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HelpTest Code FIBRO FibroTest-ActiTest, Serum
Additional Codes
Fibrosure
Hepatitis C Liver Status Biomarker Panel, 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 |
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 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test 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