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Test ID FIBRO FibroTest-ActiTest, Serum


Shipping Instructions


 



Necessary Information


Age and sex are required.



Specimen Required


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.


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: Nephelometry

HAPTF: Nephelometry

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

GGTF: Photometric Rate

TBILF: Photometric, Diazonium Salt (DPD)

Reporting Name

FibroTest-ActiTest, S

Specimen Type

Serum

Specimen 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

 

 

ALANINEAMINOTRANSFERASE (ALT)

Males

<12 months: No established reference values

≥1 year: 7-55 U/L

 

Females

<12 months: No established reference values

≥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

≥18 years: ≥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

≥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: <15.0 mg/dL

15 days to 17 years: ≤1.0 mg/dL

≥18 years: ≤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  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

Day(s) and Time(s) Performed

HAPTF, A2MF: Monday through Saturday; 3 p.m.

ALTF, GGTF, TBILF: Monday through Sunday; Continuously

APOAF: Monday through Saturday; Continuously

Analytic Time

1 day

Test Classification

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 U.S. Food and Drug Administration.

CPT Code Information

81596

 

OR

82172

83883

83010

84460

82977

82247

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 1 of the following forms with the specimen:

-General Request (T239)

-Gastroenterology and Hepatology Client Test Request (T728)