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Test Code NSFIB Nonalcoholic Steatohepatitis (NASH)-FibroTest, Serum and Plasma


Ordering Guidance


This test is not offered for patients younger than 14 years of age. Testing will be canceled if a specimen is received from a patient in this age group.



Necessary Information


Age and sex are required.



Specimen Required


Both serum and plasma are required for this test.

 

Patient Preparation: Fasting for at a minimum of 12 hours is required

 

Specimen Type: Serum

Supplies: Amber Frosted Tube, 5 mL (T915)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Amber vial

Specimen Volume: 4 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's within 4 hours of collection.

3. Label specimen as serum.

 

Specimen Type: Plasma

Collection Container/Tube: Gray top (potassium oxalate/sodium fluoride)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Centrifuge and aliquot plasma into plastic vial.

2. Label specimen as plasma.


Forms

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

Useful For

Diagnosis and the follow-up of liver fibrosis, steatosis, and inflammation

 

Estimating hepatic fibrosis

 

Assessing inflammation for metabolic diseases

 

Assessing severity of nonalcoholic steatohepatitis (NASH) in patients with nonalcoholic fatty liver disease with steatosis (NAFLD)

 

Assessing steatosis or fatty liver

 

Reassuring patients with steatosis only, without fibrosis

 

Managing patients with severe injuries such as advanced fibrosis and NASH

Profile Information

Test ID Reporting Name Available Separately Always Performed
INTNS NASH-FibroTest, 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
ASTF Aspartate Aminotransferase (AST), S Yes, (Order AST) Yes
CHOLF Cholesterol, Total, S Yes, (Order CHOL) Yes
TRIGF Triglycerides, S Yes, (Order TRIG) Yes
GLURF Glucose, Fasting, P No Yes

Method Name

INTNS: 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

ASTF: Photometric Rate, L-Aspartate with Pyridoxyl-5-Phosphate

CHOLF, TRIGF: Enzymatic Colorimetric

GLURF: Photometric, Hexokinase

Reporting Name

NASH-FibroTest

Specimen Type

Plasma NaFl-KOx
Serum

Specimen Minimum Volume

Serum: 2 mL
Plasma: 0.25 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Plasma NaFl-KOx Refrigerated (preferred) 7 days
  Frozen  14 days
  Ambient  7 days
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 <14 years of age Reject

Clinical Information

This test estimates the 3 elementary features of metabolic liver disease: steatosis, activity, and fibrosis. The estimation is made by measuring 10 standard serum biomarkers (gamma-glutamyl transferase, total bilirubin, alpha-2-macroglobulin, apolipoprotein A1, haptoglobin, alanine aminotransferase, aspartate aminotransferase, cholesterol, triglycerides, and fasting plasma glucose). Results from these tests are combined with the patient's age and sex to estimate hepatic fibrosis (FibroTest), steatosis (SteatoTest 2), and activity (NashTest 2) scores.

Reference Values

NASHTEST 2 INTERPRETATION

NashTest 2 score

Grade

Interpretation

0.00-0.25*

N0

No NASH

0.25-0.50*

N1

Mild NASH

0.50-0.75*

N2

Moderate NASH

0.75-1.00*

N3

Severe NASH

*Boundary values can apply to 2 stages based on rounding. For example, a NashTest 2 score of 0.245 will round up to 0.25 and be staged N0. A NashTest 2 score of 0.254 will round down to 0.25 and be staged N2.

 

STEATOTEST 2 INTERPRETATION

SteatoTest 2 score

Grade

Interpretation

0.00-0.40*

S0

No steatosis (<5%)

0.40-0.55*

S1

Mild steatosis (5-33%)

0.55-1.00*

S2

Moderate/severe steatosis (34-100%)

*Boundary values can apply to 2 stages based on rounding. For example, a SteatoTest 2 score of 0.395 will round up to 0.40 and be staged S0. A SteatoTest 2 score of 0.404 will round down to 0.40 and be staged S1.

 

FIBROTEST 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.

 

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 to 17 years: 0.0-1.0 mg/dL

≥18 years: 0.0-1.2 mg/dL

 

ASPARTATE AMINOTRANSFERASE (AST)

Males

0-11 months: Not established

1-13 years: 8-60 U/L

≥14 years: 8-48 U/L

 

Females

0-11 months: Not established

1-13 years: 8-50 U/L

≥14 years: 8-43 U/L

 

CHOLESTEROL, TOTAL

The National Lipid Association and the National Cholesterol Education Program (NCEP) have set the following guidelines for lipids in adults 18 years old and older:

 

TOTAL CHOLESTEROL

Desirable: <200 mg/dL

Borderline High: 200-239 mg/dL

High: ≥240 mg/dL

 

TRIGLYCERIDES

Normal: <150 mg/dL

Borderline High: 150-199 mg/dL

High: 200-499 mg/dL

Very High: ≥500 mg/dL

 

The Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents has set the following guidelines for lipids in children 2 to 17 years of age:

 

TOTAL CHOLESTEROL

Acceptable: <170 mg/dL

Borderline High: 170-199 mg/dL

High: ≥200 mg/dL

 

TRIGLYCERIDES

2-9 years

Acceptable: <75 mg/dL

Borderline High: 75-99 mg/dL

High: ≥100 mg/dL

 

10-17 years

Acceptable: <90 mg/dL

Borderline High: 90-129 mg/dL

High: ≥130 mg/dL

 

GLUCOSE FASTING

0-11 months: Not established

≥1 year: 70-100 mg/dL

Day(s) Performed

Monday through Friday

Report Available

2 to 4 days

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. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

0003M