Generations of Elisa test

[ers70x]

The 3 months is valid for FDA approved test .
Now, what generations (1 to 4) of Elisa test are approved for the FDA ?

[alienshadow]

WARNING use the same post you started with if you start a new one again it will be reported

[ers70x]

Ok.

Do you know the answer?

[regularjoey]

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.

[regularjoey]

Where does that info come from?  As far as I know, there are no 4th gen tests on the FDA-approved list.  

[Teak]

Then I suggest you get a new list. There are 4th generation tests that are FDA approved.

[wee540]

are they all conclusive w/3 months?

[regularjoey]

Here is the current list.  There aren't any combo tests on it.

http://www.fda.gov/cber/products/testkits.htm

[fly608]

what generation does QuestDiagnosis work with?

[Teak]

Vironostika® HIV Uni-Form II Ag/Ab  is a 4th generation test.

[regularjoey]

You don't see it on the list, do you?  That means it is not approved by the FDA.

[Teak]

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.

[regularjoey]

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The list that I posted includes tests approved as late as 2007, so I wouldn't call it outdated.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.

[Frank303]

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.

[regularjoey]

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

[Teak]

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.

[regularjoey]

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.

[regularjoey]

That was to Teak, not to Chris

[nonbeliever]

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