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Research Article| Volume 9, ISSUE 3, P369-392, September 1989

Laboratory Diagnosis of Human Immunodeficiency Virus Infection

  • Donald S. Burke
    Correspondence
    Corresponding author: Department of Academic Affairs, Walter Reed Army Institute of Research, Walter Reed Army Medical Center, Washington, D.C. 20307-5100.
    Affiliations
    Director, Division of Retrovirology, Walter Reed Army Institute of Research, Walter Reed Army Medical Center, Washington, DC
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      The technical issues relevant to the laboratory diagnosis of human immunodeficiency virus (HIV) infection are dealt with. Performance characteristics of the various HIV diagnostic assays are presented.
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      References

        • Abbott M.A.
        • Poiesz B.J.
        • Byrne B.C.
        • et al.
        Enzymatic gene amplification: Qualitative and quantitative methods for detecting proviral DNA amplified in vitro.
        J Infect Dis. 1988; 158: 1158
        • Albert J.
        • Bredberg U.
        • Chiodi F.
        • et al.
        A new human retrovirus isolate of West African origin (SBL-6669) and its relationship to HTLV-IV, LAV-II, and HTLV-IIIB.
        AIDS Res Hum Retroviruses. 1987; 3: 3
        • Albert J.
        • Gaines H.
        • Sonnerborg A.
        • et al.
        Isolation of human immunodeficiency virus (HIV) from plasma during primary HIV infection.
        J Med Virol. 1987; 23: 67
        • Allain J.P.
        • Laurian Y.
        • Paul D.A.
        • et al.
        Long-term evaluation of HIV antigen and anti bodies to p41 in patients with hemophilia.
        N Engl J Med. 1987; 317: 1114
        • Allan J.S.
        • Coligan J.E.
        • Barin F.
        • et al.
        Major glycoprotein antigens that induce antibodyies in AIDS patients are encoded by HTLV-III.
        Science. 1985; 228: 1091
        • Ameglio F.
        • Dolei A.
        • Benedetto A.
        • et al.
        Antibodies reactive with nonpolymorphicepitopes on HLA molecules interfere in screening tests for the human immunodeficiency virus [letter].
        J Infect Dis. 1987; 156: 1034
        • Anand R.
        • Siegal F.
        • Reed C.
        • et al.
        Noncytocidal natural variants of human immunodeficiency virus isolated from AIDS patients with neurological disorders.
        Lancet. 1987; 2: 234
        • Andiman W.A.
        Virologic and serologic aspects of human immunodeficiency virus infection in infants and children.
        Semin Perinatol. 1989; 13: 16
        • Arya S.K.
        • Gallo R.C.
        • Hahn B.H.
        • et al.
        Homology of genome of AIDS-associated virus with genomes of human T-cell leukemia virus.
        Science. 1984; 225: 927
        • Asjo B.
        • Albert J.
        • Karlsson A.
        • et al.
        Replicative capacity of human immunodeficiency virus from patients with varying severity of HIV infection.
        Lancet. 1986; 2: 660
        • Backer U.
        • Weinauer F.
        • Gathof G.
        HIV antigen screening in blood donors.
        Lancet. 1987; 2: 1213
        • Barin F.
        • McLane M.F.
        • Allan J.S.
        • et al.
        Virus envelope protein of HTLV-III represents major target antigen for antibodies in AIDS patients.
        Science. 1985; 228: 1094
        • Barnes D.M.
        New questions about AIDS test accuracy [news].
        Science. 1987; 238: 884
        • Barry M.J.
        • Cleary P.D.
        • Fineberg H.V.
        Screening for HIV infection: Risks, benefits, and the burden of proof.
        Law Med Health Care. 1986; 14: 259
        • Bedarida G.
        • Gambie G.
        • D’Agostino F.
        HIV IgM antibodies in risk groups who are seronegative on Elisa testing [letter].
        Lancet. 1986; 2: 570
        • Bender B.S.
        • Davidson B.L.
        • Kline R.
        • et al.
        Role of the mononuclear phagocyte system in the immunopathogenesis of human immunodeficiency virus infection and the acquired immunodeficiency syndrome.
        Rev Infect Dis. 1988; 10: 1142
        • Benn S.
        • Rutledge R.
        • Folks T.
        • et al.
        Genomic heterogeneity of AIDS retroviral isolates from North America and Zaire.
        Science. 1985; 230: 949
        • Blanton M.
        • Balakrishnan K.
        • Dumaswala U.
        • et al.
        HLA antibodies in blood donors with reactive screening tests for antibody to the immunodeficiency virus.
        Transfusion. 1987; 27: 118
        • Borkowsky W.
        • Paul D.
        • Bebenroth D.
        • et al.
        Human immunodeficiency virus infections in infants negative for anti-HIV by enzyme-linked immunoassay.
        Lancet. 1987; 1: 1168
        • Burke D.S.
        • Brandt B.L.
        • Redfield R.R.
        • et al.
        Diagnosis of human immunodeficiency virus infection by immunoassay using a molecularly cloned and expressed virus envelope polypeptide.
        Ann Intern Med. 1987; 106: 671
        • Burke D.S.
        • Brundage J.F.
        • Redfield R.R.
        • et al.
        Measurement of the false positive rate in a screening program for human immunodeficiency virus infections.
        N Engl J Med. 1988; 319: 961
        • Burke D.S.
        • Redfield R.R.
        False-positive Western blot tests for antibodies to HTLV-III [letter].
        JAMA. 1986; 256: 347
        • Burke D.S.
        • Redfield R.R.
        Transmission of human immunodeficiency virus (HIV) [letter].
        N Engl J Med. 1988; 318: 1202
        • Burke D.S.
        • Redfield R.R.
        • Putman P.
        • et al.
        Variations in Western blot banding patterns of human T-cell lymphotropic virus type III/lymphadenopathy-associated virus.
        J Clin Microbiol. 1987; 25: 81
        • Carne C.A.
        • Tedder R.S.
        • Smith A.
        • et al.
        Acute encephalopathy coincident with sero conversion for anti-HTLV-III.
        Lancet. 1985; 2: 1206
        • Chang K.S.
        • Wand L.C.
        • Gao C.L.
        • et al.
        Concomitant infection of HTLV-I and HIV-I: Prevalence of IgG and IgM antibodies in Washington, D.C. area.
        Eur J Epidemiol. 1988; 4: 426
        • Chiodi F.
        • Albert J.
        • Olausson E.
        • et al.
        Isolation frequency of human immunodeficiency virus from cerebrospinal fluid and blood of patients with varying severity of HIV infection.
        AIDS Res Hum Retroviruses. 1988; 4: 351
        • Chiodi F.
        • Bredberg-Raden U.
        • Biberfeld G.
        • et al.
        Radioimmunoprecipitation and Western blotting with sera of human immunodeficiency virus infected patients: a comparative study.
        AIDS Res Hum Retroviruses. 1987; 3: 165
        • Chiodi F.
        • von Gegerfeldt A.
        • Albert J.
        • et al.
        Site-directed Elisa with synthetic peptides representing the HIV transmembrane glycoprotein.
        J Med Virol. 1987; 23: 1
        • Chou M-J
        • Lee T-H
        • Hatzakis A.
        • et al.
        Antibody responses in early human immunode ficiency virus type 1 infection in hemophiliacs.
        J Infect Dis. 1988; 157: 805
        • Clavel F.
        • Guetard D.
        • Brun-Vezinet F.
        • et al.
        Isolation of a new human retrovirus from West African patients with AIDS.
        Science. 1986; 233: 343
        • Coombs R.
        • Gjerset G.
        • Nikora B.
        • et al.
        Isolation of human immunodeficiency virus (HIV) from the peripheral blood lymphocytes (PBL) and plasma of asymptomatic and symptomatic HIV seropositive hemophiliacs.
        CDC AIDS Weekly. 1988; 4: 17
        • Creemers P.C.
        • O’Shaughnessy M.
        • Boyko W.J.
        Analysis of absolute T helper cell number and cellular immune defects in HIV antibody positive and negative homosexual men.
        AIDS Res Hum Retroviruses. 1988; 4: 269
        • Damato J.
        • Fipps D.R.
        • Redfield R.R.
        • et al.
        The Department of the Army quality assurance program for human immunodeficiency virus antibody testing.
        Lab Med. 1988; 19: 577
        • De Rossi A.
        • Amadori A.
        • Chieco-Bianchl L.
        • et al.
        Polymerase chain reaction and in vitro antibody production for early diagnosis of paediatric HIV infection [letter].
        Lancet. 1988; 1: 278
        • Di Marzo Veronese F.
        • Copeland T.D.
        • Oroszlan S.
        • et al.
        Biochemical and immunological analysis of human immunodeficiency virus gag gene products p17 and p24.
        J Virol. 1988; 62: 795
        • Di Marzo Veronese F.
        • Copeland T.D.
        • Devico A.L.
        • et al.
        Characterization of highly immunogenic p66/p52 as the reverse transcriptase of HTLV-IH/LAV.
        Science. 1986; 231: 1289
        • Evans L.A.
        • McHugh T.M.
        • Stites D.P.
        • et al.
        Differential ability of human immunodeficiency virus isolates to productively infect human cells.
        J Immunol. 1987; 138: 3415
        • Fling J.A.
        • Fischer Jr., J.R.
        • Boswell R.N.
        • et al.
        The relationship of serum IgA concentration to human immunodeficiency virus (HIV) infection: A cross-sectional study of HIV-seropositive individuals detected by screening in the United States Air Force.
        J Allergy Clin Immunol. 1988; 82: 965
        • Food and Drug Administration
        Safety of immune globulins in relation to HTLV-III.
        FDA Drug Bull. 1986; 16: 3
        • Francis D.
        • Chin J.
        • Dan B.B.
        The prevention of acquired immunodeficiency syndrome in the United States: An objective strategy for medicine, public health, business, and the community.
        JAMA. 1987; 257: 1357
        • Fuchs D.
        • Reibnegger G.
        • Wachter H.
        • et al.
        Neopterin levels correlating with the Walter Reed staging classification in human immunodeficiency virus (HIV) infection.
        Ann Intern Med. 1987; 107: 784
        • Gaines H.
        • von Sydow M.
        • Parry J.V.
        • et al.
        Detection of immunoglobulin M antibody in primary human immunodeficiency virus infection.
        Aids. 1988; 2: 11
        • Gallo R.C.
        The AIDS virus.
        Sci Am. 1987; 256: 46
        • Garrett A.J.
        • Seagroatt V.
        • Supran E.M.
        • et al.
        Measurement of antibodies to human immunodeficiency virus: An international collaborative study to evaluate WHO reference sera.
        Bull WHO. 1988; 66: 197
        • Gartner S.
        • Markovits P.
        • Markovitz D.M.
        • et al.
        The role of macrophages in HTLV-Ш/LAV infection.
        Science. 1986; 233: 215
        • Gebel H.M.
        • Anderson J.E.
        • Gottschalk L.R.
        • et al.
        Determination of helper-suppressor T-cell ratios [letter].
        N Engl J Med. 1987; 316: 113
        • Gelderblom H.R.
        • Hausmann E.H.S.
        • Ozel M.
        • et al.
        Fine structure of human immunodeficiency virus (HIV) and immunolocalization of structural proteins.
        Virology. 1987; 156: 171
        • Gendelman H.E.
        • Orenstein J.
        • Martin M.A.
        • et al.
        Efficient isolation and propagation of biologically novel human immunodeficiency virus onto CSF-1 stimulated macrophages.
        J Exp Med. 1988; 167: 1428
        • Gnann J.W.
        • McCormick J.B.
        • Mitchell S.
        • et al.
        Synthetic peptide immunoassay distinguishes HIV type 1 and type 2 infections.
        Science. 1987; 237: 1346
        • Gnann J.W.
        • Schwimmbeck P.L.
        • Nelson J.A.
        • et al.
        Diagnosis of AIDS by using a 12-aminoacid peptide representing an immunodominant epitope of the human immunodeficiency virus.
        J Infect Dis. 1987; 156: 261
        • Goedert J.J.
        • Eyster M.E.
        • Biggar R.J.
        • et al.
        Heterosexual transmission of human immunodeficiency virus: Association with severe depletion of T-helper lymphocytes in men with hemophilia.
        AIDS Res Hum Retroviruses. 1987; 3: 355
        • Goudsmit J.
        • Lange J.M.A.
        • Krone W.J.A.
        • et al.
        Pathogenesis of HIV and its implications for serodiagnosis and monitoring of antiviral therapy.
        J Virol Meth. 1987; 17: 19
        • Goudsmit J.
        • de Wolf F.
        • Paul D.A.
        • et al.
        Expression of human immunodeficiency virus antigen (HIV-Ag) in serum and cerebrospinal fluid during acute and chronic infection.
        Lancet. 1986; 2: 177
        • Griffith B.P.
        Principles of laboratory isolation and identification of the human immunodeficiency virus (HIV).
        Yale J Biol Med. 1987; 60: 575
        • Healey D.S.
        • Maskill W.J.
        • Neate E.V.
        • et al.
        A preliminary evaluation of five HIV antigen detection assays.
        J Virol Meth. 1988; 20: 115
        • Ho D.D.
        • Pomerantz R.J.
        • Kaplan J.C.
        Pathogenesis of infection with HIV.
        New Engl J Med. 1987; 317: 278
        • Ho D.D.
        • Sarngadharan M.G.
        • Resnick L.
        • et al.
        Primary human T-lymphotropic virus type III infection.
        Ann Intern Med. 1985; 103: 880
        • Hollander H.
        • Levy J.A.
        Neurologic abnormalities and recovery of human immunode ficiency virus from cerebrospinal fluid.
        Ann Intern Med. 1987; 106: 692
        • Jendis J.B.
        • Tomasik Z.
        • Hunziker U.
        • et al.
        Evaluation of diagnostic tests for HIV infection in infants born to HIV-infected mothers in Switzerland.
        Aids. 1988; 2: 273
        • Kanki P.J.
        • M’Boup S.
        • Ricard D.
        • et al.
        Human T-lymphotropic virus type 4 and the human immunodeficiency virus in West Africa.
        Science. 1987; 236: 827
        • Kwok S.
        • Mack D.H.
        • Mullis K.B.
        • et al.
        Identification of human immunodeficiency virus sequences by using in vitro enzymatic amplification and oligomer cleavage detection.
        J Virol. 1987; 61: 1690
        • Lacey J.N.
        • Forbes M.A.
        • Waugh M.A.
        • et al.
        Serum beta2-microglobulin and human immunodeficiency virus infection.
        Aids. 1987; 1: 123
        • Lange J.
        • Goudsmit J.
        Decline of antibody reactivity to HIV core protein secondary to increased production of HIV antigen [letter].
        Lancet. 1987; 1: 448
        • Lange J.M.
        • Goudsmit J.
        • De Wolf F.
        • et al.
        Serological markers in HIV infection.
        Ann Med Interne (Paris). 1988; 139: 80
        • Lange J.M.
        • Parry J.V.
        • de Wolf F.
        • et al.
        Diagnostic value of specific IgM antibodies in primary HIV infection.
        Aids. 1988; 2: 31
        • Levy J.A.
        Indirect immunofluorescence assays can readily detect antibodies to the human immunodeficiency virus [letter].
        JAMA. 1987; 257: 1176
        • MacDonell K.B.
        • Chmiel J.S.
        • Goldsmith J.
        • et al.
        Prognostic usefulness of the Walter Reed staging classification for HIV infection.
        J Aids. 1988; 1: 367
        • Macy E.M.
        • Adelman D.C.
        Abnormal T-cell subsets in normal persons [letter].
        N Engl J Med. 1988; 319: 1608
        • Mayer K.H.
        • Stoddard A.M.
        • McCusker J.
        • et al.
        Human T-lymphotropic virus type III in high-risk, antibody-negative homosexual men.
        Ann Intern Med. 1986; 104: 194
        • McCormick J.B.
        • Krebs J.W.
        • Mitchell S.W.
        • et al.
        Isolation of human immune deficiency virus from African AIDS patients and from persons without AIDS or IgG antibody to human immune deficiency virus.
        Am J Trop Med Hyg. 1987; 36: 102
        • McHugh T.M.
        • Stites D.P.
        • Casavant C.H.
        • et al.
        Evaluation of the indirect immunofluo-rescence assay as a confirmatory test for detecting antibodies to the human immunodeficiency virus.
        Diagn Immunol. 1986; 4: 233
        • McHugh T.M.
        • Stites D.P.
        • Busch M.P.
        • et al.
        Relation of circulating levels of human immunodeficiency virus (HIV) antigen, antibody to p24, and HIV-containing immune complexes in HIV-infected patients.
        J Infect Dis. 1988; 158: 1088
        • Muller F.
        • Muller K.H.
        Detection of anti-HIV-1 immunoglobulin M antibodies in patients with serologically proved HIV-1 infection.
        Infection. 1988; 16: 115
        • Ou C-H
        • Kwok S.
        • Mitchell S.W.
        • et al.
        DNA amplification for direct detection of HIV-1 in DNA of peripheral blood mononuclear cells.
        Science. 1988; 239: 295
        • Parry J.V.
        • Mortimer P.P.
        Place of IgM antibody testing in HIV serology [letter].
        Lancet. 1986; 2: 979
        • Ranki A.
        • Johansson E.
        • Krohn K.
        Interpretation of antibodies reacting solely with human retroviral core proteins.
        N Engl J Med. 1988; 318: 448
        • Ranki A.
        • Walles S-L
        • Krohn M.
        • et al.
        Long latency precedes overt seroconversion in sexually transmitted human immunodeficiency virus infection.
        Lancet. 1987; 2: 589
        • Rayfield M.
        • DeCock K.
        • Heyward W.
        • et al.
        Mixed human immunodeficiency virus (HIV) infection in an individual: Demonstration of both HIV type 1 and type 2 proviral sequences by using polymerase chain reaction.
        J Infect Dis. 1988; 158: 1170
        • Reddy M.M.
        • Grieco M.H.
        Elevated soluble interleukin-2 receptor levels in serum of human immunodeficiency virus infected populations.
        AIDS Res Hum Retroviruses. 1988; 4: 115
        • Re M.C.
        • Furlini G.
        • Baldassarri B.
        • et al.
        Serological study of subjects with seroconvert sion to human immunodeficiency virus.
        Eur J Clin Microbiol Infect Dis. 1988; 7: 144
        • Redfield R.R.
        • Burke D.S.
        HIV infection: The clinical picture.
        Sci Am. 1988; 259: 90
        • Redfield R.R.
        • Wright D.C.
        • Tramont E.C.
        The Walter Reed staging classification for HTLV-III/LAV infection.
        N Engl J Med. 1986; 314: 131
        • Reesink W.H.
        • Huisman J.G.
        • Gonsalves M.
        • et al.
        Evaluation of six enzyme immunoas says for antibody against human immunodeficiency virus.
        Lancet. 1986; 2: 483
        • Richman D.D.
        • McCutchan J.A.
        • Spector S.A.
        Detecting human immunodeficiency virus RNA in peripheral blood mononuclear cells by nucleic acid hybridization.
        J Infect Dis. 1987; 156: 823
        • Salahuddin S.Z.
        • Groopman J.E.
        • Markham P.D.
        • et al.
        HTLV-III in symptom-free sero negative persons.
        Lancet. 1984; 2: 1418
        • Schochetman G.
        • Ou C.Y.
        • Jones W.K.
        Polymerase chain reaction.
        J Infect Dis. 1988; 158: 1154
        • Schwartz J.S.
        • Dans P.E.
        • Kinosian B.M.
        Human immunodeficiency virus test evaluation, performance, and use: Proposals to make good tests better.
        JAMA. 1988; 259: 2574
        • Shoeman R.L.
        • Young D.
        • Pottahil R.
        • et al.
        Comparison of recombinant human immu nodeficiency virus gag precursor and gag-env fusion proteins and a synthetic env peptide as diagnostic reagents.
        Anal Biochem. 1987; 161: 370
        • Steimer K.S.
        • Higgins K.W.
        • Powers M.A.
        • et al.
        Recombinant polypeptide from the endonuclease region of the acquired immune deficiency syndrome retrovirus polymerase (pol) gene detects serum antibodies in most infected individuals.
        J Virol. 1986; 58: 9
        • Tedder R.S.
        • Uttley A.
        • Cheingsong-Popov R.
        Safety of immunoglobulin preparation containing anti-HTLV-III [letter].
        Lancet. 1985; 1: 815
        • Tenner-Racz K.
        • Racz P.
        • Gluckman J-C
        • et al.
        Cell-free HIV in lymph nodes of patients with AIDS and generalized lymphadenopathy [letter].
        N Engl J Med. 1988; 318: 49
        • Tersmette M.
        • Lelie P.N.
        • van der Poel C.L.
        • et al.
        Confirmation of HIV seropositivity: Comparison of a novel radioimmunoprecipitation assay to immunoblotting and virus culture.
        J Med Virol. 1988; 24: 109
        • Tindall B.
        • Barker S.
        • Donovan B.
        • et al.
        Characterization of the acute clinical illness associated with human immunodeficiency virus infection.
        Arch Intern Med. 1988; 148: 945
        • Towbin H.
        • Staehlin T.
        • Gordon J.
        Electrophoretic transfer of proteins from polyacryl amide gels to nitrocellulose sheets: Procedure and some applications.
        Proc Natl Acad Sci USA. 1979; 76: 4350
        • van der Groen G.
        • Vercauteren G.
        • Piot P.
        Immunofluorescence tests for HIV antibody and their value as confirmatory tests.
        J Virol Meth. 1987; 17: 35
        • van der Poel C.L.
        • Reesink H.
        • Lelie P.
        Persistent single reactivity against p24 gag in Western blot not associated with antibodies against HIV-1, HIV-2 or HTLV-4 encoded proteins.
        CDC AIDS Weekly. 1987; 14: 15
      1. Watkins JD: Report of the Presidential Commission on the Human Immunodeficiency Virus Epidemic. Executive summary, page XVII. Washington, D.C., U.S. Government Printing Office 1988-0-214-701:QL3

        • Wittek A.E.
        • Phelan A.
        • Wells M.A.
        • et al.
        Detection of human immunodeficiency virus core protein in plasma by enzyme immunoassay.
        Ann Intern Med. 1987; 107: 286
        • Wolfe W.H.
        • Miner J.C.
        • Armstrong F.P.
        • et al.
        More on HTLV-III antibodies in immune globulin [letter].
        JAMA. 1986; 256: 2200
        • Wood C.C.
        • Williams A.E.
        • McNamara J.G.
        • et al.
        Antibody against the human immune-deficiency virus in commercial intravenous gammaglobulin preparations.
        Ann Intern Med. 1986; 105: 536
        • Yoshida T.
        • Matsui T.
        • Kobayashi S.
        • et al.
        Evaluation of passive particle agglutination test for antibody to human immunodeficiency virus.
        J Clin Microbiol. 1987; 25: 1433
        • Zolla-Pazner S.
        • Desjarlais D.C.
        • Friedman S.R.
        • et al.
        Nonrandom development of immunologic abnormalities after infection with human immunodeficiency virus: Implications for immunologic classification of the disease.
        Proc Natl Acad Sci USA. 1987; 84: 5404