Tuesday, 31 July 2012

The New Home AIDS Test: Not Perfect, But Close Enough

hiv

(CC) PLoS/Wikimedia Commons

As Long As We Use It Wisely

“We don’t have a sign on purpose. We have patients who are scared to death that people will find out about their condition. People in the South are still in the dark ages about HIV.” — Mel Prince, director, AIDS Information and Referral Center, Selma, Alabama, 2012.

AIDS and I go back a long way.

No, no, not in that sense. I mean journalistically. Years ago, I was writing an advice column for a men’s magazine on subjects including health, and on Sundays I would listen to a young eye surgeon who’d passed through his hippie dropout phase and now did a one-hour-a-week medical advice call-in show on local radio. His name was Dr. Dean Edell, and he would later go on to rather bigger things.

Because this was San Francisco in 1979, he was one of the very first to hear and take note of a local epidemic of Kaposi’s sarcoma, an otherwise uncommon connective tissue cancer that seemed to suddenly be rampant among male homosexuals, and reported it on his show. That’s where I heard about it in early 1980, and in passing it on in my column I became, to my knowledge, the first to report in a national publication what later became known as the “gay cancer” and still later, a sign of a new disease called AIDS.

Then, in 1986, I was tested for HIV myself. And no, not for that reason. Ostensibly it was at at the request of, and to reassure, a woman I had just begun dating, who was in her own words “really paranoid” about the disease, which was about as good an argument for paranoia as you could find at the time. But in reality, I decided to be tested because I had never read a first-person report from someone who’d done so, and thought it might make an interesting, i.e. marketable, article.

And so it did, for the S.F. Chronicle, whose editors seemed most impressed that I would undergo, and publicly discuss, an AIDS test when I didn’t really have to. That’s how strong the stigma was at that time: merely taking the test as a journalistic exercise seemed somehow disreputable. It’s as if I had told them I was volunteering to actually get AIDS. (My doctor at Kaiser Hospital in fact suggested I get the test done at a confidential facility because, “If we do the test, the record will go into your files here.) So it was with a sense of personal, if remote, satisfaction that I recently read the news about the new AIDS home-test kit.

As noted here in a Lab Notes posting, the Food and Drug Administration has just approved the first over-the-counter home test kit to detect the presence of HIV, the virus that causes AIDS. It’s called the OraQuick In-Home HIV Test, and it involves simply taking a swab of fluid from the upper and lower inner gums, inserting it into a vial, and waiting for 20 to 40 minutes for the results.

This is terrific news, since there are, according to CDC estimates, some 240,000 people living in the U.S. with an HIV infection that they are currently unaware of. A number of them — my personal guess would be roughly one-quarter — remain in the dark by choice, because they’re ashamed to find out; because they don’t want to appear, even if it’s just to a few impersonal and indifferent clinic workers, to be the kind of person who might contract the HIV virus. And there’s this: if the tests turn out negative, they’ll have tainted themselves for nothing.

It’s been 25 years since my HIV-test article, and yet some people still would rather risk AIDS than their reputation. Therein lies the importance of the new in-home test: given the option of privacy and anonymity, it can reasonably be expected that a lot of people who would not have gotten tested otherwise now will test themselves, and some will discover their infections and take action, and their lives will be better and longer as a result. So hooray for that.

But before we start organizing parades in celebration, let’s review the following cautionary excerpt from the FDA’s very own press release announcing the OraQuick approval:

A positive result with this test does not mean that an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the test result. Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months.

This takes some of the air out of the balloon, since a test that isn’t necessarily accurate does not sound like a test that is necessarily worth taking. But it’s not that bad. In fact, by FDA math, only about one in 5,000 uninfected test takers can be expected to get a false positive, an error that is easily exposed and corrected by a follow-up test at a clinic or doctor’s office. Unfortunately, the math in the converse situation is less reassuring. One false negative can be expected in every 12 tests of infected persons.

Given that the size of the pool of the unknowingly infected is a robust 240,000, that one-in-twelve ratio works out to 20,000, a dangerously large number of people to have returning to their social lives with the blithe, if incorrect, assurance that they won’t be passing on HIV. Of course, the actual number of unwitting carriers won’t be anywhere near the maximum of 20,000, but the total number of people they go on to have sex with could come fairly close.

And there are other questions. For one, an acquaintance who read about the OraQuick breakthrough wondered how we’ll actually use it. Will women now carry the test kits on dates or to singles’ gatherings, tucked away in their purses right next to the condoms? (And if the test is negative, do you get to skip the condom?) Could you surreptitiously swab a new lover’s toothbrush or a can or bottle they’d been drinking from and run a test on it? How about an ex-lover? Or a co-worker?

The fact that these may be bonehead ploys won’t stop some people from trying them, and since the test was not designed for such questionable, haphazard fluid sources, the result will most likely be nothing but negative results, some of them perhaps false. The prospect of people engaging in sex in the mistaken assumption that they or their partners are AIDS-free is almost as dangerous as no home test at all.

Bottom line, the Ora-Quick Test is excellent news and if used sensibly and meticulously, can save a great number of lives. Even so, I can’t shake the notion that somehow, to some extent, too many of us will find a way to misuse, misinterpret or otherwise screw it up.

(By Robert S. Wieder for CalorieLab Calorie Counter News):

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The New Home AIDS Test: Not Perfect, But Close Enough is a post from: CalorieLab - Health News & Information Blog

Source: http://calorielab.com/news/2012/07/25/the-new-home-aids-test-not-perfect-but-close-enough/

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