[Question #6379] HIV Alere Determine 1/2 Antibody only test.

68 months ago

I did two tests to completely close the chapter of my last exposure;

HIV 1/2 + p24 is negative at 85 days post exposure at Synlab Nigeria.

HIV 1/2 Alere Determine antibody only at 91 days post exposure.

Both tests were taken in Nigeria.

I will like to know what generation of test is HIV 1/2 Alere Determine antibody? is it a 2nd generation test or 3rd generation?

After the test, the nurse told me it is conclusive at 6 months which got me worried. I initially believed it was 3 months conclusive before the test.

I also notice the Alere Antibody test is not FDA approved? Does that mean it's not an accurate test.

The Alere antibody is the test that widely used in Nigeria and widely used in other African countries. Any reason why this test isn't used in the US?

Edward W. Hook M.D.

68 months ago

Welcome back to the Forum. I'm sorry that you continue to be concerned about the events you mentioned to Dr. Handsfield a month ago. I reviewed that interaction and agree with all that he said. There was no evidence of HIV of any sort at that time and there is no evidence at this time either. Your results are conclusive and do not need to be repeated. You should be confident that you did not get HIV from the events you described. Your tests prove this.

The Alere Determine tests have been approved by the World Health Organization since 2011 and by the U.S. FDA since 2013. The test is highly reliable. the antibody portion of the assay is a 3rd generation-type test which, when combined with a highly reliable p24 antigen test, makes it a "4th generation" test which provides reliable/conclusive results at any and all times more than 6 weeks after exposure. Your 85 day test results should be believed.

The Alere test is approved for use in the U.S. If it is not, I suspect that is a marketing decision. We do not track which tests are used and how often.

I hope that this information is helpful. Please believe your test results. Take care. EWH

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68 months ago

Thanks for your swift response

Also please confirm.

Just for knowledge sake, Please confirm when the HIV Alere antibody only ( not the combo) test conclusive?

I understand the Alere HIV Combo is conclusive at 6weeks.

I will believe my test results henceforth.

HIV guideline in Nigeria still advises 6 months. DO you think this is overly conservative?

Edward W. Hook M.D.

68 months ago

Antibody tests for HIV, including the Alere Determine are conclusive at 8 weeks. Recommendations for more prolonged follow-up are overly conservative and out of date. EWH
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68 months ago

I appreciate your help Dr Hook.

From you and Dr Handsfield were to amend the guideline and also from your experience on window periods over the years;

Will you conclude that;

3rd generation test is 100% conclusive at 8 weeks + and 4th generation test are conclusive 4 weeks +

Edward W. Hook M.D.

68 months ago

Almost. You are correct regarding 3rd generation antibody tests. As for 4th generation, combination HIV antigen/antibody tests, results are now officially and completely conclusive only at 6 weeks but well over 99% of results are conclusive and will not change at 4 weeks.

My 3rd reply, as per Forum guidelines this thread will now be closed. I hope that the information I have provided will allow you to move forward without further concerns. EWH

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