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CSF testing!! whats going on ???

I just was reading over the CSF report and it states that the test was not performed using a kit that has  been cleared or approved by the FDA. whas going on here?
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Avatar universal
Hi Guys, Thanks for the help!!

what a poopeeeeeeee test!! its been 2 years so iam due again. Have a great day!!

Denise  
Helpful - 0
220917 tn?1309784481
Oh, that makes sense.  I can't imagine any hospital or testing facility could get away with using techniques on a patient that were not FDA approved.

Thanks so much for the info!  As always!

Zilla*
Helpful - 0
378497 tn?1232143585
It's not a test they did on you, it's a test they did on the fluid they took out of you that the FDA has not approved as specifically diagnostic. In other words, the FDA hasn't OK'd saying that the results of that specific test are meaningful in diagnosing disease. One test of CSF (fluid from the spinal tap) that comes with that caveat is a measure of the myelin basic protein (MBP). All lumbar puncture reports say that.

Bio
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Avatar universal
HI, Thanks for responding... the test was Quest Nichols Institute,

ya, I dont no why this test says that.

Denise61
Helpful - 0
Avatar universal
Hi, the csf test
says normal!!!  Yes i will ask my  DR. I am do for a nother one. Jan ,06 was the last one.

Thank You, Denise 61
Helpful - 0
359574 tn?1328360424
My CSF report had something like that in the Lyme Disease test section--that it was some sort of Mayo patented thing that wasn't blessed by the FDA--let me dig it up

LYMES PCR  NEGATIVE
This test was developed and its performance characteristics determined by Mayo Medical Laboratories.  It has not been cleared or approved by the US Food and Drug Administration.

Is this anything like what yours said?

Holly
Helpful - 0
220917 tn?1309784481
I asked because we just heard of a newer way to test CSF, but I'm SURE it would have been approved by the FDA.  Maybe.

I wouldn;t get too alarmed.  But I would ask your doc about it when you see him/her. Or call the place where it was done, better yet.

Maybe Quix will know what's up.

How were your results?

Zilla*
Helpful - 0
Avatar universal
YES!!  order for MS.
Helpful - 0
220917 tn?1309784481
Hmmmm.  Was it for your lumbar puncture?

Z*
Helpful - 0
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