In Home HIV Tests Now Available to Mislead

Posted by textgenie
HIV Boys Pull Another Fast One With Frightening Easy Test

Chances of False Positive About 1 in 18, or 63,000 People In All

But Even Accurate Tests By Definition Useless and Dangerous

The Times boosted the July 4 celebrations of those leading the biggest scientific scam in history today with a top right front page story by its resident fellow traveler in HIV/AIDS, Donald G. McNeil, entitled Rapid H.I.V. Home Test Wins Federal Approval.

The story bears close examination as a new high point in the HIV promotion crowd’s success in stirring up trouble for which they ask vast funding to deal with.

One interesting aspect is that as stated (after the report was corrected) the tests are quite insensitive to HIV antibodies, so they are somewhat inaccurate in responding to true positives. The 92% accuracy for positives means that 8% of positive results will register negative. It’s 4999 in 5000 accuracy for negatives means (when the arithmetic is added up) that about 5 per cent of the positives it registers will be false. That is, 1 in 20 will be wrong.

This follows from the fact that CDC now tells us that as many as 1.2 million people are genuinely positive in a population of 310 million, so on average in a random sample of 31,000 people 120 will be genuinely positive, whatever that means (actually nothing in medical terms on the basis of the correct science of HIV/AIDS, rather than the inaccurate myth peddled by the handsome and well dressed (great pin stripe that, Anthony!) director of the National Institute of Allergy and Infectious Diseases and relayed by the trusting Gwen Ifill of the PBS Newshour tonight.

While the test will capture 92% or 110 out of those 120 genuine positives, the 4999/5000 accurate in-home test will also record 6 false positives out of 31000 truly negative results. So therefore it will record an false positive 6 out of 110 times, or about 5 per cent of the time. Over 5 per cent of the positives will be false, or 1 in 20.

In other words, your chances of actually being genuinely HIV (antibody) positive if it signals a positive result are 95%.

Leaving aside the fact that any concern over a positive result would be grossly misplaced, since to have antibodies to HIV means as the best research has shown that you have effectively banished all HIV from your body, so you are really HIV negative for sure, this is still not a very helpful accuracy rate. After all, if the rate of false positives among negatives is 1 in 5000, this means that the total number of false positives in the entire 308.8 million population will be 308,800,000/5000, which is 61,760.

So the new test has the potential to cause a wave of needless harmful concern among over 61,000 people and this may even extend to triggering suicides.

But of course on the positive side it will reap millions for the makers and entrench the prevailing nonsensical paradigm even more deeply into the public consciousness.

A Happy July 4 for some, for sure.

July 3, 2012
Rapid H.I.V. Home Test Wins Federal Approval
By DONALD G. McNEIL Jr.
After decades of controversy, the Food and Drug Administration approved a new H.I.V. test on Tuesday that for the first time makes it possible for Americans to learn in the privacy of their homes whether they are infected.

The availability of an H.I.V. test as easy to use as a home-pregnancy kit is yet another step in the normalization of a disease that was once seen as a mark of shame and a death sentence.

The OraQuick test, by OraSure Technologies, uses a mouth swab and gives results in 20 to 40 minutes. A previous test sold over the counter required a user to prick a finger and mail a drop of dried blood to a lab.

Dr. Anthony S. Fauci, the longtime AIDS researcher and director of the National Institute of Allergy and Infectious Diseases, called the new test a “positive step forward” and one that could help bring the 30-year-old epidemic under control.

Getting an infected person onto antiretroviral drugs lowers by as much as 96 percent the chance that he or she will transmit the virus to someone else, so testing and treatment have become crucial to prevention. About 20 percent of the 1.2 million infected Americans do not know they have the disease, the Centers for Disease Control and Prevention estimates, and about 50,000 more get infected each year.

Dr. Robert Gallo, who headed the National Institutes of Health lab that developed the first American blood test for the virus in 1984, called the F.D.A. approval “wonderful because it will get more people into care.”

The idea of a home test has long been mired in controversy. The first application for one was made in 1987, and the F.D.A. has been considering OraSure’s simple mouth-swab test since 2005.

But the history of AIDS and the human immunodeficiency virus that causes it are unique. AIDS emerged in the 1980s wrapped in a shroud of stigma. It was spread by sex, drug injections and blood transfusions. Along with hemophiliacs, heroin users and Haitians, the most vocal group of early victims was gay men, who were then in the throes of a loud and defiant liberation movement.

Because merely being tested for H.I.V. was seen as tantamount to being publicly revealed as gay or addicted to drugs, and because an H.I.V.-positive result was a death sentence, groups like the Gay Men’s Health Crisis and newspapers like The New York Native advised their members and readers to shun testing until ironclad guarantees of anonymity were put in place.

Alarmists predicted a wave of suicides if home tests were made available. At hearings, advocates for AIDS patients handed out copies of an obituary of a San Francisco man who jumped off the Golden Gate Bridge after learning he was infected. C.D.C. officials warned their F.D.A. counterparts that home testing could lead to a surge of new patients that would swamp overburdened health clinics, according to an F.D.A. document.

So, even as tests for other stigmatized diseases like syphilis were once part of getting a marriage license and home pregnancy kits became available at every corner pharmacy, H.I.V. tests lived in a special limbo, usually requiring a counseling session and the signing of a consent form, adding to the air of dread.

Even when antiretroviral drugs emerged in the mid-1990s, states were slow to rewrite laws governing testing.

Mark Harrington, the executive director of the Treatment Action Group, an AIDS advocacy organization, said in an interview that he thought such fears were “a thing of the past” now that it is clear that early treatment saves lives. “Any tool that speeds up diagnosis is really needed,” he said.

The new test has some drawbacks. While it is extremely accurate when administered by medical professionals, it is less so when used by consumers. Researchers found the home test accurate 99.98 percent of the time for people who do not have the virus. By comparison, they found it to be accurate 92 percent of the time in detecting people who do. One concern is the “window period” between the time someone gets the virus and begins to develop the antibodies to it, which the test detects. That can take up to three months.

So, while only about one person in 5,000 would get a false positive test, about one person in 12 could get a false negative.

Any positive test needs confirmation in a doctor’s office, the F.D.A. said, and people engaged in high-risk sex should test themselves regularly.

The agency does not intend for the home test to replace medical testing, but instead to provide another way for people to find out their H.I.V. status, said Dr. Karen Midthun, director of the F.D.A.’s Center for Biologics Evaluation and Research.

The home test should be available in 30,000 pharmacies, grocery stores and online retailers by October, said Douglas Michels, OraSure’s chief executive. The price has not yet been set. But he said it would be higher than the $17.50 now charged to medical professionals because the company will do more complicated packaging for the home kit, open a 24-hour question line, and advertise to high-risk groups, including gay men, blacks and Hispanics, and sexually active adults. Still, he said, it will be kept inexpensive enough to appeal to people who might want to buy several a year.

Because the F.D.A. approved the home test only for people 17 and older, retail stores may ask customers to show ID, he said. The restriction is not for medical reasons, but because only a few subjects age 14 to 16 were tested, he said, “so that was the deal we worked out with the F.D.A.”

Whether having to show identification would deter teenagers or young-looking people from buying a test is unclear. Mr. Harrington said he thought it might.

In contrast, teenage girls are not legally required to show identification to buy pregnancy tests.

This article has been revised to reflect the following correction:

Correction: July 5, 2012

Because of an editing error, an article on Wednesday about federal approval of a rapid H.I.V. test sold over the counter for use at home reversed the odds of a person’s getting a false positive or false negative result in taking the OraQuick H.I.V. test. About one person in 5,000 would get a false positive test, and about one person in 12 could get a false negative — not the other way around. The article also described the method of the test incorrectly. It requires a person to swab fluid in the mouth at the gumline; it does not require a cheek swab.

Gawd… How about a Correction to the effect that this article is withdrawn as it is complete nonsense and serves only as propaganda to keep up the most gigantic scientific three card monte game ever in the business of medicine?

A closer examination

Let’s see if any of this piece makes sense, statistically speaking. In print on Wednesday morning, it appeared as

Researchers found the home test accurate 99.98 per cent of the time for people who do not have the virus. By comparison, they found it to be accurate 92 per cent of the time in detecting people who do….So while only about one person in 5,000 would get a false negative test, about one person in 12 would get a false positive.

In other words, our print edition carried the corrected statement, as noted on the Web above.

Uncertainty as to what figures mean

Still, one sympathises with the reporters who got it wrong. One can easily get lost in this hall of mirrors. Accuracy is a function of both sensitivity and specificity, ie how sensitive the test is to the actual virus (antibody) it is searching for, so it will find it if it is there, and how much it confuses it with other things, so it will register a false positive.

Sensitivity (also called recall rate in some fields) measures the proportion of actual positives which are correctly identified as such (e.g. the percentage of sick people who are correctly identified as having the condition). Specificity measures the proportion of negatives which are correctly identified (e.g. the percentage of healthy people who are correctly identified as not having the condition).

Sensitivity is rated by how many of the real positives it finds, in this case 92%. A 100% sensitivity test could score 100% by marking everyone positive, which wouldn’t be very useful. You aim to build a test sufficiently sensitive to find the virus (antibody) where it exists, without overreacting and cross reacting and finding virus (antibody) too often where it is not present. You don’t want to impose a false positive on luckless consumers of the HIV/AIDS story.

So you try to make the sensitivity high, but not too high, when it will find too many false positives.

Specificity reflects the number of false positives it finds among true negatives. 100% specificity would find no false negatives. You could trust that every negative found was indeed truly negative for the virus (antibody) and not overlooking any with a false negative result.

What the printed report means in these terms is that sensitivity is 92% and specificity is 4999/5000.

What the accuracy/inaccuracy means

So, taking the Times correction at face value, while you have 1 in 5000 negatives that will register false positive, you will have 8% or 8 in 100 or 1 in 12 positives which are going to register as false negatives, ie be missed.

That would be the result of having a reasonably low sensitivity. It will miss some positives entirely, 8%, but it wont find too many false positives. But it will still find quite a lot. Among negatives we will also have 308.8 million divided by 5000, or 61,760 false positives, that are produced by this test.

Since there are 1.2 million genuine positives, according to the CDC current reckoning, that would mean that 96,000 positives (8%) are going to be missed, testing negative, while one in 5000 of the 308.8 million negatives are going to test false positive. That’s 61,760 false positives.

A reassuring result!

On balance, then the test will inaccurately reassure more people than it will inaccurately condemn. About one third more – 96,000 against 61,760. A happy result even for those who believe that the test is worthless, and would ideally result in zero positives. For it will succeed in misleading about a net 35,000 people they are negative when they are in fact positive, which is a good thing in a land where HIV/AIDS superstition rules.

Of course, from the point of view of anyone actually familiar with the true science of HIV/AIDS published in peer reviewed journals and what it tells us, the test will be reassuring if positive, for it will signal you are truly HIV negative.

Thus a positive test actually tells us nothing to justify alarm, but in fact, is a helpful confirmation of the fact that even if HIV is dangerous, which it is not, we have got rid of it. So the 1.2 million it registers as positive should in fact be pleased and not alarmed at the result.

Since few people even in medicine or science actually read the journals or this blog on this topic, however, anyone who registers positive is going to be upset, to say the least. But at lest the 96,000 positives it will miss are going to escape the flaming dragon breath of this scientific cult.

However, we live in the land of HIV/AIDS superstition so on the scientifically insane assumptions of standard HIV/AIDS belief, the test will first of all needlessly alarm some 1 million (92% of 1.2 million) testees with true positive results, which actually mean they are HIV negative, but they will believe and be told it means they are HIV positive.

Added to this, the test will also needlessly alarm 61,760 people with false positive results, with all that implies – usually severe, health destroying depression and suicidal thoughts, compounded by doctors and nurses whose minds are puppets of this scientific cult, who wish to give them noxious drugs so that they can “live with HIV” for longer than otherwise, although in fact the drugs damage their health and in many cases send them to the grave.

In other words, if you have the health of the general population in mind, and of gays and blacks in particular, this test is the last thing you want to be sold over the counter.

But of course if you are a member of the cult of HIV/AIDS and subscribe to the nonsensical ideology propounded by Dr Anthony Fauci wherever he is invited to explain it, then it is a very fine advance in the spread of beliefs which can only mean more business for you and your colleagues.

Stock jumps

Accordingly, Orasure stock jumped 9% on the FDA announcement, so investors are already excited.

Let’s check the figures

But are the accuracy figures precisely correct? We thought we would get the accuracy measures from the horse’s mouth, OraQuick back up staff, just to make sure.

The support center is staffed with bi-lingual (English/Spanish) representatives who are available by telephone (toll free 866-436-6527) to answer questions about HIV/AIDS, describe how to use the test and interpret the results, and to provide direct referral to care if needed. Support center representatives are available 24 hours a day, seven days a week, 365 days a year and will be active starting on Monday, July 9th.

A helpful Janice answered when we called, and gave us what she had been told. We later checked it again with a Patricia. The test was 99.97 % accurate on positives if done correctly, she said; the 91.7 % figure was when people didn’t apply it properly ie ate less than half an hour before.

Thus they had found that in that kind of real life situation it found only 88 out of 96 true positives. It would miss 8 out of 96. 8.5% would be recorded as false negative.

If they were truly negative they would get a negative result 99.9 % of the time she asserted. This figure came from their study where they found it scored a false positive once in 4903 true negative cases.

So correcting our figures to reflect these exact numbers, the number of false positives produced by the 308.8 million HIV negative people in the US will be that number divided by 4,903, or 62,981.

Among true positives in their testing it found 88 out of 96 cases, it seems. So if it is applied by the entire population, it will find 88/96 of 1.2 million true positives, or 1,100,000. 100,000 will be missed.

So it will find a total 1,100,000 positives plus 62,981 = 1,162,981 positives of which about 63,000 will be false.

So the rate of false positives in those positives it finds will be 63/1163 0r 5.4 per cent, or 1 in 18.4.

So about 1 in 18 will be false positive, 63,000 in the whole population.

Bottom line cost/benefit

What does this mean in terms of good science and bad science?

First, it means in terms of good science that 1,100,000 should be reassured by a true positive test that they are safely HIV negative, but in fact according to the bad science which rules, they will be very alarmed, scared and mismedicated with toxic drugs that can kill them.

Second, it also means that 63,000 will score a false positive result, which should reassure them they are HIV negative, when in fact they are not. But under the rule of bad science, they will believe they are in danger of dying, which is true enough, since they will be told so and mismedicated by toxic HIV drugs.

Thirdly, it means that 100,000 will be reassured by a false negative test result, so will be preserved from being grossly alarmed by a true positive test, one they should have scored and been reassured by, but in a land of HIV/AIDS superstition, one they would have been needlessly upset by and then attacked by toxic drugs. Instead, they will be reassured by the incorrect result.

So the bottom line is the test will needlessly upset 1,163,000 with bad science that suggests they will succumb to HIV when they will not, and will ensure they are medicated with noxious drugs.

By missing 100,000 true positives it will relieve that number of the serious impact of bad science and its accompanying mistreatment.