Hep C Discussion Forum

lonewolf · Member

RE: Fibrosure Test Results-Where do I stand?

RudiRoo · Senior Member

Thanks for the explanation Tig. Excellent link!

Seems like Quest should do a better job of explaining what they offer. I feel like my test is probably accurate and I'm not worried but if it turns out I didn't make SVR I would probably do a Fibroscan up in the states to be on the safe side.

Tig · Admin

Hi Roo,

They are essentially the same test. They test for various blood markers and then use an algorithm to determine the probability of fibrosis and inflammation. I read where some labs have switched from Hepascore to Fibrosure, without much explanation. I checked the Quest Diagnostics website and one section said they still offered it and another section had deleted the information provided. They both have one thing in common, they are less accurate at both high and low ends of their grading scale by a certain percentage. There are several mentions of the necessity to confirm results indicating high fibrosis in the professional articles. They are a long read but are available online.

I read where Anthem BC/BS considers them both experimental and are requiring a minimum of a Fibroscan or biopsy for fibrosis determination. Different providers accept the two blood marker tests as qualifying procedures. So the decision is left to your doctor which form of testing is acceptable. If I were concerned about my own results after any test result, you have the choice of accepting the decision and subsequent treatment recommendations or seeking a second opinion or further testing. Any doctor worth considering should be willing to both discuss your results in detail and offer additional options if needed or requested.

Looking at your scores, they do appear to indicate a low inflammation score and no indication of fibrosis. Your ALT on this test is 45 with a high normal of 40. So that is only slightly elevated. According to the report your values indicate an 85% probability of accuracy. (Both the Hepascore and Fibrosure scale are similar in accuracy percentages.) My opinion would be to trust the results and not worry about it. But again that's my opinion and if you have any concerns, please consult your doctor for additional information and options. Hope this helps explain it.

http://www.hepatitisc.uw.edu/go/evaluation-staging-monitoring/evaluation-staging/core-concept/all

Tig

RudiRoo · Senior Member

Fingers crossed for you Mike, I think Tig is correct and you will get easy approval and be on the train soon.

Your story leaves me wondering about my own test.

Tig: I'm confused. Mike's test says Hepascore, which is what my doctor ordered but the lab said it was no longer available, so they gave me a fibrosure instead. You calls Mike's test a fibrosure, so I thought they must just be the same test, different names. But I went to look at mine and see that it's quite different than Mike's. Different things tested and slightly different values for the same tests. I was on the low end, so does that mean I shouldn't trust my results?

Here's mine for comparison:

Screen Shot 2015-03-23 at 11.11.03 AM.png

-- Edited by RudiRoo on Monday 23rd of March 2015 03:13:33 PM

MechanicMike · Veteran Member

It's confusing to say the least! I haven't talked to my gi since my first visit, so I'm in wait-and-see mode. Anyway, my paperwork is in the specialty pharmacy's hands right now-I just want to hear "approved" so that I can begin killing this beast. No matter what the current damage is, it's sure not going to get better without treatment. I'd just like to know, for sure, how much of my liver is left! (lol) My doc seems like a decent guy and he patiently answered the ridiculously long list of questions I threw at him. I plan to ask what I should do to find out my actual Metavir score when I see him again (if it's even possible, I'm starting to question whether it is). And Tig, I'm starting to get the hang of "one finger" typing on this tablet AND I LIKE IT! I'm on a laptop all day at work but I haven't picked up mine at home in days.

Tig · Admin

I have to agree Duane. Fibrosure is known to be inaccurate at the lowest and upper ends of the test. Fibroscan excels in the non invasive tests available but the various biopsy options are more reliable.

Tig

Dzdayscomin · Senior Member

I have heard that the Fibrosure test is not very reliable, a better choice would be Fibroscan, or the gold standard is a biopsy.

Duane

Michaele · Guru

Hi Miracle I had a biopsy in 2012. Grade 1-2 Stage 2-3 . The fibrosure done 2 yrs later ; stage F4 with severe inflammation. Even my doctor said it seemed hard to believe, because of my clean living. Now after EOT , I bet if I retook the fibrosure I would get a much different results . The only part of the fibrosure chem panel that was highly elevated was the GGT . Alot of things beside liver damage can elevate it. Im not saying Im not F4, Im saying it is questionable. Dr said he wants to redo it in 6 months Michaele

Miracleinprogress · Member

A biopsy is not all that accurate as well. Some areas of your liver could be fine while some could be more fibrosis. So it depends where they stick that needle. That's why I opted for the Fibrosure but not sure of it as well. From a F2 a3 to an F4 severe activity in 3 years doesn't make sense to me. Especially when this disease has progressed so slowly my whole life. Had an ultrasound today and trusting Got that is shows different than the lab work.

MechanicMike · Veteran Member

Hi Malcolm, I'm sure that my results could be off, simply because I didn't fast prior to having my blood drawn. They had me take the test immediately after my initial Gi visit in the afternoon. No one mentioned anything about fasting. I'm going to call on Monday to find out what my next step should be. If they can use these results to get my treatment approved I am certainly OK with it. I would, however, like to have a biopsy performed in the future to see where I really stand. Thanks, Mike

mallani · Guru

Hi Mike,

Your result of 0.59 is equivalent to Metavir F3.

Just for interest my FibroTest (FibroSure) result was 0.58 in 2008. However a Fibroscan 6 months later showed definite F4 (cirrhosis). This was in keeping with my 2000 biopsy result of F3-4.

I don't think FibroSure is accurate enough, as it uses the GGT which jumps around like a yo-yo. Just an example: my doc wanted to show me the difference in fasting and random blood tests, so I had blood drawn on consecutive days. The fasting test showed: GGT-122, ALT-126. Random: GGT-186, ALT-120. This would have made a difference to my FibroTest score. Just my humble opinion. Cheers.

Tig · Admin

Hi Mike,

Treatment has been being approved for F3's and above by many providers, so your chances are good for approval. I'll certainly keep my fingers crossed for you. It has been getting easier, so let's hope you are approved without any difficulty. I had a BCBS policy during treatment and they were very cooperative across the board.

Let us know what you find out from your doc. The good thing is these new treatments are so effective and they're fast, without much in the way of SFX. Your chance of success is excellent, regardless of your fibrosis level. Dont worry, things are looking pretty good now and we're seeing a lot of great results. Hang in there!

Tig

PS: Once you get used to your tablet, you'll never look at your computer the same way again! It's all I use now. I would've never believed one finger could type so fast, lol!

MechanicMike · Veteran Member

... Was going to add a thank you again lol. I'm typing this on my tablet and I pretty much suck at it! Thanks, Mike

MechanicMike · Veteran Member

Sorry Tig, hit the send button by mistake. Anyway, from what I'm reading on my insurance provider's website, based on these results treatment is considered "medically necessary." It also says that they accept this test, so we'll see how round 1 plays out. I don't know that I trust the accuracy of the test honestly, but I'm certainly not qualified to have an opinion. But if it's good enough for BCBS to approve treatment I'll be a happy camper. I'm still going to ask about the possibility of getting a biopsy performed. I'll pass along your well wishes to my wife. We were relieved to say the least. Even though I knew the chances were remote it is still scary.

MechanicMike · Veteran Member

Hi Tig, Thanks for the explanation. I'm gonna call my doc Monday and, hopefully, it'll at least be the ammo needed to present

Tig · Admin

Hi Mike,

Actually history has shown Fibrosure inaccurate at the low and high end of the scale, with better accuracy in the middle. There remains some disagreement on the test, especially when compared to Fibroscan and biopsy. With that said your results appear to place you in the middle of the fibrosis scale. Your result is .59. According to the Fibrosure scale, that places you right at the low end of the F3 stage. Your test results say F2-F4, so F3 is the average by my interpretation. If you read the descriptions included with your test results, you're going to be confused. It mentions anyone with a score greater than .55 may present significant fibrosis that may need to be confirmed by biopsy. Then it lists the percentages of probability of the test's accuracy based on the score. It's a speculative test in my opinion. They also use the GGT, Bilirubin and HA levels to confirm the probability of accuracy. If you go by those levels present in your test, they are excellent! So what's right? That's why the test falls under scrutiny regarding accuracy. Based on these results, your fibrosis is staged at .59/F3. F4 is considered cirrhosis on the Metavir scale. So your fibrosis level is advanced but not yet cirrhotic according to the Fibrosure standards. It's my opinion Mike.

That's great news regarding your wife's test results! Give her my congratulations. I'm including a link to an explanation of the Fibrosure test. If I can answer anymore questions let me know.

Tig

http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/91402

MechanicMike · Veteran Member

Hi All,

Just got my fibrosure results in but haven't talked to my GI yet (he's off on Fridays, I pulled the results from my medical file online). I only know, from reading here, that these tests are fairly accurate at the low/high ends of the spectrum--the middle is iffy. That being said, I still can't figure out where these results place me. If anyone can help me make heads or tails of this I would greatly appreciate it.

BTW, my wife's HEP C screening came back negative, thank goodness.

Thanks in advance for any assistance you can provide!

Warmest regards,

Mike

Component:	Standard Range:	Your Values:	Comments:
HEPASCORE CALC		0.59	HepaScore(R) Reference Interval <0.55
ALPHA 2MACROGLOBULIN	106-279	357	TEST PERFORMED AT: QUEST DIAGNOSTICS/NICHOLS SJC 33608 ORTEGA HWY SAN JUAN CAPISTRANO, CA 92675-2042
BILIRUBIN TOTAL	0.2-1.2	0.5	TEST PERFORMED AT: QUEST DIAGNOSTICS/NICHOLS SJC 33608 ORTEGA HWY SAN JUAN CAPISTRANO, CA 92675-2042
GGT	3-95	46	TEST PERFORMED AT: QUEST DIAGNOSTICS/NICHOLS SJC 33608 ORTEGA HWY SAN JUAN CAPISTRANO, CA 92675-2042
HYALURONIC ACID	5-57	34	This test was developed and its performance characteristics have been determined by Quest Diagnostics Nichols Institute, San Juan Capistrano. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test. TEST PERFORMED AT: QUEST DIAGNOSTICS/NICHOLS SJC 33608 ORTEGA HWY SAN JUAN CAPISTRANO, CA 92675-2042
METAVIR		F2-F4	Metavir Fibrosis Scoring Scale F0 = Chronic hepatitis but no fibrosis F1 = Portal fibrosis without septa F2 = Portal fibrosis and few septa F3 = Septal fibrosis without cirrhosis F4 = Cirrhosis
F0-F1		28.6
F2		17.3
F3		20.9
F4		33.2	In a population where prevalence of significant fibrosis (Metavir>F2,F3 and F4) is 50.1%, a HepaScore(TM) cutoff of >0.55 detects significant fibrosis with a sensitivity of 83%, specificity of 65%, negative predictive value of 79% and a positive predictive value of 70%. Based on our validation data in a population with HepaScore>=0.90, the probability of significant Fibrosis is 71.4%(17.3%, 20.9%, and 33.2% for F2, F3, and F4 respectively); the probability of a false positive result(F0 and F1) is 28.6%. This test is best used as a screening tool for the presence of significant Liver Fibrosis. Clinical judgment should be applied for further evaluation of negative patients, or for need of biopsy for adequate staging in positive Hepascore(TM) patients. HepaScore(R) is an index derived from serum markers (A2-Macroglobulin, Total Bilirubin, Gamma Glutamyl-transferase (GGT) and Hyaluronic Acid (HA) and demographic risk factors (age and sex) which predicts probability of liver fibrosis. It has been validated only in patients with chronic hepatitis C infection.

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