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FDA or Oraquick,...who's the JERK
May 14, 2004

Hi Dr. Bob, how ya doing? If you feel how you look, then you're damn fine!!

Anyhow, I have repeatedly tested Negative up to 42 weeks using various tests, including probably 6 Oraquick test. Now I know I'm fine with HIV1, but then I panicked about HIV2. Well come, March I get a return call from the FDA stating that the Oraquick Rapid HIV1 test had submitted an additional claim to market it's product as HIV1/2. The rep stated that it is the same exact product that had just received the approval for the HIV-2 claim. he stated that if I had beent ested with Oraquick it had been picking up the HIV2 antibodies all along.

But, when I contacted Orasure, they told me to retest because of Quality Control issues , and now they are saying it's a different test. So again, I contacted FDA and they still claim that its' the same device that received the extended claim.

FDA even posted in their website that "Its the same exact test". I desperately want to believe the FDA, so I can put this issue behind me.

By the way my expsoure eas picking up a drop of semen with my tongue after it was exposed to air, and protected vaginal sex, with the condom intact.

Testing History 11 weeks - Mercy Hospital 1.Elisa - Negative 2. Oraquick 90 day - Negative 3. Oraquick 20 week - Negative 4. Oraquick 22 week - Negative 5. Lab Corp 5 months - Negative 6. Oraquick 24 week - Negative 7. Oraquick - 25 week - Negative 8. Quest 26 week - Negative 9. Oraquick 26 week - Negative 10. Oraquick 42 week - Negative

Do I need a retest at 1 year past exposure? DO I need an additional HIV2 test?

CBC - Hemoglobin - 14 (12-16) RBC - 4.5 (4-6) Total Lymphs 1.6 (.74 -4.5) % 17% (10-45)

Do you think I'm HIV Negative.

Also, i've made small but some donations to your fund. However I was wondering if I can set up an automated monthly withdrwal from my checking account. I do so with St. Jude and it's more convinient, like that I don't forget to send my check, is it possible to do that through your account. Please advise.

Happiness and Love for you and your loved ones

Response from Dr. Frascino

Hello,

My understanding is that OraQuick Rapid HIV is approved for detection of HIV-1. I also believe that it is the same test kit that is being evaluated for HIV-2, but this has not yet received FDA approval. That might explain the discrepancy between the information you received from the FDA and the OraSure Quality Control team. OraSure cannot make claims about HIV-2 antibody detection until the FDA gives it formal approval. That said, considering your very minimal HIV risk and impressive (and excessive) testing history, I do not feel you need any additional HIV testing whatsoever. In fact, you've had nine more tests than you need already! A single antibody test at three months was sufficient to give you a definitive result. You are HIV negative.

Regarding scheduled automated donations to my foundation, yes, we can set this up with your bank. Just contact the Foundation's office and we'll walk you through the process. It's very similar to what you have already established with the St. Jude Foundation. The Foundation's phone number is 650-917-1357. You can also send an e-mail message by clicking on the "Contact Us" icon on the Foundation's website, www.concertedeffort.org.

It's time to yell WOO-HOO and put your HIV worries to rest. By refocusing your concern and resources from irrational fear to concrete action to help those struggling with AIDS, you've just made your halo in the afterlife a bit brighter. Please accept my heartfelt thanks!

Stay well!

Dr. Bob



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