May 29, 2012
This article was cross-posted from HIVhaven.com.
Take a moment and think back to when you tested positive for HIV. What was your initial reaction? What went through your head? For most of us it was sheer panic. "What now?" is usually one of the first questions that comes to mind.
If you're not HIV positive, think of a time where you were tested for HIV and sweated it out while waiting for the results. Some of us thought we'd kill ourselves rather than live with HIV/AIDS, believing our lives would be over.
Many people go on drinking binges, drug runs and/or get extremely depressed after finding out we have HIV. Now think about what it would have been like to receive the diagnosis at home, without support to assure us that a positive result didn't mean the end of our lives.
This will be the case for many if the FDA approves OraSure's OraQuick In-Home HIV Test. The Blood Products Advisory Committee (BPAC) has already recommended the FDA do just that. The FDA usually follows the recommendations of its committees.
The whole idea behind an at-home HIV test is to give people access and options to HIV testing for those who don't want to go to a test center. But we already have that option and have since 1996 with the Home Access HIV test. The Home Access HIV test requires a drop of blood to be sent to a lab. The results are given over the phone by a trained professional. This test maintains a 98.98% accuracy rate and provides people who don't want to be tested at a clinic or HIV test site an option, but also provides mandatory counseling to access the results.
When talking about HIV home test kits, it's important to remember that we're not just talking about its appropriateness in the United States. Governments all over the world historically base their decisions on what should be approved and what shouldn't, on the FDA's decisions. Other governments will and are following the FDA's lead on HIV home tests. Uganda has already said they will also approve the OraQuick HIV home tests based on the BPAC's recommendation.
This scares the hell out of me. The possibilities for abuse in countries like Uganda are endless. We put up the news every day on my website and debate whether or not to put up some of the stories we find from Uganda and other African and Asian countries as many are just too horrible. This is a country where people are still killed for being HIV positive. It's not uncommon for people with HIV to be ostracized, beat and/or thrown out of their homes and villages. Women are often not treated with respect and are abused physically and mentally. Some men blame their HIV infection on their wives, even though the husbands are usually the ones who have been unfaithful. Is it so ridiculous to believe that people will be forced to take an HIV test against their will if it's readily available? The only saving grace in this situation is that the test may be too expensive for many.
We can say that the FDA has to do what's right for citizens of the United States and any backlash in other countries if they follow the FDA are unfortunate but a consequence we can't control. I say bullshit! People with HIV are people with HIV -- no matter where they live. It is those that don't have the advantages we have in the U.S. that we should be protecting and advocating for the most! They must be considered in the decision to support or fight the OraQuick HIV home test.
When you're tested, you have someone there to put things in perspective. With the lack of HIV education out there, this really is essential. Alone many people not familiar with HIV will think:
When you're tested for HIV in a clinic or testing center, you have a trained professional to assure you that HIV is not a death sentence and there are medications that can keep you healthy. They can make it clear that there are ways to have safe sex and sex isn't something you have to give up. A pre and post test counselor will explain that there's a huge support system of people living with HIV. There's also help with telling family and friends. They explain that you don't have to tell anyone you're not comfortable telling, except your partner. A counselor will also help a person who just tested positive to recognize what the next steps are, including a confirmatory test and an appointment at an HIV clinic.
Pre and post test counseling is mandatory not optional, for reasons. One of which is to give hope during a moment of despair. We all know there's the possibility that some people will take their life after an HIV diagnosis. Mandatory pre and post test counseling helps make suicide less probable by providing a clear perspective.
OraSure's answer to the counseling issue is an optional 24/7 hotline. Really, it's just not good enough. Who knows if people will even read the package insert with the hotline info. Even if they do read the insert, most people who will take the test at home will do so because they don't want to interact with someone else during the process.
Then of course we have the accuracy issue. The OraSure rapid HIV home test would produce one false negative result for every 13 true positive tests. The test would produce one false positive result for every 3,750 true negative tests. People who test negative will believe they are negative and may not feel the need to use protection.
Will everyone who takes the test take the time to fully read the box and package insert to determine whether they are in the 'window period' before a positive result shows up? Again, more people who will believe it is safe for them to have unprotected sex.
What's to stop an employer from demanding an HIV test under the guise of it being a drug test. Or someone testing another person's DNA. A quick swab of the mouth isn't hard to get from someone who's asleep.
If you agree that the OraQuick In-Home HIV Test should not be approved by the FDA, please visit and like our page on Facebook -- Stop the FDA Approval of the Do-It-Yourself Home HIV Test Kit. A petition to the FDA and a letter to the Ugandan government will be posted shortly. Please check for other updates and help us stop this test from being approved by the FDA.
Testing and diagnosis of a life-threatening illness should be done by a trained professional!!!