In a November 7th 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.

One of these experts, 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 lsolation.

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."

"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.'?"

• "I worked in the field of HIV diagnostic testing for 10 years (five years in collaboration with Abbott, Labs), and never heard of a test kit intended for use in diagnosing HIV."
• "If such a test existed, it would get 100% of the testing market because the manufacturer would have 100% of the liability associated with the diagnosis of infection. Any physician/institution would jump on this test regardless of the cost."
• "If such a test existed, I'm sure the FDA/CDC/NIH would have let us know about it by now."
• "I have extended the above (quoted) assertion for six years in public seminars, public access TV programmes, Radio talk shows, etc. and have never received any rebuttal to the contrary, whatsoever."

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.

*Licensed / Approved HIV, HTLV and Hepatitis Tests

• Rodney Richards, Ph.D.: Why the “HIV Tests” Can’t Tell You Whether You Have HIV
  by Mark Gabrish Conlan/Zenger's Newsmagazine

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