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J Clin Microbiol. 1989 May; 27(5): 977–982.
PMCID: PMC267466

Reliable confirmation of antibodies to human immunodeficiency virus type 1 (HIV-1) with an enzyme-linked immunoassay using recombinant antigens derived from the HIV-1 gag, pol, and env genes.


An enzyme-linked immunoassay (ELISA) using six recombinant proteins corresponding to large segments of the human immunodeficiency virus type 1 (HIV-1) gag, pol, and env gene products (HIVAGEN; SmithKline Bio-Science Laboratories, Van Nuys, Calif.) was developed to confirm the presence of antibodies to HIV-1 in sera reactive in the whole-cell-derived virion screening ELISAs. Serum samples for testing were obtained from healthy seronegative blood donors and from the different categories of HIV-infected individuals (asymptomatic, acquired immunodeficiency syndrome [AIDS]-related complex, and AIDS). A positive reaction was defined as reactivity against an env and at least one other (either gag or pol) HIV-1 gene product; negative was defined as no reaction with any antigen; and indeterminate was defined as reactivity with gag or pol (or both) or with env alone. None of the 1,180 serum samples from healthy seronegative blood donors gave a positive result, and only 49 of these samples (4%) gave indeterminate results. The recombinant HIV-1 antigen ELISA panel identified seropositive individuals with a high degree of accuracy, as a positive reaction was seen with 99.3% of asymptomatic healthy seropositive individuals, 98.1% of patients with AIDS-related complex, and 90.4% of patients with AIDS. None of the 725 HIV-1-seropositive subjects had a negative test result. Reactivity with the Kp41 antigen, corresponding to an amino-terminal portion of the gp41 envelope glycoprotein, by itself demonstrated 100% sensitivity and specificity in distinguishing seronegative from seropositive sera. A subset of seronegative and seropositive samples were tested both with the recombinant HIV-1 antigen ELISA panel and by Western blot (Du Pont Co.). The recombinant HIV-1 antigen ELISA panel accurately identified more seropositive and seronegative samples and had fewer indeterminate results than did Western blot (interpreted by Du Pont criteria).

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  • Allain JP, Laurian Y, Paul DA, Verroust F, Leuther M, Gazengel C, Senn D, Larrieu MJ, Bosser C. Long-term evaluation of HIV antigen and antibodies to p24 and gp41 in patients with hemophilia. Potential clinical importance. N Engl J Med. 1987 Oct 29;317(18):1114–1121. [PubMed]
  • Barré-Sinoussi F, Chermann JC, Rey F, Nugeyre MT, Chamaret S, Gruest J, Dauguet C, Axler-Blin C, Vézinet-Brun F, Rouzioux C, et al. Isolation of a T-lymphotropic retrovirus from a patient at risk for acquired immune deficiency syndrome (AIDS). Science. 1983 May 20;220(4599):868–871. [PubMed]
  • Biberfeld G, Bredberg-Rådén U, Böttiger B, Putkonen PO, Blomberg J, Juto P, Wadell G. Blood donor sera with false-positive Western blot reactions to human immunodeficiency virus. Lancet. 1986 Aug 2;2(8501):289–290. [PubMed]
  • Burke DS, Brandt BL, Redfield RR, Lee TH, Thorn RM, Beltz GA, Hung CH. Diagnosis of human immunodeficiency virus infection by immunoassay using a molecularly cloned and expressed virus envelope polypeptide. Comparison to Western blot on 2707 consecutive serum samples. Ann Intern Med. 1987 May;106(5):671–676. [PubMed]
  • Carlson JR, Yee J, Hinrichs SH, Bryant ML, Gardner MB, Pedersen NC. Comparison of indirect immunofluorescence and Western blot for detection of anti-human immunodeficiency virus antibodies. J Clin Microbiol. 1987 Mar;25(3):494–497. [PMC free article] [PubMed]
  • Cooper DA, Gold J, Maclean P, Donovan B, Finlayson R, Barnes TG, Michelmore HM, Brooke P, Penny R. Acute AIDS retrovirus infection. Definition of a clinical illness associated with seroconversion. Lancet. 1985 Mar 9;1(8428):537–540. [PubMed]
  • Couroucé AM, Muller JY, Richard D. False-positive Western blot reactions to human immunodeficiency virus in blood donors. Lancet. 1986 Oct 18;2(8512):921–922. [PubMed]
  • Dawson GJ, Heller JS, Wood CA, Gutierrez RA, Webber JS, Hunt JC, Hojvat SA, Senn D, Devare SG, Decker RH. Reliable detection of individuals seropositive for the human immunodeficiency virus (HIV) by competitive immunoassays using Escherichia coli-expressed HIV structural proteins. J Infect Dis. 1988 Jan;157(1):149–155. [PubMed]
  • Frösner GG, Erfle V, Mellert W, Hehlmann R. Diagnostic significance of quantitative determination of HIV antibody specific for envelope and core proteins. Lancet. 1987 Jan 17;1(8525):159–160. [PubMed]
  • Gallo D, Diggs JL, Shell GR, Dailey PJ, Hoffman MN, Riggs JL. Comparison of detection of antibody to the acquired immune deficiency syndrome virus by enzyme immunoassay, immunofluorescence, and Western blot methods. J Clin Microbiol. 1986 Jun;23(6):1049–1051. [PMC free article] [PubMed]
  • Gallo R, Wong-Staal F, Montagnier L, Haseltine WA, Yoshida M. HIV/HTLV gene nomenclature. Nature. 1988 Jun 9;333(6173):504–504. [PubMed]
  • Goudsmit J, Lange JM, Paul DA, Dawson GJ. Antigenemia and antibody titers to core and envelope antigens in AIDS, AIDS-related complex, and subclinical human immunodeficiency virus infection. J Infect Dis. 1987 Mar;155(3):558–560. [PubMed]
  • Gupta P, Balachandran R, Grovit K, Webster D, Rinaldo C., Jr Detection of human immunodeficiency virus by reverse transcriptase assay, antigen capture assay, and radioimmunoassay. J Clin Microbiol. 1987 Jun;25(6):1122–1125. [PMC free article] [PubMed]
  • Hofbauer JM, Schulz TF, Hengster P, Larcher C, Zangerle R, Kofler H, Fritsch P, Wachter H, Dierich MP. Comparison of Western blot (immunoblot) based on recombinant-derived p41 with conventional tests for serodiagnosis of human immunodeficiency virus infections. J Clin Microbiol. 1988 Jan;26(1):116–120. [PMC free article] [PubMed]
  • Lelie PN, van der Poel CL, Reesink HW. Interpretation of isolated HIV anti-p24 reactivity in Western blot analysis. Lancet. 1987 Mar 14;1(8533):632–632. [PubMed]
  • Lennette ET, Karpatkin S, Levy JA. Indirect immunofluorescence assay for antibodies to human immunodeficiency virus. J Clin Microbiol. 1987 Feb;25(2):199–202. [PMC free article] [PubMed]
  • Levy JA, Hoffman AD, Kramer SM, Landis JA, Shimabukuro JM, Oshiro LS. Isolation of lymphocytopathic retroviruses from San Francisco patients with AIDS. Science. 1984 Aug 24;225(4664):840–842. [PubMed]
  • Martin PW, Burger DR, Caouette S, Goldstein AS, Peetoom F. Importance of confirmatory tests after strongly positive HTLV-III screening tests. N Engl J Med. 1986 Jun 12;314(24):1577–1577. [PubMed]
  • Mayer KH, Falk LA, Paul DA, Dawson GJ, Stoddard AM, McCusker J, Saltzman SP, Moon MW, Ferriani R, Groopman JE. Correlation of enzyme-linked immunosorbent assays for serum human immunodeficiency virus antigen and antibodies to recombinant viral proteins with subsequent clinical outcomes in a cohort of asymptomatic homosexual men. Am J Med. 1987 Aug;83(2):208–212. [PubMed]
  • Mendenhall CL, Roselle GA, Grossman CJ, Rouster SD, Weesner RE. False positive tests for HTLV-III antibodies in alcoholic patients with hepatitis. N Engl J Med. 1986 Apr 3;314(14):921–922. [PubMed]
  • Montagnier L, Clavel F, Krust B, Chamaret S, Rey F, Barré-Sinoussi F, Chermann JC. Identification and antigenicity of the major envelope glycoprotein of lymphadenopathy-associated virus. Virology. 1985 Jul 15;144(1):283–289. [PubMed]
  • Moore JD, Cone EJ, Alexander SS., Jr HTLV-III seropositivity in 1971-1972 parenteral drug abusers--a case of false positives for evidence of viral exposure? N Engl J Med. 1986 May 22;314(21):1387–1388. [PubMed]
  • Neale TJ, Dagger J, Fong R, Humble M, Meech P, Hatfield PJ, Morrison RB. False positive anti-HTLV III serology. N Z Med J. 1985 Oct 23;98(789):914–914. [PubMed]
  • Petricciani JC. Licensed tests for antibody to human T-lymphotropic virus type III. Sensitivity and specificity. Ann Intern Med. 1985 Nov;103(5):726–729. [PubMed]
  • Popovic M, Sarngadharan MG, Read E, Gallo RC. Detection, isolation, and continuous production of cytopathic retroviruses (HTLV-III) from patients with AIDS and pre-AIDS. Science. 1984 May 4;224(4648):497–500. [PubMed]
  • Ranki A, Johansson E, Krohn K. Interpretation of antibodies reacting solely with human retroviral core proteins. N Engl J Med. 1988 Feb 18;318(7):448–449. [PubMed]
  • Saag MS, Britz J. Asymptomatic blood donor with a false positive HTLV-III Western blot. N Engl J Med. 1986 Jan 9;314(2):118–118. [PubMed]
  • Saah AJ, Farzadegan H, Fox R, Nishanian P, Rinaldo CR, Jr, Phair JP, Fahey JL, Lee TH, Polk BF. Detection of early antibodies in human immunodeficiency virus infection by enzyme-linked immunosorbent assay, Western blot, and radioimmunoprecipitation. J Clin Microbiol. 1987 Sep;25(9):1605–1610. [PMC free article] [PubMed]
  • Sayers MH, Beatty PG, Hansen JA. HLA antibodies as a cause of false-positive reactions in screening enzyme immunoassays for antibodies to human T-lymphotropic virus type III. Transfusion. 1986 Jan-Feb;26(1):113–115. [PubMed]
  • Schüpbach J, Haller O, Vogt M, Lüthy R, Joller H, Oelz O, Popovic M, Sarngadharan MG, Gallo RC. Antibodies to HTLV-III in Swiss patients with AIDS and pre-AIDS and in groups at risk for AIDS. N Engl J Med. 1985 Jan 31;312(5):265–270. [PubMed]
  • Shatzman AR, Rosenberg M. Expression, identification, and characterization of recombinant gene products in Escherichia coli. Methods Enzymol. 1987;152:661–673. [PubMed]
  • Shaw GM, Hahn BH, Arya SK, Groopman JE, Gallo RC, Wong-Staal F. Molecular characterization of human T-cell leukemia (lymphotropic) virus type III in the acquired immune deficiency syndrome. Science. 1984 Dec 7;226(4679):1165–1171. [PubMed]
  • Steimer KS, Higgins KW, Powers MA, Stephans JC, Gyenes A, George-Nascimento C, Luciw PA, Barr PJ, Hallewell RA, Sanchez-Pescador R. 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 Apr;58(1):9–16. [PMC free article] [PubMed]
  • Steimer KS, Puma JP, Power MD, Powers MA, George-Nascimento C, Stephans JC, Levy JA, Sanchez-Pescador R, Luciw PA, Barr PJ, et al. Differential antibody responses of individuals infected with AIDS-associated retroviruses surveyed using the viral core antigen p25gag expressed in bacteria. Virology. 1986 Apr 15;150(1):283–290. [PubMed]
  • Thorn RM, Beltz GA, Hung CH, Fallis BF, Winkle S, Cheng KL, Marciani DJ. Enzyme immunoassay using a novel recombinant polypeptide to detect human immunodeficiency virus env antibody. J Clin Microbiol. 1987 Jul;25(7):1207–1212. [PMC free article] [PubMed]
  • Tribe DE, Reed DL, Lindell P, Kenealy WR, Ferguson BQ, Cybulski R, Winslow D, Waselefsky DM, Petteway SR., Jr Antibodies reactive with human immunodeficiency virus gag-coded antigens (gag reactive only) are a major cause of enzyme-linked immunosorbent assay reactivity in a blood donor population. J Clin Microbiol. 1988 Apr;26(4):641–647. [PMC free article] [PubMed]
  • van der Poel CL, Reesink HW, Tersmette T, Lelie PN, Huisman H, Miedema F. Blood donations reactive for HIV in Western blot, but non-infective in culture and recipients of blood. Lancet. 1986 Sep 27;2(8509):752–753. [PubMed]
  • Wang JJ, Steel S, Wisniewolski R, Wang CY. Detection of antibodies to human T-lymphotropic virus type III by using a synthetic peptide of 21 amino acid residues corresponding to a highly antigenic segment of gp41 envelope protein. Proc Natl Acad Sci U S A. 1986 Aug;83(16):6159–6163. [PubMed]
  • Weiss SH, Goedert JJ, Sarngadharan MG, Bodner AJ, Gallo RC, Blattner WA. Screening test for HTLV-III (AIDS agent) antibodies. Specificity, sensitivity, and applications. JAMA. 1985 Jan 11;253(2):221–225. [PubMed]

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