fibrosure

[jennylynne102]

how accurate is a fibrosure test? Has anyone had one? Should I get a biopsy?

[JennyPenny]

Biopsy is considered the gold standard. Whether you should get one or not is a matter of opinion and you know what they say about opinions. I can only tell you that personally I went with a biopsy. Some people are afraid enough of the biopsy to do the other less invasive tests and I guess they are better than nothing. I've heard that they are good for people with very little damage, or lots of damage to the liver. Those who fall in between don't get such good results. At the same time biopsy has a 30% sampling error.

I know this didn't answer your question very well. I'm sorry about that. I wish we had better answers.

[copyman]

the FibroSURE would be a good starting point considering it is non-invasive and costs way less then "gold standard" biopsy. It is very reliable to rule out cirrhosis. Also you could get a FibroSCAN if you happen to live in an area where they are located. The SCAN machines are only in a few places in the USA and have yet to be approved by the FDA. They are readily available in other countries. Once again these are similar to the FibroSURE and only accurate on the low & high ends, not that accurate for middle stages. getting a biopsy is not always necessary depending on your genotype and treatment plans.

[Bill1954]

I personally have very mixed feelings about the Fibrosure. If you are currently on treatment, don’t *even* consider it; I took one on treatment, and scored F .92; pretty scary—

Bill

[Bill1954]

Oh, and even if the test was taken under good conditions, neither of my liver docs would apply any diagnostic weight to it. Their NP ordered it… against my objections. It *might* provide some use, if used in conjunction with all the other diagnostic tools--

Bill

[JennyPenny]

I totally agree with Bill and so does my doctor.

[copyman]

My docotr uses the fibrosure along with other markers to assess liver damage if the patient doesn't want a liver biopsy. The truth is any good Hepatologist can get an idea of liver damage just from blood work & physical exam.  

The biopsy is not without fault and not that much better then other tests. Unless of course good size non-fragmented samples are taken from 3 different parts of the liver. Or go all out and get a laparoscopic wedge core biopsy. And lets not forget it all comes down to the pathologist preparing the report. If you let three different pathologist read the slides you most likely will get three different results.

My own personal experience showed the FibroSURE, FibroSCAN & Biopsy to be close in result. Even when I consulted with Dr Afdhal in Boston he said the FibroSURE had some creditibility.

Like I said in my previous post the Fibrosure is "a good starting point". It is better then nothing.

[Willy50]

http://www.clpmag.com/issues/articles/2007-04_06.asp
“The correlations between a test like FibroSure and biopsy are somewhere between 70% and 80%. But studies have shown that the correlation between two biopsies on the same patient is also between 70% and 80%,” Faruki says."

http://pt.wkhealth.com/pt/re/jgah/abstract.00001753-200905000-00016.htm;jsessionid=KvBT1R63L6FFgPM4BMBxQx1zMF5S6zQnmJm14mjc1h4ztL0HJFLN!-1301
"Results: The testing algorithm using Fibrosure was the most accurate non-invasive strategy with a sensitivity, specificity, and overall accuracy of 84%, 87%, and 86%, respectively. In comparison with liver biopsy alone, there was a cost savings of approximately $770/person with the Fibrosure testing algorithm, but a net decrease in accuracy of 14%. Fibrospect II and Fibroscan had poorer accuracy (decreases of 12% and 4%, respectively) and lower costs (-$138 and -$357, respectively) compared with the Fibrosure algorithm. In uncertainty analyses in which biopsy sampling error was considered, the Fibrosure algorithm remained consistently less accurate (5-14% decrease)."
-------------------------------------------------------
I had a fibrosure in 2005 which showed stage 1.  I had a biospy in 2008 which showed 1/6 ishak.   Fairly close.  My out of pocket after the fibrosure was about 25 bucks.  

I guess that I wonder if there was some correlation it might allow people to keep a closer track as they near and enter cirrhosis.  Maybe a biopsy is more accurate, but are you going to get one per year?  Many folks with Meld scores are steered away from biopsies since they can be more risky for cirrhotics.  

I guess I wonder if having a fibrosure would be a good idea to create a baseline.  One could do another each year.  One normally gets many of the same labs anyway in liver panels.

Finally, to some extent, the more tests the better the overall picture.  
Not all patients have world class hepatologists, even if they did....would they all agree?

best,
Willy

[copyman]

great post Willy

[pjhep80]

i've had both, biopsy about 5 years ago and fibrosure blood test about a year ago, they both said the same thing, stage 2 grade 2

[snadge]

theres a lot of debate about the accuracy of the FIBROSCAN test
i Had a Biopsy in 2006 that came back as Fibrosis 2 / Inflammaton 7 and 2 years later my Fibroscan said 3.3 which is excellent - so work that one out?

my nurse says that they NEVER use fibroscan results only but all three (Fibroscan , Ultrasound, Biopsy) to paint an overall picture of ones liver state

so YES you should have a fibroscan , biopsy and ultrasound

[Willy50]

By the way, welcome to MH.

A fibroSCAN (which uses sound waves that bounce off a liver) is a different test than a fibroSURE which is a blood test which uses a variety of blood labs to approximate a liver staging score.  I think that each type of test has it's strengths and weaknesses.  Together may may help comprise a very good view of a patients staging.

Some of the function of these tests is to standardize results and may in part remove the need of some of the art, experience and expertise of the doctor.  The goal might be that a so-so doctor and end up achieving the same assessment as a world stage hepatologist.

Willy

[Bill1954]

I personally feel that the Fibrosure/Fibrospect tests yields inferior results when compared to needle biopsy. It can’t provide any information on inflammation, and its clinical utility in determining fibrosis is questionable. One of my doctors told me that although the ‘numbers’ are there to support it’s approval by the U.S. FDA, in the real world, it really isn’t worth much.

This makes me wonder about its use in any scenario; what is the benefit in utilizing an inferior test? If it’s included as a third partner with biopsy and perhaps Fibroscan, doesn’t this simply sully the other results?

And yes, I realize there’s a lot of discussion about the inaccuracy of needle biopsy in here; but I wonder how much of this is attributable to internet rumor. Outside of lay discussion, there isn’t much challenge to it, is there? My doctors still swear by it, and continue to embrace the results. I think the liver might be more homogenous in nature than a reader in here is led to believe.

I wish there was a pathologist in here that could lend authority to talks like this--

Bill

[copyman]

sorry the fibroSURE didn't work for you. it clearly states not to have it done while on TX.  Have you ever had one while NOT on TX? Just curious how it would correlate to your BX now.  I will take what a doctor like Dr Afdhal thinks when he says the fibrosure does have creditibility. like i said in my first post it is a great starting point and better then nothing. And it is definately a good test to rule out cirrhosis.

[mhudnall]

Does anyone know where ot get a Fibrosure, Fibrospect Fibrotest, or other non-invasive fbrosis staging test in AZ, CA or the surrounding area?

My doctor will order one, but he's in Washington state and I need to find one closer to home.

Thanks in advance,

Mike H

[copyman]

the fibroSURE is a bloodtest from Labcorp. They have draw sites all over the USA. Go to their website and you will find many locations in every state.

[Bill1954]

Hi Mike,

Any commercial lab should be able to access either the Fibrosure/Fibrospect; Fibrosure is performed by LabCorp. The test results I have list a contact number: [phone]; however, I think all you need is a lab slip from your doc, and a commercial lab.

To my knowledge, there is only one Fibroscan machine out west here, and it is not commercially available. Hepatitis Researcher has access to one in Los
Angeles, but until approval, he can’t take commercial traffic.

Copyman,

I think you might be missing my point. I am SVR, and have no interest for personal testing. My point is that if the Fibrosure results are indeed questionable, why consider the results when we’re trying to find consensus. To exaggerate my thoughts, why not throw a Ouija board into the mix? It’s not very accurate either, so what does that do in terms of consensus? Does that increase your decision power? It *detracts* from decision power, in my opinion--

Bill                

[mhudnall]

Thanks for the contact info. I'll give them a call. Is the Fibrosure an imaging process that goes along with the Fibrospect blood test?

Thanks,

Mike H

[Bill1954]

I believe Fibrosure and Fibrospect are competing, patented computer algorithms; neither are imaging, but attempt to provide fibrosis interpretation using blood markers.

The six values used by Fibrosure are:

Alpha 2-macroglobulins
Haptoglobin
Apolipoprotien A-1
Bilirubin, Total
GGT
ALT (SGPT)

Interpretations:

“Quantitative results of 6 biochemical tests are using a computational algorithm to provide a quantitative surrogate marker  (0.0 – 1.0) for liver fibrosis (Metavir F0 – F4) and for necroinflammatory activity Metavir (A0 – A3).”

Bill

[mhudnall]

I see what you mean about accuracy. I think I would rather couple the blood markers with an imaging test. I was under the impression that there is a commonly used imaging test that work in conjunction with the blood tests. Is that the FibroScan? Does LabCorp do that as well?

From what I've read you have to go to Europe to get a FibroSure, but the FibroScan is available in the US. Maybe LabCorp can tell me, but maybe someone here knows the answer.

Thanks,

Mike H

[mhudnall]

Sorry, I meant to say FibroScan when talking about an available scan in the US in the last post.

MH

[Marcia2202]

The fibrosure and fibrospect are blood tests.

The FibroScan is a scanning machine. They put gel on the area and scan the liver kind of like one does with an ultrasound machine. Except they stay on one place for a long time.

[Bill1954]

No, FibroSCAN is provided by a French company; the name escapes me at the time. I would love to see FibroSCAN here in the U.S.; I think the E.U. adopted it several years ago, and the results appear to be consistently concordant with needle biopsy.  LOL, the names of these tests are so similar, I get them confused in my writing as well :o). Marcia has it spelled out correctly above,


Bill

[Rockerforlife]

The FibroScan will become the standard in the future just the new PI drugs will



http://www.cadth.ca/media/pdf/442_fibroscan_cetap_e.pdf

[copyman]

Bill,
I did not miss your point. I think you missed my point, You said you had the FibroSURE test while on TX which gave you a false reading. Labcorp clearing states NOT to do this test while on TX. My point was asking if you ever had the test done any other time even if you have completed tx and are SVR. Why bash a test if you never did the test the proper way?

Great idea about the Ouija board. I actually put as much merit in that as I would some of the tests out there :-)

the FibroScan machine is from a french company called Ehcosens. I don't think they will ever get FDA approval. After my conversation with one of their representives back in 2007 they said if they didn't have FDA by end of the year they would stop pursuing the USA market.

[Rockerforlife]

I woder why FDA wont approve of something useful and safeEMMMM>?

[Marcia2202]

copyman:

'the FibroScan machine is from a french company called Ehcosens. I don't think they will ever get FDA approval. After my conversation with one of their representives back in 2007 they said if they didn't have FDA by end of the year they would stop pursuing the USA market.'

Just wanted to add something I know about this subject...

They just finished a worldwide study on the FibroScan. I know this because my hepatologist and the hepatologist who performed the scan on me were the leading doctors of the project here in Denmark. All the results were sent to somewhere in the US in the beginning of July 2009.

I could imagine that after the outcome of this study, they might apply to the FDA.

[Willy50]

Here is a utube on fibroscan.
http://www.youtube.com/watch?v=l_E4ZGmKooA

I thought that there had been a EASl presentation on it but haven't found the results yet.  To summarize though, I think they lacked sufficient ability to differentiate staging, particularly in the middle ranges.  I looks as though Fibroscan may not get FDA approval, if I recall correctly.

Like any means of testing though it may have it's strengths and weaknesses.  I've heard reports that some peoples livers are not homogeneous and that it is possible to find a range of conditions; depending upon where one took the biopsy one might get varying staging assessments.

This may account for some people who seem to rapidly progress staging with relatively great speed.  There are a few members here who have have had that and this could be one way it could explain their plight.

I don't claim to know the answer.  It is also fair to say that blood values can vary.  IF I were to take a few tylenols or have a heart attack prior to getting a fibrosSURE (bloodtest) it would skew a few markers and I would be likely be assessed a worse staging than was actually present.

No tests will be perfec, not even biopsy.
(lol; I say that autopsy is the *gold standard*).  : )

There are and have been other discussions here of fibroscan and fibro- type blood tests such as Fibrosure.  (use the board search engine)

best,
Willy

[Willy50]

http://www6.miami.edu/ummedicine-magazine/departments/clinicalnotes3.html

This link says that fibroscan WILL likely get approval.

Willy

[Rockerforlife]

BACKGROUND: The aim of this study was to assess the diagnostic performances of liver stiffness measurement (LSM), ultrasonography (US) and their combined use in predicting the extent of hepatic fibrosis. METHODS: Consecutive patients with chronic hepatitis B (HBV) or hepatitis C virus (HCV) infections, with indications for liver biopsy, were prospectively enrolled. LSM was performed on the same day as biopsy. US scores, including assessment of liver surface, liver parenchyma, intrahepatic vessels and spleen index, were used to assess the degree of hepatic fibrosis. The pathological findings were used as a reference standard and diagnostic accuracy was assessed and compared. RESULTS: Three-hundred and twenty patients, including 199 men and 121 women, with a mean age of 50.8 years, were analyzed. There were 214 (66.9%) HCV patients, 88 (27.5%) HBV patients and 18 (5.6%) patients with both HCV and HBV. LSM correlated significantly with the hepatic fibrosis (F) scores, necro-inflammatory activity and US scores in multivariate analysis. The diagnostic accuracy of LSM is significantly superior to US, and equal to combined LSM with US, in the prediction of all HCV-related fibrosis scores. The cut-off value of LSM is 6 kPa for diagnosing F > =1, with a positive predictive value of 91%. Also, the cut-off value is 12 kPa for the prediction of cirrhosis, with a negative predictive value of 94%. CONCLUSIONS: LSM is useful for predicting hepatic fibrosis and excluding cirrhosis. A combination of LSM and US does not improve the accuracy in assessing hepatic fibrosis.

[mhudnall]

So, please correct me if I'm wrong, but are are you saying that there are no imaging tests available in the US? Niether FibroScan or FibroSure nor anything else?

Thanks,

Mike H

[Marcia2202]

Once again...

FibroSure and fibrospect are blood tests available in the US (labcorp was mentioned above)


FibroScan, is a scanning device like an ultrasound, and it seems that it is only available in very few places in the US.... don't ask me where. It looks like they are not commercially available. HR uses one... Bill mentioned it above

[Willy50]

There was a clinical trial but the trial is over and I'm not sure anyone would scan you since they would no longer be compensated for the work.  Until it has approval I'm not sure that you will be able to get one.  
In that regard..... I don't know if it matters who may have one.

IF and when it is approved I think you'll see it many places.  They have expected approval and if it's going to happen it could come soon.  May be more info at fall AASLD.

best,
Willy

[Marcia2202]

Thanks for clearing that up Willy

[Willy50]

Just what I think, Marcia.  The reality may be something else.  ; )

They had one at Shands and in St Louis and there is one in the east and HR had one as bill mentioned.
Knowing where they are in the USA may not help much however.  Until the trial results are revealed there may even be a question as to the importance of the results.

I hope that the trial results are awesome, but it seems to me I've read mixed.  We will see....

Nice to say hi to you.  

Willy

[Marcia2202]

Likewise!

[copyman]

Agree that the reason it has not been approved is because it is not that accurate in the middle stages.

It is no more accurate then the FibroSURE test.

It was a great idea but failed in the trials.

It will not become the "test of the future" like the new PI's. Pi's have hard data to back it up, the Fibroscan does not.

[copyman]

From what I have read I still don't think the FDA will approve it but in all fairness I had to post the following. If I may be wrong I will be the first to admit it. According to the following article it was just approved in Canada and the manufacture says it expects to be approved in the USA in 2010. Like I posted earlier their representive told me 2007 back in 06. I hope I'm wrong and it proves to be a reliable test. The following is from HCV Advocate:


Echosens: Canada Approves FibroScan(R) and its 3 Probes
http://in.sys-con.com

PARIS, FRANCE -- (Marketwire) -- 09/09/09 -- Echosens, the French high-technology company specializing in non-invasive diagnostics in hepatology, announced that it has obtained approval for FibroScan® and its 3 probes (Pediatric, Standard and for Obese patients) in Canada.

This innovative diagnostic technique, specific to the liver, measures in a quantitative and reproducible way the "degree of hepatic fibrosis", from children to adults, of all shapes and sizes. This non-invasive diagnostic method is a real revolution for liver diseases and their monitoring, a revolution that Canadian patients will be able to benefit from.

FibroScan®, a sure and non-invasive diagnostic technique

This authorization to participate in the Canadian market comes after the world launch of the new XL probe. Echosens will now be able to market FibroScan® and its 3 probes, a product commercially available since 2005 worldwide and selected by the community of hepatologists thanks to more than 200 independent publications. According to Richard Guillaume, CEO of Echosens, "With its non-invasive nature, its ease of use and its immediate results, FibroScan® has already revolutionized the medical practice of hepatologists in Europe and Asia, and is expected to experience the same success in Canada."

A major benefit for Canadian patients
In Canada, viral hepatitis C and alcoholic diseases are the principal causes of cirrhosis. With 240,000 chronically infected people and 5,000 new cases of hepatitis C per year, taking control of this disease constitutes a major public health issue for the country.

In addition, the testimony of specialist physicians on the appearance of emerging pathologies such as Non Alcoholic Steatosic Hepatitis (NASH), which is growing rapidly in this country, reinforce the use of FibroScan®.

Without diagnosis or adapted control, hepatic fibrosis develops in 30% of these patients and can lead to cirrhosis.

Approval for an international development strategy
Canadian approval is an important step in Echosens' development strategy, but other approvals will follow. "Our product was approved in China in 2008, today in Canada, we hope in Japan at the end of 2009, and in the United States in 2010. We will focus on metabolic diseases like steatosis, but also on the study of other organs thanks to VCTE(TM) "Vibration Controlled Transcient Elastography".

Echosens: Partner for diagnostic solutions in Hepatology
A French company founded in 2001 in Paris, Echosens is an international SME specializing in the field of hepatology. The company developed and manufactures the FibroScan® device, based on VCTE(TM) "Vibration Controlled Transcient Elastography". Echosens has changed hepatologists' clinical practices by making available to them a new tool for diagnosis and follow-up of liver diseases. Echosens dedicates a significant part of its activity to Research in order to develop new medical devices and to open up new medical perspectives. The company works in close cooperation with health professionals and patients' associations to facilitate therapeutic follow up of patients. To date, 645 FibroScan® devices have been installed worldwide, including 157 in France.

For more information: www.echosens.com

Contacts:
Echosens
Cecile Guiducci
International Marketing Director
[phone]
***@****

[snadge]

thanks for that - I didnt know there was Fibro-type blood tests aswell as the scan...  now I do :)

[Bali05]

Mike,

You can get a Fibroscan in Boston but get this because it is part of a study you have

to have a biopsy first. It`s with Dr. Afdahl (spelling?)

There is all this talk about accuracy as a reason why Fibroscan is still not available

yet the bloodmarker test Fibrosure is available ??!!??

If you ask me this is all bull..... The machine is 100% harmless why is not available

to the public ? You could checkyour liver status over and over with absolutely no

harm . It is ridiculous. The machine costs about 80K.

I decided to go Dusseldorf (Germany).

Bali05

[snadge]

is this a USA thing? (no Fibroscan)  

just Im in UK and they do them at my local hospital , I had one that came back as 3.3 (perfect score) but just 2 years before a biopsy showed I had mild-mod fibrosis and moderate swelling - so makes you wonder doesn't it?

I personally think ALL the tests should be administered as they can be used to paint an overall picture of ones liver state

I had Biopsy, Fibroscan, Ultrasound - but I never heard of Fibrosure blood tests until now

[Bill1954]

Inaccuracy in medical diagnostics is NOT harmless. Clinicians use these to determine if costly and occasionally dangerous measures need to be undertaken; the notion of whether the test itself is harmless isn’t a factor here.

“You could checkyour liver status over and over with absolutely no harm.” So what?

This is my point; if the test is inaccurate, how would serial results yield better decision power?

Bill

[Bill1954]

As noted above, the FibroSCAN hasn’t been approved by the U.S. FDA; and the machine/procedure is unavailable here in commercial form. There are several machines here for research purposes, but a U.S. citizen has to go abroad to get tested commercially—

Bill

[Marc1955]

I assume that some of you saw the large scale study of a non-invasive approach to  liver scaling as opposed to biopsy in a recent issue of Hepatology:

"SAFE biopsy: A validated method for large-scale staging of liver fibrosis in chronic hepatitis C" Hepatology, Vol. 9, issue 6, 2009 conducted by a group of Italian researchers.

It found insignificant diagnostic difference between the results of the non-invasive approach based on Fiibrosure plus an AST-to-platelet-ratio computation and the results from a biopsy. But I want to make another point:

The authors of that study point out the it is not economically feasible to use biopsies to treat the worldwide population with HCV. Given the size of that community and other stresses on medical systems, the non-invasive approach is a more sensible alternative because you can reach a much larger group of people with it.

Isn't this typical of the American health system and isn't this one of the reasons we are in trouble? Those American doctors and nurses who are saying biopsy or nothing aren't  thinking about the cost/benefit relationship between the different testing methods. If twice as many people (or ten times as many people which is probably more likely) can afford the non-invasive approach and the results are roughly equivalent in the vast majority of cases, wouldn't the overall well being of the HCV community will be improved if the non-invasive approaches were widely used? I don't in fact believe that the American doctors and nurses who have been cited in this thread as strongly endorsing the biopsy as the only accurate way to approach liver damage grading are reliable. I think they have bought into certain social norms within their community. As with many other issues, they choose the more expensive alternative even if it doesn't have higher proven efficacy. This is the American approach to medical care.

[bajawoman]

I was tested fibrotest Mexico came in with a lower reading than the Firbroscan at 8.7 I beleive in my personal opinion they both serve a purpose and are harmless  but the key is interpretation and it takes a very well trained person to read the fibroscan this is or maybe why the US is dragging it's feet in FDA approval in other countries it was much more readily accepted therefore many more techincians were educated on reading the fibroscan but like anything else some are better than others  I hold HR in high regard
Baja

[snadge]

very interesting post that Marc - I agree with you

Biopsy's may be considered "the best way" by some but even they can be wrong - someone on here said that they're biopsy was incorrect due to the sample been taken from a healthier section of the liver and therefore gave off improper results as the rest of the liver was quite damaged - whereas the Fibroscan is able to give you data from MORE of the liver than a Biopsy can (hundreds of times more).

Hepatits Researcher makes an interesting read above - I agree there that all / as many  as possible shoudl be done to paint an overall picture of ones liver

[Bali05]

Hi Bill,

The process of scarring of the liver (fibrosis) does not happen uniformly.

There was one example on the forum where some one got a biopsy with

a much lower reading only to find out a short while later that they had cirrhosis.

Apparently that doctor`s answer to the problem was to have to stab the liver

multiple times to get the best reading.Well I had a Fibroscan which computed a

result from 10 different readings done in 15min. How are you going to do this with

a biopsy. Truth of the matter is none of the 3 tests FibroSure,FibroScan,Biopsy

are 100 % but the FibroScan gets to be pretty accurate for overall picture.

If I hear the term "golden standard" one more time .......!  Biopsy is not foolproof

if it were maybe we would not need pretentious explanations like that.



Bali05

[copyman]

you are right that none of the tests are perfect but if you read the study data the FibroSCAN is not that accurate for the middle stages of fibrosis. almost the same as the FibroSURE. agree that all 3 tests used together could be used to get a good idea of liver damage. This of course with a good "Hepatologist" as your doctor.

[mike716]

The Clinical Care Options website (which is a review/summary by professionals) says that Fibroscan tests a sample that is 1/500th of the liver. While that may be a lot better than the sample tested by a biopsy, it isn't much. I still believe that my FibroTC, based on tomographic images of the entire liver, is the best test of all (see my images pages for the full series of my test, both tomography and FibroTC analysis). Unfortunately, it is not yet commercially available outside Spain.

As to Fibroscan, well, I guess most Medhelpers know what recently happened to me: from a biopsy + FibroTC of F1 a year ago, to a Fibroscan of F3/F4 laast week! I wonder which one isn't telling the truth?!

Mike