NASH FibroSure

Message

This test needs to be ordered as a SENT test, it will be sent to Mayo as of 8.15.2022, Mayo test code is NSFIB
Quest is no longer performing NASH testing 39821 was discontinued on 8.15.2022.

NECESSARY INFORMATION

Age and sex are required.

Test Code

NASH

Preferred Specimen

Both serum and plasma are required for this test.
Specimen Type: Serum
Supplies: Sarstedt 5 mL Aliquot Tube (Amber) (T915)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Amber vial
Specimen Volume: 4 mL

Specimen Type: Plasma
Collection Container/Tube: Grey top (potassium oxalate/sodium fluoride)
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL

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

Instructions

Serum
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.

Plasma
Collection Instructions:
1. Centrifuge and aliquot plasma into plastic vial.
2. Label specimen as plasma.

Specimen Stability

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 Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

REJECT DUE TO

Gross hemolysis	Reject
Gross lipemia	Reject
Gross icterus	Reject
Patients <14 years of age	Reject

Methodology
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 (DPD)
ASTF: Photometric Rate, L-Aspartate with Pyridoxyl-5-Phosphate
CHOLF, TRIGF: Enzymatic Colorimetric
GLURF: Photometric, Hexokinase

Reference Range

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
< or =18 years: 178-495 mg/dL
>18 years: 100-280 mg/dL

ALANINE AMINOTRANSFERASE (ALT)
Males
<12 months: Not established
> or =1 year: 7-55 U/L

Females
<12 months: Not established
> or =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
> or =18 years: > or =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
> or =18 years: > or =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
> or =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
> or =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: < or =1.0 mg/dL
> or =18 years: < or =1.2 mg/dL

ASPARTATE AMINOTRANSFERASE (AST)
Males
0-11 months: Not established
1-13 years: 8-60 U/L
> or =14 years: 8-48 U/L

Females
0-11 months: Not established
1-13 years: 8-50 U/L
> or =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: > or =240 mg/dL

TRIGLYCERIDES
Normal: <150 mg/dL
Borderline High: 150-199 mg/dL
High: 200-499 mg/dL
Very High: > or =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: > or =200 mg/dL

TRIGLYCERIDES
2-9 years
Acceptable: <75 mg/dL
Borderline High: 75-99 mg/dL
High: > or =100 mg/dL

10-17 years
Acceptable: <90 mg/dL
Borderline High: 90-129 mg/dL
High: > or =130 mg/dL
For SI unit Reference Values, see www.mayocliniclabs.com/order-tests/si-unit-conversion.html

GLUCOSE FASTING
0-11 months: Not established
> or =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 Significance

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

Performing Laboratory
Mayo

Additional Information
Mayo NSFIB

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.