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Test Code BLOD0979 MISC LAB (MAYO) NASH FibroSure

Additional Codes

Mayo Test Code: 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

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.

Day(s) and Time(s) Performed

Monday through Friday

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