Health: Test Yourself!


On Tuesday, May 15th, the FDA unanimously voted that the benefits of OraQuick ® In-Home H.I.V. home tests outweighed the potential risks. This vote is the first major step towards testing for HIV at home.

Recently published research on HIV transmission rates from persons living with HIV who are aware and unaware of their infection was used to bolster the argument for the prevention benefits of home HIV testing.

Assuming 1 million individuals tested with the OraQuick ® In-Home HIV Test, OraSure estimates that 9,087 HIV positive individuals would be identified and that more than 700 onward transmissions would be prevented annually. These prevented infections would be in addition to those averted through current testing and intervention efforts.

OraQuick ® Advanced tests currently available in the professional market, have been used for  many years, providing rapid results within 20 minutes through a simple mouth swab.

The approval was the second in less than a week regarding HIV, as last Thursday a similar panel of drug experts endorsed the HIV daily pill Truvada for Pre-Exposure Prophylaxis (PrEP). A pill taken daily by HIV-Negative individuals to prevent infection.

One of the main concerns regarding home testing for HIV ‘insiders’ is the lack of support and counseling for those that may test positive.

One argument is that those who test positive may harm themselves or act irrationally in other ways based on the diagnosis. The opposing argument is that with ART (daily medications) an HIV diagnosis does not have the same impact as it did prior to effective treatment.

Another concern is accuracy, saliva-based tests do not appear to be as reliable as those that use blood samples.

A final concern is the potential costs, although no absolute costs have been released, the current costs for the professional version of the oral swab test is $17.50, OraSure states that the costs for the home tests will be less than $60 but I anticipate that they will be significantly more than the $17.50 needed to purchase a professional test. To quote OraSure, “the in-home kit requires more extensive labeling and has to cover the costs of the customer call center”.

I am of the opinion that making HIV tests available broadly and privately is a good thing and that allowing individuals to test themselves at home, at a party or through a private event is extremely valuable, especially when considering the hesitance of some to get tested as a result of name-based reporting and other privacy / stigma concerns based on what can (and often does) happen when an individual tests positive for HIV.

I would be more than happy to test myself and would be happy to have a few tests available for partners, what about you?



There are 37 comments

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  1. vafratboy

    Agreed. While the concern for post-result counseling is very valid at the individual level, fewer infections in the general population means fewer people needing counseling to begin with.

    Unfortunately so long as a stigma exists around HIV testing, condoms, etc; there will be folks who refuse to associate themselves with them and so easy and anonymous access is absolutely essential to slowing the spread of disease.

  2. Jerry Spaniard

    “One of the main concerns regarding home testing for HIV ‘insiders’ is the lack of support and counseling for those that may test positive. One argument is that those who test positive may harm themselves or act irrationally in other ways based on the diagnosis.” This is an absurd argument. By this reasoning, rational adult individuals are to be prohibited from exercising their choice to scientifically discover whether they are infected with HIV, because some *other* individuals might do damage to *themselves*. Excuse me: There are plenty of irrational (or emotionally compromised) people out there doing all kinds of damage to themselves all the time, for all different kinds of reasons. Just because there are a handful of people who might not deal well with discovering their HIV status on their own is *NO* excuse from forcibly prohibiting *OTHER* people who want to discover their HIV status on their own.

  3. Bryan

    I personally think this is great. One of the main reasons someone may not know their status is because they don’t want to go to a center to get test done. The thought of someone else face to face telling you is to much for them. So they continue on assuming it won’t effect them. I think this opens up the options available to people and is fantastic.

  4. Jay

    In your blog you write “A pill taken daily by HIV-Negative individuals to prevent infection.” Amazing, I wasn’t aware they had developed a vaccine….granted, this is what your statement amounts to. While I understand what you mean, i think it’s important that you perhaps be far more specific in future posts concerning such things.

  5. Stephan

    Jay – I appreciate your feedback note that there have been other posts on PrEP:

    In this post I call it what it is: a pill taken daily to prevent infection. I am not sure how to be more specific than that. It is being termed a prevention strategy and is, as you point out, not a true vaccine. The strategy does not produce an antibody to the virus and is not an inoculation.

    PrEP means that HIV-negative people regularly take antiretroviral (ARV) drugs to prevent infection.

  6. coollie

    plus people will do more bareback if they “think” they tested negative with this litte kit of stupidity, when it could be a false negative.

  7. Paul

    Jay. The FDA has been working on a vaccine for HIV for the past 2 decades. Only in the past decade has there been a real breakthrough in creating the vaccine. It has not been broadly advertised do to the potential side effects of the vaccine. In the past couple of years, scientists have been able to create a preventive application of the vaccine in a pill form, which has lead to less side effects and has proven to be more effective if taken as directed. A lot of this information can be found on the FDA website. It truly is exciting news. Granted this doesn’t mean that people can blithely have unprotected sex as there are many STD’s that are still currently incurable. But one less worry is always welcome.

  8. Brad

    The cost of Truvada will be prohibitive for a while. It costs around $11,000.00 per year. That’s over $30 a pill! I may not be technically correct, but I wouldn’t call it a vaccine. It’s a pill. Vaccines are shots, aren’t they?

  9. shimmian

    this is a terrible idea
    not because of the “lack of counseling” [which is a completely bullshit argument]
    but because these tests are incredibly inaccurate, and very frequently offer false negative results
    people using the test will read that they are negative [when they are not] and will not act as responsibly — believing they have confirmed their status, or confirmed a partner’s status, they will opt not to use protection when they very much aught to
    these tests will increase the spread of HIV — i have no doubt

  10. In the Know

    The pill taken by negative persons (called PRep) isn’t a HIV vaccine AND must be taken regularly(everyday) AND used with other safer sex methods to reduce your risks of contracting HIV. If not, you can build a resistancy to the meds, meaning if you become infected other meds wont work for you.

    Although FDA approved it only had a 44 percent effective rate in study participants that were given strict supervision…that’s a 56 percent failure rate. In certain situations, sure it could be a very good thing…in most the public jury is still out. i just wanted to clear up the myth, misnomer, rumor that it’s a cure or vaccine.

  11. jstlookin

    Home Access is another at home HIV test that has been available for years at local drug stores and is considered to be accurate in it’s results. The cost is around $60. You prick your finger and send in the drop of blood to the lab. All the supplies and the envelope are included in the kit. It is anonymous testing. You are given a code to use to identify yourself when you call to get your results.

    I guess the difference between the two tests is the Oraquick gives you immediate results where as with the Home Access you have to call in seven days later after sending in the blood sample.

    The Home Access is less likely to give a false result since you are actually using blood for the sample.

  12. Owen

    I have used in-home testing and professional testing. Here-to-fore the main drawback for the in-home testing was the long wait for the express mail return of the blood sample to the lab, and the time required for the laboratory analysis. These delays amounted to a few days, and were comparable to a standard clinically administered blood test. The quick turn around offered by the saliva test was a major breakthrough. It avoided the period of considerable anxiety between the tesing and the results, a major personal advantage. Having the saliva test available at home in 20 minutes is desirable in several respects. For some, it may be no more expensive than the drive to and from a testing facillity. It also provides a means to confirm the statement of a potential partner about their HIV status, while narrowing the range of time between testing and sex. I hope in-home testing does not simply boost promiscuity. Even if it does, I suspect it will lower the infection rate. There is still a need to “wrap it up” given the delay between infection and a positive test.

  13. Terry

    We have been using the home testing in IL for years, we seem to be leading the country in HIV preventions. Lack of funding has eliminated it from our group at this time. Sometimes I have a difficult time getting people in for testing in our area, to see this available again would be wonderful. Over the last 5 years IL has taken in over 500,000 HIV POZ people from other states that are not treating them well, it is draining our resources and skewing our numbers. Mostly these people come from the south, and a few other states that promote abstinence only education, and we all know that spreads disease and pregnancy at high rates. We need this test to continue our battle on the home front. As of recent, I have had to drive people as far as 35 miles to get HIV testing done when it was once a simple trip into the local health department. Jay, a vaccine is something generally taken via needle, one or two shots and the remainder of your life you become immune to the disease vaccinated for, taking a pill every day in prevention is far from a vaccine. the expense of these pills would be high compared to a developed vaccine, and then the fact that if we miss doses…. Just pointing out the difference, I got one polio shot when I was a small child, I will never get polio… I would have to take a pill every single day the rest of my sexually active life to prevent HIV. While this is an improvement, it is not a vaccine:)

  14. JASON

    In late 2005, counselors at several HIV testing programs (mainly in New York City and San Francisco) reported apparent clusters of positive OraQuick HIV test results on oral fluid that were ultimately found to be negative on confirmatory testing. At some locations, the reported rate of false-positive test results was as high as 9 per 1000, which is higher than the 2 per 1000 expected with a specificity of 99.8%. In response to these reports, the CDC, FDA, and test manufacturer are investigating whether changes in the testing protocol are indicated. For now, the FDA believes that use of OraQuick should proceed, as long as users are informed of the need for additional testing to confirm reactive rapid tests.

  15. JASON

    TOO MANY FALSE POSITIVES AND NEGATIVES! I am 100% for testing but I think oraquick is too inaccurate to use in a health clinic and would be a disaster for home use.

    People who use what could be the first completely at-home HIV test under development by OraSure Technologies Inc. risk receiving false results, U.S. regulators said in a report.
    But officials of the Bethlehem company maintain the OraQuick In-Home HIV Test has a 99 percent accuracy rate, and the benefits of reducing HIV transmissions through more accessible testing outweigh the risk of a small number of erroneous results.

    At issue is OraSure’s leading product, the OraQuick HIV test, which detects HIV antibodies in oral fluid and provides results within 20 minutes. The test for years has been used by hospitals and clinics. OraSure is seeking Food and Drug Administration approval to sell the test over the counter without a prescription, providing users with their HIV status at home in a similar fashion to pregnancy tests.
    On Tuesday, the product will be discussed at an FDA advisory panel meeting. The stakes are huge for OraSure, which has invested heavily in clinical studies and marketing in hopes of selling the product at such major retailers as Walmart, Target and Walgreens.
    “There is considerable personal and public health value in informing infected, but otherwise untested, persons of their true positive HIV status,” FDA staff wrote. “However, this benefit is offset in some measure by HIV-positive individuals who receive an incorrect message that they are not infected.”

    If it receives FDA approval, the company plans to begin selling the test this year.
    About 1.2 million people in the U.S. have HIV, the virus that causes AIDS, and 20 percent of them are unaware they are infected, according to the Centers for Disease Control and Prevention.

    OraSure CEO Douglas Michels said those unaware of their infections are responsible for as many as 70 percent of the 50,000 new HIV infections recorded each year. OraSure’s over-the-counter test would help reduce the spread of HIV by helping more people determine if they are infected. The company estimates that for every 1 million people using the product, potentially 700 fewer people will contract HIV annually since more people will know they are carrying the virus.

    “We think that the benefit far outweighs any potential risks,” Michels said. “If someone knows they are HIV positive, their forward transmission rate is much lower.”
    OraSure’s test would be the first of its kind. Other kits, such as Home Access Health Corp.’s Express HIV Test System, require users to anonymously send blood samples to a laboratory for testing.

    A clinical trial of OraSure’s test identified 100 previously undiagnosed people infected with HIV out of 5,800 patients who used the product, according to the company.

    OraQuick would produce one false negative result for every 13 true positive tests, FDA staff said. That would total an estimated 3,800 people with HIV who falsely test negative each year, according to the report. In addition, the test would produce one false positive result for every 3,750 true negative tests. resulting in 1,100 people a year who aren’t infected believing they are, the report said.
    The false negatives reported were higher than what the FDA considers a “minimum acceptable performance” while the false positives were lower.

  16. mark

    I think the whole ideal is stupid but alot of gay men love to throw money away. You can go get tested at Health Departments all over the usa for free. Why spend less than $60.00 which we all knows that means $59.99 when you can get tested for free. I get tested every 6 months and never pay for it. Its in a very private setting and very confidential why would I want to test at home and possibly do it wrong etc…. and get a false positive or a false negative which either one would be a disaster.

  17. Sam

    It is very interesting and helpful, But I have one more point in the negative side of this kind of testing,
    when before any sex you and your partner test with this, and the result is negative, there will be a high chance of not using condom, b/c people will be confident that there is no need to use condom.
    However, to detect the HIV infection, it needs 30 to 90 days window period, so if u get negative results, and do not use condom, this way the chance of transmitting HIV will be higher….

  18. Kyori

    Im not so sure this is such a good idea
    as some concern that have been written on some of the repliers’ i agree that some may think that they are invulnerable for they have been having unprotected sex and results came back negative (as ppl dont seem to think HIV is any more deadly condition anyway these days). Or on the other hand if the test results came back positive, ppl will be more reckless as the test is done at home with no registration whatsoever.
    as far as accuracy concern (i am not saying that the test result is accurate, just saying what it is), i get tested with OraQuick every 3 months at the GLCC center (it is free too) and plus i get tested at my physician office every time i see her annually; and results always comes back the same
    but then again i am not denying the advantage of more privacy in testing yourself and promoting ppl to test more in their own privacy but then again how far will this advantage overcome the disadvantages?

  19. muscdad59

    Does anyone know whether the accuracy of the test is correlated with the viral load? Do “undetectable” poz guys who are being treated test positive in the saliva test? How accurate is the test for guys who have just recently been infected?

    I can’t see any downside to this. The sooner someone finds out they are infected, the sooner they wil get treated, which will stop the spread of the disease and preserve their own heath.

  20. Jay

    This home test is not reliable and should be followed up with a test at your local HIV clinic. I know this as I am HIV positive for over 18 years now and have done this home testing several times and it always came back negative. Don’t bee fooled into complacency. The most accurate tests are still those administered by Elisa and PCR.

  21. noteasy2get

    I find the lack of being part of a database troubling. I am 100% certain that the records are private and it is important to be able to track HIV infections. I know many disagree and their concerns are legitimate, I was very nervous about being tested because of this caveat; however, I do not think that it is such a horrible thing to have your name on a list of positive individuals, that is all it is, a name, they don’t even ask for your ID. I think that being able to keep track of incidence of positive infection is very important in being able to fight HIV.

  22. TruthAddict

    In my home State of Alabama, if you test positive for HIV, it is required by law that your name and address be sent to the State Department of Health and your local County Department of Health. I will NEVER be tested in Alabama. I go to Atlanta and get a private, anonymous test there. But, I don’t get tested with the frequency I would like.

  23. really

    a few tests available for partners? I dont think it is your place to make other people test there infront of you right before diving to sex.

  24. Omar

    I think its great that they will have this. However, as a Health Educator i have some issues with is. Some have already been mentioned such as false negatives, false positives, pre & post test counselings and support if one tests positive. My huge concern would be people not understanding the window period. I have tested many people who have no idea what that is. Some people may use this test right before having unprotected sex or possibly immediatly after an exposure and feel that the negative is a true negative not realizing that it takes some people up to three months to start producing antibodies. This information may be provided in the take home kit however having someone else explain it in detail for those that may not understand it would be helpful. This of course is explained in the pre test. Once the result comes back, more explanation of when one should get tested again would be provided during the post counceling. Again, this is great for people who do not have testing sites in their area however i also feel this may lead to more funding cuts and more people out of jobs.

  25. Fritz

    It’s amazing how people have been snowed by this whole bogus thing. Look at the disclaimers inside each test kit. Viral load wasn’t designed for the present usage. Eugenics. Like lambs to slaughter. Wow… we are sheeple. “Official Stories” – read it.

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