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HelpTest 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
Specimen Volume: 4 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'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.
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 | 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-FibroTestSpecimen Type
Plasma NaFl-KOxSerum
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 |
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 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
≤18 years: 178-495 mg/dL
>18 years: 100-280 mg/dL
ALANINE AMINOTRANSFERASE (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.
Clinical Reference
1. BioPredictive: Technical Recommendations for FibroTest, FibroMax, and NASH-FibroTest assays, Bio Predictive. 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. doi: 10.1097/MEG.0000000000001304
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 Nov:48(10):1117-1127. doi: 10.1111/apt.14990
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. doi: 10.1097/MEG.0000000000001064
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. doi: 10.1097/MEG.0000000000001033
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. doi: 10.1111/apt.13770
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. doi: 10.1016/j.jhep.2017.11.013
8. Ratziu V, Charlotte F, Heurtier A, et al: Sampling variability of liver biopsy in nonalcoholic liver disease. Gastroenterology. 2005 Jun;128(7):1898-1906. doi: 10.1053/j.gastro.2005.03.084
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 dayTest 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 | 93691-4 |
| 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 | 48795-9 |
| STGF | FibroTest Stage | 48794-2 |
| INTEF | FibroTest Interpretation | 88447-8 |
| SCRN2 | NashTest 2 Score | 93692-2 |
| GRDN | NashTest 2 Grade | 93693-0 |
| INTEN | NashTest 2 Interpretation | 93694-8 |
| SCRS2 | SteatoTest 2 Score | 93695-5 |
| GRDS | SteatoTest 2 Grade | 93696-3 |
| INTEI | SteatoTest 2 Interpretation | 93697-1 |
| CMMS | NASH-FibroTest Comment | 48767-8 |
| NUM | BioPredictive Serial Number | 74715-4 |
mml-gi-liver-nafld-nash