"Henry": Although the FDA has not yet made an official announcement and is reluctant to replace existing tests-- that appear to be working well-- with new tests until "all the facts are in", the results obtained with the C6 ELISA appear to parallel and to be identical to those obtained with the existing 2-tiered testing.
Yes. And believe it or not, when the C6 came out, I called the contact number listed with the developers and spoke briefly with a representative of the outfit that developed it.
I asked about whether there were efforts underway to replace the two-tiered system with it, because, as you say, the C6 appeared as though it would fill the diagnostic problem with the early stage ELISA results.
Paraphrasing, they said that the Feds wanted them to put up the money to run the necessary tests, and they wanted the Feds to do it. So, they were stalled.
(Now...you are probably wondering why I would bother to do something like that...and all I can say is that I was somewhat excited and relieved back then...and anticipating that this could reduce the chances of anyone else having to experience what I went through. Which...was bad
And...I have had to learn some of this, because of all the lovely 'stuff' I experienced. I really didn't (and still do not) trust the average physician out there insofar as their knowledge of Lyme disease goes. I learned all of this fascinating stuff in order to protect myself. As I have said before, I didn't take up an interest in Lyme disease, rather, it took up an interest in me
With all of this in mind, I don't anticipate major breakthroughs in diagnostic technology in the near future.
Yes, and I suppose I should explain and perhaps apologize a bit for throwing the puzzle of my case history at you. The equivalent of a nasty spitball. Messes everyone up. I was told that some of my doctors had themselves a fine old medically- stimulating time arguing with each other about it.
I am fine, now, and not really looking for help, or answers, even. I will never really know for sure and you learn to make peace with that. That's all in the rear view mirror, now.
I just meant to illustrate the diagnostic uncertainty that a lot of us have had to live with.
And that uncertainty has a cost, too...in terms of wasted medical resources. They ran me through all kinds of torture trying to 'rule out' everything else that it could be...Parkinson's, ALS, MS, Lupus, Syphilis, Leptospirosis, benign essential tremor...probably more that escape me right now...and all of the tests...multiple CT scans, MRIs, echocardiograms, EKGs, halter monitor, ultrasounds...geez, I had to do two separate nerve conduction tests because fasciculations in my thigh muscles and speech problems that resembled ALS symptoms (I have no idea after the first, why I would agree to the second, but I did).
But to this day, those 'negative' blots notwithstanding, both my doctors and I still not only believe it was Lyme, there really seems to be no other viable explanation. And like I said...three screens in a row...near 100% odds.
So, sorry about that...just trying to illustrate a point.