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23294 NASH FibroSURE (550140)

NASH FibroSURE (550140)
Test Code: NASHSO
Synonyms/Keywords

Fatty Liver Disease, NAFLD, Nonalcoholic Fatty Liver Disease, Noninvasive Liver Biopsy, Steatohepatitis

Test Components
a2-macroglobulin, haptoglobin, apolipoprotein A1, bilirubin, y-glutamyl transpeptidase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol, triglycerides, and fasting glucose​
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.
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
Minimum of 8 hours​ Serum​ ​Red Top Tube (RTT) ​Serum Separator Tube (SST)
3.5 mL
 
 2 mL
​
 ​
Collection Processing Instructions

Patient should be fasting for at least eight hours. 

REQUIRED:  The patient's age, gender, height, and weight at the time of collection must be submitted.

Separate serum from cells within two hours of collection. Specimen can be stored refrigerated at 2°C to 8°C for 72 hours and frozen at -70°C for seven days.  Frozen samples are stable for one freeze/thaw cycle.   ​

Specimen Stability Information
Specimen Type Temperature Time
​Serum ​ ​ ​Refrigerate ​72 hours
​Frozen at -70°C​7 days

 

Rejection Criteria
Gross Hemolysis
​Gross Lipemia
Non-fasting Specimen​
​Patient younger than 14 years of age
Interference

​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.

Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
LabCorp of America​ ​Testing schedule may vary.  3-6 days​ 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.
Reference Lab
LabCorp of America
Test Information

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.​

Reference Range Information
Performing Location Reference Range
LabCorp of America​ Interpretive report​
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
83883​ ​ ​1 ​Nephelometry ​
​83010 ​ ​1 ​Haptoglobin ​
​82172 ​ ​1 ​Apolipoprotein ​
​82247 ​ ​1 ​Bilirubin Total ​
84460​ ​ ​1 ​ALT ​
​82465 ​ ​1 ​Cholesterol ​
​84478 ​ ​1 ​Triglyceride ​
​82947 ​ ​1 ​Glucose ​
​84450 ​ ​1 AST​ ​
​82977 ​ ​1 ​GGT ​
Synonyms/Keywords

Fatty Liver Disease, NAFLD, Nonalcoholic Fatty Liver Disease, Noninvasive Liver Biopsy, Steatohepatitis

Test Components
a2-macroglobulin, haptoglobin, apolipoprotein A1, bilirubin, y-glutamyl transpeptidase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol, triglycerides, and fasting glucose​
Ordering Applications
Ordering Application Description
​Centricity ​NASH FibroSURE
​Cerner ​None
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
Minimum of 8 hours​ Serum​ ​Red Top Tube (RTT) ​Serum Separator Tube (SST)
3.5 mL
 
 2 mL
​
 ​
Collection Processing

Patient should be fasting for at least eight hours. 

REQUIRED:  The patient's age, gender, height, and weight at the time of collection must be submitted.

Separate serum from cells within two hours of collection. Specimen can be stored refrigerated at 2°C to 8°C for 72 hours and frozen at -70°C for seven days.  Frozen samples are stable for one freeze/thaw cycle.   ​

Specimen Stability Information
Specimen Type Temperature Time
​Serum ​ ​ ​Refrigerate ​72 hours
​Frozen at -70°C​7 days

 

Rejection Criteria
Gross Hemolysis
​Gross Lipemia
Non-fasting Specimen​
​Patient younger than 14 years of age
Interference

​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.

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.
Test Components
a2-macroglobulin, haptoglobin, apolipoprotein A1, bilirubin, y-glutamyl transpeptidase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol, triglycerides, and fasting glucose​
Reference Range Information
Performing Location Reference Range
LabCorp of America​ Interpretive report​
For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
LabCorp of America​ ​Testing schedule may vary.  3-6 days​ 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.
Reference Lab
LabCorp of America
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
83883​ ​ ​1 ​Nephelometry ​
​83010 ​ ​1 ​Haptoglobin ​
​82172 ​ ​1 ​Apolipoprotein ​
​82247 ​ ​1 ​Bilirubin Total ​
84460​ ​ ​1 ​ALT ​
​82465 ​ ​1 ​Cholesterol ​
​84478 ​ ​1 ​Triglyceride ​
​82947 ​ ​1 ​Glucose ​
​84450 ​ ​1 AST​ ​
​82977 ​ ​1 ​GGT ​
For most current information refer to the Marshfield Laboratory online reference manual.