QUESTIONS ON HIV-ANTIBODY TESTS
By Matt Irwin
As an introduction to the problems with these tests, here is a quote from
the conventional literature about indeterminates on the Western Blot,
which is currently the heavily relied upon "confirmatory"
test for HIV infection:
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)
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 indeterminates on a test
that supposedly determines life or death issues is outragiously high,
and yet Proffitt et al. do not mention anywhere in their article that
they have any doubts about whether this is an appropriate test to use
as the final decision when diagnosing HIV infection. This is a common
reaction from people who are 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 West to diagnose
HIV infection. These are the ELISA and Western Blot tests. The ELISA
is used as a screening test, and if the ELISA result is positive, the
Western Blot is used as a confirmatory test. If the 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).
Dr. 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 people who are patients in the hospital. He became suspicious of
the ELISA test because when the test is run, the person's serum must
be diluted 400 times with a special diluent that is provided by the
manufacturer of the lab, Abbott Laboratories. What is particularly unusual
about this is that no other antibody tests require such a high dilution.
Most 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:
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)
comparison to this level of dilution 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 lupus. Another test that uses
diluted serum is the Western Blot test, 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 and others 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 wondered
what would happen if he took serum that had tested negative for HIV
when it was diluted 400 times, and rerun the ELISA test on the same
serum without diluting it at all as is done with tests for other viral
antibodies. Here is Dr. Giraldo's description of the results:
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.
At 1:1 (undiluted) it reacted positive.' (page 8)
result seems significant enough to immediately halt all ELISA testing
until it and more detailed experiments are done, which 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 above, one explanation is that HIV antibodies are actually
something that all people produce and that are not specific to any virus.
This suggests that HIV antibodies might actually be "autoantibodies",
rather than antibodies to a viral invader. The other obvious 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".
Papadopulos-Eleopulos et al. (1993a,b, 1995) have argued repeatedly
that since no one has completely isolated the HIV 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 be established. All available electron micrographic
pictures of HIV show impure solutions in which what is said to be HIV
only represents 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 you are looking at (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 they did this by lowering their scientific standards, and by
using less precise measures in order to get the results that they wanted.
De Harven began to see that the idea that retroviruses could cause disease
was highly unlikely, and he was upset to see that retrovirologists studying
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 they had even found a real retrovirus. He 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 direct quotes from Dr. de
Harven regarding these problems and how they relate to the ELISA and
Western Blot tests..
around 1980, 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 behavioural 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)
concludes his article with the following plea:
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 an antibody
test, this is much more likely to occur if antibodies are present in
large quantities, as often occurs when the immune system has been stimulated
by multiple infections or by having foreign agents injected into the
bloodstreams. All of these things are comon experiences of people in
all the major risk goups 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 are simply picking 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 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
a hyperactive antibody-mediated arm causes a suppression of cellular
immunity. He does not discuss the HIV antibody tests, but it appears
that the finding that the HIV test must be run on heavily diluted blood
shows that it is a measure for excess antibodies in the blood, also
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
about 0.4%, so that people who receive a flu vaccine are much more likely
to get a false positive than a true positive.
How did they decide that the ELISA results were false positives? They
based their decision that these were false positives on the fact that
their Western Blots, used as confirmatory tests, were negative or, in
one case, indeterminate, and that about 3 months later the six people
available for follow-up tested negative on the ELISA test (the Western
Blot was not repeated). 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 they 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 diagnosed HIV positive according to
the most recent CDC estimates. 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.
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)
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.
PROBLEMS WITH THE WESTERN BLOT ANTIBODY TEST
The specificity of the Western Blot is called into question by reports
such as the one below which is also from Proffitt et al.'s 1993 article.
The Western Blot has ten "bands", all of which have a protein
("antigen") that is supposedly only produced by HIV. The ELISA
test also uses these "HIV proteins", but they are present
as a mixture and so only one band needs to be used. The patient's serum
is run separately through all ten bands of the Western Blot to see how
it will react with each one, individually. If it reacts with a protein
in a given band, that is considered to mean that the patient's serum
contains antibodies to that protein. Not all ten bands have to be positive
in order for a person to be diagnosed HIV-positive, however, and the
combinations needed vary greatly from country to country. This fact
alone shows how arbitrary the test limits are, since a person diagnosed
HIV-positive in one country may be considered "indeterminate"
The following quote from Proffitt et al. describes the
inconsistent guidelines for the reading of this test (Proffitt 1993):
not even the interpretation guidelines in the brochures of each FDA-licensed
manufacturer of HIV Western Blots are the same. However, the majority
of the laboratories have accepted the recommendations of the ASTPHLD.
Following those recommendations, a negative Western Blot would have
no bands, a positive would have at least two of the key bands, and an
indeterminate would have a single band or a combination that does not
fit the interpretation of positive.' (page 208)
comment hardly inspires confidence that these interpretations are based
on sound scientific principles, and explains why different countries
have widely varying criteria for how to decide when a test is "positive"
and when it is "indeterminate". The most disturbing evidence
they cite, however, is the rate of indeterminates that appear for Western
Blots in healthy blood donors as discussed previously. An indeterminate
occurs when an insufficient number of bands come up positive, or when
the combination "does not fit the interpretation of positive".
One would expect, since all of the bands contain proteins that are supposedly
specific to HIV, that indeterminate results would be quite rare, but
this is hardly the case.
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... (page 209)
that any one of us, if given a Western Blot HIV antibody test, will
have a 20% to 40% chance of having our serum react with proteins that
are supposedly specific to HIV! As mentioned before, such a high rate
of indeterminates on a test that supposedly determines life or death
issues is outragious, in my opinion, and yet Proffitt et al. do not
question its accuracy in any way.
Upon hearing results like these, it is reasonable to wonder how the
extremely high specificity which is claimed for this test can possibly
be true. The specificity that is claimed is that only 1 in 20,000 tests
will give a false positive. A later article from 1995, that also supports
the use of these tests, places these two seemingly irreconcilable claims
in the very same sentence.
incidences of inaccurate results (on the Western Blot) vary from a false
positive rate of 1 in 20,000 to indeterminate results in 20% to 40%
of cases in which the ELISA test was serum negative. (Cordes 1995, page
conclusions that Proffitt et al. draw from this extremely high false
indeterminate rate is that the Western Blot should not be used as an
initial screening test, and the only harm mentioned is that "the
anxiety an indeterminate result creates in a test subject is understandably
intense" (Proffitt 1993, page 209).
If an indeterminate result creates "intense" anxiety, a result
considered to be a true positive will create levels of stress and anxiety
that are many times more intense. I have called the fear and social
isolation caused by a positive HIV antibody test result "psychological
terrorism" because of how devastating it can be, and yet the decision
about what is "true", "false" or "indeterminate"
does not appear to be based in any well controlled experiments, and
appears to ignore many conflicting results.
The arbitrary nature of the Western Blot has been analyzed in detail
by Papadopulos-Eleopulos et al. (1993), who document that all of the
proteins used in the Western Blot which are supposedly specific to HIV
have been commonly found in people who are HIV-negative on the other
HIV tests. They also point out that HIV was never isolated so there
is no way to know if these proteins are from HIV or from other cells
and viruses. Before analyzing their work, however, here is a quote from
a team of researchers who reported a number of false positive results
on the Western Blot tests.
document a fourth source of false positive HIV-1 Western Blot results,
which is the reproducible but nonspecific reactivity to (proteins from
HIV)... Preliminary studies suggest that the basis for this cross reactivity
with HIV-1 gp 41 proteins may be infection by paramyxoviruses, carbohydrate
antibodies, or autoantibodies against cellular proteins. (Sayre et al.
also looked at rates of these types of false positives among all tests
performed on blood donors in the U.S., and concluded that 1992 had the
highest rates to date with 52 out of 683, or 8% of Western Blot positives
on donated blood actually being false positives.
The quote above from Sayre et al. (1996) mentions false positives due
to reactions with the "gp 41 proteins", which include gp 41
and gp 120/160 (these proteins are sometimes referred to with only a
"p", instead of with "gp"). However, there have
been problems with the proteins in all the other bands used in the Western
Blot, as well, and it has been shown in a number of studies that none
of the ten proteins is actually specific to HIV. "Gp" stands
for "glycoprotein", which is a protein with some sugar molecules
attached to it, and the number after the letters represents the molecular
weight of the protein, in kilodaltons. Glycoproteins of all shapes and
sizes are extremely common components of cells in both plants and animals.
The research calling into question whether any of the "HIV proteins"
is really specific to HIV is presented in detail in an article published
in Bio/Technology, by Papadopulos-Eleopulos et al., entitled "Is
a Positive Western Blot Proof of HIV Infection?" (Papadopulos-Eleopulos
et al.1993). This article is available online. The authors point out
that even Luc Montagnier's original papers found gp 41 to occur in normal
cells which were not infected by HIV, and that Montagnier's group concluded
that gp 41 "may be due to contamination of the virus by cellular
actin which was present ... in all the cell extracts" (Barre-Sinoussi
et al. 1983). Actin is an extremely common protein that is present in
all cells, including bacteria and viruses. The gp 120/160 protein was
shown in 1989 to actually be several gp 41 proteins hooked together
("oligomers" of gp 41), so it is equally non-specific. This
was reported by Pinter et al in 1989 in the Journal of Virology in an
article entitled, "Oligomeric Structure of gp41, the transmembrane
Protein of HIV-1".
Another protein, gp24, is of special significance because it is often
used by itself to test for the presence of HIV. This is commonly done
in newborn children, where the ELISA and Western Blots are thought to
give false positives due to antibodies that have been supplied by the
Mother, who has already been found to be positive for "HIV antibodies".
In addition, when "cultures" of HIV are done, the way they
test to see if HIV is there is by looking for gp 24. Thus, this glycoprotein
has special importance, and one would expect that it would be extremely
rare to find it in people considered not to be infected with HIV. As
Papadopulos-Eleopulos et al. put it:
of p24 is currently believed to be synonymous with HIV isolation and
viremia. However, ... Gallo and his colleagues have repeatedly stated
that the p24's of HTLV-1 (a different retrovirus) and HIV cross-react"
(Papadopulos-Eleopulos et al.1993 page 697, Wong-Staal & Gallo 1985).
et al. continue with furthur examples showing how incredibly common
it is to find gp 24 and antibodies to gp 24 in people who are considered
et al (1989) conducted Western Blot assays in 100 ELISA-negative samples
of healthy blood donors. 20 were found to have positive bands which
... were considered indeterminate Western Blots, with p24 being the
predominant band (70% of cases). Among the recipients of Western Blot
indeterminate blood, 36% were Western Blot indeterminate 6 months after
transfusion, but so were 42% of individuals who received Western Blot-negative
blood samples. (!!!) Both donors and recipients of blood remained healthy.
They concluded that Western Blot indeterminate patterns "are exceedingly
common in randomly selected donors and recipients and such patterns
do not correlate with the presence of HIV-1 or the transmission of HIV-1...
Most such reactions represent false positives."
Antibodies to gp 24 have been detected in 1 out of 150 healthy, ELISA-negative
individuals, 13% of randomly selected otherwise healthy patients with
generalized warts, 24% of patients with cutaneous T-cell lymphoma, and
41% of patients with multiple sclerosis (Ranki et al. 1988). ...
Conversely, the p24 antigen is not found in all HIV positive or even
AIDS patients. In one study... in patients at various stages from asymptomatic
(HIV positive) to AIDS, p24 was detected in only 24% (Delord et al.
1991). (Papadopulos-Eleopulos et al. 1993b, pages 697-699).
have researchers discussing the "exceedingly common" occurence
of Western Blot indeterminate results, and deciding that they represent
false positives because the ELISA is negative. When we looked at ELISA
false positives, they were said to be false positives because the Western
Blot was negative! The incredible reliance of patients, doctors, and
scientists on tests with such obvious inconsistencies is a cause for
alarm, and yet it appears that the only people sounding the alarm are
not being heard, or at least not being listened to. The rest of the
article by Papadopulos-Eleopulos et al. goes on to discuss similar findings
with the rest of the Western Blot "HIV proteins", and concludes
with a relatively conservative call for reappraisal:
that the use of the HIV antibody tests as a diagnostic and epidemiological
tool for HIV infection needs to be reappraised. (page 696)
greater concern than the existence of these problems is the fact that
no one in the conventional medical and scientific establishment seems
to be asking questions about them.
PROBLEMS WITH THE "VIRAL LOAD" TEST
published in 1995 in the journal, Nature, appeared to resolve the dilemma
of either not being able to find any actual HIV particles, or only finding
extremely small quantities of HIV, in people diagnosed HIV-positive
(Ho 1995, Wei 1995). They used a new genetic detection system, called
"quantitative PCR", which relies on a complex mathematical
formula to quantify the amount of virus in people's blood. This abstract
quantification system is what is still used today to find what is called
a person's "viral load", and has become a major method used
by clinicians to determine the health status of people diagnosed HIV-positive.
Contrary to what most people believe, however, PCR does not actually
directly detect any intact viral particles, but instead is entirely
based on the detection of tiny fragments of HIV's genetic material.
Thus, "viral load" is not found by counting even one single
intact particle of HIV, but rather by using a complex mathematical system
of estimation. This quantification system has serious problems that
have been largely ignored, in spite of being clearly reported in the
medical literature, and yet it has become the primary marker of health
both in research as well as in treatment decisions with people diagnosed
many HIV particles does "viral load" really represent?
can only cause damage if they are infectious. That is how they are supposed
to cause ill health, by infecting cells and then causing cell death.
Researchers attempting to see what proportion of the huge numbers of
HIV reported by quantitative PCR represent active, infectious viruses,
have found that as few as 1 in 10 million are actually infectious. This
is done by "culturing" the virus, which usually means trying
to infect other cells with it and looking for surrogate markers of HIV
like gp 24. As outlined above, these proteins are actually quite non-specific
and are often found in people who are HIV-negative.
A virus that cannot infect another cell is essentially sterile, since
it cannot harm any cells if it cannot infect them. Here are some comments
on the results from one major study published in Science in 1993, where
researchers found that the vast majority of "viral particles"
found by viral load/quantitative PCR were non-infectious (Piatak et
levels of plasma virus determined by (quantitative) PCR correlated with,
but exceeded by an average of 60,000-fold, numbers of infectious HIV-1
that were determined by quantitative culture of identical portions of
plasma... Total virions have been reported (in other studies) to exceed
culturable infectious units by factors of 1000 to 10,000,000, ratios
similar to those we observed in plasma. (page 1752)
that these researchers estimated that only about 1 in 60,000 "virions"
found using "quantitative" PCR were actually infectious, and
that other studies have found even more dismal results. Because they
use the presence of gp24 which is a non-specific protein found in 41%
of patients with multiple sclerosis (Ranki et al. 1988) to determine
if a cell has become infected, even their estimate of 1 in 60,000 is
Even using a non-specific marker like gp 24 they were not able to culture
any virus at all in more than half (35 of 66) patients. People with
no infectious virus at all had "viral loads" as high as 815,000
"copies per milliliter"! The study subjects had all tested
positive on the ELISA and western blot antibody tests, the two tests
currently used to diagnose people as being "HIV-positive",
they all had extremely high "viral loads", and yet the majority
of them had no "culturable infectious units" of HIV. Results
like these bring up some obvious questions about who proved that testing
positive on antibody tests meant that a person had an active infection,
and how they proved it. Unfortunately, in the world of HIV science,
no one seems to asking questions about these tests. Instead, articles
commonly quote amazing levels of specificity and sensitivity.
This difficulty in finding active HIV particles is not surprising to
those familiar with the literature on this topic, since similar results
have been found by many researchers who have tried to confirm the presence
of HIV in people's blood (Chiodi 1988, Gallo 1984, Learmont 1992, Popovic
1984, Sarngadharan 1984, Schupbach 1984). Based on results like these,
the abstract system used by quantitative PCR technology, in which tiny
bits of genetic material are amplified by a complex set of mathematical
equations into frighteningly large numbers, is highly questionable.
Most people diagnosed HIV positive, even with high viral loads, may
have no infectious virus in them, at all. As will be discussed in the
next section, many people who test negative on both the ELISA and Western
Blot have substantial viral loads when tested using "quantitative
PCR". This brings up the question of whether PCR is capable of
mistaking tiny bits of a person's own genetic material for genetic material
of HIV. Since the human genome has about 3 billion base pairs, while
that of HIV has only about 10,000, and PCR only looks for about 3% of
HIV's genetic material, or about 300 base pairs, it appears likely that
some of the 3 billion base pairs in the human genome could accidentally
be attributed to HIV.
As mentioned before, "viral load" has become the only measure
of health in clinical trials of new drugs. News reports about people
"doing well" on the new anti-retroviral cocktails often speak
about people whose "disease is controlled" on the drugs, or
whose "disease came roaring back" after stopping the drugs.
What they are referring to, however, is not clinical health, at all.
Careful reading of such articles reveals that the person in question
often feels much better off of the drugs because of the numerous toxic
effects that they have. The description of the disease "roaring
back" is based entirely on the fact that their "viral loads"
have risen, even though they may be feeling much better.
As often occurs in studies like this one that fundamentally challenge
HIV science, however, the authors (Piatak et al.) appear unphased by
their results, and focus completely in the discussion section of their
paper on other aspects of their study that fit better with conventional
views about what it means to be "HIV-positive" and to have
a high "viral load". They do not even mention in their discussion
that the majority of their subjects had no infectious viral particles.
While it is of questionable significance to have such high "viral
loads" if only a tiny minority, or none of the particles is actually
infectious, it can still be terrifying to be told that one has several
million copies of HIV in every milliliter of blood. This type of news
has a powerful symbolic meaning to clinicians and patients, which may
result in profound immunosuppression whether HIV is causing damage,
Viral Loads in People Who Are "HIV-Negative"
Adding furthur confusion to the issue, PCR technology has found extremely
high viral loads in people who are HIV negative by the ELISA and Western
Blot antibody tests. For instance, Schwartz et al. (1997) found a person
with a viral load of 100,000 who was negative on the ELISA and Western
Blot antibody tests. The authors concluded that lab error had led to
this reading, which would be a reasonable explanation but for the presence
of other studies finding similar results.
Gerberding et al. (1994) conducted a study of HIV contaminated needle
sticks, and in the process also uncovered data that call into question
the value of viral load/PCR testing. They did PCR tests on 133 of the
327 healthy workers who had experienced needle sticks in their clinic.
All of these 133 subjects remained HIV negative on the ELISA antibody
test, but seven of them had "indeterminate" PCR results, and
four others had one or more actual positive results, for a false positive
rate of 3%. If the "indeterminate" results are counted as
well, the false positive rate is 8%. For a very rare infection like
HIV, with an estimated prevalence of only 0.4%, these rates of false
positive results in perfectly healthy people are extremely high. The
ratio of 3% to 0.4% reveals that for every 30 people with "positive
PCR's" only 4 will be considered true positives. The decision regarding
which are actual positives is based on the ELISA and Western Blot antibody
tests, which are also highly questionable as discussed above. Gerberding
et al. comment on their findings with PCR as follows:
to demonstrate seroconversion... among those with positive PCR tests
suggests that false positives occur even under stringent test conditions.
The low predicitive value of a positive or indeterminate PCR test...
contraindicates the routine use of gene amplification in this clinical
setting. (Gerberding et al. 1994, page 1415)
cases of people with positive PCR tests but who were negative on the
ELISA test were reported by Rich et al. (1999). They report on three
such cases which occurred over a two month period. The third case has
a particularly interesting series of conflicting results:
3) had a positive result on ELISA and an indeterminate result on a Western
Blot (WB) test... During a four month period after her initial indeterminate
result, she had a positive result on ELISA and another indeterminate
result on WB test, on separate occasions. Five months later, both ELISA
and WB tests yielded negative results, but the patient had a plasma
viral load of 1300 copies/mL. (page 38).
study looking at this question was published in 1992 in the Journal
of AIDS (Busch et al. 1992). They did PCR tests on 151 ELISA-negative
people and found that 18.5% (28 people) had positive PCRs. Furthurmore,
they found that only 25.5% of people diagnosed HIV-positive had "positive"
Finding viral loads and false positive PCR's in HIV-negative people
should be a major wake-up call to people diagnosed "HIV-positive",
their doctors, scientists working in the field, and the public at large,
because these tests are repeatedly used to make clinical decisions about
treatment. What makes results like these even more surprising is that
they were never reported in the media, nor were they discussed in the
research community, nor were they presented to physicians at AIDS conferences,
and finally, they were definitely never told to people diagnosed "HIV-positive".
Perhaps this is why Kary Mullis, the scientist who won the Nobel Prize
in Chemistry in 1993 for inventing the PCR test, says that the "viral
load" is meaningless (Duesberg 1996). Kary Mullis is one of the
signatories of a statement calling for a reappraisal of the causes of
The manufacturers of these tests know that their tests are of questionable
accuracy, although it is doubtful that they realize just how questionable
the accuracy really is. They reveal this knowledge through the following
disclaimers that they include with their test kits:
Abbott Laboratories puts the following statement in their ELISA test
kit: "ELISA testing alone cannot be used to diagnose AIDS."
(Abbott 1997) This warning is not surprising, since current practice,
at least in the United States, suggests that the Western blot test is
the true way to assess infection.
Epitope, the maker for one of the Western Blot kits warns in their package
insert: "Do not use this kit as the sole basis for HIV infection."
(Epitope 1997). This is somewhat more concerning, since the Western
blot is supposed to be a highly accurate test, used to confirm that
the ELISA is not a false positive.
Roche, the maker of a popular "viral load" test kit which
they call "Amplicor", state: "The amplicor HIV-1 monitor
test is not intended to be used as a screening test for HIV, nor as
a diagnostic test to confirm the presence of HIV infection."
(Roche 1996). This is also not surprising, since viral load is not normally
used to diagnose HIV infection.
we have it. All the test makers deny that their test is accurate to
diagnose HIV infection when used "alone". Combining three
inaccurate tests will create yet another inaccurate test, especially
given the evidence cited above showing how severe the accuracy problems
are. I continue to be amazed that these tests are relied upon daily
to make life or death decisions, and I would propose that simple but
thorough experiments be carried out by an independent and unbiased body
of researchers composed of some conventional and some dissenters. In
the meantime, I could not in good conscience recommend that anyone take
one of these tests.