Test Catalog

Test Id : FIBRO

FibroTest-ActiTest, Serum

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluating hepatic fibrosis in chronic hepatitis C patients

 

Diagnosing fibrosis in carriers of chronic hepatitis B virus

 

Evaluating hepatic fibrosis in co-infected HIV carriers

 

Providing access to new-generation non-interferon treatment for hepatitis

 

Evaluating fibrosis in patients suffering from metabolic conditions (nonalcoholic fatty liver disease) and patients who consume excess alcohol

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test Id Reporting Name Available Separately Always Performed
INTF FibroTest-ActiTest, Interpretation No Yes
APOAF Apolipoprotein A1, S No Yes
A2MF Alpha-2-Macroglobulin, S Yes, (Order A2M) Yes
HAPTF Haptoglobin, S Yes, (Order HAPT) Yes
ALTF Alanine Aminotransferase (ALT), S Yes, (Order ALT) Yes
GGTF Gamma Glutamyltransferase (GGT), S Yes, (Order GGT) Yes
TBILF Bilirubin, Total, S Yes, (Order BILIT) Yes

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

This test is a patented test algorithm developed by BioPredictive. FibroTest combines 5 standard biomarkers (gamma-glutamyltransferase, total bilirubin, alpha-2-macroglobulin, apolipoprotein A1, and haptoglobin). The ActiTest adds a marker for inflammatory activity (alanine aminotransferase: ALT). These markers are weighted depending on the patient's age and gender.

 

Testing is compliant with BioPredictive's technical recommendations and approvals.

Method Name
A short description of the method used to perform the test

INTF: Algorithm and interpretation provided through BioPredictive.

APOAF: Automated Turbidimetric Immunoassay

A2MF: Nephelometry

HAPTF: Nephelometry

ALTF: Photometric Rate, L-Alanine with Pyridoxal-5-Phosphate

GGTF: Photometric Rate

TBILF: Photometric, Diazonium Salt (DPD)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

FibroTest-ActiTest, S

Aliases
Lists additional common names for a test, as an aid in searching

HCV FibroSure, Liver Fibrosis

Hepatic Fibrosis

Hepatic Inflammation

Hepatitis

Liver Inflammation

Chronic Hepatitis C

Chronic Hepatitis B

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

This test is a patented test algorithm developed by BioPredictive. FibroTest combines 5 standard biomarkers (gamma-glutamyltransferase, total bilirubin, alpha-2-macroglobulin, apolipoprotein A1, and haptoglobin). The ActiTest adds a marker for inflammatory activity (alanine aminotransferase: ALT). These markers are weighted depending on the patient's age and gender.

 

Testing is compliant with BioPredictive's technical recommendations and approvals.

Specimen Type
Describes the specimen type validated for testing

Serum

Necessary Information

Age and sex are required.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Amber Frosted Tube, 5 mL (T192)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Amber vial

Specimen Volume: 3 mL

Collection Instructions:

1. Centrifuge and aliquot serum within 2 hours of collection.

2. Centrifuged serum must be light protected within 4 hours of collection. It is acceptable to draw the blood and then protect it from light after centrifugation as long as it is within 4 hours of collection.

Forms

If not ordering electronically, complete, print, and send Gastroenterology and Hepatology Client Test Request (T728) with the specimen

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

1.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject
Patients <2 years of age Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 7 days LIGHT PROTECTED
Frozen 14 days LIGHT PROTECTED
Ambient 24 hours LIGHT PROTECTED

Useful For
Suggests clinical disorders or settings where the test may be helpful

Evaluating hepatic fibrosis in chronic hepatitis C patients

 

Diagnosing fibrosis in carriers of chronic hepatitis B virus

 

Evaluating hepatic fibrosis in co-infected HIV carriers

 

Providing access to new-generation non-interferon treatment for hepatitis

 

Evaluating fibrosis in patients suffering from metabolic conditions (nonalcoholic fatty liver disease) and patients who consume excess alcohol

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

This test is a patented test algorithm developed by BioPredictive. FibroTest combines 5 standard biomarkers (gamma-glutamyltransferase, total bilirubin, alpha-2-macroglobulin, apolipoprotein A1, and haptoglobin). The ActiTest adds a marker for inflammatory activity (alanine aminotransferase: ALT). These markers are weighted depending on the patient's age and gender.

 

Testing is compliant with BioPredictive's technical recommendations and approvals.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Fibrosis and inflammatory activity are the 2 main causes of liver disease.

 

FibroTest-ActiTest estimates the levels of fibrosis and cirrhosis in the liver as well as the level of necroinflammatory activity. The estimation is made by measuring 6 standard serum biomarkers (gamma-glutamyl transferase, total bilirubin, alpha-2-macroglobulin, apolipoprotein A1, haptoglobin, and alanine aminotransferase). The activity score is a measure of liver inflammation caused by disease. Results from these tests are combined with the patient’s age and sex to estimate hepatic fibrosis and inflammatory activity scores.

 

Hepatic fibrosis is typically compared to a form of scar tissue that progresses throughout the liver. The most serious stage of fibrosis is known as cirrhosis.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

FibroTest-ActiTest, Interpretation

 

FibroTest Score

Stage

Interpretation

0.00-0.21*

F0

No fibrosis

0.21-0.27*

F0-F1

No fibrosis

0.27-0.31*

F1

Minimal fibrosis

0.31-0.48*

F1-F2

Minimal fibrosis

0.48-0.58*

F2

Moderate fibrosis

0.58-0.72*

F3

Advanced fibrosis

0.72-0.74*

F3-F4

Advanced fibrosis

0.74-1.00

F4

Severe fibrosis (Cirrhosis)

*Boundary values can apply to 2 stages based on rounding. For example, a FibroTest score of 0.305 will round up to 0.31 and be staged F1. A FibroTest score of 0.314 will round down to 0.31 and be staged F1-F2.

 

ActiTest Score

Grade

Interpretation

0.00-0.17*

A0

No activity

0.17-0.29*

A0-A1

No activity

0.29-0.36*

A1

Minimal activity

0.36-0.52*

A1-A2

Minimal activity

0.52-0.60*

A2

Significant activity

0.60-0.62*

A2-A3

Significant activity

0.62-0.100

A3

Severe activity

*Boundary values can apply to 2 grades based on rounding. For example, an ActiTest score of 0.285 will round up to 0.29 and be graded A0-A1. An ActiTest score of 0.294 will round down to 0.29 be graded A1.

 

ALPHA-2-MACROGLOBULIN

< or =18 years: 178-495 mg/dL

>18 years: 100-280 mg/dL

 

 

ALANINEAMINOTRANSFERASE (ALT)

Males

<12 months: No established reference values

> or =1 year: 7-55 U/L

 

Females

<12 months: No established reference values

> or =1 year: 7-45 U/L

 

APOLIPOPROTEIN A1

Males

<24 months: No established reference values

2-17 years

Low: <115 mg/dL

Borderline low: 115-120 mg/dL

Acceptable: >120 mg/dL

> or =18 years: > or =120 mg/dL

 

Females

<24 months: No established reference values

2-17 years

Low: <115 mg/dL

Borderline low: 115-120 mg/dL

Acceptable: >120 mg/dL

> or =18 years: > or =140 mg/dL

 

GAMMA-GLUTAMYLTRANSFERASE (GGT)

Males

0-11 months: <178 U/L

12 months-6 years: <21 U/L

7-12 years: <24 U/L

13-17 years: <43 U/L

> or =18 years: 8-61 U/L

 

Females

0-11 months: <178 U/L

12 months-6 years: <21 U/L

7-12 years: <24 U/L

13-17 years: <26 U/L

> or =18 years: 5-36 U/L

 

HAPTOGLOBIN

30-200 mg/dL

 

BILIRUBIN, TOTAL

0-6 days: Refer to www.bilitool.org for information on age-specific (postnatal hour of life) serum bilirubin values.

7-14 days: <15.0 mg/dL

15 days to 17 years: < or =1.0 mg/dL

> or =18 years: < or =1.2 mg/dL

Interpretation
Provides information to assist in interpretation of the test results

FibroTest-ActiTest provides a score that assesses hepatic fibrosis (F0-F4) and a score that assesses hepatic inflammatory activity (A0-A3). Interpretation of the score is provided in the report. Individual results from the 6 component tests are also provided with institution-specific reference intervals.

 

Fibrosis is reported relative to a scale ranging from F0-F4 (F0=no fibrosis, F1=minimal fibrosis, F2=moderate fibrosis, F3=advanced fibrosis, F4=severe fibrosis). Fibrosis scores may overlap (eg, F0/F1, F1/F2).

 

Activity is reported relative to a scale ranging from A0-A3 (A0=no activity, A1=minimal activity, A2=significant activity, A3=severe activity). Activity scores may overlap (eg, A0/A1, A1/A2).

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Defer the test in transient situations that could modify the components of FibroTest-ActiTest, such as:

-Acute hemolysis, which could decrease haptoglobin and increase unconjugated bilirubin

-Acute hepatitis, whether drug-induced, viral (superinfection by hepatitis A virus: HAV, hepatitis B virus: HBV, Epstein-Barr virus: EBV), or autoimmune. Massive hepatic necrosis leads to a large increase of transaminases and total bilirubin.

-Acute inflammation, as with concomitant bacterial or acute viral infection: bronchopulmonary or urinary tract infection. The large increase of haptoglobin can lead to false-negative results.

-Extrahepatic cholestasis, such as gallstones

 

The advice of a liver disease specialist should be sought for interpretation in chronic states in which the components of the test could be modified, such as chronic hemolysis, particularly in patients with a cardiac valvular prosthesis; Gilbert disease; protease inhibitors used in HIV treatment, which can increase unconjugated bilirubin (Indinavir, Atazanavir); or gamma glutamyltransferase (GGT) and alanine aminotransferase (Ritonavir).

 

The interpretation of FibroTest has been validated in renal transplant patients. In patients with renal insufficiency or who are on dialysis, FibroTest had an acceptable diagnostic value, though lower than in transplanted patients.

 

As a general rule, isolated extreme values of 1 of the 6 components should signal caution in interpreting the results, particularly in the following cases:

-Haptoglobin below 12 mg/dL, in which hemolysis or anhaptoglobinemia (more frequent in western African patients) must be ruled out.

-Haptoglobin above 320 mg/dL, in which acute inflammation must be ruled out.

-Transaminases above 622 IU/L, in which acute hepatitis must be ruled out.

-Bilirubin above 1.75 mg/dL and GGT below 50 IU/L, in which Gilbert syndrome must be suspected.

-Alpha2-macroglobulin above 590 mg/dL

 

In case of discordance between a biopsy result and a FibroTest result, it is advisable to seek the advice of a liver disease specialist.

 

Haptoglobin is an acute-phase reactant and increases with inflammation or tissue necrosis. Low haptoglobin is normal for the first 3 to 6 months of life; testing is not performed on patients younger than 2 years-old per BioPredictive.

 

GGT activity is inducible by drugs such as phenytoin and phenobarbital and, therefore, elevations should not be considered indicative of liver disease until drug use is ruled out. Elevations are also seen after ingestion of alcoholic beverages. In very rare cases, gammopathy, in particular, type IgM (Waldenstrom macroglobinemia) may cause unreliable results.

 

Bilirubin specimens should be protected from light and analyzed as soon as possible. Grossly hemolyzed specimens should be rejected because hemoglobin inhibits the diazo reaction and falsely decreased results may be seen. Compounds that compete for binding sites on serum albumin contribute to lower serum bilirubin levels (eg, penicillin, sulfisoxazole, acetylsalicylic acid).

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. BioPredictive: Technical Recommendations for FibroTest and FibroMax assays, Bio Predictive. Accessed  February 2018. Available at biopredictive.com/products/fibromax/

2. Halfon P, Bourliere M, Deydier R, et al: Independent prospective mulitcenter validation of biochemical markers (FibroTest-ActiTest) for the prediction of liver fibrosis and activity in patients with chronic hepatitis C: the fibropaca study. Am J Gastroenterol. 2006 Mar;101(3):547-555. doi: 10.1111/j.1572-0241.2006.00411.x

3. Houot M, Ngo Y, Munteanu M, Marque S, Poynard T: Systematic review with meta-analysis: direct comparisons of biomarkers for the diagnosis of fibrosis in chronic hepatitis C and B. Aliment Pharmacol Thera. 2016 Jan;43:16-29. doi: 10.1111/apt.13446

4. Anastasiou J, Alisa A, Virtue S, Portmann B, Murray-Lyon I, Williams R: Noninvasive markers of fibrosis and inflammation in clinical practice: prospective comparison with liver biopsy. Eur J Gastroenterol Hepatol. 2010 Apr;22(4):474-480. doi: 10.1097/MEG.0b013e328332dd0a

5. Martínez SM, Crespo G, Navasa M, Forns X: Noninvasive assessment of liver fibrosis. Hepatology. 2011 Jan;53(1):325-335. doi: 10.1002/hep.24013

Method Description
Describes how the test is performed and provides a method-specific reference

FibroTest-ActiTest, Interpretation:

Proprietary algorithm owned by BioPredictive.

 

Alpha-2-Macroglobulin and Haptoglobin:

In this method, the light scattered onto the antigen-antibody complexes is measured. The intensity of the measured scattered light is proportional to the amount of antigen-antibody complexes in the sample under certain conditions. If the antibody volume is kept constant, the signal behaves proportionally to the antigen volume.

 

A reference curve is generated by a standard with a known antigen content on which the scattered light signals of the samples can be evaluated and calculated as an antigen concentration. Antigen-antibody complexes are formed when a sample containing antigen and the corresponding antiserum are put into a cuvette. A light beam is generated with a light-emitting diode, which is transmitted through the cuvette. The light is scattered onto the immuno-complexes that are present. Antigen and antibody are mixed in the initial measurement, but no complex is formed yet. An antigen-antibody complex is formed in the final measurement.

 

The result is calculated by subtracting value of the final measurement from the initial measurement. The distribution of intensity of the scattered light depends on the ratio of the particle size of the antigen-antibody complexes to the radiated wavelength.(Unpublished Mayo method; Instruction manual: Siemens Nephelometer II, Siemens, Inc; Version 2.3. 2008; Addendum to the Instruction Manual 2.3, 08/2017)

 

Alanine Aminotransferase (ALT):

Alanine a minotransferase (ALT) activity is determined by a kinetic method using a coupled enzyme reaction where the rate of NADH consumption is measured at 340 nm. The NADH decrease is directly proportional to the ALT activity.(Package insert: Roche ALT reagent. Roche Diagnostics; 2018)

 

Apolipoprotein A1:

Anti-apolipoprotein A-1 antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, can be measured turbidimetrically.(Package insert: Tina-quant Apolipoprotein A-1. Roche Diagnostics; 2019)

 

Gamma-Glutamyltransferase (GGT):

This is an enzyme colorimetric method (rate method) where gamma-glutamyltransferase (GGT) transfers the gamma-glutamyl group of the substrate (L-gamma-glutamyl-3-carboxy-4-nitroanilide) to glycylglycine. The amount of 5-amino-2-nitrobenzoate liberated is proportional to the GGT activity and can be determined photometrically.(Package insert: Boehringer Mannheim GGT reagent. Boehringer Mannheim; 2017)

 

Bilirubin, Total:

Total bilirubin, in the presence of a suitable solubilizing agent, is coupled with 3,5-dichlorophenyl diazonium in a strongly acidic medium. The color intensity of the red azo dye formed is directly proportional to the total bilirubin and can be determined photometrically.(Package insert: Bilirubin Total Gen. 3. Roche Diagnostics; 2019)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

HAPTF, A2MF: Monday through Saturday

ALTF, GGTF, TBILF: Monday through Sunday

APOAF: Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 5 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

81596

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
FIBRO FibroTest-ActiTest, S 48796-7
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
TBILF Bilirubin, Total, S 1975-2
ALTF Alanine Aminotransferase (ALT), S 1743-4
A2MF Alpha-2-Macroglobulin, S 1835-8
APOAF Apolipoprotein A1, S 1869-7
GGTF Gamma Glutamyltransferase (GGT), S 2324-2
HAPTF Haptoglobin, S 46127-7
SCRF FibroTest Score 48795-9
STGF FibroTest Stage 48794-2
INTEF FibroTest Interpretation 88447-8
SCRA ActiTest Score 48792-6
STGA ActiTest Grade 48793-4
INTEA ActiTest Interpretation 88448-6
CMMF FibroTest-ActiTest Comment 48767-8
NUM BioPredictive Serial Number 74715-4
ERROR BioPredictive Analyte Error No LOINC Needed

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

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Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports