[Question #5137] New Alere HIV combo test (Not determine)

23 months ago
Hi doctor,

I had an exposure 8 weeks ago. I received unprotected oral from CSW in Singapore.

I had the alere HIV combo test (CE-marked) done after 17, 22, 28, 35 and 42nd day. All negative.

1) what was my risk of HIV and are my rapid tests conclusive? Do I have to go for another test at 12 weeks?

2) is there any difference between the alere determine and the alere hiv combo? The HIV combo is not FDA approved but the determine is. I understand that the determine didn’t work as well as it should have and the company came up with the Alere HIV combo.

3) are these tests as good as 4th gen lab based tests?

Thank you
H. Hunter Handsfield, MD
H. Hunter Handsfield, MD
23 months ago
Welcome to the forum. Thanks for your confidence in our services.

First, you had a zero risk exposure. Oral sex is safe sex in regard to HIV:  a few cases have occurred in oral partners after performing oral sex on men, but there has never been a proved case of HIV transmitted mouth to penis. Ahd although CSWs generally are high risk for HIV, the large majority (in Singapore or elsewhere) do not have HIV.

Second, your test results are conclusive; they prove for sure you did not catch HIV. It never takes more than 6 weeks for the antiben-antibody (combo) tests to become positive. You do not need any more tests.

I think you read news or internet information suggesting that the Determine test did not work as well as expected -- although a combo test, the antigen detection component was faulty. However, Alere corrected that problem soon after it appeared, and the currently available Determine test is completely reliable. I'm not intimately familiar with the differences between Determine and the HIV Combo test, but I believe they are equivalent. There are no unreliable AgAb tests on the market, to my knowledge. And as I said, you really weren't at risk anyway. The rapid blood tests are equally reliable as the lab-based AgAb tests.

Bottom lines:  You were at little or no risk of HIV; and even if you were, your test results are conclusive.

I hope this information is helpful. Let me know if anything isn't clear.

HHH, MD
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23 months ago
Thank you doctor! Appreciate the quick response.

One last thing, does it matter that the Alere HIV combo is not FDA approved, my tests are still 100% conclusive? It is WHO approved if I am not wrong. Should I go for a Alere determine test instead? Have you heard or read of the field performance for Alere HIV combo?
H. Hunter Handsfield, MD
H. Hunter Handsfield, MD
23 months ago
Not all companies seek regulatory approval in all countries. I'm confident that if Alere wanted to market in the US and sought FDA approval, it would have been granted. As best I know, WHO approval is equally valid.

Your test results are valid and conclusive. Believe it, suck it up, and move on. It's time to drop this from your mind.
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23 months ago
Hi doctor,

Got it. Thanks for the help and advice.  I’ve actually read some of the replies to the other questions as noted sometimes you say 6+ weeks. So is alere HIV combo test conclusive at 6 weeks or 6+ weeks?

 Can I continue sexual relations with my gf?

Thanks you so much! Really appreciate your time and effort to reply.
H. Hunter Handsfield, MD
H. Hunter Handsfield, MD
23 months ago
There's no difference. 6+ is just a brief way to say that all tests at 6 weeks and thereafter are conclusive.

Since you do not have HIV, you cannot transmit it to anyone else. So of course no problem continuing sex with your girlfriend.

Thanks for the thanks. I'm glad to have helped. That concludes this thread. Take care and stay safe.
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