jaffe HW , The acquired immunodeficiency syndrome in a cohort of homosexual men: A six year follow-up study, Annals of Internal Medicine 1985, 103: 210–14.

Morgan J , Potential source of error in HTLV-III antibody testing (letter), Lancet 1986, i: 739–40; Barr A , Anti-HTLV-III screening specificity and sensitivity (letter), Lancet 1986, i: 1032; Cayzer I Field S , Elimination of source of error in HTLV-III antibody testing (letter), Lancet 1986, i: 1032–33.

Griner PF , Selection and interpretation of diagnostic tests and procedures, Annals of Internal Medicine 1981, 94: 559–70.

Petricciani JC , Licensed tests for antibody to human T-lymphotropic virus type III: Sensitivity and specificity, Annals of Internal Medicine 1985, 103: 726–29; FDA, supra note 10.

Ransohoff DF Feinstein AR , Problems of spectrum and bias in evaluating the efficacy of diagnostic tests, New England Journal of Medicine 1978, 299: 926–30.

Burger , supra note 7; Biggar RJ , Variation in human T-lymphotropic virus III (HTLV-III) antibodies in homosexual men: Decline before onset of illness related to acquired immune deficiency syndrome (AIDS), British Medical Journal 1985, 291: 997–98.

Ho DD , Primary human T-lymphotropic virus type III infection, Annals of Internal Medicine 1985, 103: 880–83; Yomtorian R , HTLV-III antibody testing: The false negative rate (letter), New England Journal of Medicine 1986, 255: 609; Mayer KH , Human T-lymphotropic virus type III in high-risk, antibody negative homosexual men, Annals of Internal Medicine 1986, 104: 194–96; Tucker J , HTLV-III infection associated with glandular-fever-like illness in a haemophiliac Lancet 1985, i: 585.

Salahuddin SZ , HTLV-III in symptom-free seronegative persons, Lancet 1984, ii: 1418–22.

Kuhnl P Seidl S Holzberger G , HLA DR4 antibodies cause false positive HTLV-III antibody ELISA results (letter), Lancet 1985, i: 1222–23; Saag MS Britz J , Asymptomatic blood donor with a false positive HTLV-III Western blot (letter), New England Journal of Medicine 1986, 314: 118.

D'Aquila R , Prevalence of HTLV-III infection among New Haven, Connecticut, parenteral drug abusers in 1982–1983 (letter), New England Journal of Medicine 1986, 314: 117–18.

Moore JD Cone EJ Alexander SS , HTLV-III seropositivity in 1971–1972 parenteral drug abusers—A case of false positives or evidence of viral exposure? (letter), New England Journal of Medicine 1986, 314: 1387–88.

Mortimer , supra note 13.

Sox HC , Probability theory in the use of diagnostic tests, Annals of Internal Medicine 1986, 104: 60–66.

Schorr JB , Prevalence of HTLV-III antibody in American blood donors (letter), New England Journal of Medicine 1985, 313: 384–85; Kuritsky JN , Results of nationwide screening of blood and plasma for antibodies to human T-cell lymphotropic virus, type III, Transfusion 1986, 26: 205–7.

Leads from the MMWR, Human T-lymphotropic virus type III/lymphadenopathy-associated virus antibody prevalence in U.S. military recruit applicants, Journal of the American Medical Association 1986, 256: 975–76.

Ward JW , Laboratory and epidemiologic evaluation of an enzyme immunoassay for antibodies to HTLV-III, Journal of the American Medical Association 1986, 256: 357–61.

Saag and Britz , supra note 28; HTLV-III and blood donors (editorial), Lancet 1985, i: 856.

Mayer KH , Association of human T lymphotropic virus type III antibodies with sexual and other behaviors in a cohort of homosexual men from Boston with and without generalized lymphadenopathy, American Journal of Medicine 1986, 80: 357–63.

D'Aquila , supra note 29.

Moore Cone and Alexander , supra note 30; Katchaki , Anti-HTLV-III screening and false positivity (letter), Lancet 1986, i: 448.

Peterman TA , HTLV-III/LAV infection in hemodialysis patients, Journal of the American Medical Association 1986, 255: 2324–26.

Mendenhall CL , False positive tests for HTLV-III antibodies in alcoholic patients with hepatitis (letter), New England Journal of Medicine 1986, 314: 921–22.

Whittington WL , The prevalence of HTLV-III/LAV antibodies in heterosexuals (letter), New England Journal of Medicine 1986, 255: 1702–3.

Ward , supra note 35.