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Generations of Elisa test

The 3 months is valid for FDA approved test .
Now, what generations (1 to 4) of Elisa test are approved for the FDA ?
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386032 tn?1220401438
i was under the impression that the state of mass. uses 4 th gen testing, but hey i could be wrong, Like teak says it doesnt matter since 3 months is conclusive with 1,2,3,or 4
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219662 tn?1223858560
That was to Teak, not to Chris
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219662 tn?1223858560
I'm in an academic lab.  So we don't do commercial testing and we don't subscribe to the Federal Registrar, whatever it is.  I don't claim to be an expert on the FDA, I don't have any restricted access to their resources.  I only have access to what is released to the general public, same as you do.  That's why each and every one of my statements included "as far as I know".  Now I showed everyone where I'm getting my info - it's an official and recent (2007) FDA release, I think it qualifies as reliable.  If you have any ACTUAL information on the subject, I would like to see it.  Otherwise, you are just spamming the forum "like normal" and will be reported for that.
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Avatar universal
Like normal Joey you don't know that much. Do you get the Federal Registrar? If you work for a lab, I'm sure that subscribe to the Federal Registrar. You might look at it for the new approvals.
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219662 tn?1223858560
That is correct - duo and combi are 4th gen., along with the one Teak mentioned and a few others.  None of them is FDA-approved though (as far as I know) and therefore none should be used in the US
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Avatar universal
Duo and Combi are 4th Gen. It doesn't matter which gen the test is the window period is 3 months. All tests used in the USA are FDA approved.
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219662 tn?1223858560
I just did and guess what - nothing came up.
The list that I posted includes tests approved as late as 2007, so I wouldn't call it outdated.  I think you are wrong.
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Avatar universal
Go to the FDA site type in the test name get the approval letter. The test has been approved. I can't help it you don't have updated information.
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219662 tn?1223858560
You don't see it on the list, do you?  That means it is not approved by the FDA.
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Avatar universal
Vironostika® HIV Uni-Form II Ag/Ab  is a 4th generation test.

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Avatar universal
what generation does QuestDiagnosis work with?
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219662 tn?1223858560
Here is the current list.  There aren't any combo tests on it.

http://www.fda.gov/cber/products/testkits.htm
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Avatar universal
are they all conclusive w/3 months?
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Avatar universal
Then I suggest you get a new list. There are 4th generation tests that are FDA approved.
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219662 tn?1223858560
Where does that info come from?  As far as I know, there are no 4th gen tests on the FDA-approved list.  
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219662 tn?1223858560
As far as I know, only 2nd and 3rd generation tests are approved by the FDA.  4th generation tests are not used in the US, to my knowledge.  A test at 3 months is reliable for any generation.
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Avatar universal
Ok.

Do you know the answer?
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277836 tn?1359666174
WARNING use the same post you started with if you start a new one again it will be reported
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