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Test Code BLOD1457 FibroTest-ActiTest, Serum

Additional Codes

Mayo Test Code: FIBRO


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)

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

Reject Due To

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

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

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

Performing 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. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

81596

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)