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HIV 1&2 Testing kit question, Please answer, very confused
Dec 23, 2006

Dr. Frascino you are a great inspiration to everyone. The work you do is wonderful. I am a male. I just have a quick question about the testing kit. I got my test done for HIV 1 and HIV 2 by Quest Diagnostics. It was EIA Antibody test, because test was called, HIV1/HIV2 ANTIBODY EIA W/WB RFX. My test was done 5 months after my exposure. My results were negative for both HIV 1 and HIV 2. I have a concern about the testing kit that was used by Quest Diagnostics, because at the end of the report it stated, The test was performed using a kit that has not been approved or cleared by the FDA. The analytical performance characteristics of this test have been determined by Quest Diagnostics Nichols Institute. This test should not be used for diagnosis without confirmation by other medically established means. I freaked out and immediately called the Quest Diagnostics at Nichols Institute and the person on the phone told me that, All of our tests doesnt have to be approved by the FDA, but they are reliable tests. My questions #1 From the information I have given you, is it true that all the tests doesnt have to approved by the FDA, why or why not? #2 Even if the kit was NOT approved, can I be sure that test is reliable? #3 Can I be 100% sure that I am negative for both HIV 1 & 2? #4 Do you recommend me to take another test at 6 months? Dr. Frascino please shed some light on this issue, I would be greatly thankful to you. If you can take few minutes out of your time, and answer this question it will clear a big confusion I have in my mind. Please Please answer this question. I will donate. Again very much thank you for all the valuable information you provide, and answer our questions. Have a Merry Christmas and Happy Holidays.

Thanks.

Response from Dr. Frascino

Hello,

Quest Diagnostics Nichols Institute is a very reliable and well known reference laboratory. I have no reason to doubt the accuracy of their test results, their quality control procedures or any of their "analytical performance characteristics". 1. FDA-approval is not a requirement for each and every test run at reference laboratories.

2. I would have no concerns trusting the reliability of Quest's HIV-1/HIV-2 Antibody EIA W/WB RFx test results.

3. Yes, a five-month negative EIA would be considered definitive.

4. No, it's not necessary. However, if you remain worried, go ahead and take an FDA-approved antibody test at the six-month mark. It will undoubtedly be negative. However, it may be the most effective and efficient way for you to put any residual worries and fears permanently to rest.

Happy Holidays.

Be well. Stay well.

Dr. Bob



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