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Medical Forum / Diseases and Disorders / AIDS / April 2005

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Unreliable Tests

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PaulKing - 17 Apr 2005 09:28 GMT
Unreliable Tests

A September 2004, San Francisco Chronicle article considered the "beauty"
of testing. It told the story of 59 year-old veteran Jim Malone,  who'd
been told in 1996 that he was HIV positive. His health was diagnosed as
"very poor." He was classified as "permanently disabled and unable to work
or participate in any stressful situation whatsoever."

In 2004, his doctor sent him a note to tell him he was actually negative.
He had tested positive at one hospital, and negative at another.

Nobody asked why the second test was more accurate than the first (this
was the protocol at the Veteran's Hospital). Having been falsely diagnosed
and spending nearly a decade waiting, expecting to die, Malone said,  "I
would tell people to get not just one HIV test, but multiple tests. I
would say test, test and retest."

In the article, AIDS experts assured the public that the story was
"extraordinarily rare." But the medical literature differs significantly.

The Numbers

In 1985, at the beginning of HIV testing, it was known that "68% to 89% of
all repeatedly reactive ELISA (HIV antibody) tests [were] likely to
represent false positive results." (New England Journal of Medicine.
1985).

In 1992, the Lancet reported ("HIV Screening in Russia") that for 66 true
positives, there were 30,000 false positives. And in pregnant women,
"there were 8,000 false     positives for 6 confirmations."

In September 2000, the Archives of Family Medicine stated that the more
women we test, the greater "the proportion of false-positive and ambiguous
(indeterminate) test results."

The tests described above are standard HIV tests, the kind promoted in the
ads. Their technical name is ELISA or EIA (Enzyme-linked Immuno-sorbant
Assay). They are antibody tests. The tests contain proteins that react
with antibodies in your blood.

False Positives

In the U.S., you're tested with an ELISA first. If your blood reacts,
you'll be tested again, with another ELISA. Why is the second more
accurate than the first? That's just the protocol. If you have a reaction
on the second ELISA, you'll be confirmed with a third antibody test,
called the Western Blot. But that's here in America. In some countries,
one
ELISA is all you get.

It is precisely because HIV tests are antibody tests that they produce so
many false-positive results. All antibodies tend to cross-react. We
produce anti-bodies all the time, in response to stress, malnutrition,
illness, drug use, vaccination, foods we eat, a cut, a cold, even
pregnancy. These antibodies are known to make HIV tests come up as
positive.

The medical literature lists dozens of reasons for positive HIV test
results: "transfusions, transplantation, or pregnancy, autoimmune
disorders, malignancies, alcoholic liver disease, or for reasons that are
unclear..." (Archives of Family Medicine. Sept/Oct. 2000).

"[L]iver diseases, parenteral substance abuse, hemodialysis, or
vaccinations for hepatitis B, rabies, or influenza..." (Archives of
Internal Medicine, August 2000).

The same is true for the confirmatory test the Western Blot. Causes of
indeterminate Western Blots include: "lymphoma, multiple sclerosis,
injection drug use, liver disease, or autoimmune disorders. Also, there
appear to be healthy individuals with antibodies that cross-react...."
(ibid).

Pregnancy is consistently listed as a cause of positive test results, even
by the test manufacturers." [False positives can be caused by] prior
pregnancy, blood transfusions...and other potential nonspecific
reactions." (Vironostika HIV Test, 2003).

Inflated Africa Numbers

This is significant in Africa, because HIV estimates for African nations
are drawn almost exclusively from testing done on groups of pregnant
women.

In Zimbabwe last year, the rate of HIV infection among young women
decreased remarkably, from 32.5 to 6 percent. A drop of 81 percent
overnight. UNICEF's Swaziland representative, Dr. Alan Brody, told the
press that, "The problem is that all the sero-surveillance data came from
pregnant women, and estimates for other demographics was based on that."
(PLUS News, August, 2004).

Flawed Samples

When these pregnant young women are tested, they're often tested for other
illnesses, like syphilis, at the same time. There's no concern for
cross-reactivity or false-positives in this group, and no repeat testing.
One ELISA on one girl, and 32.5 percent of the population is suddenly HIV
positive.

The June 20, 2004 Boston Globe reported "the current estimate of 40
million people living with the AIDS virus worldwide is inflated by 25
percent to 50 percent." It said that HIV estimates for entire countries
have, for over a decade, been taken from "blood samples from pregnant
women at prenatal clinics."

But numbers about "AIDS deaths, AIDS orphans, numbers of people needing
antiretroviral treatment, and the average life expectancy" are all taken
from that one test.

I've certainly never seen this in a VH1 ad.

At present there are about six-dozen reasons given in the literature why
the tests come up positive. In fact, the medical literature states that
there is simply no way of knowing if any HIV test is truly positive or
negative:

"[F]alse-positive reactions have been observed with every single HIV-1
protein, recombinant or authentic." (Clinical Chemistry. 37; 1991). "Thus,
it may be impossible to relate an antibody response specifically to HIV-1
infection." (Medicine International. 1988).

Ambiguous Results

And even if you believe the reaction is not a false positive, "the test
does not indicate whether the person currently harbors the virus."
(Science. November, 1999).

The test manufacturers state that after the antibody reaction occurs, the
tests have to be "interpreted." There is no strict or clear
definition of HIV positive or negative. There's just the antibody
reaction. The reaction is colored by an enzyme, and read by a machine
called a spectro-photometer.

The machine grades the reactions according to their strength (but not
specificity), above and below a cut-off. If you test above the cut-off,
you're positive; if you test below it, you're negative. So what determines
the all-important cut-off? From The CDC's instructional material:
"Establishing the cutoff value to define a positive test result from a
negative one is somewhat arbitrary." (CDC, 2003)

PART TWO TO FOLLOW
PaulKing - 17 Apr 2005 10:48 GMT
Testing the Tests

A 1995 study comparing four major brands of HIV tests found that they
all had different cut-off points, and as a result, gave different test
results for the same sample: "[C]ut-off ratios do not correlate for any
of the investigated ELISA pairs," and one brand's cut-off point had "no
predictive value" for any other. (INCQS-DSH, Brazil 1995).

In the UK, if you get through two ELISA tests, you're positive. In
America, you get a third and final test to confirm the first two. The test

is called the Western Blot. It uses the same proteins, laid out
differently. Same proteins, same nonspecific reactions. But this time it's

read as lines on a page, not a color change. Which lines are HIV positive?

That depends on where you are, what lab you're in and what kit they're
using.

Different Standards

A 1993 review in Bio/Technology reported that the FDA, the CDC,
Department of Defense and the Red Cross all interpret WB's differently,
and
further noted, "All the other major USA laboratories for HIV testing have

their own criteria."

The medical literature adds something truly astounding to all of this.
It says that the reason HIV tests are so non-specific and need to be
interpreted is because there is "no virologic gold standard" for HIV
tests.

The meaning of this statement, from both the medical and social
perspective, is profound. The "virologic gold standard" is the isolated
virus
that the doctors claim to be identifying, indirectly, with the test.

Antibody tests always have some cross-reaction, because antibodies
aren't specific. The way to validate a test is to go find the virus in the

patient's blood.

You take the blood, spin it in a centrifuge, and end up with millions
of little virus particles, which you can easily photograph under a
microscope. You can disassemble the virus, measure the weight of its
proteins, and map its genetic structure. That's the virologic gold
standard.
For some reason, HIV tests have none.

In 1987, the New England Journal of Medicine stated that "The meaning
of positive tests will depend on the joint [ELISA/WB] false positive
rate. Because we lack a gold standard, we do not know what that rate is
now."

No Recognized Standard

In 1996, JAMA reported: "the diagnosis of HIV infection in infants is
particularly difficult because there is no reference or 'gold standard'
test that determines unequivocally the true infection status of the
patient."

In 1997, Abbott laboratories, the world leader in HIV-test production
stated: "At present there is no recognized standard for establishing the
presence or absence of HIV antibody in human blood."

In 2000 the Journal AIDS reported that "2.9% to 12.3%" of women in a
study tested positive, "depending on the test used," but "since there is
no established gold standard test, it is unclear which of these two
proportions is the best estimate of the real prevalence rate…"

If we had a virologic gold standard, HIV testing would be easy and
accurate. You could spin the patient's blood in a centrifuge and find the

particle. They don't do this, and they're saying privately, in the
medical journals, that they can't.

That's why tests are determined through algorithms above or below
sliding cut-offs; estimated from pregnant girls, then projected and
redacted
overnight.

By repeating, again and again in the medical literature that there's no
virologic gold standard, the world's top AIDS researchers are saying
that what we're calling HIV isn't a single entity, but a collection of
cross-reactive proteins and unidentified genetic material.

AIDS Without HIV

But the fact is, you don't need to test HIV positive to be an AIDS
patient. You don't even have to be sick.

In 1993, the CDC added "Idiopathic CD4 Lymphocytopenia" to the AIDS
category. What does it mean? Non-HIV AIDS.

In 1993, the CDC also made "no-illness AIDS" a category. If you tested
positive, but weren't sick, you could be given an AIDS diagnosis. By
1997, the healthy AIDS group accounted for 2/3rds of all U.S. AIDS
patients. (That's also the last year they reported those numbers).

In Africa, HIV status is irrelevant. Even if you test negative, you can
be called an AIDS patient:

From a study in Ghana: "Our attention is now focused on the
considerably large number (59%) of the seronegative (HIV-negative) group
who were
clinically diagnosed as having AIDS. All the patients had three major
signs: weight loss, prolonged diarrhea, and chronic fever." (Lancet.
October, 1992)

And from across Africa: "2215 out of 4383 (50.0%) African AIDS patients
from Abidjan, Ivory Coast, Lusaka, Zambia, and Kinshasa, Zaire, were
HIV-antibody negative." (British Medical Journal, 1991)

The terms, "Non-HIV AIDS," "HIV-negative AIDS," and "No Virologic Gold
standard, are never seen in an HIV ad. But even if you do test
"repeatedly" positive, the manu-facturers say that "the risk of an
asymptomatic
[not sick] person developing AIDS or an AIDS-related condition is not
known." (Abbott Laboratories HIV Test, 1997).

Warning Label Needed

If commerce laws were applied equally, HIV tests would have to bear a
disclaimer, just like cigarettes:

"Warning: This test will not tell you if you're infected with a virus.
It may confirm that you are pregnant or have used drugs or alcohol, or
that you've been vaccinated; that you have a cold, liver disease,
arthritis, or are stressed, poor, hungry or tired. Or that you're African.

It will not tell you if you're going to live or die; in fact, we really
don't know what testing positive, or negative, means at all."

Liam Scheff is an investigative journalist whose research was the basis
for the 2004 BBC documentary, "Guinea Pig Kids," about the forced use
of experimental AIDS drugs. His email address is: liamscheff@yahoo.com

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