Versus Biopsy
Poynard
T. et al; A prospective analysis of discordant results between
biochemical markers and biopsy in patients with chronic hepatitis C;
Cinchem 2004
“Only
a minor proportion of patients with chronic hepatitis C have an
adequate sized biopsy. Most of the discordant results were attributable
to biopsy failures.”
In Chronic Liver Diseases
Poynard T. et al; Meta-analysis of FibroTest in the diagnosis of fibrosis in the 4 most common liver diseases; BMC Gastroenterology 2007
"FibroTest
is an alternative to liver biopsy for the diagnosis of fibrosis in
patients with chronic hepatitis C as well as B, alcoholic liver
diseases and non alcoholic steatosis. FibroTest’s diagnostic value is
similar for intermediary or extreme stages diagnosis and for diagnosis
of patient presenting with normal ALT."
In Chronic Hepatitis B
Robert
P. Myers et al; Prediction of liver histological lesions with
biochemical markers in patients with chronic hepatitis B; Journal of
hepatology 2003
“The
aminotransferases and an index including five biochemical markers are
accurate noninvasive markers of HBV-related activity and fibrosis,
respectively.”
NGO Y. ET AL; AN ACCURATE DEFINITION
OF THE STATUS OF INACTIVE HEPATITIS B VIRUS CARRIER BY A COMBINATION OF BIOMARKERS
(FIBROTEST-ACTITEST) AND VIRAL LOAD; PLOSONE 2008
“In patients with chronic hepatitis B, a combination
of FibroTest-ActiTest and viral load testing accurately defined the prognosis and
the inactive carrier status.”
In Chronic Hepatitis C
Myers
R. et al; Biochemical Markers of Liver Fibrosis: A Comparison With
Historical Features in Patients With Chronic Hepatitis C; The American
Journal of Gastroenterology 2002
“(…)
is more accurate than an index of historical features, the addition of
which to the existing index was not helpful. The markers (…) are widely
available, and this validated instrument represents the most
discriminative tool available for the noninvasive prediction of
HCV-related fibrosis”
Sebastiani
G. et al; Stepwise combination algorithms of non-invasive markers to
diagnose significant fibrosis in chronic hepatitis C; Journal of
hepatology 2006
“Stepwise
combination of non-invasive markers of liver fibrosis improves the
diagnostic performance in chronic hepatitis C. Need for liver biopsy is
reduced by 50–70% but cannot be completely avoided.”
Poynard
T. et al; Overview of the diagnostic value of biochemical markers of
liver fibrosis (FibroTest, HCV Fibrosure) and necrosis (ActiTest) in
patients with chronic hepatitis C; Comparative Hepatology 2004
“Based
on these results, the use of the biochemical markers of liver fibrosis
(FibroTest) and necrosis (ActiTest) can be recommended as an
alternative to liver biopsy for the assessment of liver injury in
patients with chronic hepatitis C. In clinical practice, liver biopsy
should be recommended only as a second line test, i.e., in case of high
risk of error of biochemical tests.”
Poynard
T. et al; Biochemical surrogate markers of liver fibrosis and activity
in a randomized trial of peginterferon Alfa-2b and Ribavirin;
Hepatology 2003
“In
conclusion, these biochemical markers of fibrosis and activity could be
used as surrogate markers for liver biopsy in patients with chronic
hepatitis C, both for the initial evaluation and for follow-up.”
Poynard
T. et al; Biochemical markers of liver fibrosis in patients infected by
hepatitis C virus: longitudinal validation in a randomized trial;
Journal of viral Hepatitis 2002
“This (FibroTest) fibrosis index could be used as a surrogate
marker of the antifibrotic effect of treatments in patients
with chronic hepatitis C.”
Myers
R. et al; Biochemical markers of liver fibrosis: A comparison with
historical features in patients with chronic Hepatitis C; Journal of
Gastroenterology 2002
“A
simple index including age, sex, and five biochemical markers
accurately predicts significant hepatitis C-related fibrosis. This
index is more accurate than an index of historical features, the
addition of which to the existing index was not helpful.”
Imbert-Bismut
F. et al; Biochemical markers of liver fibrosis in patients with
hepatitis C virus infection: a prospective study, The Lancet 2001
“A
combination of basic serum markers could be used to substantially
reduce the number of liver biopsies done in patients with chronic HCV
infection.”
Ngo
Y. et al; A prospective analysis of the prognostic value of biomarkers
(FibroTest) in patients with chronic Hepatitis C; Clinical Chemistry
2006
“The FibroTest measurement of HCV biomarkers has a 5-year prognostic value similar to that of liver biopsy.”
Thabut D. et al; Non-invasive prediction of fibrosis in patients with chronic hepatitis C; Hepatology 2003
“this
retrospective comparison suggests that the Fibrotest provides a more
accurate estimate of HCV-related fibrosis than the index of Forns et
al.1 Prospective comparisons in additional centers are warranted to
confirm this finding.”
In Chronic Hepatitis B and C
Poynard T. et al; FibroTest-FibroSure: towards a universal Biomarker of liver fibrosis; Future drugs 2005
“(…) due to the limitations and risks of biopspy (…), liver biopsy should no longer be considered mandatory”
Poynard T. et al; Serum markers of liver fibrosis, Hepatology 2003
“Non-invasive biochemical markers could be used as an alternative to liver biopsy at least in chronic hepatitis C and B.”
In Other Medical Conditions
Thabut
D. et al; Diagnostic value of fibrosis biochemical markers (FibroTest)
for the screening of oesophagal varices in patients with chronic liver
diseases; LiverInt 2006
“(…)
could help clinicians predict endoscopic portal hypertension, thereby
reducing the indication for endoscopic varices screening and
simplifying medical management”
Thabut
D. et al; Non-invasive diagnosis of large scale oesophagal varices with
FibroTest in patients with cirrhosis: a preliminary retrospective
study, Liver international 2006
“FibroTest
could aid in the diagnosis of LOV and may therefore reduce the
indication of endoscopic screening in cirrhotic patients.”
Thabut
D. et al; Relationship between the Fibrotest and portal hypertension in
patients with liver disease; Aliment Pharmacol Ther. 2007
“(…)
could help clinicians predict portal hypertension, thereby reducing the
indication of endoscopic screening for varices and simplifying medical
management”
Jacqueminet
S. et al; Screening of advanced fibrosis with FibroTest in diabetic
patients with hepatitis; Comparative Hapatology 2004
“(…)
This study shows that biochemical markers can be very useful to screen
advanced fibrosis in diabetic patients with hepatitis C in order to
reduce mortality."
Ratziu
V. et al; Diagnostic value of biochemical markers (FibroTest) for the
prediction of liver fibrosis in patients with non-alcoholic fatty liver
disease, BMC Gastroenterology 2006
“In
patients with NAFLD, Fibrotest, a simple and non-invasive quantitative
estimate of liver fibrosis, reliably predicts extensive fibrosis and
cirrhosis. This should improve the identification of the population at
risk of significant liver injury and reduce the number of unnecessary
liver biopsies.”
Naveau
S. et al; Diagnostic value of biochemical markers (FibroTest) for the
prediction of liver fibrosis in patients with chronic alcoholic liver
disease, Gastroenterol hepatol 2005.
“
In heavy drinkers, Fibrotest is a simple and non-invasive quantitative
estimate of liver fibrosis with a better sensitivity than hyaluronic
acid. Fibrotest may reduce the need for liver biopsy”
In Special Population
Lamireau T et al; Non-invasive diagnosis of liver fibrosis: FibroTest’s validation in children; Hepatology 2005 – Abstract
� FibroTest shown a similar diagnostic value in childern as in adults �
Thabut
D et al; Hepatitis C in 6,865 Patients 65 yr or Older: A Severe and
Neglected Curable Disease?; Journal of Gastroenterology 2006
“In
patients ≥65 yr, (…) biochemical markers seem particularly useful as a
noninvasive alternative to liver biopsy in this population.”
Myers
R. et al ; Serum biochemical markers accurately predict liver fibrosis
in HIV and hepatitis C virus co-infected patients, AID 2003
“(…)
accurately predicts significant fibrosis in patients with HIV/HCV
co-infection, and may substantially reduce the necessity for liver
biopsy.”
Varaut
A. et al; Diagnostic accuracy of the FibroTest in hemodialysis and
renal transplant patients with chronic hepatitis C; Transplantation
2005
“(…)has
a diagnostic value in haemodialysis and renal transplant patients which
is similar to that reported in the general population (75%) and its use
could avoid 32% of liver biopsies if it were interpreted in detail in
nephrology patients.”
FRIEDRICH-RUST ET AL, NONINVASIVE ASSESSMENT OF LIVER FIBROSIS IN PATIENTS WITH FONTAN CIRCULATION USING TRANSIENT ÉLASTOGRAPHIE AND BIOCHEMICAL FIBROSIS MARKERS, J THORAC CARDIOVASC SURG 2008
“The present study shows that patients who undergo the Fontan procedure are at increased risk of developing liver fibrosis and liver cirrhosis. The risk increases with the age of the patient and the time interval since the Fontan procedure. The noninvasive measurement of liver fibrosis using transient elastography and fibrosis marker scores can be a useful tool to identify patients at risk and for noninvasive surveillance”
Variability
Halfon
P. et al; A prospective assessment of the inter-laboratory variability
of biochemical markers of fibrosis (FibroTest) and activity (ActiTest)
in patients with chronic liver disease; Comparative Hepatology 2002
“The
variability of FibroTest and ActiTest was acceptable without clinical
consequences for the prediction of the stage of liver fibrosis and
grade of activity. Standardized methods and assay calibration should be
used and expression of alanine aminotransferase and γ-glutamyl
transpeptidase in multiples of the upper limit of reference values
should not be employed.”
Munteanu
M. et al; Intra-individual fasting versus postprandial variation of
biochemical markers of liver fibrosis (FibroTest) and activity
(ActiTest); Comparative Hepatology 2004
“ The intra-individual variation of biochemical markers was low, and it
was shown that measurements of FibroTest, ActiTest and their components
are not significantly modified by meal intake. This fact makes the
screening of patients at risk of chronic liver diseases more
convenient.”
Imbert-Bismut
F. et al; Intra-laboratory analytical variability of biochemical
markers of fibrosis FibroTest) and activity (ActiTest) and reference
ranges in healthy blood donors; Clinical chemistry 2004
“
In conclusion, Fibrotest and Actitest are easily available biological
markers for fibrosis and activity lesions that can be used as
alternatives, or in addition, to liver biopsy for the follow-up of
patients with hepatitis C. Their intra-laboratory analytical
variability is low and the worldwide improvement in transferability of
biochemical parameter results will enhance Fibrotest and Actitest
reliability in the immediate future.”
Versus other non-invasive tests
Le
Calvez S. et al; The predictive values of FibroTest vs. APRI for
fibrosis diagnosis in patients with chronic hepatitis C; Hepatology
2004
“(…) In
conclusion, these comparisons suggest that FibroTest provides a more
accurate estimate of HCV-related fibrosis than the Wai indexes”
Poynard T. et al; Biomarkers of liver fibrosis; in Press
“Practices
are evolving rapidly and in France a nationwide survey recently found
that among 546 hepatologists, 81% used non-invasive biomarker
(FibroTest™-ActiTest™) (FT-AT) and 32% used elastography (Fibroscan™)
(FS), with a dramatic decrease in the use of liver biopsy for more than
50% of patients with chronic hepatitis C, and with a subsequent
increase in the number of patients treated ”
Thabut D. et al; Non-invasive prediction of fibrosis in patients with chronic hepatitis C; Hepatology 2003
“
In conclusion, this retrospective comparison suggests that the
Fibrotest provides a more accurate estimate of HCV-related fibrosis
than the index of Forns et al.1 Prospective comparisons in additional
centers are warranted to confirm this finding.”
Hilleret
M.N. et al; Diagnostic accuracy of MP3 score compared to hyaluronate
and FibroTest for evaluating liver fibrosis in chronic hepatitis B
“
Our results confirm that MP3, HA and FT have a good accuracy in HBV
infection in predicting extensive fibrosis, especially when used in
combination. They could be especially usefull in management of inactive
carriers who might have cirrhosis. Diagnostic performance seems to be
lower in discriminating mild vs moderate fibrosis than that observed in
HCV infection.”
Myers R. et al; Biochemical markers of fibrosis in patients with chronic hepatitis C; Digestive Diseases ans Sciences 2003
“
In conclusion, an index of five biochemical markers accurately predicts
significant hepatitis C-related fibrosis and is superior to traditional
markers.”
Callewaert
N. et al; Non-invasive diagnosis of liver cirrhosis using DNA
sequencer-based total serum protein glycomics; Nature medicine 2004
“Additional
Serum markers with high sensivity are therefore required. In this study
we used FibroTest to complement our new GlycoCirrhoTest, and show that
the combination of both biomarkers can achieve the desired >95%
specificity with high sensivity”
Castera
L. et al; Prospective comparison of transient Elastography, FibroTest,
Apri and liver biopsy for the assessment of fibrosis in chronic
hepatitis C; Gastroenterology 2005
“
FibroScan� is a simple and effective method for assessing liver
fibrosis, with similar performance to FibroTest� and APRI. Combined use
of FibroScan� and FibroTest� to evaluate liver fibrosis could avoid
biopsy in most patients with chronic hepatitis C.”
Adams
A. et al; Hepascore: an accurate validated predictor of liver fibrosis
in chronic hepatitis C infection; Clinical chemistry 2005
“
A model of 4 serum markers plus age and sex provides clinically useful
information regarding different fibrosis stages among hepatitis C
patients.”
Test’s parameters
F�rard
G. et al; Inter-method calibration of alanine aminotransferase (ALT)
and gama glutamyltransferase (GGT) results: application to FibroTest
and ActiTest scores; Clinical chemistry 2006
“ For each enzyme, it also permitted the retention of a common reference interval for a set of calibrated methods and the
improvement of inter-laboratory coherency of Fibrotest and Actitest scores.”
As universal Biomarker
Morra R et al; FibroMax: towards a new universal biomarker of liver disease?, Future drugs 2007
“They
allow a quantitative assessment of both fibrosis and steatosis and,
according to the cause of liver disease, an assessment of the
necroinflammatory histological activity. (…) These tests, which are now
available worldwide, can facilitate the screening and management of
fibrotic liver diseases including Hepatitis B, hepatitis C, AFLD and
NAFLD”
SteatoTest®
Poynard T. et al; The diagnostic value of biomarkers (SteatoTest) for the prediction of liver steatosis.; CompHepatol 2005
“
SteatoTest is a simple and non-invasive quantitative estimate of liver
steatosis and may reduce the need for liver biopsy, particularly in
patients with metabolic risk factor.”
NashTest®
Poynard
T. et al; Diagnostic value of biochemical markers (NashTest) for the
prediction of NASH in patients with non-alcoholic fatty liver disease,
BMC Gastroenterology 2006
“In
patients with non-alcoholic fatty liver disease, NashTest, a simple and
non-invasive biomarker reliably predicts the presence or absence of
NASH.”
AshTest®
Thabut
D. et al; The diagnostic value of biomarkers (AshTest) for the
prediction of alcoholic steato-hepatitis in patients with chronic
alcoholic liver disease, Journal of hepatology 2006
“In
heavy drinkers, AshTest is a simple and non-invasive quantitative
estimate of alcoholic hepatitis. The use of AshTest may reduce the need
for liver biopsy, and therefore allow an earlier treatment of alcoholic
hepatitis.”