FDA approves first at home rapid HIV test
July 3rd, 2012
02:02 PM ET

FDA approves first at home rapid HIV test

 The first ever over-the-counter rapid HIV test has been approved by the Food and Drug Administration.

Users of the OraQuick In-Home HIV Test swab their upper and lower gums with the included test pad device and place it into a vial of solution.  Much like a pregnancy test, one line shows up if the test is negative, two lines means a positive test. Test results take about 20 minutes.

A positive reading does not mean a definite human immunodeficiency virus, but that additional testing should be scheduled with a health professional.  However, the FDA also cautions that 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."

The FDA approved another in-home test in 1996, however those samples needed to sent away to a lab for results.

According to the Centers for Disease Control and Prevention about 1.2 million people in the United States are currently living with HIV, but about one in five don't know they're infected.

"Knowing your status is an important factor in the effort to prevent the spread of HIV," said Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."

In clinical trials the OraQuick performed at 99.98% for test specificity–the percentage of results that will be negative when HIV is not present. This means that one false positive would be expected out of every 5,000 test results in uninfected individuals. A version of this test has been used by trained technicians in clinical settings since 2004.

OraSure Technologies, the manufacturer of the OraQuick In-Home HIV Test will have a consumer support center that is available via phone and will be open 24 hours a day, seven days a week. The center will provide users with information about HIV/AIDS, the proper method for administering the test and guidance on what to do once results have been obtained.

Douglas Michels, President and Chief Executive Officer of OraSure says the approval represents a major breakthrough in HIV testing. "For the first time ever, individuals will have access to an in-home oral test that will empower them to learn their HIV status in the comfort of their home and obtain referral to care if needed. This new in-home rapid test – the same test doctors have used for years – will help individuals at risk for HIV who otherwise may not test in a professional or clinical setting."

Orasure expects the kit to be available in stores and online in early October. The professional version of the kit sells in clinics for $17.50 but Michels believes the home kit will cost a little more. He says the price will be set by retailers. More than 30,000 stores will carry the test when it launches, he adds.

soundoff (774 Responses)
  1. RV Repair Garden Grove


    June 18, 2021 at 11:43 | Report abuse | Reply
  2. Camper Repair Shops Near Me


    June 18, 2021 at 18:33 | Report abuse | Reply
  3. RV Repair Shop Near Me

    Saved as a favorite, I like your blog!


    June 18, 2021 at 21:45 | Report abuse | Reply
  4. RV Repair Around Me


    June 18, 2021 at 22:30 | Report abuse | Reply
  5. movie theater near me

    When I originally commented I seem to have clicked on the -Notify me when new comments are added- checkbox and from now on each time a comment is added I receive four emails with the exact same comment. There has to be an easy method you are able to remove me from that service? Thank you!


    June 19, 2021 at 00:53 | Report abuse | Reply
  6. Sprinter Repair Near Me


    June 19, 2021 at 01:33 | Report abuse | Reply
  7. RV Repair Shops Near My Location


    June 19, 2021 at 03:43 | Report abuse | Reply
  8. RV Repair San Clemente California

    Aw, this was an incredibly nice post. Taking the time and actual effort to make a great articleÖ but what can I sayÖ I hesitate a whole lot and never seem to get anything done.


    June 19, 2021 at 04:52 | Report abuse | Reply
  9. RV Repair Shops Near My Location


    June 19, 2021 at 05:40 | Report abuse | Reply
  10. Camper Repair Shop Near Me


    June 19, 2021 at 07:09 | Report abuse | Reply
  11. RV Repair Mission Viejo

    I enjoy reading a post that will make men and women think. Also, many thanks for allowing for me to comment!


    June 19, 2021 at 07:13 | Report abuse | Reply
  12. RV Repairs Near My Location

    I quite like reading an article that will make men and women think. Also, thank you for permitting me to comment!


    June 19, 2021 at 07:16 | Report abuse | Reply
  13. Apartment to rent Ogun

    great put up, very informative. I ponder why the
    opposite specialists of this sector do not realize this.
    You should continue your writing. I am sure, you have a great readers' base

    June 19, 2021 at 07:23 | Report abuse | Reply
  14. Apartment to rent Sokoto

    It's really very difficult in this full of activity life
    to listen news on Television, therefore I simply use internet for that reason, and obtain the most recent information.

    June 19, 2021 at 08:53 | Report abuse | Reply
  15. house for rent near me


    June 19, 2021 at 09:31 | Report abuse | Reply
  16. RV Repair California

    Saved as a favorite, I like your site!


    June 19, 2021 at 09:52 | Report abuse | Reply
  17. RV Repair Shop Near My Location


    June 19, 2021 at 11:21 | Report abuse | Reply
  18. RV Repair Garden Grove


    June 19, 2021 at 13:10 | Report abuse | Reply
  19. RV Repair Shop Near My Location

    Very good information. Lucky me I found your blog by accident (stumbleupon). I have bookmarked it for later!


    June 19, 2021 at 14:01 | Report abuse | Reply
  20. RV Repair Shops Nearby

    A motivating discussion is worth comment. I believe that you ought to write more on this issue, it might not be a taboo matter but generally people don't speak about these topics. To the next! Cheers!!


    June 19, 2021 at 16:26 | Report abuse | Reply
  21. Nearby RV Repair


    June 19, 2021 at 21:31 | Report abuse | Reply
  22. RV Repair Shop Near My Location


    June 19, 2021 at 22:26 | Report abuse | Reply
  23. RV Repair Seal Beach


    June 19, 2021 at 23:11 | Report abuse | Reply
  24. Daftar situs judi Penipu

    What's Happening i am new to this, I stumbled upon this I've
    discovered It absolutely useful and it has helped me out loads.
    I am hoping to contribute & aid different users like its helped me.
    Good job.

    June 20, 2021 at 01:17 | Report abuse | Reply
  25. Internet Marketing Firms

    After I originally commented I appear to have clicked on the -Notify me when new comments are added- checkbox and from now on each time a comment is added I receive four emails with the same comment. Is there an easy method you can remove me from that service? Appreciate it!


    June 20, 2021 at 06:12 | Report abuse | Reply
  26. Local Marketing Experts

    Very good info. Lucky me I ran across your website by chance (stumbleupon). I have bookmarked it for later!


    June 20, 2021 at 08:07 | Report abuse | Reply
  27. Local Marketing Service


    June 20, 2021 at 08:57 | Report abuse | Reply
  28. SEO Marketing Business


    June 20, 2021 at 09:40 | Report abuse | Reply
  29. SEO Marketing Companies Near Me

    I blog often and I truly appreciate your information. This article has really peaked my interest. I'm going to book mark your site and keep checking for new information about once per week. I subscribed to your RSS feed too.


    June 20, 2021 at 09:54 | Report abuse | Reply
  30. Bryan Norgard

    How can I insert a tag cloud into my blog @ blogspot?


    June 20, 2021 at 12:01 | Report abuse | Reply
  31. Caroll Boon

    Good post. I learn something new and challenging on blogs I stumbleupon on a daily basis. It's always interesting to read through articles from other writers and use something from their websites.


    June 20, 2021 at 14:31 | Report abuse | Reply
  32. Raymond Cobane

    Oh my goodness! Impressive article dude! Thanks, However I am encountering issues with your RSS. I donít understand the reason why I can't join it. Is there anyone else getting identical RSS problems? Anybody who knows the answer will you kindly respond? Thanx!!


    June 20, 2021 at 19:37 | Report abuse | Reply
  33. Mindi Stouall

    I used to be able to find good advice from your content.


    June 20, 2021 at 19:48 | Report abuse | Reply
  34. Sam Helphinstine


    June 20, 2021 at 21:22 | Report abuse | Reply
  35. RV Repair Around Me


    June 21, 2021 at 00:57 | Report abuse | Reply
  36. pharmaceptica.com

    erectile quality scale https://pharmaceptica.com/

    June 21, 2021 at 01:16 | Report abuse | Reply
  37. Nearest RV Repair

    Iím amazed, I have to admit. Rarely do I encounter a blog thatís both educative and engaging, and let me tell you, you have hit the nail on the head. The problem is an issue that too few people are speaking intelligently about. I'm very happy I stumbled across this during my hunt for something relating to this.


    June 21, 2021 at 06:09 | Report abuse | Reply
  38. rv rental near me


    June 21, 2021 at 06:28 | Report abuse | Reply
  39. RV Repairs Near My Location

    Everything is very open with a precise description of the issues. It was truly informative. Your website is extremely helpful. Thank you for sharing!


    June 21, 2021 at 07:40 | Report abuse | Reply
  40. emergency room near me


    June 21, 2021 at 11:10 | Report abuse | Reply
  41. RV Repair Shops Near My Location

    May I simply just say what a relief to uncover somebody that genuinely knows what they are talking about on the net. You actually understand how to bring a problem to light and make it important. More and more people must check this out and understand this side of the story. I was surprised you aren't more popular since you surely have the gift.


    June 21, 2021 at 16:42 | Report abuse | Reply
  42. Terrance Schuit

    Have you ever heard of second life (sl for short). It is essentially a online game where you can do anything you want. sl is literally my second life (pun intended lol). If you would like to see more you can see these second life articles and blogs


    June 21, 2021 at 20:02 | Report abuse | Reply
  43. RV And Camper Repair Near Me

    This is the right web site for anybody who wants to understand this topic. You know a whole lot its almost tough to argue with you (not that I really will need toÖHaHa). You definitely put a fresh spin on a topic which has been written about for decades. Excellent stuff, just excellent!


    June 21, 2021 at 21:15 | Report abuse | Reply
  44. RV Repair Service Near Me


    June 22, 2021 at 02:36 | Report abuse | Reply
  45. confidence training


    June 22, 2021 at 05:11 | Report abuse | Reply
  46. RV Brake Repair Near Me

    Hi, I do believe this is an excellent web site. I stumbledupon it 😉 I'm going to return once again since I book marked it. Money and freedom is the best way to change, may you be rich and continue to help others.


    June 22, 2021 at 15:34 | Report abuse | Reply
  47. RV Repair Near Me Now


    June 22, 2021 at 18:08 | Report abuse | Reply
  48. cabinet of curiosities podcast

    Iím impressed, I must say. Seldom do I encounter a blog thatís both educative and interesting, and let me tell you, you have hit the nail on the head. The issue is something which not enough people are speaking intelligently about. I'm very happy I came across this in my search for something regarding this.


    June 22, 2021 at 21:59 | Report abuse | Reply
  49. bill burr monday morning podcast

    An impressive share! I've just forwarded this onto a colleague who was doing a little research on this. And he in fact ordered me breakfast because I found it for him... lol. So let me reword this.... Thanks for the meal!! But yeah, thanx for spending some time to discuss this topic here on your site.


    June 22, 2021 at 22:39 | Report abuse | Reply
  50. spitballers podcast


    June 23, 2021 at 01:47 | Report abuse | Reply
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Leave a Reply to RV Mechanics California


CNN welcomes a lively and courteous discussion as long as you follow the Rules of Conduct set forth in our Terms of Service. Comments are not pre-screened before they post. You agree that anything you post may be used, along with your name and profile picture, in accordance with our Privacy Policy and the license you have granted pursuant to our Terms of Service.

About this blog

Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.