"The name of the test is iDart™ Lyme IgG ImmunoBlot Kit.
It’s a stand-alone test for the detection of IgG antibodies against Borrelia-causing Lyme disease.
.....These kits are not available for sale to consumers, but only to labs who perform Lyme diagnostic testing."
-------------------- Ann-OH Posts: 1746 | From Ohio | Registered: Aug 2014
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Bartenderbonnie
Frequent Contributor (1K+ posts)
Member # 49177
posted
This is huge!
“FDA clearance basically means that they've reviewed this test and determined that it is as good as all other approved tests on the market.
It's important for the Lyme community because we know that this test is significantly more accurate than quest/labcorp. In the past regular doctors and Lyme deniers have ignored the results from this lab by saying "it's not approved by the FDA", and because of that it must be a scam. They no longer can make that argument.”
From Dr. Burrascano:
• -ImmunoBlot interpretation is based upon the "IGeneX Criteria", and not CDC criteria
• -Only two bands are needed on the ImmunoBlot to be considered positive if the LSA is positive
• -Bands 31 and 34 are included- this is the only FDA-cleared Lyme serological test that includes these bands
While the CDC will still not accept 2 bands as positive, clearance is the precursor to getting the official stamp of approval. It's only a matter of time before that happens now!
Posts: 3217 | From Florida | Registered: Nov 2016
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posted
What does this mean for a regular doctor-can you request they run this test instead of the ELISA and Western Blot that they run now?
Posts: 580 | From southern new jersey | Registered: May 2003
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Bartenderbonnie
Frequent Contributor (1K+ posts)
Member # 49177
posted
Marie
There is a free webinar discussion on September 17, 2024. Answers to all your questions plus 50% off all tests now!
Yes, a physician must order you the test.
Here is a list of licensing professionals that may order/refer laboratory testing for private patients:
Physician (Doctors of Medicine or Osteopathy) MD, DO Doctors of Podiatric Medicine DPM Doctors of Optometry OD Acupuncturist AC Chiropractor DC Doctors of Dental Medicine/ Surgery DMD Naturopathic Doctor ND Certified Nurse-Midwives CNM Physician Assistant PA Nurse Practitioners NP
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