TESTS FOR HIV ARE HIGHLY INACCURATE
By Roberto Giraldo
June 2000
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.
This article was written in June 2000
and posted during the Internet Discussion
of the South African Presidential AIDS Advisory Panel
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