NEW EVIDENCE FROM
THE FDA THAT HIV TESTS ARE FUNDAMENTALLY FLAWED
http://healtoronto.com/oraquick.html
In a November 7th [2002] press release FDA Approves New Rapid HIV Test
Kit a series of startling statements were made that are a disquieting
reminder of serious questions regarding the validity of HIV tests. The purpose
of the press release was to announce the newly approved HIV test called The
OraQuick Rapid HIV-1 Antibody Test, manufactured
by OraSure Technologies, Inc., Bethlehem, Pennsylvania. The test is claimed to provide results
with 99.6 percent accuracy in as little as 20 minutes.
Within the documents provided as part of the FDA's Premarket Approval Information is the following:
"The OraQuick® Rapid HIV-1 Antibody Test is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1."
"A reactive result using the OraQuick® Rapid HIV-1 Antibody Test suggests the presence of anti-HIV-1 antibodies in the specimen." (emphasis added.)
There is also interesting new language in this package insert regarding the relationship of HIV to AIDS":
"Acquired Immune Deficiency Syndrome (AIDS), AIDS related complex (ARC) and pre-AIDS are thought to be caused by the Human Immundeficiency Virus (HIV)."
18 years after the reported discovery of HIV, it seems remarkable that these statements are so hesitant and qualified. Some experts in diagnostic testing see this as yet another admission that all HIV tests are fundamentally flawed due to the lack of a gold standard, which would be the isolation of HIV.
Dr. Rodney Richards has over 13 years of experience developing diagnostic technologies, and he collaborated with Abbott Laboratories during the time they developed the "HIV" ELISA and p24 antigen tests. Richards claims that none of the HIV tests approved to date have been validated against the only real gold standard of viral isolation.
Dr. Richards says that the sort of "disclaimers" recently published with the OraQuick® test appear in all the package inserts for other test kits he has seen. So what about the package inserts for the rest of the tests?
"I would love to get my hands on them, and a list of all 31 test kits along with the respective "disclaimers" regarding diagnosis of infection."
"Only the CDC considers antibodies to be synonymous with 'infection,' and they have never referenced any scientific study to support this declaration."
The problem is, all the test kit package inserts are copyright protected, and when Dr. Richards calls the various manufacturers to get a copy, he gets a run around instead. After spending tens of hours playing this game, he finally gave up.
"If I don't have all 31 package inserts for these products, how can I make declarations like: 'The FDA has currently approved 31 HIV-related diagnostic tests, none of which claim to be able to diagnose the presence or absence of HIV in a sample.'?"
Nevertheless, until such time as Dr. Richards might acquire all 31 package inserts, his position on this issue remains (like the CDCs position that antibodies = infection) only a declaration. One he is happy to stand behind.
Typical Disclaimers from HIV Test Manufacturers
"EIA testing alone cannot be used to diagnose AIDS, even
if the recommended investigation of reactive specimens suggests a high probability
that the antibody to HIV-1 is present. [...] At present there is no recognized
standard for establishing the presence and absence of HIV-1 antibody in human
blood. Therefore sensitivity was
computed based on the clinical diagnosis of AIDS and specificity based on
random donors"1
"Do not use this kit as the sole basis of diagnosing HIV-1 infection"2
"The Amplicor HIV-1 Monitor test is not intended to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection"3