Dear All,
I know these threads are populated with IGeneX posts but having just done my results with them I think this is a bit of a scam tbh. They said I ‘might’ have Lyme lol - You couldn’t make it up really.
When I called them actually give direct answers to the results they wouldn’t give me them. They kept fobbing me off to third party Lyme sites or send me irrelevant PDF’s. The bottom line is they charge $1500 for a couple of blood tests but then cannot give you a definitive answer. I have had blood tests before and they were always clear and transparent.
I live in Asia so no access to lyme doctors here. Perhaps someone knowledgeable hear can do the job the jokers at IGeneX could not.
Western BlotIgM
IGX: Indeterminate
CDC :Negative
Other bands negative
Band 31: +
Band 41: ++
Western BlotIgG
IGX: Positive
CDC : Negative
Other bands negative
Band 41: ++
Band 83-93: +
Borreliosis - All Negative
Bartonelliosis - All Negative
Thanks in advance,
Matthew
The reason for that is that IgenX tests have no accepted norms. In the mid-1970s, the FDA began exempting certain diagnostic tests from its approval process. Many of these tests — developed, manufactured, and offered by a single lab, such as in a hospital — were variations on common tests, low-risk, or devised for rare diseases and could not be adequately validated.
But companies are using this exemption to market thousands of these so-called lab development tests — for everything from cancer to genetic markers of disease — and many have not been rigorously validated. The labs do not market these tests directly to the public; doing so would trigger stricter FDA review. Instead doctors order the tests for patients.
The FDA is trying to regulate these tests, but clinical laboratories are vigorously opposed, saying it would be too expensive, take years to get the agency’s approval, and stifle innovation.
Although labs have to undergo certification to ensure they have the right expertise and use proper procedures, no one is actually looking if there is validity to the clinician claims [these labs] are making.
To get around all of this IgeneX only reports the results of their “development test” they do not offer an interpretation of the results leaving that to the physician ordering the test. That interpretation varies widley. Thus they use the - (not present), + (present but low), ++ (present medium) +++ (present high) +/- (indeterminite there but not as much as low) They do this because no one (including them) has been able to determine a laboratory norm. So who determine what these tests mean?
It falls to the ordering doctor who can claim to be an expert (there is no way to know as there is no regulatory body) nor is there any standard of care. You can take the results to six different docs and you can get six different treatment plans.
ModSupport - Firstly a heart felt thanks for such a detailed reply. Basically your reply is exactly what I am thinking so there is no definitive verdict unlike other conditions.