Prometheus IBD Serology 7 test reliability

[shutz1012]

Anyone know if these are accurate? My husband was dx with Crohns in 8/2011. Had all the "classic" symptoms, which were followed up with a CT scan, SBFT, and colonoscopy. So based on all those dr dx. him with Crohns.

On his last f/u visit they ran the Prometheus IBD serology 7 test and it was negative. What does this mean? My husband swears up and down he doesn't have Crohns. Not denying anything is "wrong", but still thinks it something other than Crohns.

Also with the first labs his CRP was 1.7 (8/11)-started Pentasa, 1.1 (9/11), and now .75 (2/12). This is trending down.

I appreciate any feedback.

 

[nolsen311]

From what I understand this test is considered the "gold standard" for Crohn's Dx.

 

[littlemissh]

All the information i have read including guidelines by the various societies suggest it is very unreliable. Not used in the uk much at all because of this.

 

[David]

It's unreliable from what I've been reading (there's plenty more like that). If everything but that test showed Crohn's, it's very likely Crohn's.

 

[Mark74]

I took the test 3 years ago and it came back negative. This made my first GI decide it was mainly IBS. I asked him why everytime I came off steroids I got worse but as long as I was on steroids I was ok. He didn't know. I had seen Dr. Bickston at VCU before so I went back to him. He doesn't put any merit in the test. He said all my test in the past confirmed Crohns and that I was becoming steroid dependant and it was time to start Humari.

 

[tots]

I was asked to take the test by my GI. I never heard from the hospital who is approved to take my blood here in Austin. I have heard it is very unreliable and have decided not to take it. Will call my dr and tell him. As far as my experience the is no "gold standard" in diagnosing Crohns. Colonoscopy clear- Bx negative- WBC high indicating inflamation- Hematocrit and hemaglobin low- I was bleeding. Upper GI- narrowing in the illium after one week of steroids- radiologist said that it had already taken down a significant amount of swelling down. On top of the physical symptoms- everyother day a dr came in my room yes-no-yes-no. I guess we are still on the yes as I am still on entocourt.

 

[Steven]

Atfer having my colonoscopy two weeks ago. My doc went over my byopsy results with me yesterday. He told me the thing that nailed down my DX was signs of granulomas. I'm really not sure what that is. But after months and many blood test, stool samples (which showed elevated white cell counts, being low in iron and microscopic blood in my stool among many other deficiencies) It was the last thing needed for a complete postive dx for Crohns he told me.. I also have a family history for Crohns,

 

[Rebecca85]

Even prometheus say the test has around 90% reliability and specificity. Meaning 1/10 positives are false, and 1/10 people with IBD will be missed by the test.

 

[wolfem]

Even prometheus say the test has around 90% reliability and specificity. Meaning 1/10 positives are false, and 1/10 people with IBD will be missed by the test.

I tested negative for the DNA test and only positive for one antigen. All the others were negative so my doctor told me I had a very very mild case but doesn't understand how I ended up with an abscess. He told me most people with crohn's disease test positive for several antigens. There are probably lots of variables involved.

Histology confirmed crohn's in my case but nobody knows what really causes it so no one can say for sure, the etiology behind it. So in my opinion, the prometheus testing is somewhat unreliable. However, it might become more reliable later. My instructors in microbiology research keep telling me that they are making some headway with determining better treatment and diagnostics for crohn's. Hope they are right.

 

[ade77]

so the test is called Prometheus IBD serology 7

I can call me ins and see if they wil pay for it and if i call it Prometheus IBD serology 7 they will know what it is?? thanks

 

[SevenOaks]

Had this test done three weeks ago and just received the verdict: Patter Not Consistent with IBD.

 

[tots]

Sevenoaks-

Were you previously Dx with IBD? If so how?

What was your Drs thoughts on it?

What are your symptoms?


Lauren

 

[chotovec82]

My GI doctor wants me to do the IBD-7. I am not sure that I should even do it. I had a colonoscopy about 4 weeks ago. I was told that my colon looked perfect. He took biopsies and the results came back that I have a low grade inflammation in my lower left colon (descending?). I have constipation and lower left quadrant pain that is worse with my menstrual cycle and bloating. I had a complete blood testing done at my Gynos office and nothing turned up out of the ordinary- not even white blood cell count or iron levels. My GI has put me on entocort and an IBS-C pill called Linzess. Not really sure what to think.

 

[David]

That you came back with microscopic inflammation tells me the test is worth doing. If the pathologist wasn't able to pinpoint the disease based upon the biopsies, then tests like this are going to help point them in the correct direction. No, it's not perfect but if they can get various tests that all point to the same general diagnosis, then they can feel more comfortable that they're putting you on a proper treatment regimen.

 

[Ihurt]

My GI doc said that they can find microscopic inflammation with IBS. I am not sure about the blood panels and how accurtae they are though.

My GI doctor wants me to do the IBD-7. I am not sure that I should even do it. I had a colonoscopy about 4 weeks ago. I was told that my colon looked perfect. He took biopsies and the results came back that I have a low grade inflammation in my lower left colon (descending?). I have constipation and lower left quadrant pain that is worse with my menstrual cycle and bloating. I had a complete blood testing done at my Gynos office and nothing turned up out of the ordinary- not even white blood cell count or iron levels. My GI has put me on entocort and an IBS-C pill called Linzess. Not really sure what to think.

 

[Patricia56]

The main value of the Prometheus 7 appears to lie in it's limited ability to screen out those who do not have IBD. And that's about it.

If it says you do not have IBD then it is moderately likely that you do not.

Certainly there are some cases, as David suggests, that benefit from whatever additional information can be gleaned from this test panel.

But it needs to be used with caution by a very skilled and knowledgeable GI. And it sounds like several of you are dealing with GI's who do not fit that description.

In the face of clinical evidence that clearly supports an IBD diagnosis, there is no reason to even run this expensive test IMHO. It is certainly not and never has been a gold standard. If your doc is uncertain about a diagnosis and has not yet run an MRE (CT =500 Xrays) or considered a Pill Cam then I would be asking why not do those tests instead.

I'm using numbers drawn from the following research article for examples of one real world estimate of the utility of the IBD 7 test.
http://www.ispub.com/journal/the-in...-an-academic-center.html#sthash.K2Fvby4V.dpbs

To get more technical, the IBD 7 test sensitivity appears (in the real world ) to be around 80% - meaning there are few false negatives (i.e. if you get a "not IBD" it is likely to be right). Out of every 100 people who take the test who do NOT have IBD, it will correctly identify 80. It will still get 20 wrong. So not great but better than average.

It's specificity appears to be around 61.5%. This means there are quite a few false positives where you are told you do have IBD when in fact you do not. If I have my numbers straight (David?) this would mean that out of every 100 people who do not have IBD as many as 39 are told they do have IBD. That is a lot of people.

 

[David]

It's specificity appears to be around 61.5%. This means there are quite a few false positives where you are told you do have IBD when in fact you do not. If I have my numbers straight (David?) this would mean that out of every 100 people who do not have IBD as many as 39 are told they do have IBD. That is a lot of people.

There have been various studies on the sensitivity and specificity of the test as well as the underlying markers they're using. The insurance companies tend to use the worst numbers so they don't have to pay for it and the company tends to use the best ones. For example, here is Aetna's stance on the testing.

And Prometheus states:

Overall performance of PROMETHEUS IBD sgi Diagnostic: Sensitivity IBD 74%, CD 89%, UC 98%; Specificity IBD 90%, CD 81%, UC 83%. Smart Diagnostic Algorithm technology was trained (n=1083; 39% CD, 21% UC, 29% disease controls, and 11% healthy controls) and validated (n=437; 35% CD, 23% UC, 28% disease controls, and 14% healthy controls) from results of serology, genetic, and inflammation assays.

I personally think it can be useful in cases like the OP has where they're just not sure what's going on and need additional indicators to help point them in the correct direction. It should never be used instead of something like a colonoscopy though.

 

[Sparkle2012]

It's unreliable from what I've been reading (there's plenty more like that). If everything but that test showed Crohn's, it's very likely Crohn's.

Hi David -- I have no IBD markers or symptoms and the symptoms I had before my surgery were ulcerated strictures. I do not have diarrhea or any issues with foods. Labs come back clean - the Crohns expert said it didn't look like Crohns to him -- yet my Prometheus IBD diagnostic test came back positive today.

Any input on that you can share?

 

[Sparkle2012]

hi all - I have a copy of my Prometheus IBD sgl diagnostics lab - does anyone here know how to read them? The GI says high percentage for consistent with Crohns. They don't make the labs easy to read. Do these GIs just look for the checked "crohns consistent" mark? My inflammation markers are flat in all my other tests. I'm starting on Pentasa this weekend. Would like to feel sure about all this.