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Test Code LABFNSUR NASH FibroSure

Additional Codes

Test Name in EPIC EPIC Test Code Mnemonic Mayo Test ID
NASH FIBROSURE LABFNSUR FNSUR FNSUR

 

Useful For

This test is a noninvasive assessment of liver status in patients with nonalcoholic fatty liver disease (NAFLD). Quantitative results of 10 biochemicals in combination with age, gender, height and weight are analyzed using a computational algorithm to provide a quantitative surrogate marker (0.0-1.0) of liver fibrosis (Metavir F0-F4), hepatic steatosis (0.0-1.0, S0-S3), and nonalcoholic steatohepatitis (NASH) (0.0-0.75, N0-N2). The absence of steatosis (S<0.38) precludes the diagnosis of NASH.

Method Name

FibroSURE

Reporting Name

NASH FibroSure

Specimen Type

Serum


Specimen Required


Patient Preparation: Fasting 8 hours

Specimen Type: Serum

Container/Tube: Red or SST

Specimen Volume: 3.5 mL

Collection Instructions: Draw blood in a plain red-top tube(s) or serum gel tube(s). Spin down and send 3.5 mL of serum in a plastic screw-capped vial. Ship frozen.

 

REQUIRED:

1.     Patients age

2.     Gender

3.     Height (in inches)

4.     Weight (in pounds)


Specimen Minimum Volume

2 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Frozen (preferred) 7 days
  Refrigerated  72 hours

Reject Due To

Hemolysis

Mild OK; Gross reject

Thawing

Warm reject; Cold OK

Lipemia

Mild OK; Gross reject

Icterus

N/A

Other

Improper labeling; nonfasting specimen; patients younger than 14 years of age

Reference Values

Fibrosis Score

0.00-0.21

 

Steatosis Score

0.00-0.30

 

NASH Score

0.25

 

Alpha2-Macroglobulins, Qn

110-276 mg/dL

 

Haptoglobin

34-200 mg/dL

 

Apolioprotein A-1

Females:

116-209 mg/dL

 

Males:

101-178 mg/dL

Bilirubin, Total

Adults:

0.0-1.2 mg/dL

GGT

Females:

0-60 IU/L

 

Males:

0-65 IU/L

ALT (SGPT) P5P

Females:

0-40 IU/L

 

Males:

0-55 IU/L

AST (SGOT) P5P

0-40 IU/L

 

Cholesterol, Total

100-199 mg/dL

 

Glucose, Serum

65-99 mg/dL

 

Triglycerides

0-149 mg/dL

 

 

Limitations:

NASH FibroSure is recommended for patients with suspected nonalcoholic fatty liver disease. It is not recommended for patient with other liver diseases. It is also not recommended in patients with Gilbert disease, acute hemolysis, acute viral hepatitis, drug induced hepatitis, genetic liver disease, autoimmune hepatitis and/or, extra-hepatic cholestasis. Any of these clinical situations may lead to inaccurate quantitative predictions of fibrosis.

Interpretation

Quantitative results of 10 biochemical in combination with age, gender, height, and weight, are analyzed using a computational algorithm to provide a quantitative surrogate marker (0.0-1.0) of liver fibrosis (Metavir F0-F4), hepatic steatosis (0.0-1.0, S0-S3), and Non-Alcoholic Steato-Hepatitis (NASH) (0.0-0.75, N0-N2). The absence of steatosis (S<0.38) precludes the diagnosis of NASH.

 

Fibrosis marker: In a study of 171 Non-Alcoholic Fatty Liver Disease (NAFLD) patients where 23% had significant NAFLD fibrosis (Metavir F2-F4) and 11% had cirrhosis by liver biopsy, a fibrosis result of >0.3 yielded a sensitivity of 83% and a specificity of 78% for the detection of significant fibrosis (1).


Steatosis Marker: In a population of 744 patients (583 HCV, 18 HBV, 69 NAFLD, and 74 alcoholic disease patients), where 36% had significant steatosis (>5%) on a liver biopsy, a steatosis score >0.5 had a sensitivity of 71% and a specificity of 72% for identification of significant steatosis (2).

 

NASH marker: In a population of 257 NAFLD patients, where 62% had at least some NASH by liver biopsy, a prediction of NASH had a sensitivity of 88% for identifying NASH and a specificity of 50% (3).

 

Fibrosis Scoring:

              <0.21 = Stage F0 - No fibrosis

            0.21 - 0.27 = Stage F0 - F1

            0.27 - 0.31 = Stage F1 - Portal fibrosis

            0.31 - 0.48 = Stage F1 - F2

            0.48 - 0.58 = Stage F2 - Bridging fibrosis with few septa

            0.58 - 0.72 = Stage F3 - Bridging fibrosis with many septa

            0.72 - 0.74 = Stage F3 - F4

            >0.74 = Stage F4 – Cirrhosis

 

Steatosis Grading

               <0.30 = S0 - No Steatosis

            0.30 to 0.38 = S0 – S1

            0.38 to 0.48 = S1 - Minimal Steatosis

            0.48 to 0.57 = S1 – S2

            0.57 to 0.67 = S2 – Moderate Steatosis

            0.67 to 0.69 = S2 – S3

                      >0.69 = S3 – Marked or Severe Steatosis

 

NASH Scoring

            0.25 = N0 - Not NASH

            0.50 = N1 - Borderline or probable NASH

            0.75 = N 2 - NASH

Day(s) and Time(s) Performed

Monday through Friday

Analytic Time

5 - 7 days

Performing Laboratory

LabCorp Burlington

Test Classification

This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary.

CPT Code Information

0003M

Or

82172

82247

82465

82947

82977

83010

83883

84450

84460

84478

LOINC Code Information

Test ID Test Order Name Order LOINC Value
FNSUR NASH FibroSure 48796-7

 

Result ID Test Result Name Result LOINC Value
Z4741 Fibrosis Score 48795-9
Z4742 Fibrosis Stage 48794-2
Z4743 Steatosis Score In Process
Z4744 Steatosis Grade In Process
Z4745 NASH Score 48792-6
Z4746 NASH Grade 48793-4
Z4747 Height (in inches): 3137-7
Z4748 Weight (in pounds): 3141-9
Z4749 Alpha 2-Macroglobulins, Qn 1835-8
Z4750 Haptoglobin 4542-7
Z4751 Apolipoprotein A-1 1869-7
Z4752 Bilirubin, Total 1975-2
Z4753 GGT 2324-2
Z4754 ALT (SGPT) P5P 1743-4
Z4755 AST (SGOT) P5P 30239-8
Z4756 Cholesterol, Total 2093-3
Z4757 Glucose, Serum 2345-7
Z4758 Triglycerides 2571-8
Z4759 Interpretations: In Process
Z4760 Fibrosis Scoring: In Process
Z4761 Steatosis Grading In Process
Z4762 NASH Scoring In Process
Z4763 Limitations: 8251-1
Z4764 Comment: 77202-0

Cautions

NASH FibroSure is recommended for patients with suspected nonalcoholic fatty liver disease. It is not recommended for patient with other liver diseases. It is also not recommended in patients with Gilbert disease, acute hemolysis, acute hepatitis, acute inflammation of the liver, autoimmune hepatitis, extrahepatic cholestasis, transplant patients, and/or renal insufficiency patients. Any of these clinical situations may lead to inaccurate quantitative predictions of fibrosis.