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


Necessary Information


Age and sex are required.



Specimen Required


Both serum and plasma are required for this test.

 

Patient Preparation: Fasting for 12 hours or more is required

Specimen Type: Serum

Supplies: Amber Frosted Tube, 5 mL (T192)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Amber vial (T192)

Specimen Volume: 4 mL

Collection Instructions:

1. Centrifuge and aliquot 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

Container/Tube: Grey top (potassium oxalate/sodium fluoride)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Centrifuge and aliquot plasma

2. Label specimen as plasma


Forms

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

Secondary ID

604200

Useful For

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

 

Estimating hepatic fibrosis

 

Assessing inflammation for metabolic diseases. It is interpretable for 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 Yes, (Order GLUCF) Yes

Testing Algorithm

This test is a patented test algorithm developed by BioPredictive. It combines 10 standard biomarkers: gamma-glutamyltransferase (GGT), total bilirubin, alpha-2-macroglobulin, apolipoprotein A1, haptoglobin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol, triglycerides, and fasting glucose. These markers are weighted depending on the patient's age and gender.

 

Testing is compliant with BioPredictive's technical recommendations and approvals.

Method Name

INTNS: 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)

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

CHOLF:  Enzymatic Colorimetric

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
Plasma NaFl-KOx Refrigerated (preferred) 7 days
  Frozen  14 days
  Ambient  7 days
Serum Refrigerated (preferred) 7 days
  Frozen  14 days
  Ambient  24 hours

Reject Due To

Hemolysis

Mild reject; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

Mild OK; Gross reject

Other

Patients <14 years of age; non-fasting; Serum: not light protected

Clinical Information

This test estimates the three 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 gender 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

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

 

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 (total cholesterol, triglycerides, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL] cholesterol, and non-HDL cholesterol) in adults ages 18 and up:

 

TOTAL CHOLESTEROL

Desirable: <200 mg/dL

Borderline high: 200-239 mg/dL

High: ≥240 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 (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, and non-HDL cholesterol) 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

The National Lipid Association and the National Cholesterol Education Program (NCEP) have set the following guidelines for lipids (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, and Non HDL cholesterol) in adults ages 18 and up:

 

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 (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, and non-HDL cholesterol) in children ages 2 to 17:

 

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

For SI unit Reference Values, see https://www.mayocliniclabs.com/order-tests/si-unit-conversion.html

 

GLUCOSE FASTING

0-11 months: not established

≥1 year: 70-100 mg/dL

Interpretation

This test provides numeric scores that assess hepatic fibrosis (FibroTest), hepatic inflammation (NashTest 2), and steatosis (SteatoTest 2). Interpretation of the scores is provided in the report. Individual results from the 10 component tests are also provided with institution-specific reference intervals.

 

FibroTest 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 (cirrhosis)). Fibrosis scores may overlap (eg, F0/F1, F1/F2).

 

NashTest 2 is reported relative to a scale ranging from N0-N3 (N0=no nonalcoholic steatohepatitis: NASH, N1=mild NASH, N2=moderate NASH, N3=severe NASH).

 

Steatosis is reported relative to a scale ranging from S0-S2S3 (S0=no steatosis (<5%), S1=mild steatosis (5-33%), S2/S3=moderate/severe steatosis (34-100%). A stage of S1 or S2S3 is considered clinically significant.

Cautions

The tests have to be deferred for: acute hemolysis, acute hepatitis, acute inflammation, extra hepatic cholestasis.

 

The advice of a specialist should be sought for interpretation in chronic hemolysis or Gilbert syndrome.

 

The test interpretation is not validated in liver transplant patients.

 

Isolated extreme values of 1 of the components should lead to caution in interpreting the results.

In case of discordance between a biopsy result and a test, it is recommended to seek the advice of a specialist. The causes of these discordances could be due to a flaw of the test or to a flaw in the biopsy: ie, a liver biopsy has a 33% variability rate for one fibrosis stage.

 

NashTest 2 is set to N0 is the absence of steatosis based on the definition of nonalcoholic steatohepatitis (NASH). SteatoTest 2 scores of less than 0.40 (S0) will default NashTest 2 to N0.

Clinical Reference

1. BioPredictive: Technical Recommendations for FibroTest, FibroMax, and NASH-FibroTest assays, Bio Predictive, Saint Germain, Paris France. Version 3.0

2. Poynard T, Peta V, Munteanu M, et al: The diagnostic performance of a simplified blood test (SteatoTest-2) for the prediction of liver steatosis. Eur J Gastroenterol and Hepatol. 2019 Mar;31(3)393-402

3. Munteanu M, Pais R, Peta V, et al: Long term prognostic value of the FibroTest in patients with non-alcoholic fatty liver disease, compare to chronic hepatitis C, B, and alcoholic liver disease. Aliment Pharmacol Ther 2018:48:1117-1127

4. Poynard T. Munteanu M, Charlotte F, et al: Diagnostic performance of a new noninvasive test for nonalcoholic steatohepatitis using a simplified histological reference. Eur J Gastroenterol and Hepatol. 2018 May;30(5):569-577

5. Poynard T, Munteanu M, Charlotte F, et al: Impact of steatosis and inflammation definitions on the performance of NASH tests. Eur J Gastroenterol Hepatol. 2018 Apr;30(4):384-391

6. Munteanu M, Tiniakos D, Anstee Q, et al: Diagnostic performance of FibroTest, SteatoTest and ActiTest in patients with NAFLD using the SAF score as histological reference. Aliment Pharmacol Ther. 2016 Oct;44(8):877-889

7. Vilar-Gomez E, Chalasani N: Non-invasive assessment of non-alcoholic fatty liver disease: Clinical prediction rules and blood-based biomarkers. J Hepatol 2018 Feb;68(2):305-315

8. Ratziu V, Charlotte F, Heurtier A, Gombert S, et al: Sampling variability of liver biopsy in nonalcoholic liver disease. Gastroenterology 2005 Jun;128(7):1898-1906

Day(s) and Time(s) Performed

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

ALTF, GGTF, TBILF, ASTF, CHOLF, TRIGF, GLURF: Monday through Sunday; Continuously

APOAF: Monday through Saturday; Continuously

Analytic Time

1 day

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

0003M

LOINC Code Information

Test ID Test Order Name Order LOINC Value
NSFIB NASH-FibroTest In Process

 

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
GLURF Glucose, Fasting, P 1558-6
TRIGF Triglycerides, S 2571-8
CHOLF Cholesterol, Total, S 2093-3
ASTF Aspartate Aminotransferase (AST), S 30239-8
SCRF FibroTest Score In Process
STGF FibroTest Stage In Process
INTEF FibroTest Interpretation In Process
SCRN2 NashTest 2 Score In Process
GRDN NashTest 2 Grade In Process
INTEN NashTest 2 Interpretation In Process
SCRS2 SteatoTest 2 Score In Process
GRDS SteatoTest 2 Grade In Process
INTEI SteatoTest 2 Interpretation In Process
CMMS NASH-FibroTest Comment 48767-8
NUM BioPredictive Serial Number In Process

NY State Approved

Yes