New Tests, Same Old Problems
By Christine Maggiore
 
“Contrary to the statement that the new test can tell people ‘whether they
are infected,’ the FDA has not approved the quick test (or any other HIV
test) for actually diagnosing HIV infection…”
 
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FDA Approves While-You-Wait Rapid HIV Test:
Old Problems, Questionable Results Now Come Quicker
 
Earlier this month, the US Food And Drug Administration granted approval
for the widespread use of a new HIV test that gives results in as little
as 20 minutes. According to a November 8 New York Times story, "experts
hope the rapid tests will prompt thousands more Americans to get tested."

 
Citing its "99.6 percent accuracy rate," the unnamed experts characterize
the test as "highly reliable [in telling people] whether they are
infected."
 
Apparently, these experts are not aware that the claim of 99.6% accuracy
is not based on any real data. Test accuracy can only be determined
through confirming the presence of actual HIV in people with positive
results, a necessary scientific step that has never been taken in
developing the newly approved rapid test or any other HIV test in current
use.
 
Contrary to the statement that the new test can tell people "whether they
are infected," the FDA has not approved the quick test (or any other HIV
test) for actually diagnosing HIV infection. HIV tests have FDA approval
only for prognostic use (for predicting or foretelling a future outcome),
as “an aid to a clinical diagnosis (to assist in developing a diagnosis);”
or as “highly sensitive” screening tests known to err on the side of
caution by giving false positive results for a variety of non-HIV antibody
reactions. Only a test approved specifically for the purpose of diagnosing
HIV infection can be used to say someone has HIV or is HIV infected. No
HIV test has ever been approved for this express purpose.
 
Citing more unnamed experts, the NY Times reports, "the [new] test is
important for several reasons. It may help reduce mother-to-infant
transmission of HIV by enabling doctors to test pregnant women while they
are in labor." But there’s no mention of the fact that pregnancy is one of
60 conditions that can cause false positive results on HIV tests. Or that
expectant mothers who test positive—even those in perfect health and with
no known risk factors or possibility of exposure—are routinely coerced
into taking toxic AIDS drugs during labor, ordered to have a C section
delivery, and barred from breastfeeding their babies.
 
The new test is praised for its ability to "offer health care workers
exposed to HIV-tainted blood a quick way to determine if they need
antiviral drugs that could prevent them from getting infected" then notes
"there is, however, one hitch: people infected with HIV do not develop
antibodies to the virus until three months after exposure." In other
words, the quick test should be administered 90 not-so-quick days
following a suspected exposure!
 
The idea that AIDS drugs prevent post-exposure HIV infection in healthcare
workers is not based on any properly controlled study. No research has
ever compared test results among recently exposed healthcare workers that
take AIDS drugs and those that decline treatment. Last January 4, the US
Centers for Disease Control announced that "most occupational exposures to
HIV do not result in transmission…in this setting, the risk of HIV
transmission is very low." In fact, during the past 20 years, the CDC has
reported a total of 25 cases of AIDS in healthcare professionals that
blame work related exposure to HIV for their diagnosis.
 
And how do healthcare workers that "need antiviral drugs" use them to
prevent infection if they determine this need by testing positive?
According to the article, positive results mean they’re already infected,
right?
 
Maybe not, as it seems there are more hitches involving the previous
accuracy claim: "The FDA recommends that people who test negative repeat
the test if they believe they have been exposed to the virus. The agency
also recommends that in the case of a positive test, a more traditional
test be conducted to confirm the results." So, negative results don’t
count as negative for people that believe they were exposed, while
positive results don’t count as positive for anyone.
 
The Times winds up this piece with a curious remark by Health and Human
Services director Tommy Thompson who says "an estimated 900,000 Americans
are infected with the human immunodeficiency virus, but as many as a
quarter of them do not know it." Apart from the fact this 900,000 figure
has been touted since 1995 as evidence of a growing epidemic, how does
Tommy Thompson know that 25% of these 900,000 Americans are positive but
don’t know it, when the people who are presumably positive don’t even know
it themselves?