Hiv test fda
Common Questions and Answers about Hiv test fda
hiv
Hi guys,
from my previous post of protected sex with a mexican girl I have since taken a Home HIV test, I used the iCare HIV test kit, well two of them and they both came out negative. I was just curious if anybody knew the brand and has heard that it is a good one to use. It says it is 99% accurate and was curious if this is true.
Currently, the only over the counter FDA approved home use HIV tests are the OraQuick HIV home test and the Home Access Test. It's much cheaper to just go to your local STD clinic for a free rapid HIV test. They know what they are doing, are using quality FDA approved tests, and can do the follow up confirmatory testing that your will need if the antibody test is reactive.
3- the test device is among USAID approved hiv rapid test devices.
2- the manufacturer is an american-based firm and is a FDA registered company (ACTIVE registration) and owns FDA approvals for lots of its products other than its hiv rapid tests. it is also ISO13485 certified company for its quality system and owns CE-Certificates for many of its products, which shows it is a reputable company.
3- the product i bought had the manufacturer's hologram on its package.
This test is not approved by the FDA for use. The ONLY at-home testing kit for HIV approved by the FDA is the Home Access kit.
Unfortunately, given that you have no proof or reassurance that this is a reliable test, you will need to test again. You can go to a local health clinic and get a test- many places offer free, confidential HIV testing.
If you want to do it at home, the only test you should buy is the Home Access.
If thats the case then what is the difference between hiv rna qualative and hiv quantitative? If its meant for people that are already infected then why did the fda approve the hiv rna "qualitative" test for diagnosing hiv before serocinversion?
Unapproved HIV Test Kits May Face Legal Challenge
A consumer warning posted jointly by the FDA and the Federal Trade Commission cautions that HIV test kits that have not been approved for distribution may give inaccurate results. The statement goes on to say that the agencies may take action to halt the sale of kits that aren't up to par.
The FDA has conducted several investigations of the reliability and accuracy of unapproved HIV home test kits since 1996.
You want to know about Lyme disease then I suggest you go to a forum that discusses it.
There only one FDA approved collection kit, it's home access.
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