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Reprinted from Credence Publications November 25, 2000,
http://www.creedence.org
Smart HIV Test is Dumb After All
By Steven Ransom
“When the gloss is stripped away, the “100%
accuracy” confidently trumpeted for the new Smart Test is
completely untrue. As with any other rapid test, it might show positive
results on patients with other diseases or with high amounts of
non-specific antibodies…”
===
Inaccurate HIV Test Spells Potential Disaster for Argentina and
South Africa
A quick and easy HIV diagnostic tool known as the “Smart Test”
is the latest product being vigorously promoted by World Diagnostics
Inc. The company’s web page (http://www.worlddiagnostics.com/news_f.htm)
includes the following headlines: “WDI's HIV Tests Approved
by Argentine Government” and “South African Government
Validates HIV Rapid Test.”
“We anticipate that the [SA] business will add significantly
to WDI's revenue and growth over the next twelve months… shipments
are to begin in October to supply more than 500 government-run clinics
with the rapid HIV diagnostics test… WDI's rapid HIV test
is a 100 percent positive predictor,” reports Ken Peters,
President and CEO of WDI.
Confident corporate statements, these may well be. Privately however,
Dr Martin Muy, the Technical Affairs Vice President of WDI, is not
so confident. And in a series of email correspondences, what he
has admitted to Credence personnel spells potential medical disaster
for South Africa and other recipient nations of the latest Smart
Test. Before examining Dr Muy’s statements in more detail,
let us briefly examine the inherent weakness fundamental to all
HIV predictor kits. Let the reader be assured that a medical background
is not necessary in order to grasp the key elements to the AIDS
test controversy.
In no instance does any HIV test measure the presence of a virus.
The test measures only raised levels of antibody activity in the
blood sample supplied. Raised levels of antibody activity are a
normal occurrence in the blood, and indicate primarily a well-functioning
immune system. Scientific literature records in excess of 60 separate
medical conditions that can raise sufficient levels of antibody
activity in the blood to trigger a “false” positive
reading. These separate conditions include flu, flu injection, malaria,
tetanus injection, Hepatitis A and B, Hepatitis injections, renal
failure, haemophilia (through the introduction of Factor VIII into
the bloodstream), organ transplant, alcohol and drug use, recent
viral infections and even pregnancy. These positive readings are
then misinterpreted by the AIDS orthodoxy as indicating the presence
of HIV. As a result of this misinterpretation, men, women and children
across the world are being wrongly as HIV positive.
Quite shockingly, the above anomalies are well known to the major
manufacturers of “HIV test kits,” and all leading brands
carry with them a statutory disclaimer. The Abbott Laboratories
AXSYM ELISA test for instance contains the following wording "At
present, there is no recognised standard for establishing the presence
or absence of antibodies to HIV-1 and HIV- 2 in human blood.”
To make matters worse, these manufacturers advise that confirmation
of their test can be arrived at only by employing at least two other
independent tests, and not their own. This is an excellent example
of passing the buck, transferring ultimate responsibility and potential
litigation difficulties onto a test product conveniently outside
of their own manufacturing stable. To compound the issue, the independent
“confirmatory” tests advised by these manufacturers
all carry a similar disclaimer. Thus, a test admitting that it cannot
determine the presence of HIV is being “corroborated”
by two other equally imprecise antibody detection tests. In simple
terms, a positive reading from any of these tests carries little
or no diagnostic value. What comfort then for the thousands upon
thousands of individuals who have been diagnosed HIV positive via
these tests? Their lives have been quite needlessly ruined. Those
who are battling for these simple facts to reach the wider public
domain will know that the inaccurate nature of the HIV test represents
only a small proportion of the inconsistencies in the AIDS and HIV
debate—the global phenomenon that is increasingly becoming
known as the greatest medical fraud of the 20th and 21st centuries.
And in the case of World Diagnostics International, when the gloss
is stripped away, the “100% accuracy” it so confidently
trumpets for its Smart Test is completely untrue. WDI’s 100%
accuracy statement was arrived at by “confirming” their
test with the Abbott Axsym system, the Pasteur Sanofi ELISA system,
and then by Western Blot analysis.
The Abbott Axsym system we already know about. With regard to the
Pasteur Sanofi product, a Mr Potter from Bio-Rad UK (a subsidiary
of the organisation which has since bought out Pasteur Sanofi) admitted
that illnesses such as malaria, typhoid and TB could show positive
on their tests. He admitted also that their kit should not be used
as confirmation of a positive result. Mr Potter further stated that
as yet, no company has any diagnostic tool that will accurately
predict HIVpositive status. Concerning the validity of the Western
Blot test, head of the UK Public Health Laboratory Services Dr Phillip
Mortimer has admitted that this test is not appropriate for use
in confirmatory testing for HIV, and has abandoned the use of Western
Blot.
Considering these factors, and the extent to which WDI is now contributing
to world-wide HIV testing procedure, Credence Publications approached
WDI under the assumed name of “Protec Diagnostics,”
and posed some delicate questions with regard to the possibility
of false HIV positives being delivered by their Smart Test. Dr Muy
is the Technical Affairs Vice President of WDI, and a former Senior
Product Development Manager for PharmaCorp, and engaged previously
by such companies as BPL (UK), Schering Plough (USA), Ortman Biomedics
(Switzerland) and Epitope (USA). Muy admitted to us the possibility
of false positives, stating “…the disclaimer ‘false
positive’ means that this rapid device—as with any other
rapid device in the market—might show a positive result on
certain samples coming from patients with other diseases, i.e, auto-immune
diseases, or with high amounts of non-specific antibodies as happens
in some diseases.”
When we asked how the WDI test could possibly be validated by tests
that in themselves were equally unspecific, Muy could offer no guarantees
and replied “I have to be honest with you; our rapid tests
have the same drawbacks as the ELISA tests.”
Dr. Martin Muy, Technical Affairs Vice President of WDI, admitted
the possibility of false positives, stating “…the disclaimer
'false positive' means that this rapid device—as with any
other rapid device in the market—might show a positive result
on certain samples coming from patients with other diseases, i.e,
auto-immune diseases, or with high amounts of non-specific antibodies
as happens in some diseases.”
In their thousands, WDI tests are now headed for parts of the world
where the prevalent illnesses such as TB, malaria, cholera, poor
sanitation and poverty related disease all elicit high levels of
antibody activity in the bloodstream. The potential for misdiagnosis
is rife. Simple medicines for simple illnesses will be overlooked,
as thousands are quite falsely diagnosed HIV positive. These misdiagnosed
unfortunates will then be fed that country’s generic versions
of the latest AIDS drugs, in themselves highly toxic, and having
the well-documented capacity to bring about immune-destroying illnesses
and eventual death. More than likely, they will then go on to die
a death that will quite wrongly be catalogued as “death from
AIDS.”
We then asked how anyone could accurately and with full peace of
mind pronounce a HIV positive status upon anybody. Dr Muy replied:
“Regarding your question, I personally would not be satisfied
with a rapid test nor with an ELISA test; that comes to a matter
of ethics.”
So one is bound to ask: where are ethics on the “to do”
list at WDI? At the time of writing, the latest headline on their
web page announces an AIDS catastrophe “set to engulf Russia.”
Having calculated the population of this vast continent, and despite
the unnecessary misery, suffering and death WDI and their naïve
purchasers may cause, it seems that World Diagnostics Inc are now
set to clean up North as well as South.
When asked how anyone could accurately and with full peace of mind
pronounce an HIV positive status upon anybody, Dr Muy replied: “Regarding
your question, I personally would not be satisfied with a rapid
test nor with an ELISA test; that comes to a matter of ethics.”
Steven Ransom.
Credence Publications
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