I found this article in the Journal of American Medical Association that I thought some of you might be interested in.
It upsets me because by negating other commercial lab criteria for Lyme testing, they imply that their criteria using 5/10 bands for IgG and 2/3 bands for IgM has been "adequately established."
Hasn't there been any good studies showing the sensitivity/accuracy of Lyme diagnosis using other standards from labs like Igenex and MDL?
"CDC and the Food and Drug Administration (FDA) have become aware of commercial laboratories that conduct testing for Lyme disease by using assays whose accuracy and clinical usefulness have not been adequately established."
"... interpret Western blots using criteria that have not been validated and published in peer-reviewed scientific literature."
"Health-care providers are reminded that a diagnosis of Lyme disease should be made after evaluation of a patient's clinical presentation and risk for exposure to infected ticks, and, if indicated, after the use of validated laboratory tests."
"Patients are encouraged to ask their physicians whether their testing for Lyme disease was performed using validated methods and whether results were interpreted using appropriate guidelines."
Posted by vitch (Member # 8094) on :
I'm aware of two studies concerned with the current system of testing. One study concluded the current test is 4% accurate. The other, .5% accurate. I believe the method used was spirochete culture, positive after a negative ELISA test.
It is also my belief the current test has not been scientificly validated. It's been used in the field and touted as accurate. The only reason accuracy has "been established" is because ducks say it. Again, it has never been scientificly validated.
I do not, currently, have access to the studies but I believe one was done by Dr P in CT.
Posted by lou (Member # 81) on :
The CDC does not like any test that produces positive results.
They are perfectly well aware that the surveillance criteria for testing are being used to deny treatment and they like it this way, no matter what they say. This is an epidemic they don't want. Now you know the real reason for everything they do.
Posted by 5dana8 (Member # 7935) on :
I agree with Lou . This is the unfortunate truth. It all comes down to money.
The gov knows if medicare & other insurance company's where to treat chronic lyme with the proper meds it would cost them alot of money.
If they are willing to sell off our precious federal park lands for money.