Reprinted from VirusMyth.Net, Edited and Updated for Alive & Well May 2004
Questions on HIV-Antibody Tests
By Matt Irwin, MD

"A 20 to 40% rate of indeterminate on Western Blot, a test that supposedly
determines life or death, is outrageously high. Yet few medical experts
question whether it is appropriate to use it for diagnosing HIV infection.
This is only the tip of the iceberg regarding the problems with HIV


As an introduction to the problems with HIV test, the following quote on
the Western Blot, the heavily relied upon "confirmatory" test for HIV,
raises questions about the test's reliability in making the life-altering
diagnosis of HIV positive:

"Problems may be encountered when an HIV Western Blot is done on someone
at no identifiable risk of infection. For example, recent studies of blood
donors in whom no risk of HIV infection could be ascertained, who were
nonreactive on the ELISA, and for whom all other tests for HIV were
negative, revealed that 20% to 40% might have an indeterminate Western
Blot..." (Proffitt et al 1993, page 209)

This excerpt from the medical literature demonstrates that indeterminate
results are hardly rare. It also shows the remarkable finding that any
person, if given a Western Blot HIV antibody test, will have a 20% to 40%
chance of having their serum react with proteins that are supposedly
specific to HIV. An indeterminate result by definition means that the
person's serum reacted to at least one of the "HIV-proteins" used in the
Western Blot. A 20 to 40% rate of indeterminate on a test that supposedly
determines life or death issues is outrageously high, and yet Proffitt et
al. do not mention having any doubts that this is an appropriate test to
use as the final determining factor when diagnosing HIV infection. This is
a common reaction from professionals entrenched in the HIV-causes-AIDS
belief system. The finding of how incredibly common indeterminate results
are on the Western Blot is only the tip of the iceberg regarding the
problems with these tests.

There are two tests that are primarily used in the developed areas of the
world to diagnose HIV infection, the ELISA and Western Blot. The ELISA is
used as a screening test, and if the ELISA result is positive, the Western
Blot is performed as a confirmatory test. When an ELISA result is
negative, no Western Blot test is performed, and the person is declared
"HIV-negative". In order to be considered HIV-positive one must test
positive on both tests. If someone tests positive on the ELISA but
negative on the Western Blot, they are considered HIV-negative. Following
is a detailed discussion of problems with the ELISA, Western Blot, and
viral load tests.

Problems with the ELISA Test

Everyone Tests Positive on the ELISA test

The most remarkable study of the ELISA test has unfortunately not yet been
published in a peer-reviewed medical journal. The study was described by
the physician who performed it, Roberto Giraldo, M.D., in an article that
he published in the magazine Continuum (Giraldo 1998/1999).

Giraldo has worked in a laboratory of clinical immunology at Cornell
University Hospital in New York City since 1993. This lab regularly
performs the ELISA, Western Blot, and Viral load tests on the serum of
patients in the hospital. He became suspicious of the ELISA test because
when the test is run, the serum must be diluted 400 times with a special
diluting agent that is provided by the manufacturer of the test, Abbott
Laboratories. What is particularly unusual about this practice is that no
other antibody tests require such a high dilution. Most antibody tests are
run on straight serum, with no dilution at all, as is the case for
hepatitis A and B virus, rubella virus, and many others. In Dr. Giraldo's
own words:

"This extraordinarily high dilution of the person's serum (400 times) took
me by surprise. Most serologic tests that look for the presence of
antibodies use undiluted ("neat") serum. For example, the tests that look
for hepatitis A and B viruses, rubella virus, syphilis, hystoplasma, and
cryptococcus, to mention a few of them, use straight, undiluted, serum."
(Giraldo 1998/1999, page 8)

The closest comparison to this level of dilution required for HIV tests is
the rheumatoid factor (RF) antibody test which is run at a dilution of
40:1. It is well known, however, that RF is an antibody that all humans
produce, and it is used as a non-specific marker for autoimmune processes
where the body is attacking itself. Thus RF is referred to as an
"autoantibody", and is only elevated when the immune system is
hyperstimulated as occurs in illnesses like rheumatoid arthritis and

Another test that uses diluted serum is the Western Blot, which uses a
ratio of 50:1. This may explain why the Western Blot test is almost always
positive when the ELISA is positive, because serum that reacts at a
dilution of 400:1 on the ELISA test is even more likely to react if only
diluted 50:1 on the Western Blot. One wonders what would happen if Western
Blot tests were run on healthy blood donors undiluted serum, since even
when diluted 50 times the indeterminate rate is between 20 and 40%.
Unfortunately, no one has yet tried to repeat Dr. Giraldo's experiment or
do similar tests with the Western Blot.

Given the unusual dilution required by the ELISA test, Dr. Giraldo
investigated what would happen if he took serum that had tested negative
for HIV when it was diluted 400 times, and reran the ELISA test on the
same serum without diluting it as with tests for other viral antibodies.
Here is Dr. Giraldo's description of his findings:

"I first took samples of blood that at 1:400 dilution tested negative for
antibodies to HIV. I then ran the exact same serum samples through the
test again, but this time without diluting them. Tested straight like
this, they all came up positive. Since that time I have run about 100
specimens and have always gotten the same result. I even ran my own blood
which at 1:400 reacts negative. But at 1:1 [undiluted] it reacted
positive." (page 8)

The results of this remarkable experiment seems significant enough to
immediately halt all ELISA testing until more detailed experiments are
done. This may be why Dr. Giraldo states that "No one will be willing to
publish my results because they are too threatening to the HIV
establishment" (Giraldo, personal communication).

As suggested by the comparison with RF antibodies mentioned previously,
one explanation for positive results on negative samples tested as
straight serum is that HIV antibodies are actually something that all
people produce and that they are not specific to any virus. HIV antibodies
might actually be "autoantibodies", rather than antibodies to a viral
invader. Another explanation is that all people have been exposed to HIV,
but some people produce more antibodies than others. This is equally
disconcerting if one considers the psychological terrorism that
accompanies the diagnosis "HIV-positive" or the popular theory that only a
small portion of HIV positives do not develop AIDS as a result of

Papadopulos-Eleopulos et al. (1993a,b, 1995) have argued repeatedly that
since no one has completely isolated the virus, the specificity of the
tests used to diagnose HIV-infection is completely unknown. Only by
checking the accuracy of the tests against a gold standard of purified HIV
can specificity for the tests be established. All available electron
micrographic pictures of HIV show impure solutions in which what is said
to be HIV represents only a small minority of the visible elements
(Verney-Elliott 1999, de Harven 1998a,b), and therefore there is no way to
know whether the proteins that are used in the ELISA and Western Blot
tests are from HIV or from the other cellular components present within
the sample.

The opinions of Papadopulos-Eleopulos et al. are shared by Etienne de
Harven, Ph.D., who has been one of the world's leaders in electron
microscopy for over forty years. Dr. de Harven spent most of his 37 year
research career studying retroviruses associated with leukemias in
animals. He spent 25 years at the Sloan Kettering Institute where in 1958,
he published the first electron micrographs of the Friend leukemia virus,
a retrovirus his colleague Charlotte Friend had discovered in mouse
leukemic cells. His electron micrographs from 1958 stand in stark contrast
to micrographs claimed to show pictures of HIV. This is because his
micrographs of the Friend leukemia virus show purified viral particles
with only three small impurities viewed in a field of hundreds of viruses
(Verney-Elliott 1999, de Harven 1998a,b).

The only micrographs claimed to be of HIV are 99% impurities which makes
it impossible to know for sure what the micrographs show. (Verney-Elliott
1999, de Harven 1998a,b). De Harven, like Duesberg, became disillusioned
with retrovirology as he saw more and more researchers trying to side-step
the frustration of having their work disproved. According to Dr. de
Harven, researchers did this by lowering their scientific standards and by
using less precise measures in order to get their desired results. De
Harven began to see that the idea that retroviruses could cause disease
was highly unlikely, and he was upset that retrovirologistsstudying the
issue, instead of admitting that this was so, used more and more dubious
scientific methods in an attempt to keep their research alive.

When in 1984, Gallo claimed that a retrovirus was causing AIDS, de Harven,
who was an emeritus professor of Pathology at the University of Toronto at
the time, was highly skeptical. He was not only skeptical that HIV could
be the cause of AIDS, as Duesberg was, but also skeptical as to whether
Gallo had even found a real retrovirus. De Harven had worked with many
researchers in the past who claimed to have isolated a new retrovirus only
to find upon electron microscopy that there was no virus present. This is
why true isolation was discontinued by most researchers, according to de
Harven, and why the term "isolation" is now used when the presence of
questionable surrogate markers are identified. He and
Papadopulos-Eleopulos et al. argue that what are thought to be "markers"
of HIV may simply be a collection of proteins produced by the body's own
cells when under stress. Here are some quotes from Dr. de Harven regarding
these problems and how they relate to the ELISA and Western Blot tests:

"When Gallo and his followers attempted to demonstrate that certain
retroviruses can [cause disease in humans], to the best of my
bibliographical recollection, electron microscopy was never used to
demonstrate directly viremia [the presence of viruses in the blood] in the
studied patients. Why? Most probably electron micrographic results were
negative, and swiftly ignored! But over-enthusiastic retrovirologists
continued to rely on the identification of so-called 'viral markers'
attempting to salvage their hypothesis.

ELISA, then Western Blot tests were hastily developed, at sizable profits
eagerly split between the Pasteur Institute and the U.S. 'Seropositivity'
[based on these two tests] became synonymous with the disease itself,
plunging an entire generation into behavioral panic and exposing hundreds
of thousands of people to 'preventative' antiviral AZT therapy which
actually hastened the appearance of severe or lethal immunodeficiency
syndrome." (de Harven 1998b, page 21)

De Harven concludes his article with the following plea:

"Obviously, the HIV/AIDS hypothesis has to be scientifically reappraised.
And, most urgently, the funding for AIDS research should no longer be
restricted to laboratories working on a hypothesis which has never been
proven." (de Harven 1998b, page 21)

All tests are known to have false positives. In the case of antibody tests
this is much more likely to occur when antibodies are present in large
quantities, as often happens when the immune system has been stimulated by
multiple infections or by foreign agents injected into the bloodstreams.
Such immune stimulation is common among people in the major risk groups
for testing HIV positive in the United States and Europe, including IV
drug users, male homosexuals, and hemophiliacs. The argument that ELISA
and Western Blot tests simply pick up false positives due to very high
antibody levels is supported by an article by Shallenberger on low CD4
counts. (Shallenberger F, Medical Hypotheses: 50; 67-80 1998).

He argues that AIDS is not infectious at all, but rather that is caused by
an imbalance of the immune system with a hyperstimulated antibody-mediated
immunity. He documents that this is exactly what happens to people in the
risk groups for AIDS, and that hyperactive antibody mediation causes
suppression of cellular immunity. He does not discuss the HIV antibody
tests, but it appears that the finding that HIV tests must be run on
heavily diluted blood shows that the test is a measure for excess
antibodies in the blood, also called "hypergammaglobulinemia".

Several reports discussing false positives published by researchers who
support the use of these tests and who support the conventional
explanations for AIDS shed light on why such concerns have been raised.
MacKenzie et al (1992) for example, found seven people who had repeated
false positives on the ELISA test apparently due to flu vaccination, and
estimate that "0.6% to 1.7% of blood donors who received influenza vaccine
this season had multiple false positives." This rate is much higher than
the prevalence of HIV in the US population (which is officially estimated
at about 0.4%) meaning that people who receive a flu vaccine are much more
likely to get a false positive.

If there is no independent measure or "gold standard" for determining a
true positive, how did MacKenzie et al decide that the ELISA results they
reported were false positives? They based their decision on Western Blot
confirmatory tests which were negative or in one case indeterminate, and
the fact that about 3 months later the six people available for follow-up
tested negative on the ELISA (Western Blot was not repeated after a
negative ELISA). Thus we see that the accuracy of the ELISA test is gauged
by the results of Western Blot tests.

A letter to the Western Journal of Medicine (Challakere 1993) reported
finding 5 false positives in a sample of 127 people for a false positive
rate of 4%. Through careful history taking Challakere determined that the
flu vaccine as well as previous viral infections like herpes simplex 2
were the probable causes of these false positives. A rate of 4% means that
1 in 25 people had a false positive which would lead to ten times as many
false positives as true positives since only about one in 250 people in
the United States are thought to be HIV positive according to the most
recent estimates by the Centers for Disease Control. Challakere also
relied on negative Western Blots to decide which tests were true positives
and which were false, showing again how critical the accuracy of the
Western Blot is to current practices regarding the diagnosis of HIV
infection. A summary article on the use of HIV antibody tests that
appeared in Infectious Disease Clinics of North America (Proffitt et al.
1993) discussed some of the known causes of false positives on the ELISA
HIV-1 antibody test:

"Notable causes of false positive reactions have been antibodies that
sometimes occur in multiparous women and in multiply transfused patients.
Likewise, antibodies to proteins of other viruses have been reported to
cross react with HIV determinants. False positive HIV ELISA's also have
been observed recently in persons who received vaccines for influenza and
hepatitis B virus." (page 205)

Since such heavy reliance is placed on the Western Blot test, one
rightfully needs to know how specific it is and how this specificity was
determined. As it turns out, false positives and indeterminates for the
Western Blot test are also quite common and the claimed specificity of the
test is highly questionable. The specificity of the Western Blot is called
into question by other reports, including Proffitt et al.'s 1993 article.