Dissident AIDS Database

Antibody testsUnreliabilityFalse positiveGeneral
HIV testing: State of the Art
 Sloand, E.M., et al.,
  Depending on the population tested, 20 to 70% of...two successive positive ELISAs (enzyme-linked immunosorbent assay) are confirmed by Western blot (an alternative antibody assay)." i.e. 30 to 80% are false positives
  JAMA 266, 2861-2866, 19911991
Measurement of the false positive rate in a screening program for human immunodeficiency virus infections
 Burke DS, Brundage JF, Redfield RR, Damato JJ, Schable CA, Putman P, Visintine R, Kim HI.
  In the entire AIDS literature there is only one study, that of Colonel Donald Burke and his colleagues [3] from the Walter Reed Army Institute, which is widely regarded as the definitive proof of the specificity of the HIV Western blot. Over an eighteen month period Burke and his colleagues tested 1.2 million applicants for US military service. Burke's testing procedure was a progression through two ELISAs and two Western blots. From these data the HIV seroprevalence was found to be 1.48/1000. "Approximately 1 percent of all initial screening ELISAs were reactive, 50 percent of repeat ELISAs were reactive, and 30 to 40 percent of first Western blot assays were reactive and diagnostic.” Burke then retrospectively investigated a highly selected sample of this population in which the seroprevalence was one tenth that of the 1.2 million. This group comprised 135,187 persons aged 17-18 years who resided in rural areas where the cumulative incidence of AIDS was low. Many would assume this group to be no different from healthy blood donors and regard all HIV positives as false positives but Burke and his colleagues' premises were the opposite. Assuming there were true positives amongst healthy, rural American youth and wishing to evaluate the false positive rate and specificity of the Western blot Burke needed to define HIV infection. This was done by performing a panel of four more antibody tests on sera from the 15 out of 135,187 applicants who had already been found twice ELISA and twice Western blot positive. Two of the extra tests were other Western blots and two were similar tests. Any individual positive in all four extra tests, thereby making a total of eight positive antibody tests, was deemed HIV infected. Those who failed any of the extra four tests were deemed non-HIV infected. Of the 15, one failed to complete the panel and thus Burke conceded only one, not fifteen, false-positives. From these data Burke calculated the specificity of the HIV Western blot to be in excess of 99.9%.
  New Eng. J. Med. 319, 961-964, 19881988
The significance of western blot assays indeterminate for antibody to HIV in a cohort of homosexual/bisexual men. The Multicenter AIDS Cohort Study.
 Phair J, Hoover D, Huprikar J, Detels R, Kaslow R, Rinaldo C, Saah A
  Documents 131 repeatedly ELISA-positive homosexual men with negative Western blots in a cohort of 4,994 homosexuals of which 37% were HIV-positive.
  J. AIDS 5, 988-992, 19921992
Sexual Transmission and Propagation of SIV and HIV in Resting and Activated CD4+ T Cells.
 Zhang Z-Q et al.
  “False positive and false negative results are to be expected [in HIV antibody testing] as with all screening tests… A confirmed positive test [i.e. one or two ELISA tests, followed by a Western Blot] indicates that a person has been exposed to the virus and has mounted an immunologic response (serum antibodies). However, this test does not indicate whether the person currently harbors the virus”
  Science. 1999 Nov 12;286(5443):1353-7.1999
Heterophile Antibodies to Bovine and Caprine Proteins Causing False-Positive Human Immunodeficiency Virus Type 1 and Other Enzyme-Linked Immunosorbent Assay Results.
 Willman JH et al.
  “We describe here a case of heterophile antibodies that are cross-reactive with bovine and caprine proteins occurring in a 22-month-old child, causing false-positive immunoassay results to human immunodeficiency virus type 1 (HIV-1) and a number of other infectious serology tests...we believe the positive test results observed in this patient were due to heterophile antibodies reactive with BSA and caprine proteins.”
  Clinical and Diagnostic Laboratory Immunology. 1999 Jul;6(4):615-6.1999
False-positive HIV-1 test results in a low-risk screening setting of voluntary blood donation.
 Kleinman S, Busch MP, Hall L, Thomson R, Glynn S, Gallahan D, Ownby HE, Williams AE
  "A retrospective cohort study of HIV-1 enzyme immunoassay (EIA) and Western blot results from large blood donor screening programs in which donors with suspected false-positive Western blot results underwent HIV-1 RNA polymerase chain reaction (PCR) testing and follow-up HIV-1 serology. Five US blood centers participating in the Retrovirus Epidemiology Donor Study. More than 5 million allogeneic and autologous blood donors who successfully donated blood at 1 of the 5 participating centers from 1991 through 1995. Rate of false positivity by Western blot and true HIV-1 infection status as determined by HIV-1 RNA PCR and by serologic follow-up of blood donors more than 5 weeks after donation. Of 421 donors who were positive for HIV-1 by Western blot, 39 (9.3%) met the criteria of possible false positivity because they lacked reactivity to p31. Of these, 20 (51.3%) were proven by PCR not to be infected with HIV-1. The false-positive prevalence was 4.8% of Western blot-positive donors and 0.0004% (1 in 251000) of all donors (95% confidence interval, 1 in 173000 to 1 in 379000 donors). A false diagnosis of HIV-1 infection can result from the combination of EIA and Western blot testing in blood donor and other HIV-1 screening programs".
  JAMA 1998 Sep 23-30;280(12):1080-51998
False-Positive and Indeterminate Human Immunodeficiency Virus Test Results in Pregnant Women
 Doran TI, Parra E
  "False-positive ELISA [antibody] test results can be caused by alloantibodies resulting from transfusions, transplantation, or pregnancy, autoimmune disorders, malignancies, alcoholic liver disease, or for reasons that are unclear...”
  Arch Fam Med. 2000 Sep/Oct;9:924-92000
Serologic testing for human immunodeficiency virus antibodies.
 Steckelberg JM, Cockerill F.
  “Most patients (68 to 89%) from low risk groups (prevalence of 0.1% or less) who show reactivity on screening tests will have false-positive results…The predictive value of a positive ELISA varies from 2 to 99%…the Western blot method lacks standardization, is cumbersome, and is subjective in interpretation of banding patterns.”
  Mayo Clin Proc. 1988;63:373-9.1988
Detection of antibodies to HTLV-III by ELISA in AIDS risk groups in Taiwan:
 Wang GR, Lin KT, Liu MF, Shieh CC, Shih LY, Lian DC, Lin TT,Chen CS, Chang SA.
  "Since many initially weakly-reactive samples became negative on repeated testing it appears that non-specific or false positive ELISA reactions occur frequently. Accordingly when ELISA is used for diagnostic purposes, additional confirming tests are mandatory."
  Zhonghua Min Guo Wei Sheng Wu Ji Mian Yi Xue Za Zhi 1986 Feb;19(1):7-171986
Seroprevalence of human immunodeficiency virus infection in Guinea-Bissau, west Africa.
 Chang FY, Yu MH, Shaio MF
  "The seroprevalence of human immunodeficiency virus (HIV) infection in Guinea-Bissau, West Africa, was determined by enzyme-linked immunosorbent assay (ELISA). From January 1987 to February 1993, 590 patients from the outpatient and inpatient departments of Regional Hospital at Canchungo, Cacheu, Guinea-Bissau were studied. The overall seropositive rate was 16%. The seropositive rate according to the diagnosis was: 6% in pregnant women, 40% in patients with gonorrhea/syphilis, 14% in patients with vaginitis and 22% in patients with active pulmonary tuberculosis."
  Zhonghua Min Guo Wei Sheng Wu Ji Mian Yi Xue Za Zhi 1994 May;27(2):98-1021994
manufacturer's notice
 Epitope, Organon Teknika.
  The insert for one of the kits for administering the Western blot warns: “Do not use this kit as the sole basis of diagnosis of HIV-1 infection” (195).
  Human immunodeficiency virus type 1 (HIV-1). HIV-1 Western blot kit. PN201-3039 Revision # 6, page 11.1
manufacturer's notice
 Abbott Laboratories
  “Elisa testing alone cannot be used to diagnose AIDS, even if the recommended investigation of reactive specimens suggests a high probability that the antibody to HIV-1 is present...At present there is no recognized standard for establishing the presence or absence of antibodies to HIV-1 in human blood."
  HIV/ELISA test packet insert (Human Immunodeficiency Virus Type 1. FUVAB FffVI EIA. Abbott Laboratories, 66-8805/R5, january 1997:5).1997
Report of a False-Positive HIV Test Result and the Potential Use of Additional Tests in Establishing HIV Serostatus
 Mylonakis E et al
  “[Conditions associated with false positive ELISA are] autoimmune disease, renal failure, cystic fibrosis, multiple pregnancies, blood transfusions, liver diseases, parenteral substance abuse, hemodialysis, or vaccinations for hepatitis B, rabies, or influenza...Causes of indeterminate WB [Western Blot] results include...nonspecific antibody reactions (eg, due to lymphoma, multiple sclerosis, injection drug use, liver disease, or autoimmune disorders). Also, there appear to be healthy individuals with antibodies that cross-react with specific HIV-1 peptides or recombinant antigens...”
  Arch Intern Med. 2000 Aug 14/28;160:2386-8.2000
False positive HIV-1 Western Blot tests in noninfected blood donors.
 Sayre KR et al.
  “There is approximately 15% probability that an HIV-negative sample will evidence nonspecific reactions to p24 on WB [Western Blot]...samples with strong reactivity to gag antigens...including p17, p24, p32, p46...and p55...can be misinterpreted as p17, p24, p31, gp41 and p55 bands, and this results in an overall positive interpretation...The 4 donors we studied all lacked HIV risk factors and were proven by HIV PCR and, in two cases, culture and p24 antigen analyses not to be infected”
  Transfusion. 1996;36:45-52.1996
Transient or occult HIV-1 infection in high-risk adults
 Sahu GK et al.
  “During a prospective study of seronegative sexual partners of known HIV-1-infected patients [4], we identified two apparently transiently infected individuals (nos. 1 and 2) using a live-cell immunofluorescence assay (IFA) as a test for serum anti-HIV-1 antibodies, HIV-1 DNA ampli®cation by PCR, and HIV-1 culture from the PBMC of the subjects (Table 1)... [this paper details how, for these two subjects, all evidence for the presence of HIV disappeared even after extensive re-testing]”
  AIDS. 2001 Jun 15;15(9):1175-7.2001
Human immunodeficiency virus testing for elective orthopedic procedures: results in a community-based hospital.
 LaPorte DM et al.
  “Between January 1, 1989 and July 31, 1995, voluntary preoperative screening tests for human immunodeficiency virus (HIV) infection, using an enzyme-linked immunosorbant assay, were completed on 2,727 patients who underwent elective orthopedic surgical procedures. There were 2,719 (99.7%) negative, 4 (0.15%) positive, and 3 (0.11%) false-positive results...”
  Orthopedics. 2001 Jan;24(1):52-5.2001
Blood donor sera with false-positive western blot reactions to human immunodeficiency virus.
 Biberfeld G et al.
  “Reactivity with [HIV proteins] p24 and/or gp41 has been suggested as a minimum requirement for HIV seropositivity by WB [Western Blot]. While testing ELISA positive serum from Swedish blood donors we detected 3 sera with false-positive WB reactions to p24 and p55...The 3...had no risk factors for HIV infection”
  Lancet. 1986 Aug 2;2:289-90.1986
Recognition of human immunodeficiency virus glycoproteins by natural anti-carbohydrate antibodies in human serum.
 Tomiyama, T. Lake, D. Masuho, Y. & Hersh, E.M.
  "Normal human serum contains antibodies capable of recognizing the carbohydrate moiety of the HIV envelope glycoproteins", gp41, gp120 and gp160
  Biochemical and Biophysical Research Communications 1991, 177, 279-285.1991
The AIDS virus and the AIDS test.
 Mortimer, P.P.
  "Diagnosis of HIV infection is based almost entirely on detection of antibodies to HIV, but there can be misleading cross-reactions between HIV-1 antigens and antibodies formed against other antigens, and these may lead to false-positive reactions. Thus, it may be impossible to relate an antibody response specifically to HIV-1 infection. In the presence of clinical and/or epidemiological features of HIV-1 infection there is often little doubt, but anti-HIV-1 may still be due to infection with related retroviruses (e.g. HIV-2) which, though also associated with AIDS, are different viruses"
  Medicine Internationale, 1989, 56, 2334-23391989
Detection of human anti-HTLV-III antibodies by indirect immunofluorescence using fixed cells.
 Sandstrom EG et al.
  “A total of 225 serums were tested by both IFA [Immunofluorescence Assay] and ELISA [antibody]. 180 (80%)...gave the same result. The 7 ELISA-positive and IFA-negative serums were from 4 healthy men. One of these samples also tested by Western blot assay was negative. 4 ELISA-negative serums were IFA positive. These were all positive by Western blotting and were obtained from two AIDS patients, one man with lymphadenopathy, and one healthy man. In 3 of the 4 men, additional serums were positive by ELISA.”
  Transfusion. 1985;25:308-12.1985
Pitfalls in HIV testing.
 Cordes R, Ryan M.
  “The causes of false-positives [on ELISA antibody tests] are listed in Table 1 [Hematologic malignant disorders, DNA viral infections, Autoimmune disorders, Multiple myeloma, Primary biliary cirrhosis, Alcoholic hepatitis, Influenza vaccination, Hepatitis B vaccination, Passively transferred antibodies, Antibodies to class II leukocytes, Renal transplantation, Chronic renal failure, Stevens-Johnson syndrome, Positive rapid plasma reagent test]”
  Postgraduate Medicine. 1995;98:177.1995
False positive HIV-1 ELISA results in low risk subjects.
 Challakeree K, Rapaport MH.
  “This gives a false-positive rate [on ELISA] of about 4% [manufacturer quotes 0.58%]”
  Western Journal of Medicine. 1993 Aug;159(2):214-5.1993
Serological diagnosis with recombinant peptides/proteins.
 Ng VL.
  “HIV-1 p24 is the HIV-1 protein most prone to "false-positive" reactions…false-positive reactions have been observed with every single HIV-1 protein”
  Clin Chem. 1991;37(10):1667-8.1991
Need for caution in interpretation of Western blot tests for HIV.
 Roy S et al.
  “These results, supported by previous reports of false seropositivity in asymptomatic blood donors, emphasize the need to be certain of viral antigen specificity when screening for HIV antibodies. We suggest that blood banks use both HIV-infected and noninfected cell lines when confirming seropositivity by the Western Blot test and that the presence of bands on such tests not be automatically considered to indicate positive status”
  JAMA. 1987;257:1047.1987
False-positive Western blot tests reactions to human immunodeficiency virus in blood donors.
 CouroucŽ A-M et al.
  “we tested 151,667 blood units by ELISA. 130 (8.6%) were confirmed positive by WB (in that they reacted with different HIV proteins, including gp41 and/or gp 110). 8 of these were false positive for gp18 and 23 were false positive for p25 [now known as p24]; in other words there was 1 false positive by WB for about 4 true positives in our population of blood donors and under our work conditions”
  Lancet. 1986 Oct 18;2:921-2.1986
Asymptomatic blood donor with false-positive HTLV-III western blot.
 Saag MS, Britz J.
  “Initial testing...revealed that [a 34-year old woman from rural Alabama] was positive for HTLV-III [HIV] antibody by ELISA tests on two separate occasions. Her serum was then sent for verification to the designated commercial laboratory, where three repeat ELISAs were strongly positive...as was a Western blot assay...In July 1985, the patient was informed that her serum was positive for HTLV-III antibody...Her physical examination was normal. Both she and her husband of 14 years denied any homosexual or extramarital sexual encounters, intravenous drug abuse, blood transfusions, or foreign travel. The patients T4:T8 [immune cell] ratio was 2.1:1, with a normal lymphocyte count. Her husband and their two-year-old son were both antibody negative by ELISA. More blood was drawn from the patient...Western blot, radioimmunprecipitation, and HTLV-III virus isolation studies were all negative. HTLV-III ELISAs were repeated in two laboratories, and results from both were positive...Western blot tests with positive bands at 24 and 41 kd [which this woman had, plus two others] have been used as the ‘gold standard’ by which other test results are judged to be falsely positive. Several articles refer to the inevitability of false positive Western blots.”
  NEJM. 1986 Jan 9;314(2):118.1986
Screening donated blood and plasma for HTLV-III antibody: facing more than one crisis?.
 Osterholm MT et al.
  “68% to 89% of all repeatedly reactive ELISA tests are likely to represent false positive results...each year we might expected to find 175 to 209 truly antibody-positive donors [in Minnesota] and between 371 and 1701 falsely positive donors among those who have repeatedly positive screening tests”
  NEJM. 1985;312:1185-8.1985
Genetic Evaluation of Suspected Cases of Transient HIV-1 Infection of Infants.
 Frenkel LM et al.
  “Specimens were studied from a mother and her child, both with suspected transient viremia. The mother had 2 and the infant 3 positive HIV-1 cultures, but subsequently both individuals became negative for HIV-1 by nPCR, standard virus [co-]cultures, CD8+-depleted virus [co-]cultures, and enzyme-linked immunsorbent assay. HIV-1 RNA and DNA were not detected in two lymph nodes taken from the mother 3 and 4 years after the last virus-positive [co-]culture. PCR amplifaction and DNA sequence of HIV-1 env sequences from the...culture supernatants were performed in separate laboratories to eliminate the possibility of cross-contamination. Phylogenetic analysis found that none of the five isolates were genetically linked. Although it is imporbable, these 5 virus isolates appear to have arisen from 5 separate incidents of specimen contamination or mislabeling. This case remains enigmatic, however, in that both the mother and infant had strong CD8+ cytotoxic lymphocyte proliferation to multiple HIV-1 antigens”
  Science. 15 May 1998;280:1073-1077.1998
Detection of retroviral antibodies in primary biliary cirrhosis and other idiopathic biliary disorders.
 Mason AL, Xu L, Guo L, et al.
  It was reported that 35% of patients with primary biliary cirrhosis, 39% of patients with other biliary disorders, 29% of those with lupus, 60% of patients with hepatitis B, 35% of hepatitis C, all non-HIV, non-AIDS diseases, have antibodies to the "HIV" p24 "core" protein.
  Lancet 1998, 351:1620-1624.1998
DNA amplification for direct detection of HIV-1 in DNA of peripheral blood mononuclear cells.
 Ou CY et al.
  “Serologic assays identify persons with prior exposure to human immunodeficiency virus (HIV-1), they do not specifically determine current infection...”
  Science. 1988 Jan 15;239(4837):295-7.1988
Is a positive western blot proof of HIV infection?
 Papadopulos-Eleopulos E, Turner V, Papadimitrioy JM.
  "It is currently accepted that a positive Western blot (WB) HIV antibody test is synonymous with HIV infection and the attendant risk of developing AIDS. In this communication we present a critical evaluation of the presently available data on HIV isolation and antibody testing. This evidence indicates that: (1) the antibody tests are not standardized; (2) the antibody tests are not reproducible; (3) the WB proteins (bands) which are considered to be encoded by the HIV genome and to be specific to HIV may not be encoded by the HIV genome and may in fact represent normal cellular proteins; (4) even if the proteins are specific to HIV, because no gold standard has been used to determine specificity, a positive WB may represent nothing more than cross-reactivity with non-HIV antibodies present in AIDS patients and those at risk. We conclude that the use of antibody tests as a diagnostic and epidemiological tool for HIV infection needs to be reappraised."
  Bio/Technology 1993; 11: 696-707.1993
HIV antibodies: further questions and plea for clarification.
 Papadopulos-Eleopulos E, Turner V, Papadimitrioy JM, Causer D.
  "The existence of specific antibody/protein reactions is the crucial assumption underlying proof of HIV isolation, proof of HIV infection and the causative role of HIV in AIDS. However, since 1. antibodies which react with the 'HIV' proteins arise following allogenic stimuli in non-HIV-infected animals and humans, as well as in mice and humans with autoimmune disorders; antibodies to antigens from both mycobacteria and yeasts cross-react with HIV env and gag proteins; 2. individuals belonging to the AIDS risk groups are subjected to allogenic stimuli and have high levels of autoimmune antibodies, while the vast majority of patients in the AIDS risk groups are infected with either or both mycobacteria or yeasts; the evidence for the existence of HIV and its putative role in AIDS must be reappraised."
  Curr Med Res Opin 1997; 13: 627-634.1997
HIV screening in Russia.
 Voevodin A.
  “In 1990, of 20.2 million HIV tests done in Russia only 112 were confirmed and about 20,000 were false positives, 1991 saw some 30,000 false positives out of 29.4 million tests, with only 66 confirmations.”
  Lancet. 1992;339:1548.1992
Do HIV antibody tests prove HIV infection?
 Turner V.
  No abstract
  Continnum (London) 1996; 3: 8-11.1996
Is it rational to treat or prevent AIDS with toxic antiretroviral drugs in pregnant women, infants, children, and anybody else? The answer is negative.
 Giraldo RA, Ellner M, Farber C, et al. 1.
  No abstract
  Continuum (London) 1999; 5(6): 38-521999
Factors known to cause false-positive HIV antibody test results.
 Johnson C.
  There are abundant scientific publications explaining that there are more than 70 different documented conditions that can cause the antibody tests to react positive without an HIV infection. Some of the conditions that cause false positives on HIV tests are: past or present infection with a variety of bacteria, parasites, viruses, and fungi including tuberculosis, malaria, leishmaniasis, influenza, common cold, leprosy and history of sexually transmitted diseases; the presence of polyspecific antibodies, hypergammaglobulinemias, the presence of autoantibodies against a variety of cells and tissues, vaccination, and the administration of gamma globulins or immunoglobulins; the presence of autoimmune diseases like erythematous lupus, sclerodermia, dermatomyositis and rheumatoid arthriris; the existence of pregnancy and multiparity; a history of rectal insemination; addiction to recreational drugs; several kidney diseases, renal failure and hemodialysis; a history of organ transplantation; presence of a variety of tumors and cancer chemotherapy; many liver diseases including alcoholic liver disease; hemophilia, blood transfusions and administration of coagulation factor; even the simple condition of aging, to mention just a few of the conditions.
  Zenger’s Magazine, San Diego, California, September 1996: 8-9.1996
Is anybody really positive?
 Johnson C.
  There are abundant scientific publications explaining that there are more than 70 different documented conditions that can cause the antibody tests to react positive without an HIV infection. Some of the conditions that cause false positives on HIV tests are: past or present infection with a variety of bacteria, parasites, viruses, and fungi including tuberculosis, malaria, leishmaniasis, influenza, common cold, leprosy and history of sexually transmitted diseases; the presence of polyspecific antibodies, hypergammaglobulinemias, the presence of autoantibodies against a variety of cells and tissues, vaccination, and the administration of gamma globulins or immunoglobulins; the presence of autoimmune diseases like erythematous lupus, sclerodermia, dermatomyositis and rheumatoid arthriris; the existence of pregnancy and multiparity; a history of rectal insemination; addiction to recreational drugs; several kidney diseases, renal failure and hemodialysis; a history of organ transplantation; presence of a variety of tumors and cancer chemotherapy; many liver diseases including alcoholic liver disease; hemophilia, blood transfusions and administration of coagulation factor; even the simple condition of aging, to mention just a few of the conditions.
  Continuum (London); April/May 1995.1995
Compulsory premarital screening for the human immunodeficiency virus: Technical and public health considerations.
 Cleary PD et al.
  “for HIV infection, there is no independent, unequivocal way of identifying a group of individuals who are all assuredly infected or uninfected”
  JAMA. 1987;258:1757-62.1987
Human T-lymphotropic retroviruses.
 Wong-Staal, F. & Gallo, R. C.
  Apart from a joint publication with Montagnier in 1988 (Gallo & Montagnier, 1988) where it is claimed that p24 is unique to HIV, Gallo and his colleagues have repeatedly stated that the p24 of HIV and of two other human retroviruses, HTLV-I and HTLV-II, which Gallo claims to have isolated from humans, immunologically cross-react.
  Nature 317:395-403. 1985.1985
No title
 Wooldridge HCM, Services MfHaF.
  The Australian National HIV Reference Laboratory (NRL) concedes that "False reactivity may be to one or more protein bands and is common" : 20-25% of healthy, no risk individuals have "HIV specific" WB bands
  Copy of letter sent to Senator Christopher Ellison, 1997.1997
Serological diagnosis of human immunodeficiency virus infection by Western Blot testing.
 Lundberg GD.
  The US Consortium for Retrovirus Serology Standardization reported that 127/1306 (10%) of individuals at "low risk" for AIDS including "specimens from blood donor centers" had a positive HIV antibody test by the "most stringent" US WB criteria
  JAMA 1988, 260:674-6791988