FIB-4 With Reflex to NASH FibroSure® Plus

CPT: 84450; 84460; 85049
Updated on 05/15/2024
Print Share

Synonyms

  • Fatty Liver Disease
  • Liver Fibrosis
  • MASH
  • MASLD
  • Metabolic Dysfunction-Associated Steatohepatitis
  • Metabolic Dysfunction-Associated Steatotic Liver Disease
  • NAFLD
  • NASH
  • Nonalcoholic Fatty Liver Disease
  • Steatohepatitis Cirrhosis
  • Fatty Liver Disease
  • Liver Fibrosis
  • NAFLD
  • NASH
  • Nonalcoholic Fatty Liver Disease
  • Noninvasive Liver Biopsy
  • Steatohepatitis Cirrhosis
  • Fatty Liver Disease
  • Liver Fibrosis
  • MASH
  • MASLD
  • Metabolic Dysfunction-Associated Steatohepatitis
  • Metabolic Dysfunction-Associated Steatotic Liver Disease
  • NAFLD
  • NASH
  • Nonalcoholic Fatty Liver Disease
  • Steatohepatitis Cirrhosis

Test Includes

Alanine aminotransferase (ALT/SGPT); aspartate aminotransferase (AST/SGOT); FIB-4 Index (by calculation); platelet count. If FIB-4 Index is >1.29, testing will reflex to NASH FibroSure® Plus, performed at an additional charge.


Special Instructions

The patient's age and gender must be submitted, but the patient's height and weight are not required for NASH FibroSure® Plus testing.



Related Documents


Specimen Requirements


Specimen

Serum and whole blood


Volume

Serum: 4 mL divided into two tubes, 0.5 mL for initial testing and 3.5 mL for possible reflex

Whole blood: tube filled to capacity


Minimum Volume

Serum: 3 mL divided into two tubes, 0.5 mL for initial testing and 2.5 mL for possible reflex

Whole blood: tube filled to capacity


Container

Gel-barrier tube or red-top tube and lavender-top (EDTA) tube


Collection

Serum: Separate from cells within 45 minutes of collection.

Whole blood: Invert EDTA tube immediately 8 to 10 times once tube is filled at the time of collection.


Storage Instructions

Serum sample for initial testing and whole blood can be stored room temperature. Serum sample for possible reflex can be stored refrigerated a 2°C to 8°C for 72 hours.


Stability Requirements

Temperature

Period

Room temperature

Serum: 7 days; Whole blood: 1 day

Refrigerated

Serum: 14 days; Whole blood: 3 days

Frozen

Unstable

Freeze/thaw cycles

Unstable


Patient Preparation

Patient should be fasting for at least eight hours.


Causes for Rejection

Serum: Gross hemolysis; gross lipemia; improper labeling; nonfasting specimen; patient younger than 14 years of age

Whole blood: Hemolysis; clotted specimen; tube not filled with minimum volume; improper labeling; transfer tubes with whole blood; specimen diluted or contaminated with IV fluid; specimen received with plasma removed; specimen collected in any anticoagulant other than EDTA


Test Details


Use

FIB-4 index is reported to be a simple, accurate, non-invasive and readily available laboratory test index that can help in evaluation of patients with HCV and Non-Alcoholic Fatty Liver Disease (NAFLD), now known as metabolic dysfunction-associated steatotic liver disease (MASLD), for the presence of liver fibrosis indication for liver biopsy, and other liver-related complications.

FIB-4 index is reported to be a simple, accurate, non-invasive, and readily available laboratory test index that can help in evaluation of patients with HCV and Non-Alcoholic Fatty Liver Disease (NAFLD) for the presence of liver fibrosis indication for liver biopsy, and other liver-related complications.

FIB-4 index is reported to be a simple, accurate, non-invasive and readily available laboratory test index that can help in evaluation of patients with HCV and Non-Alcoholic Fatty Liver Disease (NAFLD), now known as metabolic dysfunction-associated steatotic liver disease (MASLD), for the presence of liver fibrosis indication for liver biopsy, and other liver-related complications.


Limitations

Clumping may cause false low platelet count. Platelet satellitism around neutrophils will cause a pseudothrombocytopenia. RBC or WBC fragments including fragmented fragile leukemic cells and neutrophil pseudoplatelets may cause falsely elevated counts. NASH FibroSure® Plus is recommended for patients with suspected nonalcoholic fatty liver disease, now known as metabolic dysfunction-associated steatotic liver disease (MASLD). It is not recommended for patients 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.

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.

Clumping may cause false low platelet count. Platelet satellitism around neutrophils will cause a pseudothrombocytopenia. RBC or WBC fragments including fragmented fragile leukemic cells and neutrophil pseudoplatelets may cause falsely elevated counts. NASH FibroSure® Plus is recommended for patients with suspected nonalcoholic fatty liver disease. It is not recommended for patients 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.

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.

Clumping may cause false low platelet count. Platelet satellitism around neutrophils will cause a pseudothrombocytopenia. RBC or WBC fragments including fragmented fragile leukemic cells and neutrophil pseudoplatelets may cause falsely elevated counts. NASH FibroSure® Plus is recommended for patients with suspected nonalcoholic fatty liver disease, now known as metabolic dysfunction-associated steatotic liver disease (MASLD). It is not recommended for patients 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.

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.


Methodology

See individual test components.


Additional Information

FIB-4 index is calculated first; if FIB-4 index value is between 0 and 1.29, testing stops; if FIB-4 index value is greater than 1.29, testing is reflexed to NASH FibroSure® Plus at an additional cost.

NASH FibroSure® Plus 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 and gender 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<0.41) precludes the diagnosis of NASH, now known as metabolic dysfunction-associated steatohepatitis (MASH).

The FIB-4 index value is calculated using the 4 parameters formula: FIB-4 = [Age(Years) x AST(IU/L)]/[Platelets(10E3/L) x ALT^.5 (IU/L)]


References

Angulo P, Bugianesi E, Bjornsson ES, et al. Simple noninvasive systems predict long-term outcomes of patients with nonalcoholic fatty liver disease. Gastroenterology. 2013 Oct;145(4):782-789.e4.23860502
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 Hepatol. 2018 May;30(5):569-577.29406435
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 Hepatol. 2019 Mar;31(3):393-402.30516570
Ratziu V, Massard J, Charlotte F, et al. Diagnostic value of biochemical markers (FibroTest-FibroSURE) for the prediction of liver fibrosis in patients with non-alcoholic fatty liver disease. BMC Gastroenterol. 2006 Feb 14;6:6.16503961
Shah AG, Lydecker A, Murray K, et al. Comparison of noninvasive markers of fibrosis in patients with nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2009 Oct;7(10):1104-1112.19523535
Vallet-Pichard A, Mallet V, Nalpas B, et al. FIB-4: an inexpensive and accurate marker of liver fibrosis in HCV infection. Comparison with liver biopsy and fibrotest. Hepatology. 2007 Jul;46(1):32-36.17567829

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
402146 FIB-4 w/Rx NASH FibroSure Plus 001123 AST (SGOT) IU/L 1920-8
402146 FIB-4 w/Rx NASH FibroSure Plus 001545 ALT (SGPT) IU/L 1742-6
402146 FIB-4 w/Rx NASH FibroSure Plus 015172 Platelets x10E3/uL 777-3
402146 FIB-4 w/Rx NASH FibroSure Plus 011582 FIB-4 Index N/A
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550963 Fibrosis Score 48795-9
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550964 Fibrosis Stage 48794-2
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550965 Steatosis Score 93695-5
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550966 Steatosis Grade 93696-3
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550967 NASH Score 93692-2
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550968 NASH Grade 93693-0
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550398 Methodology: 62364-5
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 122137 Alpha 2-Macroglobulins, Qn mg/dL 1835-8
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 001629 Haptoglobin mg/dL 4542-7
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 016874 Apolipoprotein A-1 mg/dL 1869-7
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 001100 Bilirubin, Total mg/dL 1975-2
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 001960 GGT IU/L 2324-2
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 001547 ALT (SGPT) P5P IU/L 1743-4
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 001125 AST (SGOT) P5P IU/L 30239-8
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 001067 Cholesterol, Total mg/dL 2093-3
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 001036 Glucose, Serum mg/dL 2345-7
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 001175 Triglycerides mg/dL 2571-8
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550969 Interpretations: 93694-8
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550107 Fibrosis Scoring: N/A
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550971 Steatosis Scoring N/A
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550972 NASH Scoring N/A
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550973 Limitations: 62364-5
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 550974 Comment: 8251-1
Reflex Table for FIB-4 Index
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 550960 NASH FibroSure(R) Plus 123099 Comment: 77202-0

For Providers

Please login to order a test

Order a Test

© 2021 Laboratory Corporation of America® Holdings and Lexi-Comp Inc. All Rights Reserved.

CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf