My Extremely Weird Prometheus Blood Draw...

[Silo City]

A quick preamble: I was diagnosed with ulcerative colitis in 1993, had j-pouch surgery in '97, and have pretty much been CURED for 20 years. I've eaten any damn thing with impunity, pretty much just went back to normal -- of course, the readjusted normal includes becoming a water-bottle-based lifeform to stay hydrated, getting up a couple of times at night for bathroom breaks, etc. Still: basically great. Most folks had no idea I'd ever been sick...

Back in May or so of this year I developed an anal fistula. At the time, my surgeon said, basically, "Either you have ulcerative colitis and got unlucky, or you have Crohn's." Holy Sweet Crap! Later I developed a 2nd fistula, and the surgeon said "We'll see what's what, but this really looks like Crohn's.

After the surgery for the 2nd fistula, the picture was less clear: It turned out I had 1 y-shaped fistula with 2 exits -- it was basically a single, complicated, fistula. I currently have 2 setons. I can live with these if I gotta.

The surgeon wanted me to have the Prometheus test to determine the next step. With my history (including family history: my mom had UC), he was back to thinking I was in the "UC but unlucky" camp after all... If I have UC, surgery and full recovery are real possibilities. If I have Crohn's, the surgery is out because it would never properly heal...

Got the test results yesterday: Crohn's.

So: I don't love that result, and I have stakes here obviously -- so it might seem that I'm just clutching at straws.

BUT: something that struck me as extremely odd happened during my Prometheus blood draw. And it leaves me wondering...

Prometheus actually sends somebody to your house to do this -- their samples need some sort of special handling or something, so they'd rather have their own folks do it.

The Very Nice Blood Draw Man came to my house. He needed 2 vials. After ENTIRELY filling the first, he lost the vein before he could get the 2nd one going. I girded my loins for a 2nd attempt (he had a bit of a tough time finding the vein the first time...).

"Oh, no problem," he said. "I always fill the first one full just in case this happens." He proceeded to lift the caps off both vials, then pour blood from the full one to the other.

Okay. Wow, haven't seen that before. But, whatever, he's the pro. Then, he had trouble getting more into the 2nd vial. "Air bubble," he said, then raised it to his mouth and blew a couple of puffs of air into it to pop the bubble! I was surprised, but said nothing, figured "well, he MUST know what he's doing..."

Ain't this a genetic test? Doesn't this seem like something that could corrupt the sample?

Again, I have stakes here, so maybe I'm just grasping at anything. But I'm trying to decide how to proceed here, since this test will determine treatments going forward that will affect the rest of my life...

I will be bringing this up with my doctor next week, but I'd love any knowledgable person's take and advice on this in the meantime! Thanks...

 

[ronroush7]

Welcome. It seems to me by him blowing into the vial would contaminate it. It seems to me that they would have to do the whole test again. I could be wrong.

 

[Scipio]

Prometheus makes several different tests. Was this the Prometheus sgi test - the one intended to distinguish Crohn's from UC? If so that guy really botched the blood draw. That test uses two different types of collection tubes - a red top for the serum-based antibody tests and a purple top (that has an anti-coagulant to prevent the blood from clotting) for the cell-based genetic tests.

Are you saying he mixed the contents of the red top tube and the purple top tube? If so he ruined the sample for either type of testing.

And putting the open tube near his mouth to blow into it is shocking, not only from a sample contamination issue that you note, but also for his own safety. He has no idea whether any given blood he is drawing is positive for all kinds bad things such as HIV or hepatitis. (I'm not suggesting you have these diseases, but he has no way of knowing that in advance and is violating safety procedures).

I don't know whether a retest will give different result. I'm surprised they were able to generate the first result with ruined samples. If I were you I'd tell your doc this and also call Prometheus customer service and explain about how your sample was drawn and insist on a FREE retest with a new, properly drawn, sample.

 

[ronroush7]

Agree

 

[my little penguin]

Yikes and wow
Definitely call both
Retest

What have you latest scopes and imaging shown ?
Only because more than a few folks here have had a mixed bag with regards to Prometheus test and determine crohns vs UC

Good luck

 

[dave13]

Perhaps I'm not getting it all. A Prometheus test detects the amount of Remicade once a person has started infusions. Antibodies are tested for too,very important.

 

[Clash]

Dave13, there are different tests that Prometheus jas. There are the two you mentioned but there are also in depth genetic tests that can be helpful in determining between CD and UC and a couple more I think.

 

[Silo City]

Many thanks for the responses here (with a special nod to Scipio's very helpful post...). This was indeed the test to distinguish Crohn's from UC. The blood was poured from the red top tube into the purple. I'll be following up on this in the next week and seeing where it goes... Thanks!

 

[MissLeopard83]

A quick preamble: I was diagnosed with ulcerative colitis in 1993, had j-pouch surgery in '97, and have pretty much been CURED for 20 years. I've eaten any damn thing with impunity, pretty much just went back to normal -- of course, the readjusted normal includes becoming a water-bottle-based lifeform to stay hydrated, getting up a couple of times at night for bathroom breaks, etc. Still: basically great. Most folks had no idea I'd ever been sick...

Back in May or so of this year I developed an anal fistula. At the time, my surgeon said, basically, "Either you have ulcerative colitis and got unlucky, or you have Crohn's." Holy Sweet Crap! Later I developed a 2nd fistula, and the surgeon said "We'll see what's what, but this really looks like Crohn's.

After the surgery for the 2nd fistula, the picture was less clear: It turned out I had 1 y-shaped fistula with 2 exits -- it was basically a single, complicated, fistula. I currently have 2 setons. I can live with these if I gotta.

The surgeon wanted me to have the Prometheus test to determine the next step. With my history (including family history: my mom had UC), he was back to thinking I was in the "UC but unlucky" camp after all... If I have UC, surgery and full recovery are real possibilities. If I have Crohn's, the surgery is out because it would never properly heal...

Got the test results yesterday: Crohn's.

So: I don't love that result, and I have stakes here obviously -- so it might seem that I'm just clutching at straws.

BUT: something that struck me as extremely odd happened during my Prometheus blood draw. And it leaves me wondering...

Prometheus actually sends somebody to your house to do this -- their samples need some sort of special handling or something, so they'd rather have their own folks do it.

The Very Nice Blood Draw Man came to my house. He needed 2 vials. After ENTIRELY filling the first, he lost the vein before he could get the 2nd one going. I girded my loins for a 2nd attempt (he had a bit of a tough time finding the vein the first time...).

"Oh, no problem," he said. "I always fill the first one full just in case this happens." He proceeded to lift the caps off both vials, then pour blood from the full one to the other.

Okay. Wow, haven't seen that before. But, whatever, he's the pro. Then, he had trouble getting more into the 2nd vial. "Air bubble," he said, then raised it to his mouth and blew a couple of puffs of air into it to pop the bubble! I was surprised, but said nothing, figured "well, he MUST know what he's doing..."

Ain't this a genetic test? Doesn't this seem like something that could corrupt the sample?

Again, I have stakes here, so maybe I'm just grasping at anything. But I'm trying to decide how to proceed here, since this test will determine treatments going forward that will affect the rest of my life...

I will be bringing this up with my doctor next week, but I'd love any knowledgable person's take and advice on this in the meantime! Thanks...

I studied healthcare - including phlebotomy - and I know that is absolutely a contaminated sample. I would complain to the company that sent the "phlebotomist" out and have your doctor request another sample. They should do it free of charge. Not only is it a biological hazard for the "phlebotomist," it gets all sorts of microbes into the vial when he lifted the top. It's supposed to be a STERILE sample - from the vein to the vial. When I was in training, we were absolutely NEVER allowed to lift off the top. That was very unprofessional.

 

[Silo City]

A follow-up: heard back today from Prometheus's client services senior manager.

He agreed that what happened is a mess, and they'll be redoing the test (with a different person doing the draw) at no charge. They're also going to call my doctor to give him a head's up that the test needs to be redone and the current results are invalid.

I've already heard from their local contractor, who told me they'll be sending someone else to do the draw, and will be informing the guy who did mine to, basically, not do that any more (yeah, that sounds odd -- I mean, what kind of training did this guy have?).

But there's nothing more I could really ask them to do for me -- they're doing everything I wanted. I thought it'd be harder than this, that it would take more monkey business on my part to get them to make this right, but it appears that they're doing what needs to be done here...

 

[CavsFan]

How long did it take for your Prometheus results? I had mine done about two weeks ago and haven't heard anything yet.

 

[ronroush7]

I had mine done today and they said 5 to 7 days before the doctor's office should get the results.

 

[dave13]

Prometheus is in California. I know because I get bills from them. I think you will get results from Prometheus Labs in the mail regarding your test.

 

[dave13]

You should get results in 4 weeks or so...possibly.

 

[CavsFan]

Does anybody know of any good resources for understanding the Prometheus IBD sgi Diagnostic Test? I received my results and it says "Pattern Not Consistent with IBD", but was looking to understand the Serology, Genetics, and Inflammation Results. I searched their website but couldn't really find much. If anyone knows of any resources that would be great! I can share my results too if somebody understands how to interpret them.

 

[Scipio]

I know something about the individual tests. Post them up and I'll see what I can do (if anything).

 

[CavsFan]

Here are my results "Pattern not consistent with IBD"

Serology Results
ASCA IgA ELISA - Result <3.1 EU/ml - Reference <8.5 EU/ml
ASCA IgG ELISA - Result 28.2 EU/ml - Reference <17.8 EU/ml
Anti-OmpC IgA ELISA - Result <3.1 EU/ml - Reference <10.9 EU/ml
Anti-CBir1 IgG ELISA - Result 23.2 EU/ml - Reference <78.4 EU/ml
Anti-A4-Fla2 IgG ELISA - Result 10.3 EU/ml - Reference <44.8 EU/ml
Anti-FlaX IgG ELISA - Result 14.7 EU/ml - Reference <33.4EU/ml

IBD-specific pANCA
AutoAntibody ELISA - Result 16.9 EU/ml - Reference <19.8 EU/ml
IFA Perinuclear Pattern - Result Not detected - Reference Not Detected
DNAse Sensitivity - Result Not detected - Reference Not Detected

Genetics Results
ATG16L1 - Genotype Variant Detected Heterozygous - Reference Variant Not Detected
ECM1 - Genotype Variant Detected Heterozygous - Reference Variant Not Detected
NKX2-3 - Genotype Variant Detected Heterozygous - Reference Variant Not Detected
STAT3 - Genotype Variant Detected Heterozygous - Reference Variant Detected

Inflammation Results
ICAM-1 - Result 0.32 ug/ml - Reference <0.54 ug/ml
VCAM-1 - Result 0.43 ug/ml - Reference <0.68 ug/ml
VEGF - Result <63 pg/ml - Reference <345 pg/ml
CRP - Result 0.3 mg/L - Reference <13.2 mg/L
SAA - Result 1.4 mg/L - Reference <10.9 mg/L

Thank you for your feedback. I understand very little about this stuff.

 

[Scipio]

CavsFan - I can see why it called you negative for IBD, since you are negative for basically every sub-component test. In other words, for the ten antibodies against bacterial and yeast proteins that have been shown to be associated with IBD, you have normal (negative) levels for all of them. Same for the five inflammation makers they test.

You are heterozygous (meaning you have one normal gene and one disease-associated gene) for the four genetic markers they test. This means you are at moderate genetic risk or susceptibility to IBD, but that theoretical risk is pretty meaningless in the context of being negative for all those other markers.

What does your colonoscopy show?

 

[CavsFan]

Thanks. Your information and expertise is very helpful.

The letter from my colonoscopy stated the following:

It was noted "patchy congestion, erythema, friability and ulceration with no bleeding were noted in the terminal ileum. These findings are compatible with Crohns." However the biopsy from the colonoscopy "The histology is consistent with Crohn's, however no granulomas of Crohn's disease are seen and similar histology can be seen with NSAIDs.

I also had the following tests run as well:

Fast forward after loads of blood work and here are my results:

- Blood work - high for possible celiac
- Upper Endoscopy - fine - ruled out celiac
- MR Enterography - came back fine
- Other Blood work - all normal

 

[Scipio]

So the pathology report is saying that your ileum looks chewed up in a way to could be Crohn's but the definitive granulomas were not seen. And that sort of lesion could also could have been caused by NSAIDs.

Were you taking aspirin or ibuprofen or naproxen or any other NSAID around that time?

The Prometheus test is certainly not definitive either. It is measuring things that are commonly associated with IBD but may not be present in all cases of IBD. There can be both false positives and false negatives with the Prometheus test. What I find kind of surprising is that you would positive for none of the antibody and inflammation markers and still have IBD.

 

[CavsFan]

I was talking NSAIDs at the time, but a very small amount. However, I have never really taken any medicine or NSAIDs at all throughout my life so the fact that I was taking Ibuprofen periodically leading up to the colonoscopy could have had an impact. I don't remember exactly how often I was taking Ibuprofen, but know I was taking it occasionally in November and for about 1-2 in December and possibly once in a while in January. My colonoscopy was Jan 29.

I mentioned minor use of it to my Gastro, but maybe I undersold the amount that I used because like I said I never really took ibuprofen in my entire life so maybe the small amount had a bigger impact on me that it would somebody else.