How Accurate Is The OraQuick HIV Test?

Hidden Facts and Dangers of HIV Tests
What's in the Fine Print


Remarkable information about HIV tests including the fact that no HIV test has ever been approved by the US Food and Drug Administration for the actual diagnosing of HIV infection.

Few doctors, clinics, journalists, or AIDS organizations know that all current HIV tests are approved only as screening tests, prognostic tests (for predicting a possible future outcome) or as "an aid in diagnosis" and are not intended to be used for determining if a person actually has HIV.

The FDA's lack of such approval speaks to the fact that no HIV test can directly detect or quantify HIV or determine the presence of specific HIV antibodies in human blood.

Recent changes in the fine print of the test kits acknowledge this little known data and seem to indicate a change of thought with regard to the role of HIV in AIDS.

From 1984 until last year, test literature contained the very certain statement that "AIDS is CAUSED by HIV." Then in November of 2002, a new test kit started what now seems to be a trend toward rethinking the causal link between HIV and AIDS. It states, "AIDS, AIDS related complex and pre-AIDS
are THOUGHT TO BE CAUSED by HIV." (OraQuick Rapid HIV-1 Antibody Test, OraSure Technologies, Inc)

Now it appears we've gone from "HIV is thought to cause AIDS," to something even more uncertain: "Published data indicate A STRONG CORRELATION between the acquired immunodeficiency syndrome (AIDS) and a retrovirus REFERRED TO as Human Immunodeficiency Virus (HIV)."

This last quote is found in the package insert for a new ELISA test (Vironostika HIV-1 Plus O Microelisa System) the FDA approved in June 2003.
The entire package insert can be downloaded from

http://www.fda.gov/cber/pma/P020066.htm

According to Alive & Well advisor Dr Rodney Richards, a chemist and co-creator of the very first HIV test, as of June 2003, the number of FDA approved tests that contain the term HIV or LAV (the old school term for the so-called virus) have risen to 36. Of these, 13 have been approved in just the last three years.

Richards points out that "despite the increased number of HIV tests, there is still no manufacturer that claims their test can be used to diagnose infection with HIV. All of the RNA based tests for viral load and genotyping clearly state they are 'NOT intended for use in diagnosing HIV infection.'
Instead of an indication for use in detecting or quantifying the actual virus, these tests are approved only for prognosis or monitoring therapy for people who doctors assume are infected.锟?br>
Richards is working on a document to clarify what HIV test
manufacturers mean by the terms "prognosis," "monitoring of therapy," and "aid in the diagnosis of HIV." His report will focus on what the tests cannot do (diagnose HIV infection) and what exactly they can.

At first glance, the rapid tests may appear relatively benign since the manufacturers clearly emphasize that "preliminary positives" must be confirmed with follow up testing. This emphasis is due to the fact that the accuracy of the rapid tests锟?is widely known to be more questionable than the already dubious HIV ELISA or Western Blot. But the notion that
medical personnel will await confirmation of results before insisting patients take action is entirely misguided since the true market for rapid tests is pregnant women in labor

Incredibly, the recommendation to misuse rapid tests for women in labor comes directly from the Deputy Commissioner of the FDA himself, Dr. Lester M Crawford. The good doctor says "OraQuick will be a great help in identifying pregnant HIV-infected women going into labor who were not tested during pregnancy so that precautionary steps can be taken to block their newborns from being infected with HIV." (FDA News, November 7, 2002)

These precautionary steps include IV infusion of the toxic chemotherapy AZT during labor, C-section delivery, six weeks of mandatory AZT treatment for the baby regardless of their own HIV status, and orders to the mother not to breastfeed. Even though chemotherapy, surgery and denial of normal
feeding are based on preliminary results from a test never approved for detecting HIV infection, a mother who declines such intervention risks losing custody of her child.

Perhaps more remarkable than official calls for misuse of rapid tests is a disclosure by the manufacturer of the OraQuick that 7% of women with a history of prior pregnancy will score falsely positive on their test. Further, the manufacturer of the newly approved Reveal test didn't even evaluate their product in multiparous women.

Worse still, as Dr Richards points out, the rapid tests may soon be routinely administered to women tested negative before labor. "Based on the erroneous belief these tests can actually diagnose HIV infection, doctors may want to retest women in labor who锟絭e previously come up negative just to
be sure they haven't seroconverted in the mean time."

Another lucrative market for the rapid tests is among healthcare workers who experience accidental needle sticks or other unintentional contact with patient fluids. As Richard points out, this opens a Pandora锟絪 box of potential life-altering situations.

"Imagine a nurse sticks herself with a used needle. Ora-Sure gives her the impression she can find out quickly if that needle is contaminated with HIV. Should the needle score positive, she would then be urged to start prophylactic chemotherapy right away. Of course, if the needle scores positive, hospitals would most likely feel an ethical responsibility to
inform the patient and to urge them to also start 'saving their lives' with AIDS meds. Since there are 600,000 to 1,000,000 accidental needles sticks in the US annually, this is a huge market for both the test and treatment manufacturers."

The great influence of drug and test manufacturers on public health policy, media presentations and among AIDS activist groups may mean that the hidden dangers of rapid tests will remain unknown.

The test seems to be reasonable accurate at detecting the HIV-1 and HIV-2 antibodies, with a 99% detection rate. However, if you think you've been recently infected you need to wait a few months before you take the test. The antibodies the test looks for are not prevalent for a few months because of the time it takes for the disease to build up. Immediate signs of infection include flu-like symptoms for about a week or so.

If you're concerned that you have HIV, go to a testing center. Due to the fact that there is a degree of error in all tests, it's best to get a second opinion from a physician.

The manufacturer conducted clinical studies that yielded 0.7 percent false positives and 0.2 percent false negatives. Or the other way around. I worked as an EIP counseler. They will always recommend a second test to be done 3 months later. It's also not a good idea to get tested right after suspected exposure as it takes up to three months for your body to make detectable amounts of antibodies. Early stages of HIV infection have low viral load, and the viruses are mostly intracellular, away from immune detection. This is why there is such a delay in antibody production.

Several rapid HIV tests have been approved for the FDA, all of which can only be performed by healthcare providers (they cannot be purchased directly by consumers). The approved tests are the Oraquick庐 Rapid HIV Antibody Test (using oral fluid or blood samples), the Oraquick庐 Rapid HIV-1/2 Antibody Test (tests for both HIV-1 and HIV-2 using blood samples), the Clearview庐 Complete HIV 1/2 and HIV 1/2 STAT-PAK (a blood sample is used to check for antibodies to HIV-1 and HIV-2), the Reveal庐 Rapid HIV-1 Antibody Test (requires a blood sample), and the Uni-Gold Recombigen鈩?HIV Test (requires a blood sample). While the time to conduct each of these tests do vary, they all yield results in less than an hour. If you are interested in any of these tests, you should call your healthcare provider to see if he or she conducts these tests and, if not, where you may go to have one done.

The collection of oral fluids to look for HIV antibodies using the Oraquick Rapid HIV Antibody Test may not be as accurate as the other rapid assays that use blood samples. As of mid-December 2005, clinics in Los Angeles, San Francisco, and New York City have reported high rates of false-positive test results, meaning that the Oraquick Rapid HIV Antibody Test using oral fluids (but not blood samples) falsely detected antibodies in several people who were not infected with HIV. However, the test is still highly accurate in terms of detecting antibodies in people who are infected with HIV (it has an extremely low false-negative rate).

It's very important to understand these new tests do not change the length of time you have to wait after a possible exposure to HIV to get a reliable result. You still need to wait three months (13 weeks), to allow time for antibodies to become detectable in the blood for an accurate result.

The Oraquick, Clearview, Reveal Rapid, and Uni-Gold Recombigen tests are not the only rapid tests available. Some hospitals, clinics and a few private doctors' offices have their own in-house rapid tests, which are also completely reliable.

99.6% as stated by the manufacturer is misleading at best and meaningless at worst. This can be said of most any immunoglobulin assay though. This simply shows the relative accuracy of the detection of a reaction between proteins and antibodies thought to be specific to HIV. Contrary to popular belief, this test is NOT FDA approved to diagnose infection with HIV. Meaning, a positive result can not prove you actually are infected with actual HIV virus as it does NOT test for the virus itself.

Heres a few reasons why, as stated in the package insert for the Oraquick test.

"This test is suitable for use in multitest algorithms designed for statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms."

Comment-- This means you have to confirm it with another test. This begs the question of what "99.6% accurate" means if you must confirm the result with another test.

"Acquired Immune Deficiency Syndrome (AIDS), AIDS related complex (ARC) and pre-AIDS are *thought* to be caused by the Human Immunodeficiency Virus (HIV). [emphasis mine]

Comment-- The phrase "thought to be caused by the Human Immunodeficiency Virus" speaks for itself. Since the test maker shows little faith in HIV science, why should anyone else? Since the word "thought" infers doubt, that begs the same question, what "99.6% accurate" really means.

"The OraQuick庐 Rapid HIV-1 Antibody Test is a point-of-care test to *aid* in the diagnosis of infection with HIV-1."
[emphasis mine]

Comment-- "aid" meaning to help or offer assistance. This indicates the test can't establish whether you are infected with HIV, or even infer the presence of antibodies when used alone.

"A Reactive result using the OraQuick庐 Rapid HIV-1 Antibody Test *suggests* the presence of anti-HIV-1 antibodies in the specimen. The OraQuick庐 Rapid HIV-1 Antibody Test is intended as an aid in the diagnosis of infection with HIV-1. AIDS and AIDS-related conditions are clinical syndromes and their diagnosis can only be established clinically." [emphasis mine]

Comment-- 99.6% accurate at "suggesting" you are infected with a supposedly deadly virus. I for one demand a bit more support for its conclusion.

"One specimen from subjects known to be positive for EBV, for HBV, or for rheumatoid factor, one from a multiparous woman, and three specimens from known HAV infected subjects *gave false positive results*. [emphasis mine]

Comment-- 7 of the 321 tested gave false positives. How would you determine whether you are a true or false positive?Thats just 321 tested which equals about 2% being false+. Imagine if you tested, oh say, 290 million? Hmm thats nearly 6 million potential false positives.

Wow. Accurate huh?


Who ever thumbed me down, WHAT PART OF "THESE TEST DO NOT TEST FOR HIV DID YOU FAIL TO COMPREHEND"? Im unclear in your apparent inability to read. EVEN ******IF******* THESE TESTS WERE 1 MILLION % ACCURATE, THE PRESENCE OF ANTIBODIES DOES *********NOT********** PROVE INFECTION WITH ANY VIRUS. RE-READ THIS IF YOU FAILED TO UNDERTSTAND. But as I pointed out, the test insert itself backs what I just said.

the / person/ that does it/ says /it /is 99.99% accurate

Hi there,

OraQuick is a form of Rapid Testing. Samples are obtained and analyzed using the ELISA test. The results are usually available within ten to sixty minutes. If the result is positive, a follow-up test is required, usually by drawing blood and sending the sample to a laboratory for Western blot testing. If the result is negative, there is no need for additional testing and the result can be considered conclusive.
Convenient and faster, this method is often used in healthcare settings, particularly where urgency is an issue such as with someone who is pregnant or about to give birth. Because it provides a result so quickly, this is an increasingly popular method for testing.

Several rapid HIV tests have been approved for the FDA, all of which can only be performed by healthcare providers (they cannot be purchased directly by consumers). The approved tests are the Oraquick庐 Rapid HIV Antibody Test (using oral fluid or blood samples), the Oraquick庐 Rapid HIV-1/2 Antibody Test (tests for both HIV-1 and HIV-2 using blood samples), the Clearview庐 Complete HIV 1/2 and HIV 1/2 STAT-PAK (a blood sample is used to check for antibodies to HIV-1 and HIV-2), the Reveal庐 Rapid HIV-1 Antibody Test (requires a blood sample), and the Uni-Gold Recombigen鈩?HIV Test (requires a blood sample). While the time to conduct each of these tests do vary, they all yield results in less than an hour. If you are interested in any of these tests, you should call your healthcare provider to see if he or she conducts these tests and, if not, where you may go to have one done.

The collection of oral fluids to look for HIV antibodies using the Oraquick Rapid HIV Antibody Test may not be as accurate as the other rapid assays that use blood samples. As of mid-December 2005, clinics in Los Angeles, San Francisco, and New York City have reported high rates of false-positive test results, meaning that the Oraquick Rapid HIV Antibody Test using oral fluids (but not blood samples) falsely detected antibodies in several people who were not infected with HIV. However, the test is still highly accurate in terms of detecting antibodies in people who are infected with HIV (it has an extremely low false-negative rate).

It's very important to understand these new tests do not change the length of time you have to wait after a possible exposure to HIV to get a reliable result. You still need to wait three months (13 weeks), to allow time for antibodies to become detectable in the blood for an accurate result.

The Oraquick, Clearview, Reveal Rapid, and Uni-Gold Recombigen tests are not the only rapid tests available. Some hospitals, clinics and a few private doctors' offices have their own in-house rapid tests, which are also completely reliable.


Hope this helps.

Cheers.

Read the World's largest studies on sexual transmission and decide for yourself.....

The 10-year Padian study observed sexually active
couples in which one partner was HIV positive. The result: in 10 years, not one uninfected partner contracted HIV, even though all participants admitted to having sex without condoms. The study states, 'We followed up 175 HIV-discordant couples over time, for a total of approximately 282 couple-years of follow up. The longest duration of follow-up was 12 visits (6 years).

We observed no seroconversion [infection] after entry into the study."

In the three-year Stewart study (1985) not one male partner of HIV-positive women contracted HIV. Prostitution is not even listed as an HIV risk category by the CDC, because of the extremely low incidence of HIV transmission to clients who have no other risk factors (i.e. drug abuse).

These findings bolster the hypothesis of some AIDS scientists that chronic malnutrition and other environmental factors, and not a sexually-transmitted virus, are the causes of weakened immunity in people diagnosed with one of the nearly 30 AIDS-defining diseases (which vary from country to country).





ORAL SEX

Page-Shafer is a researcher at the Center for AIDS Prevention at the University of California, San Francisco. At the 2004 World AIDS Conference, she presented data from a study of 400 men whose only form of sexual behavior was receiving oral sex. Despite little condom use with multiple partners -- including partners known to be infected with HIV -- none of the men came down with HIV infection.

"We had zero infections over 1,493 person-years of exposure to oral receptive sex," Page-Shafer tells WebMD. "This doesn't mean there aren't factors that contribute to easier HIV transmission by oral sex. It does happen. But data confirm it is a pretty rare occurrence."

Sex And HIV: Behaviour-Change Trial Shows No Link
The East African (Nairobi)

March 17, 2003

Posted to the web March 19, 2003

By Paul Redfern, Special Correspondent Nairobi

A UK funded trial aimed at reducing the spread of Aids in Uganda by modifying sexual behaviour appears to have had little discernible effect.


The trial, carried out on around 15,000 people in the Masaka region, involved distributing condoms, treating around 12,000 victims of sexually transmitted diseases and counselling.

However, while the trial led to a marked change in sexual behavioural patterns, with the proportion reporting causal sexual partners falling from around 35 per cent to 15 per cent, there was no noticeable fall in the number of new cases of HIV infection, although there was a significant reduction in sexually transmitted diseases such as syphilis and gonorrhoea.

The trial results, which were reported in the British medical journal The Lancet, have already aroused some controversy.

The team leader of the trial, Dr Anatoli Kamalai, acknowledged that there was "no measurable reduction" in HIV incidence with "no hint of even a small effect."