Enterolab...legit?

[linz7997]

so i work in a diagnostics lab...and i know its illegal per CLIA and I think FDA regulations for a patient to order their own tests w/ out going through a Dr. first. I was just wondering how Enterolab can do this...are they regulated by government? I am sure they are great but I just want to make sure I make an informed decision before I drop $369 on a test...ya know!!?!?!?!

[CarlaB]

I don't know the laws, could it be because you are getting consultation from the doc who runs it?

I was very happy with their service.

[AndreaB]

I don't know, but Carla sounds like she's on the nose with her thought.

I do know I've read that some doctors do use them, and other doctors will take the results of people's tests by them and accept it as diagnosis.

I am also very happy with them and Dr. Fine does/has written up the analysis info for us and is available for questions as well.

[mmaccartney]

so i work in a diagnostics lab...and i know its illegal per CLIA and I think FDA regulations for a patient to order their own tests w/ out going through a Dr. first.

Wow, I had no idea ordering your own tests would be illegal. Seems strange that my insurance company would pay for this type of test then, but it wouldn't be the first strange thing they've done. Seems odd for the gov't to restrict commerce like that.

After looking briefly, are you sure about the illegal status?

Open Original Shared Link

“Direct access testing” (DAT) is generally defined as consumer (as opposed to physician) initiated testing of human specimens. DAT is also known as "direct-to-consumer" or "patient-authorized" testing. Some states do not allow for DAT. Where DAT is permitted, it is commonly ordered by an individual without a prior consultation with a physician or a physician’s request for testing.

it seems that IF the state allows it patients can order their own tests. Enterolab is in Texas where DAT seems to be allowed. It also seems that the lab must be regulated by CLIA regardless.

More: Open Original Shared Link

More: Open Original Shared Link

I didn't see them on the list of violaters which could be a positive.

I used Enterolab for me, and both my children and am quite happy with the results. The results also line up well with what I found through food challenges as well.

[linz7997]

thanks for that!!! maybe we cant test those sp. here in Indiana but they can there??? who knows. i may try it. thanks again!!!

[Nancym]

This information is cleverly hidden on the front page of their web site:

Open Original Shared Link

EnteroLab is registered with the U.S. Government's Department of Health and Human Services department as part of the Clinical Laboratory Improvement Amendments (CLIA). This agency oversees clinical laboratory standards and quality. We have also opted for (at our own expense) third-party accreditation from COLA, a non-profit national laboratory accreditation organization. EnteroLab passed this accreditation inspection in 2001 and re-accreditation in 2003 and 2005 with the highest standards. COLA accreditation is given only to laboratories that apply rigid standards of quality in day-to-day operations and pass a rigorous on-site laboratory survey. COLA is approved by the federal government and sponsored by the American Medical Association, the American College of Physicians-American Society of Internal Medicine, the American Academy of Family Physicians, the College of American Pathologists, and the American Osteopathic Association. Top

[Mayflowers]

This information is cleverly hidden on the front page of their web site:

Open Original Shared Link

I'm goin' in. I ordered the complete panel. (gulp) I hope it's worth it.

[mmaccartney]

I'm goin' in. I ordered the complete panel. (gulp) I hope it's worth it.

I found it to be well worth it.

I "knew" I was at least gluten intolerant.

I thought I was lactose intolerant.

My biopsies all came back negative; my bloodwork only showed a "slightly positive IgA"

My tests showed not only positive IgA, but also positive TTG. Pos ttg

My casein test showed that I was casein intolerant, not lactose. (This was a bummer, lactose intolerance can go away, but not casein)

My genetic test showed a celiac gene, and a non-celiac gluten intolernace gene.

Knowing all of this, I knew I had to have my children tested.

I suspected one of my children had celiac as well, and in fact we had them on a gluten-free diet too.

Their bloodwork came back negative, except one had a positive IgG test. The pediatric GI wanted to get a biopsy from him; we didn't want that (yet).

Well, their tests all came back negative for gluten and casein, except the genetics. They were both lucky enough to get the dq2 gene from me, and each got a gluten intolerant gene from mom too. Lucky enough they don't have active celiac.

So, in the end Enterolab gave me solid confirmation of what I thought was going on. They gave me more information then I had in regards to the casein intolerance. They told me that I had the genes, as do my children though they aren't active yet. I would not have this level of information from traditional testing methods; and I would never have let them biopsy my children (at that point; had they been in really bad shape, yes I would have).

At the end of the day my insurance is covering 80% of it too!

[debbiewil]

It depends on the state. California has some specific legal requirements for ordering tests, and New York flatly forbids certain tests to be ordered without a physician, but it really depends on the state - not federal laws.

Debbie

[rinne]

I'm wondering if any Canadians have done this testing, anyone? Or if there is somewhere in Canada to have this done?

[linz7997]

so here is my question....if you have been tested and know you are gluten sensitive/allergic...what is the point of having the genetic testing done?? dont you then have to assume you have the gene??

[Nancym]

so here is my question....if you have been tested and know you are gluten sensitive/allergic...what is the point of having the genetic testing done?? dont you then have to assume you have the gene??

The genetic info is interesting and might correlate to your symptoms. For instance, the 0501 gene seems to be associated with neurological effects of gluten sensitivity. You can always google your specific genes and read up!

[AndreaB]

so here is my question....if you have been tested and know you are gluten sensitive/allergic...what is the point of having the genetic testing done?? dont you then have to assume you have the gene??

Also if you have just an allergy it may get better over time and you would be able to consume some products again. With an intolerance/sensitivity you can't. I found out I was allergic to the gluten and some gluten products and with enterolab found out that I was also intolerant to all gluten. My allergy tests didn't give me the whole picture since I didn't register allergic to oats and barley and had still been eating those. The gene testing was to know what genes I had, I happen to have one of each as does my daughter. My husband and son have 2 celiac predisposing genes.

[Mayflowers]

My genetic test showed a celiac gene, and a non-celiac gluten intolernace gene.

Very interesting! So if you have a celiac gene, Entrolab can tell if it's active and means you have celiac disease? I don't understand. I hope they explain the results when I get them so I'm not clueless.

[AndreaB]

Mayflowers,

They can't tell you whether you have celiac, only whether you have an active gluten intolerance. They do catch the disease earlier than blood so the severity shouldn't be as bad in either case. As far as I understand, those with gluten sensitive genes can't get celiac per say, but sometimes can be just as bad as celiac. Isn't celiac linked with other autoimmune diseases? That may be the only difference between celiac and gluten intolerance.

[Mayflowers]

Mayflowers,

They can't tell you whether you have celiac, only whether you have an active gluten intolerance. They do catch the disease earlier than blood so the severity shouldn't be as bad in either case. As far as I understand, those with gluten sensitive genes can't get celiac per say, but sometimes can be just as bad as celiac. Isn't celiac linked with other autoimmune diseases? That may be the only difference between celiac and gluten intolerance.

This is from the Enterolab website

"Gluten sensitivity stool test, tissue transglutaminase stool test (test for the autoimmune reaction caused by gluten sensitivity"

Wouldn't the autoimmune reaction be celiac?

[mle-ii]

This is from the Enterolab website

"Gluten sensitivity stool test, tissue transglutaminase stool test (test for the autoimmune reaction caused by gluten sensitivity"

Wouldn't the autoimmune reaction be celiac?

Depends on who you ask. I haven't been diagnosed as having celiac, though I have the gene for it. As well as having tested postitive for gluten intolerance via Enterolab. I also have Microscopic Colitis (Lymphocytic Colitis) which from everything I've read reads to me to be Celiac, but in a different part of the intestines.

So I have an autoimmune reaction but supposedly don't have celiac.

I should get tested again, but I need to consume gluten for some time and there's no way I'm going back to the symptoms and problems of that again.

[AndreaB]

Can autoimmune diseases or reactions improve with a gluten-free diet?

Clearly most immune-related damage in the intestine heals with a gluten-free diet. Now it appears from early research of this question that many if not all autoimmune diseases such as autoimmune thyroid disease, psoriasis, alopecia, arthritis, lupus, hepatitis, diabetes, among others, and autism improve with a gluten-free diet. Because the immune reactions to cow's milk proteins also are immune and autoimmune stimulating, new research is focusing on the benefits of what has come to be called a gluten-free/casein-free diet, which likely is more beneficial in this regard than a gluten-free diet alone (see below). The less immune-stimulating the diet, the less fuel on which the immune fire has to burn. Other immune-stimulating foods include other grains, legumes (including soy), dietary yeast, and especially for arthritic patients, nightshades (tomatoes, potatoes, egg plant, and hot red peppers).

Don't know if this really answers your question but it is on the enterolab site.

[Mayflowers]

So what's left to eat?