Suggestions for false positives.
Whether Tara Lohan from the Voice prints my letter to the editor or not hardly matters at this point. I mean, yeah, sure, I want to see it printed, but having to get it out in 700 words or fewer proved a useful excercise to me in that I had a letter pretty much ready to go to the proper authorities. And that's exactly where it went -- the same day that I sent it off to her.
If, by any chance, you tested false positive for HIV using the OraSure ADVANCE Rapid HIV-1/2 Antibody Test, be sure to check out the FDA Office of Special Health Issues: What's New on the HIV/AIDS Web Site Report.
While you're at it, file a report! The FDA oversees approval of drugs and medical devices, and these reports are considered in the approval process -- remember OraSure wants to market this test as a home kit. (What would have happened to you if you'd gotten your false positive results at home?) It only takes one or two reports for the FDA to realise the problem's bigger than they thought. This is especially important if you live outside of San Francisco or New York, 'cause OraSure is trying to get out of their responsibility for marketing a faulty product by saying that there's something wrong with the guys in those cities who are getting tested, and are trying to say it's Hepatitis C. Sorry, but you know what? I don't have that, and my blood work confirms it. The form's available online, and has the sexy title MedWatch Secure Online Voluntary Reporting Form 3500.
It takes maybe five or ten minutes at most to fill out and submit. It's got some stuff you'd almost have to be a healthcare professional to figure out, but don't worry -- all "required" fields in the form are clearly marked as such, and they're all super easy. It's specifically for consumer reporting of adverse effects from regulated products and, for a government document, is quite user friendly. You've also got something like 6,200 characters worth of space in which to tell your own story (the letter below is under 5,000). Just remember that OraSure Technologies is located in Bethlehem, Pennsylvania, try and remember when and where you tested (how could you possibly forget?), and everything else will fall right into place.
You can also email the FDA's Office of Special Health Issues at OSHI@oc.fda.gov. Or telephone them toll free at 1-888-INFO-FDA. For mailing addresses and fax numbers you can email me or else just find it on their website -- it won't lead you wrong.
The report on the high percentages of false positives in those two coastal cities was apparently first made public by the Centers for Disease Control, or CDC, in a dispatch of their Morbidity and Mortalit Weekly Report (MMWR), a publication which first made AIDS history by reporting the mysterious appearance of Kaposi's Sarcoma (a rare skin cancer primarily associated with elderly Jewish men living in the Meditteranian) in gay men living in -- you guessed it: New York and San Francisco -- back oh I guess in the late 'seventies. When that happened, it took years for them to figure out there wasn't just something wrong with the guys in those cities but a whole new virus. During those years the virus spread, and exponentially. Let's not let something like this happen again.
Be sure and check out their dispatch: Supplemental Testing for Confirmation of Reactive Oral Fluid Rapid HIV Antibody Tests, in which they reaffirm the importance of confirmatory blood work for *all* persons testing positive. You might also consider sending a thank you note to Mary Lou Lindegren, M.D., who edits the MMWR. She can be reached at mmwrq@cdc.gov.
If, by any chance, you tested false positive for HIV using the OraSure ADVANCE Rapid HIV-1/2 Antibody Test, be sure to check out the FDA Office of Special Health Issues: What's New on the HIV/AIDS Web Site Report.
While you're at it, file a report! The FDA oversees approval of drugs and medical devices, and these reports are considered in the approval process -- remember OraSure wants to market this test as a home kit. (What would have happened to you if you'd gotten your false positive results at home?) It only takes one or two reports for the FDA to realise the problem's bigger than they thought. This is especially important if you live outside of San Francisco or New York, 'cause OraSure is trying to get out of their responsibility for marketing a faulty product by saying that there's something wrong with the guys in those cities who are getting tested, and are trying to say it's Hepatitis C. Sorry, but you know what? I don't have that, and my blood work confirms it. The form's available online, and has the sexy title MedWatch Secure Online Voluntary Reporting Form 3500.
It takes maybe five or ten minutes at most to fill out and submit. It's got some stuff you'd almost have to be a healthcare professional to figure out, but don't worry -- all "required" fields in the form are clearly marked as such, and they're all super easy. It's specifically for consumer reporting of adverse effects from regulated products and, for a government document, is quite user friendly. You've also got something like 6,200 characters worth of space in which to tell your own story (the letter below is under 5,000). Just remember that OraSure Technologies is located in Bethlehem, Pennsylvania, try and remember when and where you tested (how could you possibly forget?), and everything else will fall right into place.
You can also email the FDA's Office of Special Health Issues at OSHI@oc.fda.gov. Or telephone them toll free at 1-888-INFO-FDA. For mailing addresses and fax numbers you can email me or else just find it on their website -- it won't lead you wrong.
The report on the high percentages of false positives in those two coastal cities was apparently first made public by the Centers for Disease Control, or CDC, in a dispatch of their Morbidity and Mortalit Weekly Report (MMWR), a publication which first made AIDS history by reporting the mysterious appearance of Kaposi's Sarcoma (a rare skin cancer primarily associated with elderly Jewish men living in the Meditteranian) in gay men living in -- you guessed it: New York and San Francisco -- back oh I guess in the late 'seventies. When that happened, it took years for them to figure out there wasn't just something wrong with the guys in those cities but a whole new virus. During those years the virus spread, and exponentially. Let's not let something like this happen again.
Be sure and check out their dispatch: Supplemental Testing for Confirmation of Reactive Oral Fluid Rapid HIV Antibody Tests, in which they reaffirm the importance of confirmatory blood work for *all* persons testing positive. You might also consider sending a thank you note to Mary Lou Lindegren, M.D., who edits the MMWR. She can be reached at mmwrq@cdc.gov.
posted by xeltifon at 10:17 AM
0 Comments:
Post a Comment
Links to this post:
Create a Link
<< Home