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HelpTest ID: FIBRO FibroTest-ActiTest, Serum
Necessary Information
Age and sex are required.
Specimen Required
Supplies: Amber Frosted Tube, 5 mL (T915)
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 into an amber vial 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.
Useful For
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
| 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
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
INTF: Algorithm and Interpretation Provided through BioPredictive
APOAF: Automated Turbidimetric Immunoassay
A2MF, HAPTF: Nephelometry
ALTF: Photometric Rate, L-Alanine with Pyridoxal-5-Phosphate
GGTF: Photometric Rate
TBILF: Photometric, Diazonium Salt
Reporting Name
FibroTest-ActiTest, SSpecimen Type
SerumSpecimen Minimum Volume
1.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 7 days | LIGHT PROTECTED |
| Frozen | 14 days | LIGHT PROTECTED | |
| Ambient | 24 hours | LIGHT PROTECTED |
Clinical Information
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
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
≤18 years: 178-495 mg/dL
>18 years: 100-280 mg/dL
ALANINE AMINOTRANSFERASE (ALT)
Males
<12 months: Not established
≥1 year: 7-55 U/L
Females
<12 months: Not established
≥1 year: 7-45 U/L
APOLIPOPROTEIN A1
Males
<24 months: Not established
2-17 years
Low: <115 mg/dL
Borderline low: 115-120 mg/dL
Acceptable: >120 mg/dL
≥18 years: ≥120 mg/dL
Females
<24 months: Not established
2-17 years
Low: <115 mg/dL
Borderline low: 115-120 mg/dL
Acceptable: >120 mg/dL
≥18 years: ≥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
≥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
≥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: 0.0-14.9 mg/dL
15 days-17 years: 0.0-1.0mg/dL
≥18 years: 0.0-1.2 mg/dL
Interpretation
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).
Clinical Reference
1. BioPredictive. Technical Recommendations for FibroTest and FibroMax assays, Bio Predictive. Accessed September 19, 2023. 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;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;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;22(4):474-480. doi:10.1097/MEG.0b013e328332dd0a
5. MartÃnez SM, Crespo G, Navasa M, Forns X. Noninvasive assessment of liver fibrosis. Hepatology. 2011;53(1):325-335. doi:10.1002/hep.24013
Day(s) Performed
HAPTF, A2MF: Monday through Saturday
ALTF, GGTF, TBILF: Monday through Sunday
APOAF: Monday through Saturday
Report Available
2 to 5 daysTest Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
81596
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| FIBRO | FibroTest-ActiTest, S | 48796-7 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 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 |
Forms
If not ordering electronically, complete, print, and send Gastroenterology and Hepatology Test Request (T728) with the specimen
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