Tests for HIV are highly inaccurate
This article was written in June 2000
and posted during the Internet Discussion
of the South African Presidential AIDS Advisory Panel
For the last 6 years I have been working at a laboratory of clinical immunology in one of the most prestigious University Hospitals in the City of New York. Here I have had the opportunity to personally run and get to know in detail the current tests used for the diagnosis of HIV status, namely, the ELISA, Western blot and Viral Load tests.
1. The ELISA, Western blot, and Viral Load tests, used for the diagnosis of "HIV infection" are not at all accurate
There are many arguments against the accuracy of these tests to diagnose infection by what is known as HIV. For those who want to search the issue deeper I strongly recommend begin studying the 1993 article in Bio/Technology by Eleni Papadopulos-Eleopulos and her group of researches from Perth, Western Australia (12).
Here are some facts that support that a person who reacts positively on these tests does not mean that he/she is infected with HIV:
1.1. The definition of AIDS, as developed by the United States Federal Governments Centers for Disease Control and Prevention, requires a positive result on the antibody test for HIV (1). This definition is accepted worldwide. The importance of HIV in this definition is so strong that, currently, many AIDS researchers, health care professionals and lay people, in following the lead of the United States Institute of Medicine, the National Academy of Sciences and most AIDS researchers now refer to "AIDS" as "HIV Disease" (2-7).
However, AIDS in Africa can be diagnosed without HIV test or any other laboratory test. This was decided by American public health officials at a conference in Bangui, in the Central African Republic in October 1985 (WHOs Weekly Epidemiological Record 1986; 61:69-76 and Science magazine 21 November 1986). This allows health professionals to diagnosis AIDS in Africa based only on the symptoms and signs that a patient manifests.
1.2. The tests that are used most frequently to diagnose HIV status are the ELISA "screening test", the Western blot "confirmatory test" and the PCR "Viral Load test" (8-11). In the United States the ELISA and Western blot tests, when done together, have become known as "the AIDS test". These tests supposedly detect antibodies against HIV. The "Viral Load" or PCR test is a genetic test that makes copies of small fragments of nucleic acids that, it is claimed, belong exclusively to HIV. These are the same tests that are used to check for HIV in mothers, infants, children, and in the population at large. The problem with all of these tests is that a positive HIV reaction does not guarantee that the person is really infected with HIV at all (12-21).
1.3. Currently, a positive result on "the AIDS test" - ELISA and Western blot antibody tests - is synonymous with HIV infection and the attendant risk of developing AIDS (8-11).
However, these antibody tests are neither standardized nor reproducible, with respect to HIV they are themselves meaningless because they mean different things in different individuals, they also mean different things in different laboratories and in different countries (12). They are interpreted differently in the United States, Russia, Canada, Australia, Africa, Europe and South America (22-27), which means that a person who is positive in Africa can be negative when tested in Australia; or a person who is negative in Canada can become positive when tested in Africa (28). The other problem is that the same sample of blood when tested in 19 different laboratories gets 19 different results on the Western blot test (29).
1.4. The Western blot antigens, proteins or bands - p120, p41, p32, p24/25, p17/18 - which are considered to be specific to HIV, may not be encoded by the HIV genome and may in fact represent human cellular proteins (12-14,20,30).
1.5. The only valid method of establishing the sensitivity and the specificity of a diagnostic test in clinical medicine is to compare the test in question with its gold standard. The only possible gold standard for the HIV tests is the human immunodeficiency virus itself. Since HIV has never been isolated as an independent free and purified viral entity (31), it is not possible to properly define the sensitivity or the specificity of any of the tests for HIV (12). Currently, the sensitivity and the specificity of the tests for HIV are defined not by comparison to purified HIV itself, but by comparison of the tests in question with the clinical manifestations of AIDS, or with T4 cell counts (12). Abbott states, "At present there is no recognized standard for establishing the presence and absence of HIV-1 antibody in human blood. Therefore sensitivity was computed based on the clinical diagnosis of AIDS and specificity based on random donors" (32). Since there is no gold standard for defining the specificity of the tests used for the diagnosis of HIV infection, all HIV-positive results for HIV infection must be considered false-positives.
1.6. 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 (12-14,17,19,30). In other words, there are more than 70 scientifically acknowledged reasons for false positives when testing for HIV. This fact has been abundantly documented in the scientific literature.
1.7. Of course, it is shocking to find out that a diagnosis of HIV infection is based on tests that are not specific for HIV. However, the scientific evidence tells us that a person can react positive on the test for HIV even though he or she is not infected with HIV (12-14,17,21,30,33).
1.8. The pharmaceutical companies that make and commercialize the kits for these tests acknowledge the inaccuracy of them, and this is why the inserts that come with the kits typically state the following: "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" (32). 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" (34). The insert that comes with a popular kit to run viral load warns, "The amplicor HIV-1 Monitor test is not intended to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection" (35). The problem is that not only most AIDS researchers, journalists and lay people but health care workers themselves do not know these facts about the tests because they do not have access to them. There likewise appears to be little or no concern on the part of the knowing faculty of institutions to communicate these facts to physicians, let alone the general public.
1.9. Since the viral load results are given in copies per ml of plasma (35) AIDS researchers, health care professionals, and lay people may think that they represent copies or counts of the virus itself (12,36-41). However, the viral load test only makes copies of fragments of nucleic acids. It does not count HIV itself. A positive viral load test cannot be regarded as signifying the presence of the whole HIV genome, and therefore the test cannot be used to measure virus.
1.10. Results of the viral load test cannot be reproduced. This can be seen in the wide range of variability that is accepted in the quality controls set by the companies that make and commercialize the test kits. For example, Roche accepts low control having a range between 1,200 and 11,000 copies per ml [Lot # 0047], and high control having a range between 99,000 and 750,000 copies per ml [Lot # A00246] [Roche, Amplicor HIV-1 Monitor test Lot # B00985, expiration August 2000]. Most important of all, the problems with the lack of a gold standard for HIV infection also apply to the evaluation of the accuracy of the PCR or Viral load test (12,41,42). As a consequence, the specificity of the viral load test for HIV has never been defined properly. Therefore, all viral load positive results are likewise false-positives for HIV.
1.11. The fact that the defenders of HIV as the cause of AIDS, had to appeal to a genetic trick the PCR test is a strong argument against HIV as the cause of AIDS. To have to amplify tiny amounts of genetic material in the blood of the AIDS patients to try to identify HIV, instead of culturing the entire virus, isolate it and purify it, violates one of the central rules of infectious diseases: in the climax or maximum state of severity of any infectious disease is when the patient has the higher amount of microbes in his/her tissues. Is in those moments when it is easier to isolate and purify the microbes that are really causing a disease.
1.12. People have the right to make informed choices (43-45). However, the right of informed choice implies a right to good information. There is no justification for the fact that most people have not been informed about the serious inaccuracy of the tests for HIV infection. Withholding or obscuring these facts is a serious breach of public trust, violating as it does a persons right to informed consent when making decisions about their health care. The legal implications of this situation have been noted (46).
2. Being "HIV-positive" does not mean that a person is infected with "HIV"
2.1. There are a growing number of scientific publications explaining in detail that the tests for HIV infection are not specific for HIV (12-14,47). There are many reasons other than a past or present HIV infection to explain why an individual reacts positive on these tests. In other words these tests can react positive in the absence of HIV (12-14,17-19,30).
2.2. Some of the conditions that cause false positives on the so-called "AIDS test" are: past or present infection with a variety of bacteria, parasites, viruses, and fungi including tuberculosis, malaria, leishmaniasis, influenza, the common cold, leprosy and a history of sexually transmitted diseases; the presence of polyspecific antibodies, hypergammaglobulinemias, the presence of auto-antibodies against a variety of cells and tissues, vaccinations, and the administration of gamma globulins or immunoglobulins; the presence of auto-immune diseases like erythematous systemic lupus, sclerodermia, dermatomyositis and rheumatoid arthritis; 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 the administration of coagulation factor; and even the simple condition of aging, to mention a few of them (12-14,17,18,30).
2.3. It is interesting to note that all of these conditions that cause the "HIV tests" to react positive in the absence of HIV, are conditions which are present with varied distribution and concentration in all of the conventionally recognized AIDS risk groups in the developed countries, as well as in the vast majority of inhabitants of the underdeveloped world. This means that in all probability many drug users [including mothers], certain gay males, and some hemophiliacs in the developed countries, as well as the vast majority of inhabitants in most countries of Africa, Asia, South America and the Caribbean, who have positive reactions to the tests for HIV, may very well do so due to conditions other than being infected with HIV (12-14,30,48).
2.4. Further, it is well known that people with or at risk for AIDS have high levels of antibodies - immunoglobulins - as a consequence of having been exposed to significant quantities of a variety of foreign substances such as recreational drugs, semen, factor VIII, blood and blood components, sexually transmitted infections and other infections (12-14,49). All these substances are oxidizing agents that cause oxidative stress (47,50,51).
2.5. Recently I had the opportunity to carry out an experiment by which I was able to demonstrate that all blood react positively on the ELISA test when run the test with neat or non-diluted serum. This could indicate that everybody has antibodies against what is supposed to be HIV. The ones that only react positively with straight or neat serum would have fewer amount of antibodies than the ones that continue reacting positively even when the serum is diluted 400 times (88). This possibility has been confirmed by Yugoslavian and Italian researchers (90)
2.6. There is also a great deal of scientific data indicating the widespread presence of non-specific interactions between what are considered to be retroviral antigens and unrelated antibodies (12,52-54). It is then possible to conclude that the tests for HIV react positively in the presence of those antibodies; in other words, that a positive result on an antibody test for HIV may be the result of previous antigenic over-stimulation, rather than a result of an HIV or any other retroviral infection (12-14).
2.7. Finally, it has been proposed that antibodies against HIV are surrogate markers for recreational drug use in the United States and in Europe (55,56).
2.8. On the other hand, even if "the AIDS test" were able to detect antibodies to HIV, it would not be logical to say that the presence of those antibodies indicate an active infection. The presence of antibodies to any virus simply means humoral immune response to that virus and not necessarily that the virus is still active and pathogenic (48,58). One can have antibodies against many germs without those germs being active, pathogenically active or even present at all (58,59). In most instances, antibodies against viruses indicate immunity. This is the very basis of vaccination against viral diseases (48,58,60). Even if the tests were specific for antibodies against HIV, the question would then be the following: Why is it that only in the case of AIDS the presence of antibodies indicates the presence of disease, rather than protection against it?
2.9. There is no justification for the fact that both patients and the general public have had all of the preceding facts withheld from them. Without the merits and demerits of the tests for HIV, people cannot make informed decisions.
3. The so-called "AIDS virus", HIV, may not even exist
Biophysicist Eleni Papadopulos-Eleopulos and her group of researchers at Royal Perth Hospital in Perth, Western Australia, were the very first scientists in mentioning the fact that HIV has never been isolated (12). For several years Papadopulos-Eleopulos and coworkers, have been publishing papers where they have described in detail, the scientific facts that support the assertion that the so-called AIDS virus, HIV, may not even exist (12-14,20,30,31,47,50,61-64):
3.1. The correct procedures (31) employed for over half a century to achieve isolation of a retrovirus are: a) to find in infected cell cultures particles with a diameter of 100-120 nM that contain the so-called condensed inner bodies or cores and that have surfaces studded with projections - spikes, knobs - b) In sucrose density gradients the particles band at a density of 1.16 gm/ml; c) At the density of 1.16 gm/ml there is nothing else but particles with the morphological characteristics of retroviral particles; d) The particles contain only RNA and not DNA, and the RNA consistently has the same length [number of bases] and composition no matter how many times the experiment is repeated; e) When the particles are introduced into secondary cultures they are taken up by the cells, the entire RNA is reverse transcribed into cDNA, the entire cDNA is inserted into the cellular DNA, and the DNA is transcribed back into RNA which is then translated into proteins; f) As a result of e the cells in the secondary cultures release particles into the culture medium; g) The particles released into the secondary culture medium have exactly the same characteristics as the original particles, that is, they must have identical morphology, band at 1.16 gm/ml and contain the same RNA and proteins (31).
None of these procedures have been achieved in the case of HIV (12,14,31,47).
3.2. None of the researchers who claim to have isolated HIV have shown the presence of particles with the morphological characteristics of retroviruses banding at 1.16 gm/ml (31).
Even the word "isolation" as used by the most noted researchers (65-67) is incorrect and misleading since neither Montagnier, Gallo nor Levy isolated HIV particles, particles of any other human retrovirus, or even virus-like-particles at all (12-14,30,31,47,61,68-74).
3.3. Since no "retroviral particles" [retroviruses] have ever been isolated from any culture (12-14,31,47,61-63,69-75), the existence of HIV has been established indirectly: by the presence in blood cultures of AIDS and "HIV-positive" individuals, proteins/glycoproteins such as gp 160/150, gp120, gp41/45/40, p34/32, p24, and p18/17, each claimed to belong to HIV; by the presence of enzymes such as reverse transcriptase that supposedly belongs to HIV; and by the presence of RNA or DNA fragments that supposedly belong to HIV (12-14,31,47,61-63,69-75).
However, none of these substances have been proven to belong to HIV at all (12-14,31,47,61-63,69-75). How can anybody prove that the substances found in those cultures belong to a viral particle that has never been found at 1.16 gm/ml? To prove that those substances are part of a retrovirus named HIV, it is absolutely necessary that the retroviral particles have been previously separated - isolated - from everything else. This has never been done with HIV (31).
3.4. It is interesting to note that the substances listed in 6.3. are claimed to appear exclusively when one co-cultures supposedly infected blood with abnormal cells from leukemia patients, or from umbilical cord lymphocytes (31). The problem is that the same substances can be obtained from the same cultures in the absence of the supposedly HIV-infected blood (31).
3.5. The cultures where the above substances have been found are cultures that have been heavily stimulated with substances such as phytohemagglutinin, IL-2, antiserum to human interferon, and other agents (31). These culture stimulants are oxidizing agents (31,47). The problem is that the same type of material can be observed in stimulated cultures of lymphocytes from healthy persons (31,76).
It is interesting to note than in the presence of antioxidants, no HIV phenomena can be observed in culture; nor can HIV substances be found (12,64,76).
3.6. The substances listed in 6.3. are not specific to HIV at all (31). For instance, it is currently known that reverse transcriptase can be found associated with entities other than retroviruses, including eukaryote cells, some animal and plant DNA viruses, and even some introns (77).
Gallo and co-workers have claimed that the cell-free supernatants from "infected" cultures have HIV-DNA (78,79). They forgot that by definition retroviruses are infectious particles that contain only RNA. When retroviruses enter a cell the RNA is reverse transcribed into DNA, which is then integrated into cellular DNA as a provirus, which means that "HIV DNA" will be present only in the cell and no where else (31).
There is also ample evidence that any RNA or DNA present in the supernatant of the cultures is there as an effect of stimulation by polycations and oxidizing agents, rather than as an effect of the presence of a retrovirus (31).
"HIV cloning" is likewise misleading. Without isolating a retroviral particle containing RNA inside its core, the cloning of that "specific HIV-RNA" is not possible (31).
3.7. To date nobody has presented evidence that the so-called HIV proteins or antigens [gp160/150, gp120, gp41/45/40, p34/32, p24, p18/17], are constituents of a retrovirus particle or even retrovirus-like particle let alone a unique retrovirus, HIV (31).
3.8. The proteins or antigens derived from stimulated cultures form the basis for the ELISA and Western blot HIV antibody tests (31,73). Fragments of RNA from stimulated cultures form the basis of the HIV viral load test (31,73). This is the main reason why the current tests used for the diagnosis of HIV are not specific for it (12-14,31,61,62).
3.9. In the January 1997 issue of the journal Virology, two independent groups of researchers published experiments claiming to isolate HIV. Now and for the first time in the history of HIV, the researchers followed the internationally accepted procedures to isolate retroviral particles. Not surprisingly, in the sedimented bands at 1.16 gm/ml of sucrose, where retroviruses are known to be located, nothing was found but cellular debris. At 1.16 gm/ml there was nothing that even looked like a retroviral particle (80-81). They could not have isolated HIV simply because HIV was not there to be isolated.
It has been proposed that all those substances that indicate the existence of HIV are nothing more than non-viral material altogether, induced by the agents to which the AIDS patients and cultures are exposed (31). When found in people, these substances would be seen as regular products of the stress response (82), secondary to exposure to chemical, physical, biological, mental, and nutritional stressor agents (48,51,57,83-87).
3.10. It is therefore possible to conclude that the entire model of AIDS as an infectious and transmissible viral disease has its basis on a non-existing organism. The foundation stone for the HIV-AIDS model then, is a ghost.
4. The real meaning of being HIV-positive
4.1. Above considerations allow one to propose that the reactivity on the ELISA, Western blot, and PCR tests is caused by multiple, repeated, and chronic exposure to chemical, physical, biological, mental, and nutritional stressor agents. The degree of reactivity would be proportional to the level of exposures to immunological stressor or oxidizing agents (12-14,20,30,31,63,88,89).
Positive results on ELISA and Western blot tests, can also be understood as the consequence of the presence of high levels of polyspecific antibodies, due to a state of chronic polyantigenic stimulation (52-54). The reactivity on the three main tests for HIV -ELISA, Western blot, and PCR or viral load - would be simply the result of the stress response (82,88,89,91-94).
4.2. Being "HIV-positive" - reacting positive on the tests for HIV would then mean simply that the person has been exposed to many antigenic and toxic challenges, i.e., to many oxidizing agents (47,50,89). His or her immune system has been responding a lot to these immunogenic and immunotoxic challenges (51,57,89). The immune system of these "HIV-positive" individuals would be debilitated - oxidized - after it has been over-stimulated and intoxicated. Therefore, their risk for AIDS is higher than those who are "HIV-negative" (12,13,49,51).
4.3. Undoubtedly, there is almost a perfect correlation between the reactivity on the so-called "tests for HIV" and AIDS.
Exposure to immunological stressors makes the tests to react positively. At the same time, the exposure to immunological stressors or oxidizing agents is the cause of the mild to moderate levels of immune suppression present in all non-symptomatic individuals who react positively on the "tests for HIV." If the exposure to immunological stressor is not stopped, and if the individual is not disintoxicated, it is very probably that the non-symptomatic "HIV-positive" individual will worsen his/her immune suppression, and will develop the clinical manifestations of AIDS.
What we know as HIV has not causative role in AIDS. By the contrary, the HIV phenomenon is one of the effects of the stress response to multiple repeated, and chronic exposures to chemical, physical, biological, mental, and nutritional stressor agents.
5. Possible trial to find out the real meaning of the tests for HIV
To take blood from four groups of people and run the tests highly diluted, undiluted and at a wide spectrum of dilutions in between. a) The first group would be a group of healthy people of many age groups, b) the second group would be a group of people from the conventional AIDS risk groups, c) the third group would be a group of people with clinical conditions unrelated to AIDS, and d) the fourth group would be a group of patients with full manifestations of AIDS.
All groups would be subjected to both ELISA and Western blot tests. Additionally, all blood samples could be subjected to the viral load test for HIV.
The result of such experiment could determine whether these tests measurements bear any relationship to an individuals level of exposure to stressor or oxidizing agents. If so, the tests could be salvaged as a measure of individuals level of intoxication.
Roberto A. Giraldo